Warum spricht keiner über Alkermes - 500 Beiträge pro Seite

[StLeske]

Hallo allerseits,

von und über so ziemlich alle Firmen wird hier gesprochen, über die Fa. Alkermes hört man jedoch so gut wie nichts.

Leider habe ich weiß Gott nicht die große Ahnung, aber ich glaube das schlechteste Unternehmen ist Alkermes nicht. Habt Ihr irgendwelche Zahlen über das Unternehmen und was denkt Ihr darüber? Sollte nicht Alkermes schon demnächst (oder machen sie es schon) schwarze Zahlen schreiben? Wann gibt es Quartalszahlen?

Seid nicht so faul - meldet Euch mal.

Bis dahin!!

[StLeske]

Morjen, morjen

was ist los mit Euch? Seid Ihr nur schreibfaul oder kennt Ihr Alkermes nicht weiter? Das sollte mich allerdings wundern.

Sicherlich ist diese Aktie nicht so interessant für Spekulationen wie z.B. Aktien aus der Genforschung, dafür sicherlich aber weitaus sicherer. Vielleicht höre ich ja doch noch mal was von Euch.

Bis dahin und noch einen guten Start ins WE

[StLeske]

Needham & Cowiederholt STRONG BUY Rating für Alkermes (ALKS) mit Kursziel 64 Dollar

Gruß StLeske

[StLeske]

Weiß einer was aktuelles über Alkermes. Vor allem gestern gingen sie richtig gut ab.

Gruß Stleske

[naiv]

Was ist die Ursache für den starken Kursrutsch???

[StLeske]

"Nicht entzückt waren die Investoren von den kürzlich veröffentlichten Plänen des Biotechunternehmens Alkermes, Inc. nun auch noch den Rest des Privatunternehmens Reliant Pharmaceuticals LLC, von dem sich bereits 17,6% im Besitz von Alkermes befinden, zu einem Preis von $934 Million zu übernehmen. Wie bekannt wurde, wird Reliant im Anschluss an die Übernahme als vollständiges Tocherunternehmen des in Cambridge, Mass., ansässigen Medikamentenherstellers Alkermes operieren. Und trotz der Tatsache, dass Reliant bereits fünf pharmazeutische Produkte mit einem Jahresumsatz in 2001 von $277 Millionen vermarktet, musste Alkermes nach Bekanntwerden des Deals einen Abschlag von 8% hinnehmen. Richard Pops, CEO des Unternehmens Alkermes, das auf die Produktentwicklung spezialisiert ist, sagte, wir werden auf jeden Fall von dieser Übernahme profitieren und zwar nicht nur dadurch, dass wir an den Produktumsätzen partizipieren werden, viel wichtiger erscheint uns die Expertise von Reliant bei der Vermarktung von Produkten. Diese Kenntnisse werden uns bei der Zulassung unserer eigenen Produkte von großem Nutzen sein." - aus deraktionär

Ich denke mal wie so oft reagieren einige über, wenn sie die großen Summen sehen, welche für solch eine Übernahme gezahlt werden. Ich glaube, der Kurs wird sich recht schnell wieder erholen und die Übernahme wird schon seine Richtigkeit haben.

[gholzbauer]

Monday July 1, 7:28 am Eastern Time

Reuters Company News
FDA rejects J&J`s injectable Risperdal

NEW YORK, July 1 (Reuters) - Health-care products maker Johnson & Johnson (NYSE:JNJ - News) and partner Alkermes Inc. (NasdaqNM:ALKS - News) on Monday said the U.S. Food and Drug Administration rejected their bid to market a long-acting, injectable version of the lucrative schizophrenia treatment Risperdal.

ADVERTISEMENT


J&J, of New Brunswick, New Jersey, said the FDA had questions about pre-clinical data relating to the new version of the drug, called Risperdal Consta. Pre-clinical data usually stems from the testing of a drug in animals.

"We believe we will be able to satisfactorily resolve the FDA`s questions about the pre-clinical data," said Dr. Harlan Weisman, executive vice president of research and development at J&J`s pharmaceutical research and development operations.

Risperdal, often administered to elderly patients in nursing homes, had first-quarter sales of $547 million, up 21 percent. The drug is currently administered as a pill or an oral liquid solution.

A spokeswoman for J&J said additional discussions with the FDA were needed before the companies could decide whether additional clinical trials would be necessary.



http://finance.yahoo.com/q?s=alks&d=e

[gholzbauer]

ALKS
8:15am 7.80$ -8.21$ -51.28%

[gholzbauer]

Sagt mal, wenn die FDA "nur" Fragen zu präklinischen Daten hat, dagegen an Phase-I/II/III offenbar nichts auszusetzen hat, so müßten JNJ und ALKS doch in der Lage sein, in relativ kurzer Zeit die unklaren Punkte auszuräumen?

