Okpo Health - Früherkennung bei Prostatakrebs ?
| eröffnet am: | 13.02.14 19:16 von: | Spaetschicht |
| neuester Beitrag: | 25.04.21 02:34 von: | Kristinvpuka |
| Anzahl Beiträge: | 624 | |
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29.03.14 16:15
#27
Spaetschicht
Opko
Warum 2014 ein großes Jahr für Opko sein wird... Stelle mal die Google übersetzung rein.
http://www.fool.com/investing/general/2014/03/28/...ear-for-opko.aspx
Philip Frost war noch nie schüchtern über die Sicherung seiner Investitionen. Frost, der ehemalige Gründer von IVAX , und Vorsitzender des generischen Schwergewicht Teva Pharmaceuticals , hat große Beteiligungen an einer Reihe von aufstrebenden Gesundheitsunternehmen. Doch aus all seinen Investitionen, er ist wahrscheinlich gerade Opko Health ( NYSE: OPK ) am nächsten.
Frost hat eine wirklich massiven Beteiligung an Opko, die fast 140 Millionen Aktien, von denen 398.000 wurden im März gekauft haben, beträgt laut SEC eingereichten Unterlagen. Das bedeutet, dass Frost besitzt etwa 40% der Opko Lager. Da Frost hat einen solchen ins Auge fallenden Anteil an Opko angehäuft, lassen Sie uns einen Blick auf die Katalysatoren, die Opko-Aktien bewegen kann dieses Jahr, einschließlich der Tesaro ( NASDAQ: TSRO ) Potenzial FDA Einreichung
Zuerst ein wenig Hintergrund
Frost ist kein Neuling, wenn es um den Aufbau erfolgreicher Unternehmen kommt. Seine Erfolgsbilanz umfasst Gründungs Ivax im Jahr 1987 und dem Verkauf an Teva für 7 Milliarden Dollar im Jahr 2006. Frost gebaut Ivax in ein generisches Kraftwerk durch Ausführen einer Reihe von Akquisitionen, und es scheint, dass er die Ausführung eine ähnliche Strategie mit Opko, die Beteiligungen an gefunden hat - in den letzten Jahren eine Vielzahl von faszinierenden jungen Unternehmen - oder erworben.
Im vergangenen Jahr erwarb Opko Cytochroma seine Hände auf Cytochroma Prohormon Vitamin D bekommen, und PROLOR Biotech, Lock-up-Technologie, die Prohormone macht länger, so dass die Patienten benötigen weniger Dosen. Diese Technologie wurde bereits gestellt, auf einem langwirkenden Faktor-VIIa-Behandlung für Hämophilie, die kürzlich von der FDA Orphan-Drug-Arbeit ausgezeichnet wurde.
Opko hat auch eine Beteiligung an winzigen Arno Therapeutics , die Opko das Recht gibt, schließlich erwerben, und Cokristalls , ein Unternehmen, das Hepatitis-C-Therapien arbeiten ist. Im Januar, half Frost orchestrieren die Fusion von Biozone , einem Unternehmen, in dem Opko hatte zuvor eine 12%-Beteiligung, mit Cokristalls. Dieser Deal verriegelt effektiv die Kontrolle über Biozone die Technologie zur Verbesserung der Therapien, wie aktuell und OTC-Produkte werden über die Haut aufgenommen.
Zusätzlich hat Opko eine Beteiligung an Tesaro, der Firma, Opko Anti-Drogen-Rolapitant Übelkeit und eine 19% Beteiligung an Unternehmen lizenziert sRNA RXi Pharmaceuticals, die Opko im Austausch für alle Opko der RNAi-Technologie erhielt März 2013.
Konvertieren von Produkten in die Gewinn
Opko war ein Schlag im Dezember behandelt, wenn Tesaro berichtet, dass Rolapitant versäumt, einen sekundären Endpunkt in Studien erfüllen. , Die gestrichelten Anleger Hoffnungen für einen Slam Dunk auf die beiden Studien "primären und sekundären Endpunkte, Senden Aktien sowohl in Opko und Tesaro Kokons. Allerdings Rolapitant hat erfolgreich bei der Erreichung ihrer primären Endpunkt zur Reduzierung Erbrechen, und das hat Tesaro auf Kurs, um die FDA-Zulassung für die Datei später in diesem Jahr. Falls genehmigt, wird eine Meilensteinzahlung Opko sammeln, sowie zweistellige Lizenzgebühren auf den Umsatz.
Opko ist auch in den Prozess der Einführung seiner 4kscore Test. Dieser Test bietet Ärzten eine neue Prostatakrebs-Screening-Tool, das die Zahl der unnötigen Biopsien zu falsch positiven PSA-Tests gebunden verringern kann. Opko werden diese Tests im eigenen Labor durchzuführen, und schließlich plant, den Test als Teil eines Point-of-Care-Lösung für Arztpraxen bieten.
Zusätzlich zu diesen beiden Entwicklungen erwartet Opko noch in diesem Jahr, wie ihre Vitamin-D-Drogen Rayaldy, in der Cytochroma Deals erworben, in der Phase 3 durchgeführt melden. Das hat eine Studie geplanten Fertigstellung Datum Juni 2014.
Narr-würdig abschließende Gedanken
wird viel los bei Opko in diesem Jahr, dass die Investoren benötigen, um zu verfolgen. Investoren werden eine frühe Lese in den nächsten Quartalen in die Nachfrage nach dem 4kscore Prostata-Test zu erhalten, sollten Tesaro Datei für Rolapitant Genehmigung zu sehen, und lernen, wie Rayaldy in Studien habe, auch. Wenn Rayaldy die Ergebnisse günstig sind, plant Opko für die FDA-Zulassung im Jahr 2015 einzureichen. Wenn ja, würde das bedeuten könnte Rayaldy beitragen Bedeutung mit Opko im Jahr 2016 beginnen.
Opko könnte eine (oder mehrere) dieser Produkte verwenden, um pan out, weil es durch Cash-Brennen. Das Unternehmen verlassen letzten Quartal 185 Millionen Dollar in bar, aber die Kosten beliefen 176.000.000 $ im letzten Jahr. Das handlich seine Schatten gestellt 96.000.000 $ Umsatz, und schlägt vor, dass die Anleger immer noch als eine spekulative Opko Spiel, wenn auch ein faszinierend.
http://www.fool.com/investing/general/2014/03/28/...ear-for-opko.aspx
Philip Frost war noch nie schüchtern über die Sicherung seiner Investitionen. Frost, der ehemalige Gründer von IVAX , und Vorsitzender des generischen Schwergewicht Teva Pharmaceuticals , hat große Beteiligungen an einer Reihe von aufstrebenden Gesundheitsunternehmen. Doch aus all seinen Investitionen, er ist wahrscheinlich gerade Opko Health ( NYSE: OPK ) am nächsten.
Frost hat eine wirklich massiven Beteiligung an Opko, die fast 140 Millionen Aktien, von denen 398.000 wurden im März gekauft haben, beträgt laut SEC eingereichten Unterlagen. Das bedeutet, dass Frost besitzt etwa 40% der Opko Lager. Da Frost hat einen solchen ins Auge fallenden Anteil an Opko angehäuft, lassen Sie uns einen Blick auf die Katalysatoren, die Opko-Aktien bewegen kann dieses Jahr, einschließlich der Tesaro ( NASDAQ: TSRO ) Potenzial FDA Einreichung
Zuerst ein wenig Hintergrund
Frost ist kein Neuling, wenn es um den Aufbau erfolgreicher Unternehmen kommt. Seine Erfolgsbilanz umfasst Gründungs Ivax im Jahr 1987 und dem Verkauf an Teva für 7 Milliarden Dollar im Jahr 2006. Frost gebaut Ivax in ein generisches Kraftwerk durch Ausführen einer Reihe von Akquisitionen, und es scheint, dass er die Ausführung eine ähnliche Strategie mit Opko, die Beteiligungen an gefunden hat - in den letzten Jahren eine Vielzahl von faszinierenden jungen Unternehmen - oder erworben.
Im vergangenen Jahr erwarb Opko Cytochroma seine Hände auf Cytochroma Prohormon Vitamin D bekommen, und PROLOR Biotech, Lock-up-Technologie, die Prohormone macht länger, so dass die Patienten benötigen weniger Dosen. Diese Technologie wurde bereits gestellt, auf einem langwirkenden Faktor-VIIa-Behandlung für Hämophilie, die kürzlich von der FDA Orphan-Drug-Arbeit ausgezeichnet wurde.
Opko hat auch eine Beteiligung an winzigen Arno Therapeutics , die Opko das Recht gibt, schließlich erwerben, und Cokristalls , ein Unternehmen, das Hepatitis-C-Therapien arbeiten ist. Im Januar, half Frost orchestrieren die Fusion von Biozone , einem Unternehmen, in dem Opko hatte zuvor eine 12%-Beteiligung, mit Cokristalls. Dieser Deal verriegelt effektiv die Kontrolle über Biozone die Technologie zur Verbesserung der Therapien, wie aktuell und OTC-Produkte werden über die Haut aufgenommen.
Zusätzlich hat Opko eine Beteiligung an Tesaro, der Firma, Opko Anti-Drogen-Rolapitant Übelkeit und eine 19% Beteiligung an Unternehmen lizenziert sRNA RXi Pharmaceuticals, die Opko im Austausch für alle Opko der RNAi-Technologie erhielt März 2013.
Konvertieren von Produkten in die Gewinn
Opko war ein Schlag im Dezember behandelt, wenn Tesaro berichtet, dass Rolapitant versäumt, einen sekundären Endpunkt in Studien erfüllen. , Die gestrichelten Anleger Hoffnungen für einen Slam Dunk auf die beiden Studien "primären und sekundären Endpunkte, Senden Aktien sowohl in Opko und Tesaro Kokons. Allerdings Rolapitant hat erfolgreich bei der Erreichung ihrer primären Endpunkt zur Reduzierung Erbrechen, und das hat Tesaro auf Kurs, um die FDA-Zulassung für die Datei später in diesem Jahr. Falls genehmigt, wird eine Meilensteinzahlung Opko sammeln, sowie zweistellige Lizenzgebühren auf den Umsatz.
Opko ist auch in den Prozess der Einführung seiner 4kscore Test. Dieser Test bietet Ärzten eine neue Prostatakrebs-Screening-Tool, das die Zahl der unnötigen Biopsien zu falsch positiven PSA-Tests gebunden verringern kann. Opko werden diese Tests im eigenen Labor durchzuführen, und schließlich plant, den Test als Teil eines Point-of-Care-Lösung für Arztpraxen bieten.
Zusätzlich zu diesen beiden Entwicklungen erwartet Opko noch in diesem Jahr, wie ihre Vitamin-D-Drogen Rayaldy, in der Cytochroma Deals erworben, in der Phase 3 durchgeführt melden. Das hat eine Studie geplanten Fertigstellung Datum Juni 2014.
Narr-würdig abschließende Gedanken
wird viel los bei Opko in diesem Jahr, dass die Investoren benötigen, um zu verfolgen. Investoren werden eine frühe Lese in den nächsten Quartalen in die Nachfrage nach dem 4kscore Prostata-Test zu erhalten, sollten Tesaro Datei für Rolapitant Genehmigung zu sehen, und lernen, wie Rayaldy in Studien habe, auch. Wenn Rayaldy die Ergebnisse günstig sind, plant Opko für die FDA-Zulassung im Jahr 2015 einzureichen. Wenn ja, würde das bedeuten könnte Rayaldy beitragen Bedeutung mit Opko im Jahr 2016 beginnen.
