Immupharma Plc.: Dr. House lässt grüssen
| eröffnet am: | 12.06.12 20:26 von: | TheBigBangTheory |
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12.06.12 20:26
#1
TheBigBangTheory
Immupharma Plc.: Dr. House lässt grüssen
Blockbuster Potential? Ich glaube Ja.
Ungewöhnliche Story...
http://www.immupharma.com/
81 Mio Aktien.
News-Medical: Was ist Lupus?
http://www.news-medical.net/health/What-is-Lupus-%28German%2…
Lady Gaga positiv getestet Wie gefährlich ist Lupus?
http://www.bild.de/ratgeber/gesund-fit/promi/auto-immunkrank…
Dr House: http://de.wikipedia.org/wiki/Dr._House
http://www.proactiveinvestors.co.uk/LON:IMM/ImmuPharma-PLC/
ImmuPharma: A second bite at the cherry, but is the market really plugged into Lupuzor's potential?
28th Feb 2012, 2:11 pm by Ian Lyall The potential market for the product is such that Lupuzor is a blockbuster in the makingThe potential market for the product is such that Lupuzor is a blockbuster in the making
Very rarely does a small drug company have the opportunity to do the same transaction twice – with every prospect of getting an even better deal the second time around.
But this is exactly what has happened with ImmuPharma (LON:IMM) and its leading drug, Lupuzor, which is expected to attract the attention of the sector’s big boys.
ImmuPharma’s good fortune was the result of the US$6.8 billion takeover of joint venture partner Cephalon by generic drug maker Teva.
After the deal was consummated, ImmuPharma was able to wrestle back the rights to Lupuzor, a treatment for the auto-immune disease lupus.
The point to emphasise is the British minnow took the drug back - thanks mainly to a watertight contract, which allowed it to regain control of Lupuzor. It wasn’t returned unwanted.
Not just that, it received all the data collated by Cephalon free of charge.
The potential market for the product is such that Lupuzor is a blockbuster in the making.
“It is quite unusual to get a second bite of the cherry in this way,” says chief executive Dimitri Dimitriou.
That’s an understatement. It is unheard of to reclaim such a precious asset, and ImmuPharma’s management and lawyers should be commended for their diligence in drafting the initial contract with Cephalon.
The next step is to find a new licensing partner for Lupuzor, which has the all-clear to go into phase III clinical trials.
Once completed, the approval process will be fast-tracked by America’s all powerful Food & Drug Administration, shaving around a year off the process.
The company has also been given approval to start the next phase of development with a Special Protocol Assessment. This SPA is an important sign-off on the company’s clinical trial protocols.
The agency is essentially saying that, assuming no unforeseen issues, it will approve the drug if it matches or exceeds certain criteria.
Since the SPA is granted before the data is generated, the FDA tends to be conservative when handing them out.
Dimitriou revealed recently he has “rekindled” negotiations with big pharma companies interested in Lupuzor.
And it seems the interest is coming from all around the world, including the UK, US, Europe and Japan.
“The names include the top 10 or 15 in the world,” he adds.
“We had discussions with companies before Cephalon. It was very easy to rekindle those discussions. The great thing is the stage Lupuzor has got to.”
ImmuPharma is likely to be able to negotiate a very attractive deal given Lupuzor is so far advanced through the clinical trials process.
The headline value of the Cephalon licensing agreement included double-digit royalties plus US$500 million cash, including upfront payments of US$45 million which ImmuPharma received and are not refundable.
“The deal with Cephalon was large,” says Dimitriou. “I would like to get a big upfront this time around too.”
The potential market for the drug is significant, with around 1.5 million sufferers just in the G7 countries. The potential worldwide is even larger.
Benlysta, a new drug launched earlier this year by GlaxoSmithKline and Human Genome Sciences, is the first new drug in 50 years for lupus and should help pave the way for ImmuPharma’s drug.
HGS, before the launch, suggested Benlysta could effectively target around 200,000 suffers of this debilitating illness.
At this point the company was talking about selling the treatment for US$20,000 a year, giving potential peak sales of around US$4 billion. However it is currently being marketed at US$35,000 per annum.
“We have said for Lupuzor our target price may be around US$10,000 – US$15,000 a month,” Dimitriou reveals.
“Perhaps the licensee will go with another figure. But it is still going to be a lot less than US$35,000.”
The price differential is explained by the fact that Lupuzor is significantly cheaper to produce.
However it’s not an inferior product. Tests have shown it is more efficacious, well tolerated and easier to administer than Benlysta.
All of which should help open the drug to a much wider audience.
Dimitriou expects it will take around two years from the start of phase III to get Lupuzor out into the market, although cash will come in much before that if ImmuPharma does a deal with a pharma company.
To keep the risk low, ImmuPharma plans to let the partner start, manage and fund phase III. Normally, a beauty parade of this kind takes anywhere up to a year, but the company is well into partnering discussions.
The ImmuPharma chief hopes to have concluded a licensing deal in six to eight months, and adds: “I would really hope by the end of this year we will have a deal.”
There is the other alternative: that ImmuPharma is taken out before it can conclude these negotiations.
