Bei Indevus wird es demnächst, genauer gesagt am 28.5., wieder spannend. Dann steht nämlich die Zulassung von Sanctura (Trospium) gegen overactive bladder durch die FDA an. Die Entscheidung wurde zwar schonmal um 3 Monate verschoben, doch sollte die Zulassung eigentlich irgendwann mal erfolgen, denn dieses Mittel wird bereits seit Jahren in Europa verkauft. Gegenüber der Konkurrenz im über 1 Mrd. USD großen Markt bestehen angeblich auch entscheidende Vorteile. Als Bonus gibt es bei erfolgreicher Zulassung vom Partner Pliva (50:50 Vermarktungspartner) einen Meilenstein von 120 Mio USD, was etwa 1/3 der MK von IDEV entspricht, die zur Zeit 340 Mio. USD beträgt. Ich denke, bei Zulassung könnte diese Aktie im Depot sehr lohnend sein.



Indevus' Big Score (Maybe)

By Charly Travers
April 8, 2004

Yesterday, small biotech Indevus Pharmaceuticals (Nasdaq: IDEV) announced that it has reached an agreement with the European pharmaceutical company PLIVA to market Indevus' drug Sanctura (Trospium). The deal is especially noteworthy because PLIVA is paying Indevus $30 million now and another $120 million if the Food and Drug Administration (FDA) approves the drug next month.

The cash payments totaling $150 million are a huge amount for Indevus, a company with a market cap just under $300 million. Given the magnitude of this potential payment compared to the company's market cap, it is interesting that the stock price has barely budged compared to the $6.05 closing price the day before the deal was announced.

The FDA decision on Sanctura can be expected right around May 28. That is the Prescription Drug User Fee Act action date by which the FDA should choose whether or not to approve the drug. This can almost be viewed as make or break for Indevus, at least with respect to the company's near-term fortunes. The other drugs in its pipeline are years from commercialization. Therefore, an extreme price move on this decision is probably to be expected.

If the FDA signs off on Sanctura, Indevus would pocket another $120 million and would have an approved drug that should be pretty competitive in the overactive bladder market despite competition from companies like Pfizer (NYSE: PFE). Under that scenario, I think we could expect the stock to take off from its current level. On the other hand, if the FDA turns the drug down or asks for additional data, then a standard biotech stock nosedive is probably to be expected. In this situation the magnitude of the decline would depend upon the ability to address the FDA's concerns in a timely manner.

Sanctura has points in its favor. It has been on the market in Europe for years; unlike some of the approved drugs in this segment, it does not cross the blood-brain barrier; and clinical data suggest that it has a lower incidence of dry mouth than the competitors. That said, guessing what the FDA will do can be playing with fire, and in this case, it looks like the market is being cautious.

mfg ipollit  

die Pipeline ist neben Sanctura auch gut gefüllt mit weiteren 2 Kandidaten in Phase III, 1 in Phase II und 2 in Phase I:

http://www.indevus.com/flash/ipi_products.swf

mfg ipollit  

mfg ipollit
 

bei 3,5 Mio shares neues 52W-Hoch... nächste Woche ist entsprechend der FDA-Entscheidung alles möglich bis hin zu einem 100%-spike



mfg ipollit :-)  

solche Leute brauchen wir !!

Danke ipollit !

Gruß
leo  

ich denke mal die Zulassung ist ziemlich sicher... die Frage ist nur, wie reagiert der Kurs. Naja immerhin gibt es im Erfolgsfall sofort 120 Mio USD... denke 50% sollten drin sein.

*********
alte Meldung zum Pliva-Deal...

Indevus' stock price has been creeping up as investors gradually realize just how good the co-promotion and licensing deal for Sanctura (trospium) is that was announced last Wednesday between the company and Pliva. Initial tepid response may have been because Pliva is not exactly a household word. Digging deeper, however, it is an international pharmaceutical company, based in Eastern Europe, listed on the London stock exchange, with annual sales of around $1 billion. In addition, Pliva is highly familiar with the product, having successfully marketed trospium in The Netherlands and Finland, and is obviously gung ho to establish a broader international marketing presence. The details of the deal are terrific. IDEV receives an upfront payment of $30 million and $120 million upon approval. (The PDUFA date is May 28.) Much of the latter sum will be funneled back into the Sanctura launch. IDEV and Pliva will co-promote Sanctura through a 500-person sales force. (IDEV will field 280 of these.) Initially, Pliva will pay IDEV a commission on net sales. Sometime within six months after approval, either company has the option to convert that agreement into a traditional royalty structure. (Details on the amount of that royalty will not be disclosed.) Down the road, Pliva will pay IDEV up to $65 million if certain milestones are met. Again, this is a great deal; IDEV shareholders should be very pleased with all it provides. Pfizer's Detrol is Sanctura's main competition in the overactive bladder market. Sanctura has a better side-effect profile than does Detrol, however, so we are optimistic about its potential assuming FDA approval.

mfg ipollit ;-)  

1. The FDA did not question anything in the Trospium NDA except for the QT Interval trial. All else was OK otherwise IDEV would have been compelled to additional disclosure.

2. The QT Interval Trial was submitted later than the rest of the NDA, and showed excellent results however the FDA needed the additional time to complete its review of this QT trial.