Opko könnte eine (oder mehrere) dieser Produkte verwenden, um pan out, weil es durch Cash-Brennen. Das Unternehmen verlassen letzten Quartal 185 Millionen Dollar in bar, aber die Kosten beliefen 176.000.000 $ im letzten Jahr. Das handlich seine Schatten gestellt 96.000.000 $ Umsatz, und schlägt vor, dass die Anleger immer noch als eine spekulative Opko Spiel, wenn auch ein faszinierend.
31.03.14 18:38
#28
Spaetschicht
Es geht los
OPKO Announces Launch of 4Kscore Test for Prostate Cancer
“We believe the 4Kscore TestTM will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs”
http://www.businesswire.com/news/home/...Prostate-Cancer#.UzmZT_l_teo
March 31, 2014 11:29 AM Eastern Daylight Time
MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) announced the availability of the 4KscoreTM Test through its CLIA-accredited OPKO Lab in Nashville, TN. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the United States, leads to approximately 1 million biopsies being performed annually, with 80% of the results indicating no cancer or a low-grade cancer. The 4KscoreTM Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.
The 4KscoreTM Test was developed by OPKO Lab, a division of OPKO Health, and tested in collaboration with 26 Urology centers across the United States from October 2013 to March 2014. Results showed that the 4Kscore TestTM was highly accurate for predicting the presence of high-grade cancer (Gleason score 7 or higher) prior to prostate biopsy. The full data from the blinded, prospective U.S. clinical validation study will be presented at the AUA Annual Meeting in Orlando, FL on May 18th at Plenary Session I.
“We are pleased to offer the 4Kscore TestTM at OPKO Lab to provide Urologists with new information to inform them of the risk of a patient’s having high-grade prostate cancer and help clarify the decision process surrounding prostate biopsy,” said David Okrongly, President of OPKO Diagnostics.
“We believe the 4Kscore TestTM will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs,” said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.
About the 4Kscore™ Test
The 4Kscore™ Test measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient's age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The 4Kscore Test TM was developed by OPKO Lab, a division of OPKO Health, Inc., and will be performed at OPKO Lab’s CLIA-accredited facility in Nashville, Tennessee. The four kallikrein panel of biomarkers utilized in the test is based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading European institutions. The information provided by the 4Kscore TestTM can add new information to the shared decision making discussion between a Urologist and patient in determining the advisability of a prostate biopsy.
About Prostate Cancer
In 2014, over 233,000 new cases of prostate cancer will be identified and 29,480 men will die from the disease according to estimates released by the National Cancer Institute, making it the second most deadly cancer in U.S. men. Prostate cancer is usually first detected by elevations in serum PSA. However, PSA level is often elevated for reasons unrelated to prostate cancer. Although an elevated PSA level often leads to biopsy, about 80% of all prostate biopsies performed are either negative or indicate a low likelihood of high-grade cancer.
ABOUT OPKO HEALTH, INC.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the 4Kscore™, whether the 4Kscore™ will be an important tool in the fight against prostate cancer and help reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer, whether it will accurately predict high-grade cancers, whether the full data will be presented at AUA, whether the test will clarify the decision making process surrounding prostate biopsy, whether OPKO successfully launch and commercialize the 4Kscore™, the market for and expected sales of 4Kscore™, whether the test will be an important benefit for Urologists and their patients and will lead to lower overall healthcare costs, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
“We believe the 4Kscore TestTM will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs”
http://www.businesswire.com/news/home/...Prostate-Cancer#.UzmZT_l_teo
March 31, 2014 11:29 AM Eastern Daylight Time
MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) announced the availability of the 4KscoreTM Test through its CLIA-accredited OPKO Lab in Nashville, TN. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the United States, leads to approximately 1 million biopsies being performed annually, with 80% of the results indicating no cancer or a low-grade cancer. The 4KscoreTM Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.
The 4KscoreTM Test was developed by OPKO Lab, a division of OPKO Health, and tested in collaboration with 26 Urology centers across the United States from October 2013 to March 2014. Results showed that the 4Kscore TestTM was highly accurate for predicting the presence of high-grade cancer (Gleason score 7 or higher) prior to prostate biopsy. The full data from the blinded, prospective U.S. clinical validation study will be presented at the AUA Annual Meeting in Orlando, FL on May 18th at Plenary Session I.
“We are pleased to offer the 4Kscore TestTM at OPKO Lab to provide Urologists with new information to inform them of the risk of a patient’s having high-grade prostate cancer and help clarify the decision process surrounding prostate biopsy,” said David Okrongly, President of OPKO Diagnostics.
“We believe the 4Kscore TestTM will be an important benefit for Urologists and their patients and may lead to lower overall healthcare costs,” said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer.
About the 4Kscore™ Test
The 4Kscore™ Test measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient's age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The 4Kscore Test TM was developed by OPKO Lab, a division of OPKO Health, Inc., and will be performed at OPKO Lab’s CLIA-accredited facility in Nashville, Tennessee. The four kallikrein panel of biomarkers utilized in the test is based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading European institutions. The information provided by the 4Kscore TestTM can add new information to the shared decision making discussion between a Urologist and patient in determining the advisability of a prostate biopsy.
About Prostate Cancer
In 2014, over 233,000 new cases of prostate cancer will be identified and 29,480 men will die from the disease according to estimates released by the National Cancer Institute, making it the second most deadly cancer in U.S. men. Prostate cancer is usually first detected by elevations in serum PSA. However, PSA level is often elevated for reasons unrelated to prostate cancer. Although an elevated PSA level often leads to biopsy, about 80% of all prostate biopsies performed are either negative or indicate a low likelihood of high-grade cancer.
ABOUT OPKO HEALTH, INC.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the 4Kscore™, whether the 4Kscore™ will be an important tool in the fight against prostate cancer and help reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer, whether it will accurately predict high-grade cancers, whether the full data will be presented at AUA, whether the test will clarify the decision making process surrounding prostate biopsy, whether OPKO successfully launch and commercialize the 4Kscore™, the market for and expected sales of 4Kscore™, whether the test will be an important benefit for Urologists and their patients and will lead to lower overall healthcare costs, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
31.03.14 18:59
#29
Spaetschicht
Opko Health Company Profile (NYSE:OPK)
Die gesammelten Trades von Herrn Frost am Freitag kamen noch mal 37.700 dazu
http://www.analystratings.net/stocks/NYSE/OPK/...p;DefaultTab=Insider
http://www.analystratings.net/stocks/NYSE/OPK/...p;DefaultTab=Insider
01.04.14 16:51
#30
Spaetschicht
Google übersetzung
Bis vor kurzem war der Test für Prostatakrebs PSA ein üblicher Teil des Lebens eines jeden Mannes mittleren Alters gewesen. Aber es Ungnade gefallen ist, als Ärzte erkannte der PSA führte viele Männer, unnötige und schmerzhafte Prostata-Biopsien und unnötigen Krebsbehandlungen haben.
Orginal
http://med.news.am/eng/news/1367/...ter-test-for-prostate-cancer.html
In der Tat haben großen medizinischen Gruppen gestoppt empfehle Routine PSA-Tests für die meisten Männer, Newsmax Gesundheit berichtet.
Aber jetzt eine bessere Prostatakrebstest hat sich zur Verfügung, um das Problem.
Es heißt die 4Kscore-Test. Statt der Prüfung nur für einen Biomarker für Prostatakrebs als der PSA-Test macht, die 4Kscore Tests für vier Biomarker und fügt ein Mann Alter, seine digitale rektale Untersuchung durch, und ob er eine vor Prostata-Biopsie, um mit hatten oder nicht sein punkten. Die Wahrscheinlichkeit 4Kscore ist ein Mann für mit lebensbedrohlichen Prostatakrebs, und ermöglicht ihren Ärzten, dies dem PSA und anderen klinischen Informationen hinzufügen, um abzuschätzen, ob eine Prostatabiopsie notwendig ist.
"Es wird sowohl den Urologen und den Patienten bessere Informationen, um eine fundierte Entscheidung über eine Prostata-Biopsie machen können", so David Okrongly, Präsident der OPKO Diagnostics, dem Hersteller der Test.
Orginal
http://med.news.am/eng/news/1367/...ter-test-for-prostate-cancer.html
In der Tat haben großen medizinischen Gruppen gestoppt empfehle Routine PSA-Tests für die meisten Männer, Newsmax Gesundheit berichtet.
Aber jetzt eine bessere Prostatakrebstest hat sich zur Verfügung, um das Problem.
Es heißt die 4Kscore-Test. Statt der Prüfung nur für einen Biomarker für Prostatakrebs als der PSA-Test macht, die 4Kscore Tests für vier Biomarker und fügt ein Mann Alter, seine digitale rektale Untersuchung durch, und ob er eine vor Prostata-Biopsie, um mit hatten oder nicht sein punkten. Die Wahrscheinlichkeit 4Kscore ist ein Mann für mit lebensbedrohlichen Prostatakrebs, und ermöglicht ihren Ärzten, dies dem PSA und anderen klinischen Informationen hinzufügen, um abzuschätzen, ob eine Prostatabiopsie notwendig ist.
"Es wird sowohl den Urologen und den Patienten bessere Informationen, um eine fundierte Entscheidung über eine Prostata-Biopsie machen können", so David Okrongly, Präsident der OPKO Diagnostics, dem Hersteller der Test.
01.04.14 21:24
#31
Spaetschicht
Opko
Health care stocks are outperforming
http://finance.yahoo.com/blogs/breakout/...-funtleyder-165416123.html
http://finance.yahoo.com/blogs/breakout/...-funtleyder-165416123.html
17.04.14 19:12
#32
Spaetschicht
OPKO Health (OPK) to Acquire Inspiro Medical
Opko erweitert die Produktpalette mit einem "intelligenen" Inhalator für Atemwegserkrankungen wie z. B Asthma
http://www.streetinsider.com/Corporate+News/...o+Medical/9389501.html
OPKO Health, Inc. (NYSE: OPK) has entered into a definitive agreement to acquire Inspiro Medical Ltd. (“Inspiro”), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists or larger molecules to treat respiratory diseases. Inspiro’s Inspiromatic™ is a “smart” easy-to-use dry powder inhaler with several advantages over existing devices.
Inspiromatic™ offers improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring. The device has an internal microcontroller and flow sensor that controls the delivery of the medication and, using micro-pump technology, dispenses the drug particles at the right speed without the need for forceful inhalation. It also provides instant feedback to the patient with a green or red flasher light to indicate proper inhalation and a beeper after the dose has been delivered. For physicians, Inspiromatic™ provides a built-in logger that stores patient use data for easy access and transmission by electronic devices such as smart phones.
In a recently completed, First In Man double blinded clinical study conducted in 30 asthmatic children comparing Inspiromatic™ to a market leading dry powder inhaler, Inspiromatic™ demonstrated superior pulmonary delivery of the active drug.