Certainly with company’s market value, sitting at £65 million, it might make financial sense for a predatory drugs company to make a play for the group.
“We would be open to something that offered value. But the simple fact is big pharma tends not to like to buy companies outright; a licensing deal comes usually first,” says Dimitriou.
And he is right. They prefer the more collaborative, ‘suck and see’ approach that a licence or joint venture deal affords.
As well as Lupuzor, ImmuPharma also has IPP-204106, a cancer compound born of its collaboration with France’s Centre Nationale Recherche Scientifique.
It has a dual action in that it targets cell proliferation and the development of new blood vessels, a process called angiogenesis.
With around £10 million in the bank the group has the funds to take it to the end phase.
Any extra cash will allow the company to progress potential drug candidates for the hospital super-bug MRSA, severe pain and inflammation.
What ImmuPharma won’t be doing is spending its new found wealth on acquisitions.
However, Dimitriou might consider a special dividend if it is deemed an appropriate use of any excess funds. “We do not have a closed mindset on the idea,” the ImmuPharma CEO adds.
According to brokers, the current share price of 79 pence wildly under-estimates the company’s potential, and the value of Lupuzor.
Merchant Securities reckons ImmuPharma is worth 323 pence a share.
In a note to clients it said: “ImmuPharma is one of the few biotechnology companies in the UK market with full control over a late-stage asset which is ready to start Phase III (pivotal) clinical trials in the short-term, and be re-licensed for a second time to a major pharmaceutical company, as a potential best in class product.”
Hi Leute
Blockbuster Potential? Ich glaube Ja.
Ungewöhnliche Story...
http://www.immupharma.com/
81 Mio Aktien.
News-Medical: Was ist Lupus?
http://www.news-medical.net/health/What-is-Lupus-%28German%2…
Lady Gaga positiv getestet Wie gefährlich ist Lupus?
http://www.bild.de/ratgeber/gesund-fit/promi/auto-immunkrank…
Dr House: http://de.wikipedia.org/wiki/Dr._House
http://www.proactiveinvestors.co.uk/LON:IMM/ImmuPharma-PLC/
ImmuPharma: A second bite at the cherry, but is the market really plugged into Lupuzor's potential?
28th Feb 2012, 2:11 pm by Ian Lyall The potential market for the product is such that Lupuzor is a blockbuster in the makingThe potential market for the product is such that Lupuzor is a blockbuster in the making
Very rarely does a small drug company have the opportunity to do the same transaction twice – with every prospect of getting an even better deal the second time around.
But this is exactly what has happened with ImmuPharma (LON:IMM) and its leading drug, Lupuzor, which is expected to attract the attention of the sector’s big boys.
ImmuPharma’s good fortune was the result of the US$6.8 billion takeover of joint venture partner Cephalon by generic drug maker Teva.
After the deal was consummated, ImmuPharma was able to wrestle back the rights to Lupuzor, a treatment for the auto-immune disease lupus.
The point to emphasise is the British minnow took the drug back - thanks mainly to a watertight contract, which allowed it to regain control of Lupuzor. It wasn’t returned unwanted.
Not just that, it received all the data collated by Cephalon free of charge.
The potential market for the product is such that Lupuzor is a blockbuster in the making.
“It is quite unusual to get a second bite of the cherry in this way,” says chief executive Dimitri Dimitriou.
That’s an understatement. It is unheard of to reclaim such a precious asset, and ImmuPharma’s management and lawyers should be commended for their diligence in drafting the initial contract with Cephalon.
The next step is to find a new licensing partner for Lupuzor, which has the all-clear to go into phase III clinical trials.
Once completed, the approval process will be fast-tracked by America’s all powerful Food & Drug Administration, shaving around a year off the process.
The company has also been given approval to start the next phase of development with a Special Protocol Assessment. This SPA is an important sign-off on the company’s clinical trial protocols.
The agency is essentially saying that, assuming no unforeseen issues, it will approve the drug if it matches or exceeds certain criteria.
Since the SPA is granted before the data is generated, the FDA tends to be conservative when handing them out.
Dimitriou revealed recently he has “rekindled” negotiations with big pharma companies interested in Lupuzor.
And it seems the interest is coming from all around the world, including the UK, US, Europe and Japan.
“The names include the top 10 or 15 in the world,” he adds.
“We had discussions with companies before Cephalon. It was very easy to rekindle those discussions. The great thing is the stage Lupuzor has got to.”
ImmuPharma is likely to be able to negotiate a very attractive deal given Lupuzor is so far advanced through the clinical trials process.
The headline value of the Cephalon licensing agreement included double-digit royalties plus US$500 million cash, including upfront payments of US$45 million which ImmuPharma received and are not refundable.
“The deal with Cephalon was large,” says Dimitriou. “I would like to get a big upfront this time around too.”
The potential market for the drug is significant, with around 1.5 million sufferers just in the G7 countries. The potential worldwide is even larger.
Benlysta, a new drug launched earlier this year by GlaxoSmithKline and Human Genome Sciences, is the first new drug in 50 years for lupus and should help pave the way for ImmuPharma’s drug.
HGS, before the launch, suggested Benlysta could effectively target around 200,000 suffers of this debilitating illness.