Habe mir ALKS nach langer Zeit wieder etwas genauer angesehen. Die Cash-Burn-Rate von März `01 bis März `02 war ja grausam! (330Mio $ -> 160 Mio $, allerdings wurde ein Teil davon in Reliant gesteckt)
Cash 160 Mio $ sind nur noch 2,5$/Aktie, dafür sind 43 Mio $ Kurzfristverbindlichkeiten und 200 Mio Convertible Loans unterwegs.
ALKS wurde durch diese Zurückweisung der FDA wirklich auf dem falschen Fuß erwischt.




---------


Alkermes Plunges on Johnson & Johnson`s Nonapprovable Letter

By Michael Dunn
Staff Reporter
07/01/2002 09:15 AM EDT


Johnson & Johnson (JNJ:NYSE - news - commentary - research - analysis) said on Monday that the
Food and Drug Administration rejected its application for a long-lasting, injectable version of the schizophrenia drug Risperdal Consta.


The company received a nonapprovable letter from the agency, but, according to Johnson & Johnson, the letter "invited further dialogue with the agency to resolve questions regarding certain aspects of the pre-clinical data."

J&J added that no significant concerns were raised about the manufacturing process, so the company feels it can resolve the FDA`s questions.

Risperdal Consta was developed using the extended-release drug delivery technology created by Alkermes (ALKS:Nasdaq - news - commentary - research - analysis). If the drug were to be approved by the FDA, Alkermes would manufacture it, while Janssen Pharmaceutical Products, a wholly owned subsidiary of Johnson & Johnson, would market it in the U.S.

Shares of J&J were recently trading down about 2% to $51.25 in Instinet premarket trading, while Alkermes was plunging about 50% to $8.20.

[johnfromaustria]

Hier die Produktpipeline (www.alkermes.com)
___________________________________________
Projects..................Indication................Technology..............Collaborator.........Stage
Nutropin Depot®(hGH.....Growth Hormone Deficiency Pediatric....ProLease®....Genentech....Marketed
RisperdalConsta™....Schizophrenia...Medisorb®....Janssen....Filed for regulatory approvals
Nutropin Depot(hGH)....Growth Hormone Deficiency -Adults....ProLease®...Genentech....Phase III
r-hFSH....Infertility....ProLease®...Serono S.A....Phase I completed
Exendin-4(AC2993)...Diabetes....Medisorb® ...Amylin....Phase II
Insulin.....Diabetes....AIR™....Eli Lilly.....Undisclosed
hGH.....Growth Hormone Deficiency....AIR™....Eli Lilly....Phase I completed
Albuterol.....Asthma....AIR™...................Phase II completed
Vivatrex™*....Alcoholism and Opiate Abuse.....Medisorb®....................Phase III
__________________________________________

Das Unternehmen baut auf 3 verschiedene Technologien, mit denen Produkte in neuartigen Verabreichungsformen entwickelt werden. Die Pipeline spricht eigentlich für sich.

Die Ablehnung von Risperdal Consta durch die FDA führte zu einem finalen Sell-Off was den Kurs auf ein Niveau von ca. USD 4 brachte. Angesichts der prall gefüllten Produktpipeline eine ganz klare Unterbewertung, die allerdings durch die aktuelle Marktsituation untestützt wurde.

Etwas Entsprannung brachte dann die Meldung der Zulassung von Risperdal Consta für Deutschland.
____________________

Alkermes Announces Approval in
Germany for Risperdal Consta; First
Atypical Antipsychotic to be Available as
Long-Acting Injection

August 01, 2002 06:06:00 (ET)

CAMBRIDGE, Mass., Aug 1, 2002 (BW HealthWire) -- Alkermes, Inc. (ALKS, Trade) today announced that its
partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), has received approval to market
Risperdal Consta(TM) (risperidone) in Germany. The first launch of Risperdal Consta, the only approved
long-acting injection developed for a newer-generation, atypical antipsychotic, will occur in Germany following
yesterday`s approval by the national regulatory agency. The launch of Risperdal Consta in Germany by
Janssen-Cilag GmbH is planned for August 15. In a number of other countries, Risperdal Consta is in late-stage
regulatory review.

Risperdal Consta is administered once every two weeks, rather than daily, for the management of schizophrenia
-- a brain disorder affecting 1-2% of the world`s population. Until now, long-acting injectable formulations of
antipsychotics have been available only for older, conventional treatments. However, these conventional
antipsychotics are more likely to cause serious movement disorders and are not considered by most experts to
be as effective in treating "negative" symptoms (such as social withdrawal and apathy), as they are in alleviating
"positive" symptoms (including hallucinations and delusions).

"We are very pleased Risperdal Consta has been approved in this significant market," commented Richard Pops,
Chief Executive Officer of Alkermes. "The approval represents an important milestone in our goal of developing
Medisorb technology into innovative products that offer major therapeutic benefits for patients."