"We are pleased to add this next generation inhaler to OPKO’s growing product portfolio," stated Phillip Frost, M.D., OPKO’s CEO and Chairman. "We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases. We plan to use the Inspiromatic™ device to test the inhaled form of OPKO’s new sulfated disaccharide drug against these disorders. This drug product is still undergoing pre-clinical testing prior to submission of an IND, but animal data indicates safety and efficacy for both inhaled and orally delivered forms. Of course, we believe that Inspiromatic™ can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed. This acquisition fits our strategy of developing new products that address large markets in need of more effective therapeutic solutions."
Nimrod Kaufmann, CEO and Co-Founder of Inspiro, commented, “We are extremely proud of Inspiro’s success in bringing our smart Inspiromatic™ respiratory drug-delivery device to market. With Inspiro now a part of OPKO, we will be able to help more people faster. Inspiro joining OPKO is a big win for the shareholders of both Inspiro and OPKO, as well as good news for our patients and physicians."
Eran Feldhay, M.D., CEO of Trendlines Medical, Inspiro’s largest shareholder, added, “The acquisition of Inspiro is our third exit in eight months, all to U.S.-based multinational corporations. This success brings continuing confirmation of the strength of the Trendlines team in fulfilling our vision of creating and developing companies to improve the human condition. We are very pleased to see OPKO take the Inspiro opportunity forward.”
http://www.streetinsider.com/Corporate+News/...o+Medical/9389501.html
OPKO Health, Inc. (NYSE: OPK) has entered into a definitive agreement to acquire Inspiro Medical Ltd. (“Inspiro”), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists or larger molecules to treat respiratory diseases. Inspiro’s Inspiromatic™ is a “smart” easy-to-use dry powder inhaler with several advantages over existing devices.
Inspiromatic™ offers improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring. The device has an internal microcontroller and flow sensor that controls the delivery of the medication and, using micro-pump technology, dispenses the drug particles at the right speed without the need for forceful inhalation. It also provides instant feedback to the patient with a green or red flasher light to indicate proper inhalation and a beeper after the dose has been delivered. For physicians, Inspiromatic™ provides a built-in logger that stores patient use data for easy access and transmission by electronic devices such as smart phones.
In a recently completed, First In Man double blinded clinical study conducted in 30 asthmatic children comparing Inspiromatic™ to a market leading dry powder inhaler, Inspiromatic™ demonstrated superior pulmonary delivery of the active drug.
"We are pleased to add this next generation inhaler to OPKO’s growing product portfolio," stated Phillip Frost, M.D., OPKO’s CEO and Chairman. "We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases. We plan to use the Inspiromatic™ device to test the inhaled form of OPKO’s new sulfated disaccharide drug against these disorders. This drug product is still undergoing pre-clinical testing prior to submission of an IND, but animal data indicates safety and efficacy for both inhaled and orally delivered forms. Of course, we believe that Inspiromatic™ can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed. This acquisition fits our strategy of developing new products that address large markets in need of more effective therapeutic solutions."
Nimrod Kaufmann, CEO and Co-Founder of Inspiro, commented, “We are extremely proud of Inspiro’s success in bringing our smart Inspiromatic™ respiratory drug-delivery device to market. With Inspiro now a part of OPKO, we will be able to help more people faster. Inspiro joining OPKO is a big win for the shareholders of both Inspiro and OPKO, as well as good news for our patients and physicians."
Eran Feldhay, M.D., CEO of Trendlines Medical, Inspiro’s largest shareholder, added, “The acquisition of Inspiro is our third exit in eight months, all to U.S.-based multinational corporations. This success brings continuing confirmation of the strength of the Trendlines team in fulfilling our vision of creating and developing companies to improve the human condition. We are very pleased to see OPKO take the Inspiro opportunity forward.”
17.04.14 19:44
#33
Spaetschicht
Opko Health CEO
Zur Feier des Tage hat sich Dr. Frost noch mal für ne mille Shares gegönnt ;-)
Opko Health CEO Phillip Md Et Al Frost Acquires 129,800 Shares (OPK)
http://www.google.com/finance?q=NYSE%3AOPK&ei=ExJQU4jBIaWGwAOLGw
Opko Health (NYSE:OPK) CEO Phillip Md Et Al Frost purchased 129,800 shares of the stock in a transaction dated Tuesday, April 15th. The stock was purchased at an average cost of $8.04 per share, for a total transaction of $1,043,592.00. Following the completion of the purchase, the chief executive officer now directly owns 1,987,500 shares of the company’s stock, valued at approximately $15,979,500. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.
Opko Health CEO Phillip Md Et Al Frost Acquires 129,800 Shares (OPK)
http://www.google.com/finance?q=NYSE%3AOPK&ei=ExJQU4jBIaWGwAOLGw
Opko Health (NYSE:OPK) CEO Phillip Md Et Al Frost purchased 129,800 shares of the stock in a transaction dated Tuesday, April 15th. The stock was purchased at an average cost of $8.04 per share, for a total transaction of $1,043,592.00. Following the completion of the purchase, the chief executive officer now directly owns 1,987,500 shares of the company’s stock, valued at approximately $15,979,500. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.
17.04.14 19:47
#34
Spaetschicht
Sorry falscher link
http://tickerreport.com/banking-finance/189160/...-129800-shares-opk/
17.04.14 20:21
#35
Spaetschicht
Andere Quelle
Frost’s Opko buys Israeli medical device firm
http://www.bizjournals.com/southflorida/news/2014/...irm.html?ana=twt
Opko Health, led by billionaire entrepreneur Dr. Phillip Frost, acquired Israeli medical device company Inspiro Medical.
The Miami-based biotech and pharmaceutical company (NYSE: OPK) did not disclose the financial terms of the deal, although they will likely be revealed later in a Securities and Exchange Commission filing. Inspiro is developing a dry powder inhaler to deliver both small molecule drugs and larger molecules to treat respiratory diseases.
The pumps feature a green or red flashes of light to tell patients whether they have properly inhaled the medicine. It also stores patient data for transmission to their medical providers via smartphone.
Opko said a clinical trial of 30 asthmatic children showed that Inspiro’s device performed drug delivery better than a currently available inhaler.
"We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases,” Frost said in a news release. “We plan to use the Inspiromatic device to test the inhaled form of Opko’s new sulfated disaccharide drug against these disorders …. Of course, we believe that Inspiromatic can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed.”
Opko shares were down 26 cents, or 3 percent, to $8.07 on Thursday afternoon. The 52-week high was $12.95 on Oct. 16. The 52-week low was $6.14 on June 5.
http://www.bizjournals.com/southflorida/news/2014/...irm.html?ana=twt
Opko Health, led by billionaire entrepreneur Dr. Phillip Frost, acquired Israeli medical device company Inspiro Medical.
The Miami-based biotech and pharmaceutical company (NYSE: OPK) did not disclose the financial terms of the deal, although they will likely be revealed later in a Securities and Exchange Commission filing. Inspiro is developing a dry powder inhaler to deliver both small molecule drugs and larger molecules to treat respiratory diseases.
The pumps feature a green or red flashes of light to tell patients whether they have properly inhaled the medicine. It also stores patient data for transmission to their medical providers via smartphone.
Opko said a clinical trial of 30 asthmatic children showed that Inspiro’s device performed drug delivery better than a currently available inhaler.
"We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases,” Frost said in a news release. “We plan to use the Inspiromatic device to test the inhaled form of Opko’s new sulfated disaccharide drug against these disorders …. Of course, we believe that Inspiromatic can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed.”
Opko shares were down 26 cents, or 3 percent, to $8.07 on Thursday afternoon. The 52-week high was $12.95 on Oct. 16. The 52-week low was $6.14 on June 5.
06.05.14 18:30
#36
Spaetschicht
Biotech of the Week: Opko Health Inc.
Opko Health (NYSE: OPK ) is the biotech of the week for the Fool's biotech-focused show, Biotech Banter. Of course, "biotech" is a bit of a stretch with Opko, because it's working on both diagnostics and therapeutics.
http://www.fool.com/investing/general/2014/05/05/...o-health-inc.aspx
https://www.youtube.com/watch?v=UUwyvFU2Eeo
http://www.fool.com/investing/general/2014/05/05/...o-health-inc.aspx
https://www.youtube.com/watch?v=UUwyvFU2Eeo
06.05.14 18:36
#37
Spaetschicht
OPKO
OPKO Completes Patient Enrollment in Third Phase 3 Trial of RAYALDEE™
Rayalddee ist ein
Orginaltext:
http://www.marketwatch.com/story/...se-3-trial-of-rayaldee-2014-05-06
Übersetzung Google :
Diese Studie ist entworfen, um ein Produkt der langfristigen Sicherheit und Wirksamkeit bei der Behandlung von sekundärem Hyperparathyreoidismus (SHPT) bei Patienten mit Stadium 3 oder 4 chronischer Nierenerkrankung (CKD) und Vitamin-D-Mangel zu bewerten.
Diese dritte Phase-3-Studie ist ein 6-Monats-Open-Label-Verlängerung von zwei laufenden und identischen randomisierten, doppelblinden, Placebo-kontrollierte, Multi-Site-zulassungsrelevanten Phase-3-Studien für RAYALDEE soll die Marktzulassung unterstützen in den Vereinigten Staaten (US) . Gemeinsam sind die beiden Zulassungsstudien beinhalten ca. 430 Patienten rekrutiert bei etwa 90 US-Standorte, das sich in sechs Monaten Behandlung mit entweder RAYALDEE oder Placebo. Beide Studien werden im Juli 2014 und das Unternehmen erwartet, Top-Line-Daten, die während des dritten Quartals 2014 bekannt zu geben. In der Open-Label-Erweiterungsstudie, die Patienten entweder weiterhin RAYALDEE Behandlung oder wechseln Sie zu RAYALDEE von Placebo-Behandlung. Weitere Patienten werden dürfen, in der Open-Label-Erweiterungsstudie bis Juli einschreiben, wenn sie aus den Zulassungsstudien verblindet. Die Endpunkte aller drei Studien der Phase 3 sind Vitamin D-Status und Veränderungen der Plasma intakten Parathormon (PTH), Serum-Calcium-und Serumphosphor.
Kürzlich OPKO schloss zudem eine Studie zur Pharmakokinetik von RAYALDEE in etwa 50 gesunden US-Freiwilligen. Diese Studie, die entworfen, um die Wirkung von Nahrung auf die intestinale Resorption von RAYALDEE zu bewerten, ist die letzte klinische Studie (abgesehen von der oben genannten Phase-3-Studien) benötigt, um die bevorstehende New Drug Application (NDA) zu unterstützen. OPKO erwartet, dass ein NDA für RAYALDEE wird mit der US Food and Drug Administration im ersten Quartal 2015 eingereicht werden.
"Die Entwicklung verläuft RAYALDEE voll wie erwartet: im Zeitplan und im Budget", sagte Phillip Frost, MD, CEO und Chairman von OPKO. "Wir glauben, dass unsere proprietäre First-in-Class-Vitamin-D-Produkt wird eine wertvolle neue Behandlung für chronische Patienten mit Nierenerkrankungen, und wir freuen uns auf die Berichterstattung endgültigen Daten aus den laufenden klinischen Studien prompt."