At this point the company was talking about selling the treatment for US$20,000 a year, giving potential peak sales of around US$4 billion. However it is currently being marketed at US$35,000 per annum.
“We have said for Lupuzor our target price may be around US$10,000 – US$15,000 a month,” Dimitriou reveals.
“Perhaps the licensee will go with another figure. But it is still going to be a lot less than US$35,000.”
The price differential is explained by the fact that Lupuzor is significantly cheaper to produce.
However it’s not an inferior product. Tests have shown it is more efficacious, well tolerated and easier to administer than Benlysta.
All of which should help open the drug to a much wider audience.
Dimitriou expects it will take around two years from the start of phase III to get Lupuzor out into the market, although cash will come in much before that if ImmuPharma does a deal with a pharma company.
To keep the risk low, ImmuPharma plans to let the partner start, manage and fund phase III. Normally, a beauty parade of this kind takes anywhere up to a year, but the company is well into partnering discussions.
The ImmuPharma chief hopes to have concluded a licensing deal in six to eight months, and adds: “I would really hope by the end of this year we will have a deal.”
There is the other alternative: that ImmuPharma is taken out before it can conclude these negotiations.
Certainly with company’s market value, sitting at £65 million, it might make financial sense for a predatory drugs company to make a play for the group.
“We would be open to something that offered value. But the simple fact is big pharma tends not to like to buy companies outright; a licensing deal comes usually first,” says Dimitriou.
And he is right. They prefer the more collaborative, ‘suck and see’ approach that a licence or joint venture deal affords.
As well as Lupuzor, ImmuPharma also has IPP-204106, a cancer compound born of its collaboration with France’s Centre Nationale Recherche Scientifique.
It has a dual action in that it targets cell proliferation and the development of new blood vessels, a process called angiogenesis.
With around £10 million in the bank the group has the funds to take it to the end phase.
Any extra cash will allow the company to progress potential drug candidates for the hospital super-bug MRSA, severe pain and inflammation.
What ImmuPharma won’t be doing is spending its new found wealth on acquisitions.
However, Dimitriou might consider a special dividend if it is deemed an appropriate use of any excess funds. “We do not have a closed mindset on the idea,” the ImmuPharma CEO adds.
According to brokers, the current share price of 79 pence wildly under-estimates the company’s potential, and the value of Lupuzor.
Merchant Securities reckons ImmuPharma is worth 323 pence a share.
In a note to clients it said: “ImmuPharma is one of the few biotechnology companies in the UK market with full control over a late-stage asset which is ready to start Phase III (pivotal) clinical trials in the short-term, and be re-licensed for a second time to a major pharmaceutical company, as a potential best in class product.”
116 Postings ausgeblendet.
01.04.19 10:40
#118
clint65
das Einzige an der Meldung, was gut ist, ist
das Ende:
"For further information please contact:
ImmuPharma plc (www.immupharma.com)
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Vassil Kirtchev
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes
SI Capital (Joint Broker)
Nick Emerson"
Stanford Capital Partners und SI Capital sind wohl noch engagiert. Da kann man nur auf deren Professionalität setzen und ich hoffe, dass der Laden komplett verkauft wird an jemanden, der die nötigen Schritte durchziehen und finanzieren kann. Zumindest setze ich auf einen Verkauf der NASH-Aktivitäten.
Noch mal zu der Meldung: Warum sollte sich jemand melden, um ein besseres Angebot abzugeben als Incanthera. Soll er bei Tim MC anrufen und nachfragen, wo der doch mit sich selber verhandelt und auch die Interessen Incantheras vertritt, also des Interessenten.
Negativ bleibt, das bis jetzt nichts kursbewegendes oder inhaltliches passiert ist, obwohl wohl noch die joint broker an Bord sind und damit zumindest Professionalität gebucht wurde.
Nur meine Meinung!
"For further information please contact:
ImmuPharma plc (www.immupharma.com)
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Vassil Kirtchev
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes
SI Capital (Joint Broker)
Nick Emerson"
Stanford Capital Partners und SI Capital sind wohl noch engagiert. Da kann man nur auf deren Professionalität setzen und ich hoffe, dass der Laden komplett verkauft wird an jemanden, der die nötigen Schritte durchziehen und finanzieren kann. Zumindest setze ich auf einen Verkauf der NASH-Aktivitäten.
Noch mal zu der Meldung: Warum sollte sich jemand melden, um ein besseres Angebot abzugeben als Incanthera. Soll er bei Tim MC anrufen und nachfragen, wo der doch mit sich selber verhandelt und auch die Interessen Incantheras vertritt, also des Interessenten.
Negativ bleibt, das bis jetzt nichts kursbewegendes oder inhaltliches passiert ist, obwohl wohl noch die joint broker an Bord sind und damit zumindest Professionalität gebucht wurde.
Nur meine Meinung!
07.05.19 14:20
#120
clint65
Immupharma bewegt sich - endlich!