Risperdal Consta is a long-acting injectable formulation of Risperdal(R) that uses Alkermes` Medisorb(R)
drug-delivery technology. Risperdal Consta will be manufactured by Alkermes and the product will be marketed
by Janssen-Cilag in Germany.

Risperdal Consta was developed by J&JPRD to combine the advantages of long-acting delivery with the
established benefits of oral risperidone. Risperdal has been marketed in tablet form in the United States by
Janssen Pharmaceutica Products, L.P., since 1994, and is the most widely prescribed atypical antipsychotic in
the world. In a study published in a January issue of The New England Journal of Medicine, Risperdal was found
to be significantly more effective in reducing the risk of relapse than haloperidol, a conventional antipsychotic long
considered the "gold standard" in treatment of psychosis.

Using proprietary Medisorb technology developed by Alkermes, the new formulation encapsulates risperidone in
microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into
the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to
provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which
the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the
body.

Risperdal Consta has been submitted for review around the world. In the United States, discussions are ongoing
with the Food and Drug Administration (FDA), which has issued a non-approvable letter based on questions
related to certain aspects of the pre-clinical data. J&JPRD, which is responsible for obtaining regulatory approval
of Risperdal Consta, is currently in discussions with the FDA and is working to answer the agency`s questions.**
If approved in the US, Canada and elsewhere, Risperdal Consta will be manufactured by Alkermes and the
product will be marketed by Janssen Pharmaceutica Products, L.P. in the United States, Janssen-Ortho in Canada
and Janssen-Cilag elsewhere.

In the United States, Risperdal is indicated for the treatment of schizophrenia and is currently available in 0.25,
0.5, 1, 2, 3 and 4 mg tablets as well as a 1mg/mL oral solution. In clinical trials, Risperdal was generally well
tolerated. However, as with all other antipsychotics, Risperdal can cause some adverse events. In two controlled
trials, adverse events with an incidence of 5% or greater in at least one of the Risperdal groups and that
occurred at a rate at least twice that of placebo were anxiety, drowsiness, extrapyramidal symptoms
(uncontrolled tremors and muscle stiffness), dizziness, constipation, nausea, dyspepsia (upset stomach), rhinitis
(inflammation of nasal membranes), rash and tachycardia (rapid heart beat).
_________________________

Einige Marktteilnehmer haben diese Meldung wohl richtig interpretiert und haben den Kurs der Aktie in der letzten Woche um ca. 40 % ansteigen lassen. Deutschland sollte sich wohl als Brückenkopf für den europäischen Markt erweisen. Die Zulassung ist sicher richtungsweisend für andere Länder und auch in den USA ist das letzte Wort noch nicht gesprochen. J&J liefert zur Zeit Details an die FDA und was bei einem positiven Bescheid in den USA mit dem Aktienkurs passieren dürfte, kann sich jeder selbst ausdenken. Es ist vielleicht kein Fehler, jetzt schon einen Fuß in die Tür zu stellen.
Die neue Formulierung wird dann sehr schnell aufgrund der Anwendung nur alle zwei Wochen, das bisherige Medikament sehr rasch vollständig ablösen. Keiner der Konkurrenten hat ein Produkt in dieser Formulierung auf dem Markt.


LG johnfromaustria

[Simonswald]

Die machen ja noch nicht mal 100 Mio. $ Umsatz!

[johnfromaustria]

Wie erwartet folgte nach Deutschland nun auch die nächste Zulassung in Europa.
Hier die Nachricht über die Zulassung in GB.

_________________________________________
August 09, 2002 11:48:13 (ET)

NEW YORK, Aug 9 (Reuters) - Shares of Alkermes Inc. (ALKS,Trade) soared on Friday after its partner, Johnson
& Johnson (JNJ,Trade), received approval in the United Kingdom to sell a long-acting form of J&J`s schizophrenia
drug, Risperdal.

The U.K. approval comes only a week after Germany approved the injectable drug, called Risperdal Consta,
which uses Alkermes technology. It only needs to be given every two weeks instead of the daily dosing required
for J&J`s popular tablet form of Risperdal that has been sold since 1994.

Alkermes was up $1.59, or 25.7 percent, to $7.78 in Friday midday trade on the Nasdaq after hitting a session
high of $8.10. But shares of the Cambridge, Massachusetts-based drugmaker remain in the doldrums compared
to their 52-week high of $31.39.

They tumbled 68 percent on July 1 after the U.S. Food and Drug Administration rejected the injectable drug,
apparently over concerns it increased the risk of cancer in rodents.

Many schizophrenia patients fail or refuse to take medications to control hallucinations and other symptoms, a
reason Alkermes and J&J developed a more convenient form of Risperdal.