Über RAYALDEE
RAYALDEE ist ein First-in-Class-oralen Vitamin-D-Prohormon-Behandlung, die für SHPT bei Patienten mit Stadium 3 oder 4 CKD-und Vitamin-D-Insuffizienz entwickelt. Es verfügt über eine proprietäre Formulierung mit veränderter Wirkstofffreisetzung zur Serum-Gesamt-25-Hydroxy-Vitamin D (Prohormon)-Konzentrationen, um gezielte Ebenen (mindestens 30 ng / ml) nach und nach und zuverlässig zu erhöhen, während die Vermeidung von Hochregulation von CYP24, eines Cytochrom-P-450-Enzym, das reduziert PTH-senkende Potenz der aktuellen Vitamin-D-Präparate. Aktivierung calcifediol, wird der Wirkstoff in RAYALDEE, von der Niere stark reguliert und so eine übermäßige Erhöhung der Serum-Calcium-und damit verbundenen Nebenwirkungen, die den Wert der aktuellen Vitamin D-Therapien durch die Förderung der vaskulären und renalen Kalzifikation begrenzen. RAYALDEE wird erwartet, dass die rund 4 Millionen Patienten in den USA anzugehen, und viele mehr an anderer Stelle, im Stadium 3 oder 4 CKD, sHPT und Vitamin-D-Mangel.
Über chronische Nierenerkrankung
CKD ist eine Erkrankung, die durch eine fortschreitende Abnahme der Nierenfunktion. Die Niere ist normalerweise verantwortlich für die Ausscheidung von Abfall und überschüssiges Wasser aus dem Körper, und für die Regelung verschiedener Hormone. Mild (Stufe 1) bis schwer (Stufe 5) Krankheit - - CKD wird in fünf verschiedene Stufen eingeteilt, wie die Niere die glomeruläre Filtrationsrate gemessen. Nach Angaben der National Kidney Foundation, CKD leiden über 26 Millionen Menschen in den USA, darunter mehr als acht Millionen (4 Stufen 3 oder) der Patienten mit mittelschwerer und schwerer (Stufe 5) Formen von CKD. In Stufe 5 CKD ist die Nierenfunktion minimal fernzubleiben und Patienten erfordern regelmäßige Dialyse oder eine Nierentransplantation für das Überleben.
Über Vitamin D-Insuffizienz
Vitamin-D-Insuffizienz ist ein Zustand, in dem der Körper niedrige Vitamin D-Shops, gekennzeichnet durch unzureichende Blutspiegel von Vitamin-D-Prohormon, wie 25-Hydroxy-Vitamin D. Schätzungsweise 70-90% der CKD-Patienten Vitamin-D-Insuffizienz, die führen können, haben bekannt zu SHPT und daraus resultierende schwächenden Knochenerkrankungen.
Über Sekundärer Hyperparathyreoidismus (SHPT)
SHPT ist ein Zustand, häufig mit CKD, in denen die Nebenschilddrüsen sezernieren große Mengen an PTH. SHPT entsteht als Folge von Vitamin-D-Insuffizienz oder eingeschränkter Nierenfunktion, die ausreichende Produktion von Vitamin D-Hormon verhindert, um richtig zu regulieren Kalzium-und Phosphorstoffwechsels und der PTH-Sekretion. Verlängerte Erhöhung des Blut PTH verursacht übermäßige Calcium und Phosphor aus Knochen freigesetzt werden, was zu erhöhten Serum-Calcium und Phosphor, Knochenerweichung (Osteomalazie) und vaskulärer Verkalkung und Nierengewebe. SHPT betrifft 40-60% der Patienten mit moderater CKD und etwa 90% der Patienten mit schwerer CKD.
Über OPKO
OPKO ist ein multinationales biopharmazeutisches und Diagnostik-Unternehmen, die führenden Positionen in großen, schnell wachsenden Märkten durch den Einsatz ihrer Entdeckung, Entwicklung und Vermarktung Know-how und neue und proprietäre Technologien zu etablieren sucht.
Diese Pressemitteilung enthält "zukunftsgerichtete Aussagen", wie dieser Begriff nach dem Private Securities Litigation Reform Act von 1995 (PSLRA) definiert ist, in Bezug auf Produktentwicklung und andere nicht-historische Fakten über unseren Erwartungen, Überzeugungen oder Absichten für unser Geschäft, Technologien und Produkte, die finanzielle Lage, Strategien und Aussichten, einschließlich Aussagen über unsere Fähigkeit, erfolgreich zu starten und Vermarktung proprietärer Produkte Nierenerkrankung, Erwartungen über RAYALDEE, das Marktpotenzial, dass es die rund 4 Millionen Patienten in den USA, und viele mehr ansprechen an anderer Stelle, mit der Stufe 3 oder 4 CKD, sHPT und Vitamin-D-Insuffizienz, dass RAYALDEE wird eine wertvolle neue Behandlung für Patienten mit chronischer Niereninsuffizienz, die erwartete Zeitpunkt für Abschluss unserer klinischen Studien für RAYALDEE, Ankündigung von Top-Line-Ergebnisse, und die Vorlage eines sein NDA, ob die Studien für RAYALDEE wird weiterhin im Zeitplan und im Budget zu gelangen, und dass wir in der Lage, erfolgreich zu entwickeln, zu erhalten Zulassung für und Vertrieb von RAYALDEE.Many starten Faktoren können dazu führen, unsere tatsächlichen Aktivitäten oder Ergebnisse wesentlich von der unterscheiden Aktivitäten und Ergebnisse in den zukunftsgerichteten Aussagen abweichen. Diese Faktoren schließen diejenigen ein, in unseren Einreichungen bei der Securities and Exchange Commission, sowie Risiken, die bei der Finanzierung beschrieben, die Entwicklung und den Erhalt der behördlichen Genehmigungen für neue, marktfähige und wettbewerbsfähige Produkte und Behandlungen, einschließlich der Risiken, dass die klinischen Phase-3-Studien für RAYALDEE kann nicht erfolgreich sein, oder die erwarteten Ergebnisse oder Wirksamkeit und kann keine Daten, die der Zustimmung oder Vermarktung dieses Produkts für die Indikationen untersucht, dass andere Produkte, die überlegen RAYALDEE entwickeln unterstützt generieren würde, und das kann nicht RAYALDEE Vorteile haben oder sich als überlegen gegenüber derzeit vermarkteten Produkte, einschließlich der derzeit verwendeten hohen monatlichen Dosen von verschreibungspflichtigen Vitamin D2, Vitamin-D-Hormon aktiviert und over-the-counter Vitamin D sein. Darüber hinaus zukunftsgerichteten Aussagen können auch nachteilig von allgemeinen Marktfaktoren, wettbewerbsfähige Produktentwicklung, Produktverfügbarkeit, Bundes-und staatlichen Vorschriften und Gesetze, den Regulierungsprozess für neue Produkte und Indikationen, Fertigungsprobleme, die entstehen können, Patent-und Rechtspositionen beeinträchtigt werden neben anderen Faktoren. Die in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen gelten nur zum Zeitpunkt der Aussagen gemacht wurden und wir übernehmen keine Verpflichtung, zukunftsgerichtete Aussagen zu aktualisieren. Wir wollen, dass alle vorausschauenden Aussagen unterliegen den Safe-Harbor-Bestimmungen des PSLRA sein.
QUELLE: OPKO Health, Inc.
OPKO Completes Patient Enrollment in Third Phase 3 Trial of RAYALDEE™
Rayalddee ist ein
Orginaltext:
http://www.marketwatch.com/story/...se-3-trial-of-rayaldee-2014-05-06
Übersetzung Google :
Diese Studie ist entworfen, um ein Produkt der langfristigen Sicherheit und Wirksamkeit bei der Behandlung von sekundärem Hyperparathyreoidismus (SHPT) bei Patienten mit Stadium 3 oder 4 chronischer Nierenerkrankung (CKD) und Vitamin-D-Mangel zu bewerten.
Diese dritte Phase-3-Studie ist ein 6-Monats-Open-Label-Verlängerung von zwei laufenden und identischen randomisierten, doppelblinden, Placebo-kontrollierte, Multi-Site-zulassungsrelevanten Phase-3-Studien für RAYALDEE soll die Marktzulassung unterstützen in den Vereinigten Staaten (US) . Gemeinsam sind die beiden Zulassungsstudien beinhalten ca. 430 Patienten rekrutiert bei etwa 90 US-Standorte, das sich in sechs Monaten Behandlung mit entweder RAYALDEE oder Placebo. Beide Studien werden im Juli 2014 und das Unternehmen erwartet, Top-Line-Daten, die während des dritten Quartals 2014 bekannt zu geben. In der Open-Label-Erweiterungsstudie, die Patienten entweder weiterhin RAYALDEE Behandlung oder wechseln Sie zu RAYALDEE von Placebo-Behandlung. Weitere Patienten werden dürfen, in der Open-Label-Erweiterungsstudie bis Juli einschreiben, wenn sie aus den Zulassungsstudien verblindet. Die Endpunkte aller drei Studien der Phase 3 sind Vitamin D-Status und Veränderungen der Plasma intakten Parathormon (PTH), Serum-Calcium-und Serumphosphor.
Kürzlich OPKO schloss zudem eine Studie zur Pharmakokinetik von RAYALDEE in etwa 50 gesunden US-Freiwilligen. Diese Studie, die entworfen, um die Wirkung von Nahrung auf die intestinale Resorption von RAYALDEE zu bewerten, ist die letzte klinische Studie (abgesehen von der oben genannten Phase-3-Studien) benötigt, um die bevorstehende New Drug Application (NDA) zu unterstützen. OPKO erwartet, dass ein NDA für RAYALDEE wird mit der US Food and Drug Administration im ersten Quartal 2015 eingereicht werden.
"Die Entwicklung verläuft RAYALDEE voll wie erwartet: im Zeitplan und im Budget", sagte Phillip Frost, MD, CEO und Chairman von OPKO. "Wir glauben, dass unsere proprietäre First-in-Class-Vitamin-D-Produkt wird eine wertvolle neue Behandlung für chronische Patienten mit Nierenerkrankungen, und wir freuen uns auf die Berichterstattung endgültigen Daten aus den laufenden klinischen Studien prompt."
Über RAYALDEE
RAYALDEE ist ein First-in-Class-oralen Vitamin-D-Prohormon-Behandlung, die für SHPT bei Patienten mit Stadium 3 oder 4 CKD-und Vitamin-D-Insuffizienz entwickelt. Es verfügt über eine proprietäre Formulierung mit veränderter Wirkstofffreisetzung zur Serum-Gesamt-25-Hydroxy-Vitamin D (Prohormon)-Konzentrationen, um gezielte Ebenen (mindestens 30 ng / ml) nach und nach und zuverlässig zu erhöhen, während die Vermeidung von Hochregulation von CYP24, eines Cytochrom-P-450-Enzym, das reduziert PTH-senkende Potenz der aktuellen Vitamin-D-Präparate. Aktivierung calcifediol, wird der Wirkstoff in RAYALDEE, von der Niere stark reguliert und so eine übermäßige Erhöhung der Serum-Calcium-und damit verbundenen Nebenwirkungen, die den Wert der aktuellen Vitamin D-Therapien durch die Förderung der vaskulären und renalen Kalzifikation begrenzen. RAYALDEE wird erwartet, dass die rund 4 Millionen Patienten in den USA anzugehen, und viele mehr an anderer Stelle, im Stadium 3 oder 4 CKD, sHPT und Vitamin-D-Mangel.