"Lupuzor™ is the Company's late stage asset for Lupus, a potential life threatening auto-immune disease. Following the conclusion of the pivotal Phase III trial in 2018, ImmuPharma continues to look at opportunities which the Board believes over the longer term have the potential of bringing Lupuzor™ to market. As part of this strategy, the Company confirms that it continues to engage with potential corporate partners as well as consulting with regulatory advisors on potential pathways to market. Whilst these activities continue the commencement of the Managed Access Program for Lupuzor™ will be postponed until the Company has further clarification on these activities." Alleine können sie das wohl nicht stemmen, es wird nach einer Alternative zum Alleingang gesucht.
"Merger of Elro Pharma and Ureka", da erscheint mehr Potential zu sein, indem man die beiden restlichen Pipelinekandidaten zusammenfasst, um die Ausgliederung voran zu treiben, Finanzierung, Deal, IPO ... "Further details will be announced in due course." Da stehen schon Interessenten in der Warteschleife, ansonsten macht dieses Vorgehen keinen Sinn.
"Further to the announcement of 1 April 2019, all discussions with Incanthera on the Nucant cancer programme and broader collaboration discussions have now terminated." Oh la la, Tim Mc gescheitert und das ganz offiziell! Da setze ich auf Zimmer, der jetzt wohl endgültig zurück gepfiffen hat. Tim mit sich selber verhandelt (Board of Incanthera) und nichts bewirkt, außer 2 Millionen abgezogen von Immupharma für eine 16 Prozent Beteiligung an Incanthera. Damit ist sein Gehalt dort gesichert, aber für ihn eine offizielle Blamage. Vielleicht kostet ihm das den Kopf bei Immu.
"ImmuPharma will provide a further update on its operations and strategy in its Final results for the year ended 31 December 2018, which are expected to be announced by the end of this month." Also Ende Mai als Zeitfenster, das ist doch mal was.
"and the overall P140 platform for different auto-immune indications." Vielleicht geht da ja auch noch was außer Lupus.
Und die sind auch noch dabei: Stanford Capital Partners (Joint Broker) als Unterzeichner. Die sollen jetzt mal aktiv werden für das Geld, was sie verdienen. Eigentlich für Lupus Deal geholt, könnten Sie jetzt goldwert sein mit ihren Erfahrungen und Beziehungen für eine Finanzierung, Deal, Auslagerung etc.
Erst mal läßt die Meldung vieles offen, sorgt aber für Phantasie und stützt mit dem Zeitfenster auch den Aktienkurs, der ja unter 10 Pence gerutscht ist, ich meine auf Allzeittief.
Bin gespannt!
"Lupuzor™ is the Company's late stage asset for Lupus, a potential life threatening auto-immune disease. Following the conclusion of the pivotal Phase III trial in 2018, ImmuPharma continues to look at opportunities which the Board believes over the longer term have the potential of bringing Lupuzor™ to market. As part of this strategy, the Company confirms that it continues to engage with potential corporate partners as well as consulting with regulatory advisors on potential pathways to market. Whilst these activities continue the commencement of the Managed Access Program for Lupuzor™ will be postponed until the Company has further clarification on these activities." Alleine können sie das wohl nicht stemmen, es wird nach einer Alternative zum Alleingang gesucht.
"Merger of Elro Pharma and Ureka", da erscheint mehr Potential zu sein, indem man die beiden restlichen Pipelinekandidaten zusammenfasst, um die Ausgliederung voran zu treiben, Finanzierung, Deal, IPO ... "Further details will be announced in due course." Da stehen schon Interessenten in der Warteschleife, ansonsten macht dieses Vorgehen keinen Sinn.
"Further to the announcement of 1 April 2019, all discussions with Incanthera on the Nucant cancer programme and broader collaboration discussions have now terminated." Oh la la, Tim Mc gescheitert und das ganz offiziell! Da setze ich auf Zimmer, der jetzt wohl endgültig zurück gepfiffen hat. Tim mit sich selber verhandelt (Board of Incanthera) und nichts bewirkt, außer 2 Millionen abgezogen von Immupharma für eine 16 Prozent Beteiligung an Incanthera. Damit ist sein Gehalt dort gesichert, aber für ihn eine offizielle Blamage. Vielleicht kostet ihm das den Kopf bei Immu.
"ImmuPharma will provide a further update on its operations and strategy in its Final results for the year ended 31 December 2018, which are expected to be announced by the end of this month." Also Ende Mai als Zeitfenster, das ist doch mal was.
"and the overall P140 platform for different auto-immune indications." Vielleicht geht da ja auch noch was außer Lupus.
Und die sind auch noch dabei: Stanford Capital Partners (Joint Broker) als Unterzeichner. Die sollen jetzt mal aktiv werden für das Geld, was sie verdienen. Eigentlich für Lupus Deal geholt, könnten Sie jetzt goldwert sein mit ihren Erfahrungen und Beziehungen für eine Finanzierung, Deal, Auslagerung etc.
Erst mal läßt die Meldung vieles offen, sorgt aber für Phantasie und stützt mit dem Zeitfenster auch den Aktienkurs, der ja unter 10 Pence gerutscht ist, ich meine auf Allzeittief.
Bin gespannt!
22.05.19 08:53
#121
clint65
gute Analyse ...