It is the first newer-generation schizophrenia drug to become available in injectable form, although older
long-acting injectable treatments are available that J&J says are less effective and more likely to cause serious
movement disorders.


Alkermes Announces Approval in United
Kingdom for Risperdal Consta

August 09, 2002 09:33:00 (ET)

CAMBRIDGE, Mass., Aug 9, 2002 (BW HealthWire) -- Alkermes, Inc. (ALKS, Trade) today announced that its
partner, Johnson and Johnson Pharmaceutical Research & Development (J&JPRD), has received approval from
The Medicines Control Agency to market Risperdal Consta(TM) (risperidone) in the United Kingdom. The UK
approval follows the recent approval of Risperdal Consta in Germany. The product will be launched in both
countries next week. Risperdal Consta is in late-stage regulatory review in number of other countries.

Risperdal Consta is administered once every two weeks, rather than daily, for the management of schizophrenia
-- a brain disorder affecting 1-2% of the world`s population. Until now, long-acting injection formulations of
antipsychotics have been available only for older, conventional treatments. However, these conventional
antipsychotics are more likely to cause serious movement disorders and are not considered by most experts to
be as effective in treating "negative" symptoms (such as social withdrawal and apathy), as they are in alleviating
"positive" symptoms (including hallucinations and delusions).

Risperdal Consta is a long-acting injection formulation of Risperdal(R) that uses Alkermes` Medisorb(R)
drug-delivery technology. Risperdal Consta will be manufactured by Alkermes and the product will be marketed
by Janssen-Cilag in the United Kingdom and Germany.

Risperdal Consta was developed by J&JPRD to combine the advantages of long-acting delivery with the
established benefits of oral risperidone. Risperdal has been marketed in tablet form in the United States by
Janssen Pharmaceutica Products, L.P., since 1994, and is the most widely prescribed atypical antipsychotic in
the world. In a study published in a January issue of The New England Journal of Medicine, Risperdal was found
to be significantly more effective in reducing the risk of relapse than haloperidol, a conventional antipsychotic long
considered the "gold standard" in treatment of psychosis.

Using proprietary Medisorb technology developed by Alkermes, the new formulation encapsulates risperidone in
microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into
the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to
provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which
the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the
body.

Risperdal Consta has been submitted for review around the world. In the United States, discussions are ongoing
with the Food and Drug Administration (FDA), which has issued a non-approvable letter based on questions
related to certain aspects of the pre-clinical data. J&JPRD, which is responsible for obtaining regulatory approval
of Risperdal Consta, is currently in discussions with the FDA and is working to answer the agency`s
questions.(1) If approved in the US, Canada and elsewhere, Risperdal Consta will be manufactured by Alkermes
and the product will be marketed by Janssen Pharmaceutica Products, L.P. in the United States, Janssen-Ortho in
Canada and Janssen-Cilag elsewhere.

In the United States, Risperdal is indicated for the treatment of schizophrenia and is currently available in 0.25,
0.5, 1, 2, 3 and 4 mg tablets as well as a 1mg/mL oral solution. In clinical trials, Risperdal was generally well
tolerated. However, as with all other antipsychotics, Risperdal can cause some adverse events. In two controlled
trials, adverse events with an incidence of 5% or greater in at least one of the Risperdal groups and that
occurred at a rate at least twice that of placebo were anxiety, drowsiness, extrapyramidal symptoms
(uncontrolled tremors and muscle stiffness), dizziness, constipation, nausea, dyspepsia (upset stomach), rhinitis
(inflammation of nasal membranes), rash and tachycardia (rapid heart beat)
_______________________

An der Börse wird ja bekanntlich die Zukunft gehandelt. Daher sind die 99m USD Umsatz, die bisher erreicht werden für den aktuellen Börsenkurs völlig irrelevant. Was viel mehr zählt, sind die Umsätze und Gewinne, die in der Zukunft gemacht werden. Diese beeinflussen den aktuellen Kurs. Alleine durch die Zulassung in D und GB hat sich der Kurs verdoppelt. Für die USA sind die Verhandlungen noch im Gange. Sollte auch hier die Zulassung erfolgen, zählen wieder die bisherigen Umsätze von Johnson & Johnson mit dem Ursprungsmedikament Risperdal, das weltweit vertrieben wird. Es kann erwartet werden, dass dieses dann sehr rasch durch die neue Formulierung abgelöst wird. Dies ist auch im Sinne von J&J, da man hierdurch nicht nur Marktanteile halten, sondern sogar ausbauen kann. Deshalb haben J&J und Alkermes schon frühzeitig eine Kooperation für diese Neuentwicklung abgeschlossen. Beide Unternehmen werden davon profitieren. J&J behält seine Marktanteile und Umsätze, der große Gewinner ist aber das kleinere Unternehmen Alkermes, für das diese Umsätze ein enormes Wachstum bedeuten.

johnfromaustria