Über chronische Nierenerkrankung
CKD ist eine Erkrankung, die durch eine fortschreitende Abnahme der Nierenfunktion. Die Niere ist normalerweise verantwortlich für die Ausscheidung von Abfall und überschüssiges Wasser aus dem Körper, und für die Regelung verschiedener Hormone. Mild (Stufe 1) bis schwer (Stufe 5) Krankheit - - CKD wird in fünf verschiedene Stufen eingeteilt, wie die Niere die glomeruläre Filtrationsrate gemessen. Nach Angaben der National Kidney Foundation, CKD leiden über 26 Millionen Menschen in den USA, darunter mehr als acht Millionen (4 Stufen 3 oder) der Patienten mit mittelschwerer und schwerer (Stufe 5) Formen von CKD. In Stufe 5 CKD ist die Nierenfunktion minimal fernzubleiben und Patienten erfordern regelmäßige Dialyse oder eine Nierentransplantation für das Überleben.
Über Vitamin D-Insuffizienz
Vitamin-D-Insuffizienz ist ein Zustand, in dem der Körper niedrige Vitamin D-Shops, gekennzeichnet durch unzureichende Blutspiegel von Vitamin-D-Prohormon, wie 25-Hydroxy-Vitamin D. Schätzungsweise 70-90% der CKD-Patienten Vitamin-D-Insuffizienz, die führen können, haben bekannt zu SHPT und daraus resultierende schwächenden Knochenerkrankungen.
Über Sekundärer Hyperparathyreoidismus (SHPT)
SHPT ist ein Zustand, häufig mit CKD, in denen die Nebenschilddrüsen sezernieren große Mengen an PTH. SHPT entsteht als Folge von Vitamin-D-Insuffizienz oder eingeschränkter Nierenfunktion, die ausreichende Produktion von Vitamin D-Hormon verhindert, um richtig zu regulieren Kalzium-und Phosphorstoffwechsels und der PTH-Sekretion. Verlängerte Erhöhung des Blut PTH verursacht übermäßige Calcium und Phosphor aus Knochen freigesetzt werden, was zu erhöhten Serum-Calcium und Phosphor, Knochenerweichung (Osteomalazie) und vaskulärer Verkalkung und Nierengewebe. SHPT betrifft 40-60% der Patienten mit moderater CKD und etwa 90% der Patienten mit schwerer CKD.
Über OPKO
OPKO ist ein multinationales biopharmazeutisches und Diagnostik-Unternehmen, die führenden Positionen in großen, schnell wachsenden Märkten durch den Einsatz ihrer Entdeckung, Entwicklung und Vermarktung Know-how und neue und proprietäre Technologien zu etablieren sucht.
Diese Pressemitteilung enthält "zukunftsgerichtete Aussagen", wie dieser Begriff nach dem Private Securities Litigation Reform Act von 1995 (PSLRA) definiert ist, in Bezug auf Produktentwicklung und andere nicht-historische Fakten über unseren Erwartungen, Überzeugungen oder Absichten für unser Geschäft, Technologien und Produkte, die finanzielle Lage, Strategien und Aussichten, einschließlich Aussagen über unsere Fähigkeit, erfolgreich zu starten und Vermarktung proprietärer Produkte Nierenerkrankung, Erwartungen über RAYALDEE, das Marktpotenzial, dass es die rund 4 Millionen Patienten in den USA, und viele mehr ansprechen an anderer Stelle, mit der Stufe 3 oder 4 CKD, sHPT und Vitamin-D-Insuffizienz, dass RAYALDEE wird eine wertvolle neue Behandlung für Patienten mit chronischer Niereninsuffizienz, die erwartete Zeitpunkt für Abschluss unserer klinischen Studien für RAYALDEE, Ankündigung von Top-Line-Ergebnisse, und die Vorlage eines sein NDA, ob die Studien für RAYALDEE wird weiterhin im Zeitplan und im Budget zu gelangen, und dass wir in der Lage, erfolgreich zu entwickeln, zu erhalten Zulassung für und Vertrieb von RAYALDEE.Many starten Faktoren können dazu führen, unsere tatsächlichen Aktivitäten oder Ergebnisse wesentlich von der unterscheiden Aktivitäten und Ergebnisse in den zukunftsgerichteten Aussagen abweichen. Diese Faktoren schließen diejenigen ein, in unseren Einreichungen bei der Securities and Exchange Commission, sowie Risiken, die bei der Finanzierung beschrieben, die Entwicklung und den Erhalt der behördlichen Genehmigungen für neue, marktfähige und wettbewerbsfähige Produkte und Behandlungen, einschließlich der Risiken, dass die klinischen Phase-3-Studien für RAYALDEE kann nicht erfolgreich sein, oder die erwarteten Ergebnisse oder Wirksamkeit und kann keine Daten, die der Zustimmung oder Vermarktung dieses Produkts für die Indikationen untersucht, dass andere Produkte, die überlegen RAYALDEE entwickeln unterstützt generieren würde, und das kann nicht RAYALDEE Vorteile haben oder sich als überlegen gegenüber derzeit vermarkteten Produkte, einschließlich der derzeit verwendeten hohen monatlichen Dosen von verschreibungspflichtigen Vitamin D2, Vitamin-D-Hormon aktiviert und over-the-counter Vitamin D sein. Darüber hinaus zukunftsgerichteten Aussagen können auch nachteilig von allgemeinen Marktfaktoren, wettbewerbsfähige Produktentwicklung, Produktverfügbarkeit, Bundes-und staatlichen Vorschriften und Gesetze, den Regulierungsprozess für neue Produkte und Indikationen, Fertigungsprobleme, die entstehen können, Patent-und Rechtspositionen beeinträchtigt werden neben anderen Faktoren. Die in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen gelten nur zum Zeitpunkt der Aussagen gemacht wurden und wir übernehmen keine Verpflichtung, zukunftsgerichtete Aussagen zu aktualisieren. Wir wollen, dass alle vorausschauenden Aussagen unterliegen den Safe-Harbor-Bestimmungen des PSLRA sein.
QUELLE: OPKO Health, Inc.
07.05.14 16:23
#38
Spaetschicht
Opko
OPKO Acquires Inspiromatic Dry Powder Inhaler
http://bionews-tx.com/news/2014/05/06/...r-cystic-fibrosis-treatment/
Potential for Cystic Fibrosis Treatment
A new acquisition agreement between OPKO Health, Inc. and Israeli medical device company Inspiro Medical Ltd. will incorporate a new drug delivery platform into OPKO"s repertoire. Inspiro"s Inspiromatic™ is a dry powder inhaler that can deliver small or large molecule drugs to treat respiratory diseases. "We are pleased to add this next generation inhaler to OPKO"s growing product portfolio," stated Phillip Frost, M.D., OPKO"s CEO and Chairman, in a press release from OPKO. "We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases."
MRSA is a serious threat to CF patients. Get more information about .
Dry-powder inhalers are an attractive alternative to nebulizers to deliver cystic fibrosis treatment. It is more convenient and time-efficient for patients to inhale dry-powder medication than wet aerosols. Nebulizers need a compressor unit or pressurized air if they are jet-type and electricity if they are unltrasonic, which largely immobilize the patient. What"s more, only approximately 1-32% of the intended dose reaches patients lungs when delivered via nebulizer. Studies have demonstrated that at least 40% of the intended dose from dry-powder inhalers is emitted, and the duration of administration of medication can decrease from at least 20 minutes to less than a minute. Therefore, not only are dry-powder inhalers more efficient, but also they may increase patient comfort, making cystic fibrosis therapy more effective overall.
Inspiromatic™ is designed for optimized delivery and enhanced patient compliance monitoring. An internal microcontroller, flow sensor controls, and micro-pump technology dispense drug particles in the correct dose at the right speed to prevent the need for forceful inhalation. Upon inhalation, a green or red light flashes to alert the patient if they properly inhaled, and a beep is sounded once the dose has been delivered. A built-in logger stores patient use data until physicians meet and evaluate the patient"s health.
"We are extremely proud of Inspiro"s success in bringing our smart Inspiromatic™ respiratory drug-delivery device to market," said Nimrod Kaufmann, CEO and Co-Founder of Inspiro. "With Inspiro now a part of OPKO, we will be able to help more people faster. Inspiro joining OPKO is a big win for the shareholders of both Inspiro and OPKO, as well as good news for our patients and physicians."
http://bionews-tx.com/news/2014/05/06/...r-cystic-fibrosis-treatment/
Potential for Cystic Fibrosis Treatment
A new acquisition agreement between OPKO Health, Inc. and Israeli medical device company Inspiro Medical Ltd. will incorporate a new drug delivery platform into OPKO"s repertoire. Inspiro"s Inspiromatic™ is a dry powder inhaler that can deliver small or large molecule drugs to treat respiratory diseases. "We are pleased to add this next generation inhaler to OPKO"s growing product portfolio," stated Phillip Frost, M.D., OPKO"s CEO and Chairman, in a press release from OPKO. "We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases."
MRSA is a serious threat to CF patients. Get more information about .
Dry-powder inhalers are an attractive alternative to nebulizers to deliver cystic fibrosis treatment. It is more convenient and time-efficient for patients to inhale dry-powder medication than wet aerosols. Nebulizers need a compressor unit or pressurized air if they are jet-type and electricity if they are unltrasonic, which largely immobilize the patient. What"s more, only approximately 1-32% of the intended dose reaches patients lungs when delivered via nebulizer. Studies have demonstrated that at least 40% of the intended dose from dry-powder inhalers is emitted, and the duration of administration of medication can decrease from at least 20 minutes to less than a minute. Therefore, not only are dry-powder inhalers more efficient, but also they may increase patient comfort, making cystic fibrosis therapy more effective overall.
Inspiromatic™ is designed for optimized delivery and enhanced patient compliance monitoring. An internal microcontroller, flow sensor controls, and micro-pump technology dispense drug particles in the correct dose at the right speed to prevent the need for forceful inhalation. Upon inhalation, a green or red light flashes to alert the patient if they properly inhaled, and a beep is sounded once the dose has been delivered. A built-in logger stores patient use data until physicians meet and evaluate the patient"s health.
"We are extremely proud of Inspiro"s success in bringing our smart Inspiromatic™ respiratory drug-delivery device to market," said Nimrod Kaufmann, CEO and Co-Founder of Inspiro. "With Inspiro now a part of OPKO, we will be able to help more people faster. Inspiro joining OPKO is a big win for the shareholders of both Inspiro and OPKO, as well as good news for our patients and physicians."
Angehängte Grafik:
shutterstock_187120415-300x200.jpg
shutterstock_187120415-300x200.jpg
07.05.14 16:34
#39
Spaetschicht
OPKO (OPK)
OPKO (OPK) Health Creates Global Supply Chain Structure
http://www.streetinsider.com/Corporate+News/...Structure/9455063.html
OPKO Health, Inc. (NYSE: OPK), announced that it is expanding its global presence with the establishment of a global supply chain operation in Ireland. OPKO is recruiting employees immediately for a range of initial positions, including material and vendor selection, quality assurance, quality control, manufacturing, logistics and sales functions to support the ongoing global launch of its 4Kscore™ diagnostic test and in anticipation of the commercial launch of RAYALDEE™. OPKO’s supply chain operation in Ireland is also expected to manage the global supply of other products over the next several years. The Irish operation will also serve as a global holding company for many of OPKO’s non-U.S. subsidiaries and as a platform for future strategic acquisitions.