"On Dallo's scenarios:
1 Lupuzor
A partnership with a large Pharma to develop Lupuzor: IMM has clearly signalled a deal is under discussion, to the extent they have postponed the MAP. Having spent time in the data room, it is possible the party has reasons to be attracted by the opportunity to trial Lupuzor on other indications as well as Lupus. A deal with a pharma with credibility to progress to another PIII trial would trigger a rerating of the sp.
2 Elro Pharma / Ureka merger
A trade buyer found or an announcement to float on European Stock Market: IMM have clearly spent time assessing the potential of the Ureka peptide platform and optimal route to realising value from this and the Nucant programme. A float is the more likely outcome as IMM could take forward the drug development programmes.
3 Extension Trials
A positive result from the limited Extension Trials. News of a possible deal during the late stages of the study could be linked. However, the results will be of limited value as the number of participants is small and it is not a randomised double blind study with a balance between patients on active and placebo.
4 Incanthera
Incanthera announce a date to float on AIM. Only a genius could put a positive spin on spending £2m on an unlisted company with no early possibility of an exit. Utter madness, what on were the directors thinking?
5 Offer for Immupharma
A bid for the entire company for a price that would be petty cash for a large Pharma: In our collective wildest dreams. Zimmer isn't selling, he'll take his shares to his grave and beyond.
So we live in hope: 2 a real possibility within say 12 months, 1 a possibility. More news has been flagged for the end of the month, ie next week and after that a AGM is due as are the Extension Study results. All fuel to power the sp pending announcement re deal and float."
vom 21.05.2019 User YoungHarry ...
1 Lupuzor
A partnership with a large Pharma to develop Lupuzor: IMM has clearly signalled a deal is under discussion, to the extent they have postponed the MAP. Having spent time in the data room, it is possible the party has reasons to be attracted by the opportunity to trial Lupuzor on other indications as well as Lupus. A deal with a pharma with credibility to progress to another PIII trial would trigger a rerating of the sp.
2 Elro Pharma / Ureka merger
A trade buyer found or an announcement to float on European Stock Market: IMM have clearly spent time assessing the potential of the Ureka peptide platform and optimal route to realising value from this and the Nucant programme. A float is the more likely outcome as IMM could take forward the drug development programmes.
3 Extension Trials
A positive result from the limited Extension Trials. News of a possible deal during the late stages of the study could be linked. However, the results will be of limited value as the number of participants is small and it is not a randomised double blind study with a balance between patients on active and placebo.
4 Incanthera
Incanthera announce a date to float on AIM. Only a genius could put a positive spin on spending £2m on an unlisted company with no early possibility of an exit. Utter madness, what on were the directors thinking?
5 Offer for Immupharma
A bid for the entire company for a price that would be petty cash for a large Pharma: In our collective wildest dreams. Zimmer isn't selling, he'll take his shares to his grave and beyond.
So we live in hope: 2 a real possibility within say 12 months, 1 a possibility. More news has been flagged for the end of the month, ie next week and after that a AGM is due as are the Extension Study results. All fuel to power the sp pending announcement re deal and float."
vom 21.05.2019 User YoungHarry ...
24.05.19 13:07
#122
clint65
Zahlen 2018 und Infos ...
nix Besonderes, außer Ende Q 2 Ergebnisse der verlängerten open-label Studie zu Lupus (62 Patienten), Verhandlungen mit Partnern P 140, 7,2 Millionen übrig (bestens der Deal mit Incanthera für 2 Millionen, Gegenleistung gen Null) ...
Geld reicht vielleicht noch bis Beginn 2021 positiv geschätzt und ohne Gewähr (Kosten P III Lupus weg)
eigentlich nix Neues!
Geld reicht vielleicht noch bis Beginn 2021 positiv geschätzt und ohne Gewähr (Kosten P III Lupus weg)
eigentlich nix Neues!
28.05.19 16:03
#123
clint65
jeder sollte sich bewußt sein, dass Immupharma
mit einer MK von ca. 14 Millionen Pfund gehandelt wird an der Börse und das nicht ohne Grund ... wenn die Aussichten so rosig sind und Lupuzor Blockbusterpotential hat, warum dann diese MK? Alles andere ist Geseiere von Tim MC wie schon so oft gehört ...
29.05.19 11:18
#124
clint65
Interview mit Tim MC
https://www.directorstalk.net/...mccarthy-at-immupharma-plc-lonimm-3/
05.06.19 15:51
#126
clint65
ich sag mal so, wenn Immupharma
mit Lupozor in der Europa-Cohorte mit Antibody "Kennung" einen statistischen Erfolg aufweisen könnte in einer neuen Trial, dann ja und dann ... nur, warum wurde das nicht vorab veröffentlicht, nachdem man die Subgruppenanalyse der failed P III angekündigt hat? Und warum hat Big Pharma, die ein Stillschweigeabkommen unterzeichnet hatten, nicht zugeschlagen im letzten Jahr nach Datensichtung P III?
Sollte Lupuzor -auch wenn nur in einer Untergruppe - erfolgreich sein, dann sind 92 Pence eher konservativ.
Keine Handelsempfehlung!!!
Sollte Lupuzor -auch wenn nur in einer Untergruppe - erfolgreich sein, dann sind 92 Pence eher konservativ.