3. This QT Interval Trial was listed by IDEV as the only reason why the FDA extended the PADUFA Date to May 28.

4. Trospium is sold in many countries in Europe and other parts of the world and has a very well established market presence in these regions.

5. Trospium has a better efficacy profile than competing OAB drugs.

6. Trospium has a better side effect profile than competing OAB drugs.

7. Trospium does not have the same adverse interaction with many other drugs taken by seniors and others, as do the competing OAB drugs.

8. Trospium does not cross the blood / brain barrier like the competing OAB drugs.

9. If the Trospium is approved, IDEV will receive $120,000,000 by no later than May 28 and this will add to the $30,000,000 they already received.

10. IDEV stock was purchased TODAY by staff members at BioTech Monthly, which is of course a great sign.

11. IDEV Stock has moved down recently because of a broad based stock market selloff that has nothing to do with IDEV. IDEV had also moved down slowly just prior to the date by when the FDA had to accept or reject the Trospium NDA back in April 2003 -- and of course the FDA accepted the Trospium NDA.

12. All is on track for a Great Day later in May so lets sit back and enjoy the great prospects that IDEV's management has built for Trospium, and the remainder of their pipeline!!

13. THIS STOCK WAS TAKEN UP 33 percent FROM $6 to $8 by "SOPHISTICATED INSTITUTIONAL INVESTORS" just before the recent stock market selloff and just after the Pliva deal was announced.

14. IDEV and Pliva have/are hiring hundreds of salesreps for an IMMEDIATE PRODUCT Launch.

15. IDEV has already stockpiled millions of dollars of Trospium. It will be IMMEDIATELY available to wholesalers are approval.

********

mfg ipollit  

Gruss E.

http://ariva.de/board/128646/thread.m?a=  

ich bin gespannt...

A 30% share of a $3 billion OAB market in 2008, would give Santura sales of $900 million. Let's be real conservative and say that IDEV only gets 30% of that amount which would be $270 million. Subtract out about $50 million in annual R&D expenses and that would be $220 million in profits or roughly $4 per share.

Give IDEV a PE ratio of 25 and the same discount rate for 4 yrs to come up with the current fair market value based on future earnings.

25 * $4 = $100 and multiply it by (.75)(.75)(.75)(.75) which equals a $31.64 price per share. That would be the CURRENT fair market value since it has been discounted by 25%/yr for 4 years. Also, this value is based on sales from Sanctura alone! It doesn't include any revenues from other drugs in the pipeline. In fact this price doesn't reflect any value for IDEV's pipeline or their cash on hand.

Another guy named build a burger (or something like that) did a much more thorough analysis a long time ago, and also came up with about a $30 price per share using different numbers. Anyway, my point is, the OAB market is huge and growing. Once analysts get on this stock and start running the numbers we should get numerous "Strong Buy" recommendations.

auch wenn die obrige Rechnung vielleicht zu optimistisch ist... noch sind sie für 8.42€ zu haben...

mfg ipollit  

Die heisse Luft ist raus !  

jetzt scheint alles (r)aus zu sein !!  

oder muß ich das Licht ausmachen?Ich Depp habe mich durch eine Empfehlung des Aktionärs vor kurzem in Indevus Pharma locken lassen.Ich muß dringend das Abo kündigen,die Tipps des Aktionärs treiben mich in Hartz 4.Zwei Anmerkungen bzw. Fragen an Leidensgenossen,falls es noch welche gibt.1).Das die FDA z.Z.gegen europäische Pharma Amok läuft ( Jerini etc.etc.)ist mir schon klar,nur Indevus ist eine US Firma.Eine total überzogene Entscheidung,zumal Nebido seit Jahren problemlos in Europa im Einsatz ist.2).Die Aktie stürzt um 70%,obwohl Indevus Pharma noch etliche Medikamente am Markt hat.Dann werden am nächsten Tag 17 Millionen Aktien gehandelt,und der Kurs verwurzelt.Da macht sich jemand billig die Taschen voll.Übernahme?Ich würde mich nicht wundern,wenn am nächsten FDA-Termin am 27 Juni eine Rolle rückwärts folgt.Ich werde jedenfalls aufstocken.Ich würde mich über andere Meinungen freuen.Gruß Wilbär.  

Das sehe ich genau so...Stich-Tag war gestern der 27.- war klar das dies mit einem rücksetzen noch mal kommt.
Ein Unternehmen mit 5 Produkten auf dem Markt wird sich wenn der Rauch verzogen hat wieder gegen Süden steuern...
Wirst sehen das wir in ein paar Monaten wo ganz anders stehen werden .
Ganz sicher ....
Grüße Bio
 

 

Kaufkurs  $ 2,10

denke das es hier wenn sich der Markt erholt steil bergauf geht

IDEV  hat sich mit FDA geeinigt
lest mal die Kursziele, welche nach der Veröffentlichung herausgegeben wurden
$  3,50 - 4  sollten bis Jahresende möglich sein  

 

das läuft auch TOPPPPPPPPPPP  

 

8 - 9 % Minus im Gesamtmarkt, da kann selbst  IDEV  sich nicht entziehen  

ca. 100 %  waren gut drin  

 

das ist schwach  !!!