“Ireland’s government and universities have a proven record of commitment and robust partnerships with regard to education and training for pharmaceutical manufacturing, quality assurance, quality control and supply logistics. As we build our global supply chain and quality team, we are excited to choose Ireland for its highly skilled and educated workforce,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
OPKO Health, Inc. (NYSE: OPK), announced that it is expanding its global presence with the establishment of a global supply chain operation in Ireland. OPKO is recruiting employees immediately for a range of initial positions, including material and vendor selection, quality assurance, quality control, manufacturing, logistics and sales functions to support the ongoing global launch of its 4Kscore™ diagnostic test and in anticipation of the commercial launch of RAYALDEE™. OPKO’s supply chain operation in Ireland is also expected to manage the global supply of other products over the next several years. The Irish operation will also serve as a global holding company for many of OPKO’s non-U.S. subsidiaries and as a platform for future strategic acquisitions.
“Ireland’s government and universities have a proven record of commitment and robust partnerships with regard to education and training for pharmaceutical manufacturing, quality assurance, quality control and supply logistics. As we build our global supply chain and quality team, we are excited to choose Ireland for its highly skilled and educated workforce,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
http://www.streetinsider.com/Corporate+News/...Structure/9455063.html
OPKO Health, Inc. (NYSE: OPK), announced that it is expanding its global presence with the establishment of a global supply chain operation in Ireland. OPKO is recruiting employees immediately for a range of initial positions, including material and vendor selection, quality assurance, quality control, manufacturing, logistics and sales functions to support the ongoing global launch of its 4Kscore™ diagnostic test and in anticipation of the commercial launch of RAYALDEE™. OPKO’s supply chain operation in Ireland is also expected to manage the global supply of other products over the next several years. The Irish operation will also serve as a global holding company for many of OPKO’s non-U.S. subsidiaries and as a platform for future strategic acquisitions.
“Ireland’s government and universities have a proven record of commitment and robust partnerships with regard to education and training for pharmaceutical manufacturing, quality assurance, quality control and supply logistics. As we build our global supply chain and quality team, we are excited to choose Ireland for its highly skilled and educated workforce,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
OPKO Health, Inc. (NYSE: OPK), announced that it is expanding its global presence with the establishment of a global supply chain operation in Ireland. OPKO is recruiting employees immediately for a range of initial positions, including material and vendor selection, quality assurance, quality control, manufacturing, logistics and sales functions to support the ongoing global launch of its 4Kscore™ diagnostic test and in anticipation of the commercial launch of RAYALDEE™. OPKO’s supply chain operation in Ireland is also expected to manage the global supply of other products over the next several years. The Irish operation will also serve as a global holding company for many of OPKO’s non-U.S. subsidiaries and as a platform for future strategic acquisitions.
“Ireland’s government and universities have a proven record of commitment and robust partnerships with regard to education and training for pharmaceutical manufacturing, quality assurance, quality control and supply logistics. As we build our global supply chain and quality team, we are excited to choose Ireland for its highly skilled and educated workforce,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
09.05.14 20:10
#40
Spaetschicht
Opko Health Loss Widens
5/9/2014 12:03 PM ET
Biopharmaceuticals company Opko Health Inc (OPK: Quote) Friday reported first-quarter net loss of $44.6 million or $0.11 per share compared with a loss of $34.6 million last year.
Results were partly due to the prior year's $12.5 million of non-cash income related to the RXi transaction.
Revenues for the quarter were lower at $22.3 million compared with $31.3 million in the prior year.
Analysts polled by Thomson Reuters estimated a loss of $0.10 per share on revenues of $22.77 million for the quarter. Analysts' estimates typically exclude special items.
Total expenses for the quarter grew to $52.6 million from $38 million a year ago, partly reflecting higher research expense.
Biopharmaceuticals company Opko Health Inc (OPK: Quote) Friday reported first-quarter net loss of $44.6 million or $0.11 per share compared with a loss of $34.6 million last year.
Results were partly due to the prior year's $12.5 million of non-cash income related to the RXi transaction.
Revenues for the quarter were lower at $22.3 million compared with $31.3 million in the prior year.
Analysts polled by Thomson Reuters estimated a loss of $0.10 per share on revenues of $22.77 million for the quarter. Analysts' estimates typically exclude special items.
Total expenses for the quarter grew to $52.6 million from $38 million a year ago, partly reflecting higher research expense.
09.05.14 20:15
#41
Spaetschicht
Schlechtes Quartal
Bin ein wenig entäuscht. Aber die Aussichten sind weiter sehr gut, deswegen steigt sie wohl auch heute.
http://www.twst.com/update/...nounces-first-quarter-operating-results
4Kscore? Test successfully completed clinical validation study and launched on March 31, 2014
All RAYALDEE? Phase 3 clinical trials have completed enrollment on schedule - top line data expected for release mid-2014
Cash and cash equivalents totaled $156.4 million providing sufficient liquidity to fund development programs
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its first quarter ended March 31, 2014.
Business Highlights
4KscoreTest Launch: During the first quarter 2014, OPKO successfully completed the 4Kscore Test clinical trial in the U.S. and on March 31, 2014, launched the 4Kscore Test in the U.S. through its CLIA-accredited OPKO Lab in Nashville, TN. OPKO expects to begin offering the 4Kscore Test through its Spanish subsidiary in late 2014 and through its other subsidiaries shortly thereafter. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the U.S., leads to approximately 1 million biopsies being performed annually, with 80% of the results indicating no cancer or a low-grade cancer. The 4Kscore Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.
4Kscore Data Presentations: OPKO will present data from its recently completed U.S. clinical validation study at two upcoming conferences: the American Urological Association (AUA) in Orlando, which selected "The 4Kscore Test as a Predictor of High-Grade Prostate Cancer on Biopsy" as a Late-Breaking Abstract for presentation in Plenary I on Sunday, May 18, 2014; and, the 83rd Annual Meeting of the New England Section of the AUA in October 2014 in Newport.
Completed Patient Enrollment in the Third Phase 3 Trial of RAYALDEE: This trial is a 6-month open-label extension of two ongoing identical randomized, double-blind, placebo-controlled, multi-site pivotal phase 3 studies for RAYALDEE intended to support marketing approval in the U.S. This third study is designed to evaluate the product's long-term safety and efficacy in treating secondary hyperparathyroidism (SHPT) in subjects with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. OPKO is on schedule for releasing top-line pivotal data in the third quarter of 2014 and filing a New Drug Application (NDA)with the FDA in the first quarter of 2015.
Inspiro Acquisition: In April, OPKO entered into a definitive agreement to acquire Inspiro Medical Ltd., an Israeli medical device company with a new platform to deliver small molecule drugs such as corticosteroids and beta agonists, as well as its own new drug working with a novel mechanism of action, to treat respiratory diseases. Inspiro's Inspiromatic? is a "smart" easy-to-use dry powder inhaler with several advantages over existing devices.
Rolapitant Continues on Schedule For a Mid-Year NDA Filing: OPKO's partner, TESARO announced it is on track for its NDA filing for rolapitant mid-2014 and anticipates completing a dose study for the intravenous (IV) formulation during the second quarter of 2014. The IV formulation is expected to be launched approximately one year after the oral product becomes available.
Key Management Positions Added: OPKO made a number of important additions to its management team: Greg Stanley joined OPKO as Vice President of Sales and Marketing for the Global Diagnostics Business Unit, and Scott Toner joined OPKO as Vice President, U.S. Marketing and Sales for the Renal Division.
Establishment of a Global Supply Chain Infrastructure and Holding Company Based in Dublin, Ireland: OPKO is expanding its presence by establishing a global supply chain operation and holding company in Ireland. OPKO is recruiting employees to support the ongoing launch of the 4Kscore diagnostic test and in anticipation of the commercial launch of RAYALDEE. The Irish operation is also expected to manage the global supply of other products over the next several years and to serve as a holding company for many of OPKO's non-U.S. subsidiaries.
InJanuary, OPKO completed the acquisition of Laboratorio Arama de Uruguay Limitada ("Arama Uruguay"), a privately-owned company located in Montevideo, Uruguay. Arama Uruguay will expand OPKO's presence in Latin America and complement the business activities of its operations in Chile and Mexico, as well as permit commercialization of OPKO's products currently commercialized and those in development.
"We made significant progress during the first quarter of 2014," stated Dr. Phillip Frost, Chairman and CEO. "The completion of our validation study for the 4Kscore and subsequent launch were significant milestones which we expect will provide substantial benefits to both patients and healthcare professionals by informing them of the risk of a patient having high-grade prostate cancer and helping clarify the decision process surrounding prostate biopsy. Our RAYALDEE phase 3 clinical trials continue on track for release of top line data later this summer and our hGH-CTP clinical trials continue on schedule. In addition to these important project developments, we expanded the global footprint of our commercial platform with the entry into the Uruguayan market. With our planned acquisition of Inspiro, we will also add an innovative next generation platform drug delivery system."
Financial Highlights
At March 31, 2014, OPKO had cash and cash equivalents of $156.4 million providing OPKO with strong liquidity and the ability to continue the development of its product candidates. During the three months ended March 31, 2014, OPKO continued to invest in its research and development programs and as a result, utilized cash in operations of $29.0 million for the three months ended March 31, 2014. Cash used in operations include the final deferred acquisition payments for OPKO Spain and FineTech totaling $7.9 million. The remaining cash used in operations reflects OPKO's continued investment in research and development activities including its ongoing phase 3 clinical trials for RAYALDEE and hGH-CTP and the clinical validation study for 4Kscore Test which was completed in March 2014.
Product revenue for the quarter increased approximately 28% to $19.8 million compared to $15.5 million for the 2013 period. The increase in product revenue was principally the result of increased revenue from OPKO Spain and FineTech. Total revenue for the three months ended March 31, 2014 was $22.3 million compared to $31.3 million for the 2013 period. Total revenue for the three months ended March 31, 2013 included non-cash, non recurring revenue of $12.5 million related to OPKO's transaction with RXi, which was partially offset by increased product revenue.
Net loss attributable to common shareholders increased to $45.1 million for the three months ended March 31, 2014 compared to $34.6 million in the comparable period of 2013 partially as a result of the 2013 period including $12.5 million of non-cash income related to the RXi transaction. In addition, OPKO continued to increase its investment in research and development activities related to its ongoing phase 3 programs for RAYALDEE and hGH-CTP as well as costs associated with the clinical validation study for the 4Kscore. As a result, OPKO's spending on research and development increased $11.0 million to $21.0 million for the three months ended March 31, 2014 from $9.9 million for the three months ended March 31, 2013. Net loss for the three months ended March 31, 2014 included $10.5 million of non-cash expense related to the mark to market of certain derivative instruments related to our convertible debt instruments compared to $23.5 million for the three months ended March 31, 2013.