Keine Handelsempfehlung!!!
05.06.19 16:53
#127
clint65
mal ne gute Analyse von einem User
auf dem lse chat zu dem obigen Interview:
"It could be argued this interview provides investors with the most significant news since the PIII read out.
First, it provides a third party endorsement of the Board's view that Lupuzor will reach the market.
Second, it explains this endorsement by arguing a second PIII trial with patients who have 'the true Lupus condition' (ie those with high levels of anti-ds DNA positive) has a real prospect of success.
Third, it refers to the responder rate of 71.% among the European cohort of patients with the above biomarker. A response rate not achieved in any other Lupus PIII trial. This is of course a cohort within a cohort and the responder rate was 35.7% among the equivalent US cohort. However Navid argues a PIII trial could combine:
I) A better targeted patient group: the target patients being those with the biomarker who account for around 70% of the Lupus patient population (in the PIII trial this group on active accounted for 58.5% of the Europe cohort (actual 38 out of 65) and 38.9% of the US cohort (actual numbers 14 of 36)
2) A more helpful regulatory regime with evidence of a pragmatism around end points and trial design.
On this basis it is easier to understand the company's confidence in Lupuzor and prospects for a licence deal and second PIII trial"
"It could be argued this interview provides investors with the most significant news since the PIII read out.
First, it provides a third party endorsement of the Board's view that Lupuzor will reach the market.
Second, it explains this endorsement by arguing a second PIII trial with patients who have 'the true Lupus condition' (ie those with high levels of anti-ds DNA positive) has a real prospect of success.
Third, it refers to the responder rate of 71.% among the European cohort of patients with the above biomarker. A response rate not achieved in any other Lupus PIII trial. This is of course a cohort within a cohort and the responder rate was 35.7% among the equivalent US cohort. However Navid argues a PIII trial could combine:
I) A better targeted patient group: the target patients being those with the biomarker who account for around 70% of the Lupus patient population (in the PIII trial this group on active accounted for 58.5% of the Europe cohort (actual 38 out of 65) and 38.9% of the US cohort (actual numbers 14 of 36)
2) A more helpful regulatory regime with evidence of a pragmatism around end points and trial design.
On this basis it is easier to understand the company's confidence in Lupuzor and prospects for a licence deal and second PIII trial"
05.06.19 20:01
#128
clint65
#127, zum nachlesen (Interview)
https://www.directorstalk.net/...mccarthy-at-immupharma-plc-lonimm-3/
28.06.19 08:01
#130
clint65
vielleicht war das ja der Preis für die Lanstead-
"ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, held its AGM earlier today and is pleased to announce that all resolutions were duly passed."
Auch die Entlastung Tim MCC ...
Vielleicht ja heute morgen noch die News zur open label extension Studie von Immupharma für spätestens Ende Q 2 angekündigt ...
Investition:
"ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, held its AGM earlier today and is pleased to announce that all resolutions were duly passed."
Auch die Entlastung Tim MCC ...
Vielleicht ja heute morgen noch die News zur open label extension Studie von Immupharma für spätestens Ende Q 2 angekündigt ...
28.06.19 08:21
#131
clint65
News ...
wie die zu werten sind, muss jeder selber entscheiden ...
http://www.lse.co.uk/...ar96yzl&ArticleHeadline=Update_on_Lupuzor
http://www.lse.co.uk/...ar96yzl&ArticleHeadline=Update_on_Lupuzor
28.06.19 12:07
#132
clint65
bin raus, aus meiner
Sicht hat Tim MC sich mit dem Lanstead Deal Zeit verschafft; kein Pharmaunternehmen wird Lupuzor zur Zulassung bringen. So ist meine Meinung. Die Werte (Pipeline) werden wohl sukzessive verhökert werden. Darauf kann man setzen, aber nicht zu dem aktuellen Kurs.
Eine Einttäuschung für mich, die Patienten, Sylvaine Muller usw.
P 140 mag funktionieren, aber es lässt sich nicht validieren. Die P III in den Teich gesetzt, weil schlecht geplant mit den Location. Open Label schlecht ausgefallen. Ich erinnere mich an die Aussage von Chalifman mir gegenüber hier, dem Poeten: "Lupus ist eine der am schwersten zu behandelnden Erkrankungen!" Und er hatte recht behalten.
Nur meine Meinung!
Eine Einttäuschung für mich, die Patienten, Sylvaine Muller usw.
P 140 mag funktionieren, aber es lässt sich nicht validieren. Die P III in den Teich gesetzt, weil schlecht geplant mit den Location. Open Label schlecht ausgefallen. Ich erinnere mich an die Aussage von Chalifman mir gegenüber hier, dem Poeten: "Lupus ist eine der am schwersten zu behandelnden Erkrankungen!" Und er hatte recht behalten.
Nur meine Meinung!
