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[Larry_1]

15.06.09
Jazz Pharma says Phase III data suggest Sodium Oxybate Significantly Improves key Symptoms of Fibromyalgia - Update



(RTTNews) - Monday, Jazz Pharmaceuticals (JAZZ) said that its sodium oxybate demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms in the treatment of fibromyalgia.

The Palo Alto, California headquartered specialty pharmaceutical company, while presenting Phase III data last week at the 2009 Associated Professional Sleep Societies meeting in Seattle, Washington, said that the data have not been evaluated by the U.S. Food and Drug Administration or FDA or other regulatory authorities.

The company said that the 14-week randomized, double-blind, placebo-controlled study included 548 adult patients with fibromyalgia randomized to one of sodium oxybate 4.5 g/night, sodium oxybate 6 g/night or placebo treatment arms. The primary outcome measure was the proportion of patients who achieved at least 30% reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS).

At three months, 54.2% of patients treated with sodium oxybate 4.5 g/night and 58.5% of patients treated with sodium oxybate 6 g/night showed significantly greater reduction in pain as measured by at least a 30% improvement in baseline pain VAS score, compared with 35.2% of patients taking placebo.

"The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances," said Dr. Todd Swick, one of the study's investigators and Medical Director of the Houston Sleep Center and Assistant Clinical Professor of Neurology at the University of Texas-Houston School of Medicine.

Jazz Pharmaceuticals has completed its second Phase III clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009. Assuming positive results, the company expects submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the FDA by the end of 2009.

UCB anticipates filing in the EU shortly after. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.

JAZZ closed Friday's regular trading at $2.64.

[Larry_1]

Meinungen zu diesem Wert ?

Wer ist fit in der Biotech Branche und kann JAZZ PHARMACEUTICALS
etwas ergründen?

Ich bin vom Thema zu "weit weg" zumal meine Englischkentnisse miserabel sind.

Dieser Wert scheint aber für long Interessierte interessant zu sein!!

[blb]

Antwort auf Beitrag Nr.: 37.396.358 von Larry_1 am 15.06.09 19:15:25

@Larry: Sorry, aber, wenn dein Englisch miserabel ist, warum kaufst du dir dann das Ding? Ohne Fundamentals einfach mal ins Blaue zu traden find ich ehrlich gesagt etwas krass.

Ich kann mir das Ding mal anschauen, aber hab von Jazz bis zum Kurssprung vor ein paar Tagen nichts gehört. Vom Gefühl her würd ich nach nem Satz von über 60 Prozent erstmal glattstellen. Meist folgt dann die Wochen drauf eine Konsolidierung.

Grüße
blb

[BloodySunday]

Antwort auf Beitrag Nr.: 37.396.480 von blb am 15.06.09 19:33:00

Wo steht das er gekauft hat?

[Larry_1]

Antwort auf Beitrag Nr.: 37.396.480 von blb am 15.06.09 19:33:00

Nun, ganz so blauäugig bin ich nun auch nicht, ich "arbeite" aber eben nur mit Übersetzungsprogrammen.

Und habe immer wieder mal bei Biowerten auch super Glück

Die Frage war ja eigentlich auch, ob jemand diesen Wert schon in der Vergangenheit beobachtet hatte

[Larry_1]

Antwort auf Beitrag Nr.: 37.396.634 von BloodySunday am 15.06.09 19:52:46

stimmt!
hatte ich vergessen zu schreiben

[Larry_1]

+73,48% starker Schlußkurs !!

da scheint tatsächlich Substanz in dem Wert zu stecken, vorallem wenn man bedenkt, wo der Wert herkommt

[Larry_1]

gestern nachbörslich weiterhin stabil geblieben.
Es besteht die Chance das Jazz heute weiterläuft
(nach ca. 420%) Anstieg

[Larry_1]

Antwort auf Beitrag Nr.: 37.400.244 von Larry_1 am 16.06.09 11:06:23

Bin gespannt auf die Eröffnung.

Nach dem gestrigen Anstieg sind Gewinnmitnahmen bei der Eröffnung bis max 20% noch ok.

[Larry_1]

Das ist doch wirklich ein Sche... Teil.
Habe heute nachmittag mit Verlust verkauft und jetzt steigt die Aktie wieder.

[Larry_1]

leider nicht mehr investiert

[Airwave72]

Antwort auf Beitrag Nr.: 37.467.141 von Larry_1 am 25.06.09 16:04:46

Hatte gestern noch überlegt hier einzusteigen

[Airwave72]

60% Plus

[Airwave72]

NEW YORK (Dow Jones)--Shares of Jazz Pharmaceuticals Inc. (JAZZ) jumped as much as 62% Thursday, a day after the drug company said preliminary results from a second Phase III clinical trial of its fibromyalgia treatment backed positive results from its first study.

Shares were recently trading at $4.83, up $1.58 or 49%. Shares have quintupled in June, but they're still well off their 52-week high of $8.95 from June 2008.

The company has been developing sodium oxybate - which is currently marketed as Xyrem to treat narcolepsy - to be used for the second indication of fibromyalgia treatment. Sodium oxybate hasn't been evaluated by regulators for the treatment of fibromyalgia and isn't approved for this use, but the company said it intends to file for Food and Drug Administration approval by the end of the year.

Jazz said in a release Wednesday that the drug showed meaningful improvement in treating the pain and the main symptoms associated with fibromyalgia, a chronic illness characterized by widespread pain, unrefreshing sleep, chronic fatigue and psychological distress.

"These results were very strong and confirm results from the previous study," Leerink Swann analyst Gary Nachman told Dow Jones Newswires, adding that the results mean there's a good chance Jazz could get an expanded indication approval for fibromyalgia. "This is really the only thing the company's working on in its pipeline, so it's an important milestone for the company."

He said that the fibroymyalgia market is large, about $1 billion based on what some other companies have said. Nachman said Jazz's drug would likely be more of a "niche product," as distribution for Xyrem for narcolepsy is restricted.

He added that Xyrem currently generates about $60 million, and Nachman believes with the additional indication for fibromyalgia could bring in about $100 million.

A representative from Jazz wasn't immediately available to comment Thursday.

Jazz has been plagued by a heavy debt load and weak liquidity. As of March, the company was in default on $119 million in debt and was burning through its remaining cash, hoping cost cuts and sales growth from its two marketed products would enable it to survive.

Leerink's Nachman said that while the results are promising, the drug isn't the answer to all of Jazz's problems.

"The data is very positive, but people just have to put it in proper context with what the company is going through," Nachman said. "The company still needs to find some additional money."

Nachman said Jazz needs to find partnerships for the other projects in its pipeline that have been put on hold.

He added that the company hasn't been making interest payments on its debt, so it could possibly face bankruptcy at some point.

"Debt holders have been giving them some slack, but that's certainly a priority for the company right now to solve this issue," Nachman said. "Having this positive data might help buy them a little time, but it's not the solution right now."



-By Shara Tibken, Dow Jones Newswires; 212-416-2189; [e-mail]

(Kathy Shwiff contributed to this report)

[Netflirter]

Bin jetzt auch mal rein die 4,50$ (altes hoch) hat super gehalten beim Test. Solte ein neuer Wiederstand sein. Na mal gucken