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance, continued revenue growth and our ability to build a profitable business, whether we have sufficient liquidity to fund our research and development and operations, our product development effort and the expected benefits of our products, including whether the phase 3 clinical trials for RAYALDEE, hGH-CTP, and rolapitant will be completed on a timely basis or at all and whether the data will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, including RAYALDEE and hGH-CTP, the expected timing of our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, our ability to market and sell any of our products in development, including RAYALDEE, the 4Kscore, and hGH-CTP, our ability to launch sales of the 4Kscore Test in Spain and through our other subsidiaries, the timing for submission of an NDA by us for RAYALDEE and by TESARO for rolapitant, whether TESARO will complete a dose study for its IV formulation and the timing thereof, whether the 4Kscore will provide substantial benefits to patients and doctors by informing them of the risk of a patient having a high-grade cancer and clarify the decision making process, whether the 4Kscore will reduce unnecessary biopsies, whether the Irish operation will manage, oversee and contribute to the manufacturing and sale of the 4Kscore, RAYALDEE, and other products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the 4Kscore, RAYALDEE, rolapitant, hGH-CTP, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
http://www.twst.com/update/...nounces-first-quarter-operating-results
4Kscore? Test successfully completed clinical validation study and launched on March 31, 2014
All RAYALDEE? Phase 3 clinical trials have completed enrollment on schedule - top line data expected for release mid-2014
Cash and cash equivalents totaled $156.4 million providing sufficient liquidity to fund development programs
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its first quarter ended March 31, 2014.
Business Highlights
4KscoreTest Launch: During the first quarter 2014, OPKO successfully completed the 4Kscore Test clinical trial in the U.S. and on March 31, 2014, launched the 4Kscore Test in the U.S. through its CLIA-accredited OPKO Lab in Nashville, TN. OPKO expects to begin offering the 4Kscore Test through its Spanish subsidiary in late 2014 and through its other subsidiaries shortly thereafter. The laboratory-developed test is designed to enhance the prostate biopsy decision making process that, in the U.S., leads to approximately 1 million biopsies being performed annually, with 80% of the results indicating no cancer or a low-grade cancer. The 4Kscore Test will help to reduce unnecessary prostate biopsies by providing information on the risk (probability) of having high-grade prostate cancer.
4Kscore Data Presentations: OPKO will present data from its recently completed U.S. clinical validation study at two upcoming conferences: the American Urological Association (AUA) in Orlando, which selected "The 4Kscore Test as a Predictor of High-Grade Prostate Cancer on Biopsy" as a Late-Breaking Abstract for presentation in Plenary I on Sunday, May 18, 2014; and, the 83rd Annual Meeting of the New England Section of the AUA in October 2014 in Newport.
Completed Patient Enrollment in the Third Phase 3 Trial of RAYALDEE: This trial is a 6-month open-label extension of two ongoing identical randomized, double-blind, placebo-controlled, multi-site pivotal phase 3 studies for RAYALDEE intended to support marketing approval in the U.S. This third study is designed to evaluate the product's long-term safety and efficacy in treating secondary hyperparathyroidism (SHPT) in subjects with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. OPKO is on schedule for releasing top-line pivotal data in the third quarter of 2014 and filing a New Drug Application (NDA)with the FDA in the first quarter of 2015.
Inspiro Acquisition: In April, OPKO entered into a definitive agreement to acquire Inspiro Medical Ltd., an Israeli medical device company with a new platform to deliver small molecule drugs such as corticosteroids and beta agonists, as well as its own new drug working with a novel mechanism of action, to treat respiratory diseases. Inspiro's Inspiromatic? is a "smart" easy-to-use dry powder inhaler with several advantages over existing devices.
Rolapitant Continues on Schedule For a Mid-Year NDA Filing: OPKO's partner, TESARO announced it is on track for its NDA filing for rolapitant mid-2014 and anticipates completing a dose study for the intravenous (IV) formulation during the second quarter of 2014. The IV formulation is expected to be launched approximately one year after the oral product becomes available.
Key Management Positions Added: OPKO made a number of important additions to its management team: Greg Stanley joined OPKO as Vice President of Sales and Marketing for the Global Diagnostics Business Unit, and Scott Toner joined OPKO as Vice President, U.S. Marketing and Sales for the Renal Division.
Establishment of a Global Supply Chain Infrastructure and Holding Company Based in Dublin, Ireland: OPKO is expanding its presence by establishing a global supply chain operation and holding company in Ireland. OPKO is recruiting employees to support the ongoing launch of the 4Kscore diagnostic test and in anticipation of the commercial launch of RAYALDEE. The Irish operation is also expected to manage the global supply of other products over the next several years and to serve as a holding company for many of OPKO's non-U.S. subsidiaries.
InJanuary, OPKO completed the acquisition of Laboratorio Arama de Uruguay Limitada ("Arama Uruguay"), a privately-owned company located in Montevideo, Uruguay. Arama Uruguay will expand OPKO's presence in Latin America and complement the business activities of its operations in Chile and Mexico, as well as permit commercialization of OPKO's products currently commercialized and those in development.
"We made significant progress during the first quarter of 2014," stated Dr. Phillip Frost, Chairman and CEO. "The completion of our validation study for the 4Kscore and subsequent launch were significant milestones which we expect will provide substantial benefits to both patients and healthcare professionals by informing them of the risk of a patient having high-grade prostate cancer and helping clarify the decision process surrounding prostate biopsy. Our RAYALDEE phase 3 clinical trials continue on track for release of top line data later this summer and our hGH-CTP clinical trials continue on schedule. In addition to these important project developments, we expanded the global footprint of our commercial platform with the entry into the Uruguayan market. With our planned acquisition of Inspiro, we will also add an innovative next generation platform drug delivery system."
Financial Highlights
At March 31, 2014, OPKO had cash and cash equivalents of $156.4 million providing OPKO with strong liquidity and the ability to continue the development of its product candidates. During the three months ended March 31, 2014, OPKO continued to invest in its research and development programs and as a result, utilized cash in operations of $29.0 million for the three months ended March 31, 2014. Cash used in operations include the final deferred acquisition payments for OPKO Spain and FineTech totaling $7.9 million. The remaining cash used in operations reflects OPKO's continued investment in research and development activities including its ongoing phase 3 clinical trials for RAYALDEE and hGH-CTP and the clinical validation study for 4Kscore Test which was completed in March 2014.
Product revenue for the quarter increased approximately 28% to $19.8 million compared to $15.5 million for the 2013 period. The increase in product revenue was principally the result of increased revenue from OPKO Spain and FineTech. Total revenue for the three months ended March 31, 2014 was $22.3 million compared to $31.3 million for the 2013 period. Total revenue for the three months ended March 31, 2013 included non-cash, non recurring revenue of $12.5 million related to OPKO's transaction with RXi, which was partially offset by increased product revenue.
Net loss attributable to common shareholders increased to $45.1 million for the three months ended March 31, 2014 compared to $34.6 million in the comparable period of 2013 partially as a result of the 2013 period including $12.5 million of non-cash income related to the RXi transaction. In addition, OPKO continued to increase its investment in research and development activities related to its ongoing phase 3 programs for RAYALDEE and hGH-CTP as well as costs associated with the clinical validation study for the 4Kscore. As a result, OPKO's spending on research and development increased $11.0 million to $21.0 million for the three months ended March 31, 2014 from $9.9 million for the three months ended March 31, 2013. Net loss for the three months ended March 31, 2014 included $10.5 million of non-cash expense related to the mark to market of certain derivative instruments related to our convertible debt instruments compared to $23.5 million for the three months ended March 31, 2013.
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance, continued revenue growth and our ability to build a profitable business, whether we have sufficient liquidity to fund our research and development and operations, our product development effort and the expected benefits of our products, including whether the phase 3 clinical trials for RAYALDEE, hGH-CTP, and rolapitant will be completed on a timely basis or at all and whether the data will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, including RAYALDEE and hGH-CTP, the expected timing of our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, our ability to market and sell any of our products in development, including RAYALDEE, the 4Kscore, and hGH-CTP, our ability to launch sales of the 4Kscore Test in Spain and through our other subsidiaries, the timing for submission of an NDA by us for RAYALDEE and by TESARO for rolapitant, whether TESARO will complete a dose study for its IV formulation and the timing thereof, whether the 4Kscore will provide substantial benefits to patients and doctors by informing them of the risk of a patient having a high-grade cancer and clarify the decision making process, whether the 4Kscore will reduce unnecessary biopsies, whether the Irish operation will manage, oversee and contribute to the manufacturing and sale of the 4Kscore, RAYALDEE, and other products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the 4Kscore, RAYALDEE, rolapitant, hGH-CTP, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
12.05.14 17:12
#42
Spaetschicht
Oppenheimer Lowers Opko Health Price Target to $12
Immer noch Outperform aber das Kurziel auf 12 $ gesenkt
http://zolmax.com/investing/...alth-price-target-to-12-00-opk/263739/
Stock analysts at Oppenheimer cut their target price on shares of Opko Health (NYSE:OPK) from $13.00 to $12.00 in a report issued on Monday, Stock Ratings Network.com reports. The firm currently has an “outperform” rating on the stock. Oppenheimer’s target price indicates a potential upside of 45.63% from the stock’s previous close.
http://zolmax.com/investing/...alth-price-target-to-12-00-opk/263739/
Stock analysts at Oppenheimer cut their target price on shares of Opko Health (NYSE:OPK) from $13.00 to $12.00 in a report issued on Monday, Stock Ratings Network.com reports. The firm currently has an “outperform” rating on the stock. Oppenheimer’s target price indicates a potential upside of 45.63% from the stock’s previous close.
12.05.14 17:55
#43
Spaetschicht
Rolapitant
Opko Health (OPK) Notes Positive Top-Line Results Presented by TESARO, Inc. (TSRO) from Rolapitant Phase 3
http://www.streetinsider.com/Corporate+News/...t+Phase+3/9472396.html
OPKO Health, Inc. (NYSE: OPK), reported that its licensee, TESARO, Inc. (Nasdaq: TSRO), announced positive top-line results from the third and final Phase 3 trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.
The third Phase 3 study of rolapitant was an international, multicenter, randomized, double-blind, active-controlled study that enrolled 532 cancer patients receiving cisplatin-based chemotherapy regimens at a dose equal to or greater than 60 mg/m2. Patients were randomized to receive either control, which consisted of a 5-HT3 receptor antagonist plus dexamethasone, or 200 milligrams of oral rolapitant plus control. The rolapitant arm in this study successfully achieved statistical significance over the control arm for the primary endpoint of complete response (CR) in the delayed phase of CINV. In addition, the rolapitant arm also successfully achieved statistical significance over the control arm for the key secondary endpoints of CR in the acute (0 to 24 hour) and overall (0 to 120 hour) phases of CINV, for the secondary endpoint of no significant nausea, and for all other secondary endpoints.
Safety and tolerability data for patients who received rolapitant were similar to the results for those who received control, and were consistent with earlier clinical studies. The most frequently observed adverse events were balanced across treatment arms and included fatigue, constipation and loss of appetite.
TESARO continues preparations in support of a submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in mid-2014. The oral rolapitant NDA will include data from one Phase 3 study in patients receiving moderately emetogenic chemotherapy (MEC), in addition to one Phase 2 and two Phase 3 trials in patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), including the trial announced today. The top-line results of the Phase 3 trial in MEC and the prior Phase 3 trial in HEC were previously announced by TESARO in December 2013.