28.11.19 09:52
#134
clint65
schön für die Betroffenen und
Sylviane Muller und die französische Forschungsabteilung. Hatte die ganze Zeit im Gefühl, dass jetzt etwas kommen musste ... aber natürlich nicht investiert, da im Prinzip die Aktie am Ende war ...
https://www.lse.co.uk/news/IMM/...-united-states-itpggk48fv1avp4.html
https://www.lse.co.uk/news/IMM/...-united-states-itpggk48fv1avp4.html
24.07.21 13:09
#139
bmuesli
News vom 16.07.21
IN BRIEF: ImmuPharma appoints COO Tim Franklin to board of directors
Fri, 16th Jul 2021 11:24Alliance News
ImmuPharma PLC - pharmaceutical company based in London - Appoints Tim Franklin to the board of directors. Says Franklin has worked with the company for over three years and was appointed as chief operating officer in November 2020. Notes that Franklin currently holds 1.5 million options over ordinary shares in the company.
Says Franklin will lead collaboration with Avion Pharmaceuticals LLC, based in the US state of Georgia, to progress lupuzor through a phase-three trial and towards regulator approval. The two firms partnered in 2020 to develop lupazor, used to treat systemic lupus erythematosus, a potentially life-threatening autoimmune disease.
Franklin formerly worked in clinical research and sales for pharmaceutical companies Warner Lambert and SmithKline Beecham, which now is GlaxoSmithKline PLC. Previously, he was a pharmaceuticals analyst for German investment bank Dresdner Kleinwort.
Chair Tim McCarthy says: "[Franklin's] extensive pharmaceutical and capital markets experience will contribute enormously to the team as we look to move into the next phase of our journey for the company."
Current stock price: 8.85 pence, up 7.4% on Friday morning
Year-to-date change: down 34%
By Scarlett Butler; scarlettbutler@alliancenews.com
Fri, 16th Jul 2021 11:24Alliance News
ImmuPharma PLC - pharmaceutical company based in London - Appoints Tim Franklin to the board of directors. Says Franklin has worked with the company for over three years and was appointed as chief operating officer in November 2020. Notes that Franklin currently holds 1.5 million options over ordinary shares in the company.
Says Franklin will lead collaboration with Avion Pharmaceuticals LLC, based in the US state of Georgia, to progress lupuzor through a phase-three trial and towards regulator approval. The two firms partnered in 2020 to develop lupazor, used to treat systemic lupus erythematosus, a potentially life-threatening autoimmune disease.
Franklin formerly worked in clinical research and sales for pharmaceutical companies Warner Lambert and SmithKline Beecham, which now is GlaxoSmithKline PLC. Previously, he was a pharmaceuticals analyst for German investment bank Dresdner Kleinwort.
Chair Tim McCarthy says: "[Franklin's] extensive pharmaceutical and capital markets experience will contribute enormously to the team as we look to move into the next phase of our journey for the company."
Current stock price: 8.85 pence, up 7.4% on Friday morning
Year-to-date change: down 34%
By Scarlett Butler; scarlettbutler@alliancenews.com
24.07.21 13:13
#140
bmuesli
News vom 24 Juni 2021
BRIEF: Immupharma nähert sich der Phase-3-Studie von Lupazor
Do, 24.06.2021 13:40Allianz News
Immupharma PLC – ein in London ansässiges Pharmaunternehmen – bestätigt, dass sein Partnerunternehmen Avion Pharmaceuticals eine positive Antwort von der US-amerikanischen Food & Drug Administration erhalten hat, um eine Phase-3-Studie seiner Lupazor-Behandlung zu beginnen. Die beiden Firmen haben sich zusammengetan, um Lupazor zu entwickeln, das zur Behandlung von systemischem Lupus erythematodes, einer potenziell lebensbedrohlichen Autoimmunerkrankung, eingesetzt wird.
"Wir würdigen die Unterstützung der FDA nach konstruktiven Besprechungen und Feedback in diesem Jahr mit unserem Partner Avion weiterhin", sagt Tim Franklin, Chief Operating Officer von Immupharma.
"Immupharma und Avion sind fest entschlossen, in diesem Jahr mit der Lupuzor-Phase-3-Studie bei Lupus-Patienten zu beginnen."
Aktueller Aktienkurs: 8,84 Pence, ein Plus von 6,5% am Donnerstag
Veränderung seit Jahresbeginn: minus 34 %
Von Will Paige; willpaige@alliancenews.com
Copyright 2021 Alliance News Limited. Alle Rechte
https://www.lse.co.uk/news/...-phase-three-trial-sf8763y22xtylt2.html
Do, 24.06.2021 13:40Allianz News
Immupharma PLC – ein in London ansässiges Pharmaunternehmen – bestätigt, dass sein Partnerunternehmen Avion Pharmaceuticals eine positive Antwort von der US-amerikanischen Food & Drug Administration erhalten hat, um eine Phase-3-Studie seiner Lupazor-Behandlung zu beginnen. Die beiden Firmen haben sich zusammengetan, um Lupazor zu entwickeln, das zur Behandlung von systemischem Lupus erythematodes, einer potenziell lebensbedrohlichen Autoimmunerkrankung, eingesetzt wird.
"Wir würdigen die Unterstützung der FDA nach konstruktiven Besprechungen und Feedback in diesem Jahr mit unserem Partner Avion weiterhin", sagt Tim Franklin, Chief Operating Officer von Immupharma.
"Immupharma und Avion sind fest entschlossen, in diesem Jahr mit der Lupuzor-Phase-3-Studie bei Lupus-Patienten zu beginnen."
Aktueller Aktienkurs: 8,84 Pence, ein Plus von 6,5% am Donnerstag
Veränderung seit Jahresbeginn: minus 34 %
Von Will Paige; willpaige@alliancenews.com
Copyright 2021 Alliance News Limited. Alle Rechte
https://www.lse.co.uk/news/...-phase-three-trial-sf8763y22xtylt2.html
24.07.21 13:17
#141
bmuesli
nächste Woche wird spannend
ImmuPharma plc E-Mail-Benachrichtigungsdienst
ImmuPharma SPS
("ImmuPharma" oder das "Unternehmen")
FDA stimmt der Lupzuor PK-Studie über eine schriftliche Antwort auf das „Typ C“-Meeting zu, während Avion sich auf die internationale Phase-3-Studie vorbereitet
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), das auf Arzneimittelforschung und -entwicklung spezialisierte Unternehmen, gibt bekannt, dass sein US-LupuzorPartner Avion Pharmaceuticals (Avion) eine positive Antwort von der US-amerikanischen Food & Drug Administration erhalten hat ("FDA") für ein "Typ C"-Meeting. Die FDA hat mitgeteilt, dass kein formelles persönliches Treffen erforderlich ist, und wird Avion ihre schriftliche Antwort voraussichtlich bis Ende Juli 2021 übermitteln.
Wie in unserer vorherigen Ankündigung vom 9. Februar erwähnt, ist dies die letzte Sitzung mit Leitlinien, auf der die FDA die vorgeschlagene Methodik der pharmakokinetischen Studie („PK“) überprüfen wird. Diese Studie wurde von der FDA als Teil der neuen optimierten internationalen Phase-3-Studie zu Lupuzor bei systemischem Lupus erythematodes ("SLE"), einer potenziell lebensbedrohlichen Autoimmunerkrankung, angefordert.
ImmuPharma wird ein Update bereitstellen, sobald Avion die schriftliche Antwort der FDA erhalten und ImmuPharma über die nächsten Schritte und den Zeitplan für den Beginn der Phase-3-Studie in diesem Jahr informiert hat.
Die Ankündigung kommentierte Tim Franklin, COO von ImmuPharma:
„Wir würdigen weiterhin die Unterstützung der FDA nach konstruktiven Treffen und Feedback in diesem Jahr mit unserem Partner Avion. ImmuPharma und Avion sind fest entschlossen, in diesem Jahr mit der Lupuzor Phase-3-Studie bei Lupus-Patienten zu beginnen. Auch hier wiederholen wir den einzigartigen Wirkmechanismus von Lupuzo und bisher ein robustes Sicherheitsprofil, von dem wir glauben, dass es Lupuzor als Erstlinientherapie für viele Lupus-Kranke weltweit positionieren wird."
Resom
ImmuPharma SPS
("ImmuPharma" oder das "Unternehmen")
FDA stimmt der Lupzuor PK-Studie über eine schriftliche Antwort auf das „Typ C“-Meeting zu, während Avion sich auf die internationale Phase-3-Studie vorbereitet
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), das auf Arzneimittelforschung und -entwicklung spezialisierte Unternehmen, gibt bekannt, dass sein US-LupuzorPartner Avion Pharmaceuticals (Avion) eine positive Antwort von der US-amerikanischen Food & Drug Administration erhalten hat ("FDA") für ein "Typ C"-Meeting. Die FDA hat mitgeteilt, dass kein formelles persönliches Treffen erforderlich ist, und wird Avion ihre schriftliche Antwort voraussichtlich bis Ende Juli 2021 übermitteln.
Wie in unserer vorherigen Ankündigung vom 9. Februar erwähnt, ist dies die letzte Sitzung mit Leitlinien, auf der die FDA die vorgeschlagene Methodik der pharmakokinetischen Studie („PK“) überprüfen wird. Diese Studie wurde von der FDA als Teil der neuen optimierten internationalen Phase-3-Studie zu Lupuzor bei systemischem Lupus erythematodes ("SLE"), einer potenziell lebensbedrohlichen Autoimmunerkrankung, angefordert.
ImmuPharma wird ein Update bereitstellen, sobald Avion die schriftliche Antwort der FDA erhalten und ImmuPharma über die nächsten Schritte und den Zeitplan für den Beginn der Phase-3-Studie in diesem Jahr informiert hat.
Die Ankündigung kommentierte Tim Franklin, COO von ImmuPharma:
„Wir würdigen weiterhin die Unterstützung der FDA nach konstruktiven Treffen und Feedback in diesem Jahr mit unserem Partner Avion. ImmuPharma und Avion sind fest entschlossen, in diesem Jahr mit der Lupuzor Phase-3-Studie bei Lupus-Patienten zu beginnen. Auch hier wiederholen wir den einzigartigen Wirkmechanismus von Lupuzo und bisher ein robustes Sicherheitsprofil, von dem wir glauben, dass es Lupuzor als Erstlinientherapie für viele Lupus-Kranke weltweit positionieren wird."
Resom