Rolapitant is an investigational agent and, as such, has not been approved by the U.S. FDA or any regulatory agencies.
http://www.streetinsider.com/Corporate+News/...t+Phase+3/9472396.html
OPKO Health, Inc. (NYSE: OPK), reported that its licensee, TESARO, Inc. (Nasdaq: TSRO), announced positive top-line results from the third and final Phase 3 trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.
The third Phase 3 study of rolapitant was an international, multicenter, randomized, double-blind, active-controlled study that enrolled 532 cancer patients receiving cisplatin-based chemotherapy regimens at a dose equal to or greater than 60 mg/m2. Patients were randomized to receive either control, which consisted of a 5-HT3 receptor antagonist plus dexamethasone, or 200 milligrams of oral rolapitant plus control. The rolapitant arm in this study successfully achieved statistical significance over the control arm for the primary endpoint of complete response (CR) in the delayed phase of CINV. In addition, the rolapitant arm also successfully achieved statistical significance over the control arm for the key secondary endpoints of CR in the acute (0 to 24 hour) and overall (0 to 120 hour) phases of CINV, for the secondary endpoint of no significant nausea, and for all other secondary endpoints.
Safety and tolerability data for patients who received rolapitant were similar to the results for those who received control, and were consistent with earlier clinical studies. The most frequently observed adverse events were balanced across treatment arms and included fatigue, constipation and loss of appetite.
TESARO continues preparations in support of a submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in mid-2014. The oral rolapitant NDA will include data from one Phase 3 study in patients receiving moderately emetogenic chemotherapy (MEC), in addition to one Phase 2 and two Phase 3 trials in patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), including the trial announced today. The top-line results of the Phase 3 trial in MEC and the prior Phase 3 trial in HEC were previously announced by TESARO in December 2013.
Rolapitant is an investigational agent and, as such, has not been approved by the U.S. FDA or any regulatory agencies.
12.05.14 18:05
#44
Spaetschicht
Rolapitant
http://www.opko.com/therapeutics/cinv-and-ponv/
Google ÜS:
Lizenzvereinbarung mit TESARO
Gemäß den Bedingungen der Lizenz mit TESARO ist OPKO Anspruch auf Vorab-und Meilensteinzahlungen von bis zu 121.000.000 $ zu erhalten.
OPKO ist auch ein zweistelliges mehrstufige Tantiemen auf den Umsatz des lizenzierten Produkts, einem Anteil der zukünftigen Gewinne aus Kommerzialisierung in Japan, und eine Option, um das Produkt in Lateinamerika vermarkten berechtigt.
OPKO hat auch einen Kapitalanteil an TESARO erworben.
Google ÜS:
Lizenzvereinbarung mit TESARO
Gemäß den Bedingungen der Lizenz mit TESARO ist OPKO Anspruch auf Vorab-und Meilensteinzahlungen von bis zu 121.000.000 $ zu erhalten.
OPKO ist auch ein zweistelliges mehrstufige Tantiemen auf den Umsatz des lizenzierten Produkts, einem Anteil der zukünftigen Gewinne aus Kommerzialisierung in Japan, und eine Option, um das Produkt in Lateinamerika vermarkten berechtigt.
OPKO hat auch einen Kapitalanteil an TESARO erworben.
21.05.14 20:11
#45
Spaetschicht
Senesco Completes Acquisition of Fabrus
An OPKO Portfolio Company
http://www.fortmilltimes.com/2014/05/19/3490051/...s-acquisition.html
MIAMI — OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported that Senesco Technologies, Inc. (“Senesco”) (OTCQB: SNTI), completed its acquisition of Fabrus, Inc. (“Fabrus”), an OPKO portfolio company focused on expanding the clinical impact of antibodies by addressing drug targets resistant to traditional antibody discovery methods.
Fabrus has been successful in generating antibodies against difficult, therapeutically important cell surface receptors and ion channels resulting in an internal pipeline that includes next generation antibodies targeting cancer and inflammation. It also has collaborations in place with large pharma and biotech companies to discover antibodies to their targets. Dr. Vaughn V. Smider, founder of Fabrus and faculty member at The Scripps Research Institute in La Jolla, CA, will become acting CEO of Senesco.
In the short term, the business focus of the combined company will be to realize the synergies of the combination, advancing the SNS01-T clinical program and bringing new candidates into clinical development in the next two years.
About Senesco Technologies, Inc.
Senesco Technologies is a clinical-stage biotech company specializing in cancer therapeutics. Its proprietary gene regulation technology has demonstrated the ability to kill cancer cells and protect healthy cells from premature death in disease models. The Company is currently in a Phase 1b/2a trial with a product candidate that is designed to treat B-cell cancers, which include multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin’s B-cell lymphomas. Trial sites include Mayo Clinic and the Fred Hutchinson Cancer Research Center in Seattle. The technology was developed over the last 15 years through the discovery that the genetic pathway for cell growth control is common to both plants and humans. For more information, please visit Senesco.com..
http://www.fortmilltimes.com/2014/05/19/3490051/...s-acquisition.html
MIAMI — OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported that Senesco Technologies, Inc. (“Senesco”) (OTCQB: SNTI), completed its acquisition of Fabrus, Inc. (“Fabrus”), an OPKO portfolio company focused on expanding the clinical impact of antibodies by addressing drug targets resistant to traditional antibody discovery methods.
Fabrus has been successful in generating antibodies against difficult, therapeutically important cell surface receptors and ion channels resulting in an internal pipeline that includes next generation antibodies targeting cancer and inflammation. It also has collaborations in place with large pharma and biotech companies to discover antibodies to their targets. Dr. Vaughn V. Smider, founder of Fabrus and faculty member at The Scripps Research Institute in La Jolla, CA, will become acting CEO of Senesco.
In the short term, the business focus of the combined company will be to realize the synergies of the combination, advancing the SNS01-T clinical program and bringing new candidates into clinical development in the next two years.
About Senesco Technologies, Inc.
Senesco Technologies is a clinical-stage biotech company specializing in cancer therapeutics. Its proprietary gene regulation technology has demonstrated the ability to kill cancer cells and protect healthy cells from premature death in disease models. The Company is currently in a Phase 1b/2a trial with a product candidate that is designed to treat B-cell cancers, which include multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin’s B-cell lymphomas. Trial sites include Mayo Clinic and the Fred Hutchinson Cancer Research Center in Seattle. The technology was developed over the last 15 years through the discovery that the genetic pathway for cell growth control is common to both plants and humans. For more information, please visit Senesco.com..
22.05.14 17:15
#46
Spaetschicht
OPKO Completes
ACQUISITION OF INSPIRO MEDICAL LTD.
http://www.twst.com/update/...etes-acquisition-of-inspiro-medical-ltd
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) announced that it has completed the acquisition of Inspiro Medical Ltd. ("Inspiro"), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists or larger molecules to treat respiratory diseases. Inspiro's Inspiromatic? is a "smart" easy-to-use dry powder inhaler with several advantages over existing devices.
In a recently completed, First In Man double blinded clinical study conducted in 30 asthmatic children comparing Inspiromatic? to a market leading dry powder inhaler, Inspiromatic? demonstrated superior pulmonary delivery of the active drug.
About Inspiromatic
Inspiromatic? offers improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring. The device has an internal microcontroller and flow sensor that controls the delivery of the medication and, using micro-pump technology, dispenses the drug particles at the right speed without the need for forceful inhalation. It also provides instant feedback to the patient with a green or red flasher light to indicate proper inhalation and a beeper after the dose has been delivered. For physicians, Inspiromatic? provides a built-in logger that stores patient use data for easy access and transmission by electronic devices such as smart phones.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected benefits of the acquisition of Inspiro Medical, the expected benefits of the Inspiromatic? inhaler, whether it will offer improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring, whether it will provide superior delivery of active drug over other inhalers, whether it will play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases, whether the Inspiromatic? or any of OPKO's drugs or other products under development will ever be successfully developed or commercialized, whether the Inspiromatic? can improve outcomes of treatment, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the Inspiromatic? and/or any of our compounds or products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, that the various conditions to the closing of the transaction with Inspiro Medical may not be met, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
News Provided by Acquire Media
http://www.twst.com/update/...etes-acquisition-of-inspiro-medical-ltd
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK) announced that it has completed the acquisition of Inspiro Medical Ltd. ("Inspiro"), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists or larger molecules to treat respiratory diseases. Inspiro's Inspiromatic? is a "smart" easy-to-use dry powder inhaler with several advantages over existing devices.
In a recently completed, First In Man double blinded clinical study conducted in 30 asthmatic children comparing Inspiromatic? to a market leading dry powder inhaler, Inspiromatic? demonstrated superior pulmonary delivery of the active drug.
About Inspiromatic
Inspiromatic? offers improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring. The device has an internal microcontroller and flow sensor that controls the delivery of the medication and, using micro-pump technology, dispenses the drug particles at the right speed without the need for forceful inhalation. It also provides instant feedback to the patient with a green or red flasher light to indicate proper inhalation and a beeper after the dose has been delivered. For physicians, Inspiromatic? provides a built-in logger that stores patient use data for easy access and transmission by electronic devices such as smart phones.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected benefits of the acquisition of Inspiro Medical, the expected benefits of the Inspiromatic? inhaler, whether it will offer improved drug deposition to the lower airways of patients and real time data for patient compliance monitoring, whether it will provide superior delivery of active drug over other inhalers, whether it will play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases, whether the Inspiromatic? or any of OPKO's drugs or other products under development will ever be successfully developed or commercialized, whether the Inspiromatic? can improve outcomes of treatment, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the Inspiromatic? and/or any of our compounds or products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, that the various conditions to the closing of the transaction with Inspiro Medical may not be met, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
News Provided by Acquire Media
27.05.14 20:33
#47
Spaetschicht
Video
MAD MONEY W/ JIM CRAMER – OPKO FULL EPISODE VIDEO 05/22/14
https://opkodd.wordpress.com/2014/05/26/...full-episode-video-052214/
https://opkodd.wordpress.com/2014/05/26/...full-episode-video-052214/
30.05.14 17:27
#48
Spaetschicht
Opko Health Inc Stock Upgraded (OPK)
NEW YORK (TheStreet) -- Opko Health (NYSE:OPK) has been upgraded by TheStreet Ratings from sell to hold
http://www.thestreet.com/story/12728256/1/...-stock-upgraded-opk.html
http://www.thestreet.com/story/12728256/1/...-stock-upgraded-opk.html
03.06.14 22:13
#49
Spaetschicht
Jefferies 2014
Global Healthcare Conference
June 3, 2014
http://files.shareholder.com/downloads/OPKO/...20Jeffries%20Final.pdf
June 3, 2014
http://files.shareholder.com/downloads/OPKO/...20Jeffries%20Final.pdf
04.06.14 01:47
#50
MasterbrokerUSA
Ja
in der tat ein sehr interresanter Wert habe mir Sie ebend auch mal angesehen. ;-) Also wenn überlegt das die sehr breit auf gestellt sind und einige Sache dies Jahr wohl noch dazu beitragen werden das,die den Wert weiter steigen lassen,muss ich mir heute nacht mal noch weitere Sachen zu OPKO ansehen.