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Heute aufgrund einer FDA Erklärung zu einem Schlafmittel fast 60% abgeschmiert

By Peter Loftus
Of DOW JONES NEWSWIRES


The U.S. Food and Drug Administration rejected an extended-release
formulation of Neurocrine Biosciences Inc.'s (NBIX) experimental insomnia
treatment and delayed approval of two lower doses of the drug, delivering a
setback to both Neurocrine and its marketing partner Pfizer Inc. (PFE).

The news sent shares of San Diego-based Neurocrine tumbling $32.58, or 60%,
to $22.05, amid heavy volume.

The FDA told Neurocrine Biosciences late Monday the 5-milligram and
10-milligram capsules of indiplon are "approvable," according to Neurocrine,
which typically means the agency might approve them after getting more
information from the company.

But the FDA also told the company the 15-milligram, extended-release tablets
aren't approvable at this time, Neurocrine said. That is especially worrisome
from a marketing standpoint because some analysts believed this formulation was
what set indiplon apart from rival medications.

Neurocrine had intended to market the lower-dose capsules for people with
trouble falling asleep or who wake up during the night and can't get back to
sleep. The higher-dose tablet was to be used to rapidly induce sleep and
maintain sleep through the night.

The FDA action creates serious uncertainty for the future of a drug that
analysts had considered a potential blockbuster, with some estimating annual
sales could exceed $1 billion. Under terms of a 2002 partnership agreement, New
York-based Pfizer funded the ongoing development of indiplon and was to pay
royalties on the worldwide sales and co-promotion fees in the U.S. upon
indiplon's market launch. Pfizer also was to make milestone payments to
Neurocrine

Reasons for the FDA's action weren't immediately clear. Neurocrine, which has
no products on the market, said in a press release the FDA indicated it didn't
have an opportunity to review all the information submitted during the
application process.

An FDA spokeswoman couldn't immediately be reached.

There have been signs of FDA concerns about indiplon, however. In January,
the FDA asked Neurocrine to submit results of a study of indiplon's effects on
driving that was completed in late 2005. Neurocrine said the study showed no
impairment in next-day driving performance.

Moreover, the potential side effects of other sleep medications have drawn
scrutiny recently, including media reports about sleepwalking or over-eating
after use of Ambien, a sleep aid from Sanofi-Aventis (SNY). Sanofi has said
Ambien is safe and effective when taken as directed.

Neurocrine Chief Executive Gary Lyons told analysts during a conference call
Tuesday that the company hoped to meet with FDA staff soon to help determine
what the company needs to do to resubmit indiplon for approval.

Lyons said the FDA news was a "surprise to us," adding that Neurocrine still
didn't have a full understanding of the agency's reasons. Still, he tried to
sound a positive note about indiplon's future.

"We remain fully confident and bullish on the ultimate success of this
product and timely commercialization," Lyons said. He declined to take
questions from analysts.

Pfizer spokesman Andy McCormick said Pfizer was working with Neurocrine to
address the matter.

The FDA action also dealt a blow to DOV Pharmaceutical Inc. (DOVP), of
Hackensack, N.J., which licensed indiplon to Neurocrine in 1998 and stood to
collect royalties on the drug's sales.

Several analysts downgraded their ratings for Neurocrine, citing the FDA
action. CIBC World Markets analyst Bret Holley suggested indiplon may not get
launched until 2008, which could hurt its market penetration.

A.G. Edwards analyst Albert Rauch suggested Pfizer wouldn't have a strong
incentive to maintain its partnership with Neurocrine if the extended-release
tablets don't make it to market.

Indiplon works by targeting a receptor in the brain for a chemical called
gamma amino-butyric acid, or GABA, which is believed to promote and maintain
sleep. Similar drugs already on the market include Ambien, Sepracor Inc.'s
(SEPR) Lunesta and King Pharmaceuticals Inc.'s (KG) Sonata, but Neurocrine said
studies suggest indiplon had fewer side effects than some of these drugs.

Sepracor shares rose $5.52, or 12%, to $50.34. Sanofi's American depositary
shares rose $1.38 to $48.59; King shares rose 29 cents to $18.45.

DOV shares took a hit Tuesday, falling $3.77, or 54%, to $3.28. Pfizer shares
fell 7 cents to $24.82.

-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
[e-mail]


(END) Dow Jones Newswires

05-16-06 1254ET

[seppelbroker]

[nort.]

[Michi301]

Noch ne Meldung:


CNNMoney.com
Neurocrine stock takes a big hit on FDA's Indiplon review
Tuesday May 16, 2:51 pm ET
By Aaron Smith, CNNMoney.com staff writer


Neurocrine Biosciences' stock price plunged nearly 60 percent after the FDA gave mixed approval to Indiplon, a sleeping pill that the biotech developed with Pfizer, and analysts believe the partnership is at risk.
ADVERTISEMENT


The Food and Drug Administration approved 5 mg and 10 mg immediate release pills for Indiplon, but did not approve 15 mg extended release pills.

Pfizer spokeswoman Betsy Raymond said her company was informed Monday night of the FDA decision by Neurocrine.

Neurocrine released this statement from chief executive officer Gary Lyons: "While we are disappointed in the FDA action, we will move forward expeditiously to address the FDA's outstanding questions regarding the applications."

Barbara Ryan, analyst for Deutsche Bank North America, said Pfizer will probably cut its partnership with Neurocrine, because the FDA's decision to not approve the larger-dose Indiplon - the dose that allows insomniacs to sleep through the night - has "no appeal whatsoever for Pfizer."

"In light of today's developments, we expect that Pfizer will terminate its collaboration with Neurocrine for Indiplon," said Ryan in a published note.

Al Rauch, analyst for A.G. Edwards & Sons, also said the Pfizer-Neurocrine partnership could be at risk.

"We believe that if the XR tablet does not make it to the market, Pfizer's incentive to remain in the relationship with Neurocrine on Indiplon is greatly diminished; we are therefore removing Indiplon from our estimates," said Rauch, in an analyst note.

Rauch said the impact on Pfizer was "negligible."

Miller Tabak analyst Les Funtleyder said the FDA might have gotten scared over the fallout surrounding another sleeping pill: Ambien from the drugmaker Sanofi-Aventis. Researchers from the University of Minnesota Medical School and the Mayo Clinic recently found that Ambien causes some people to gorge on food while sleeping in the middle of the night. There have also been reports of sleep-driving and sleep-sex, with no memory of it afterwards.

"It appears the FDA watches television news and did not like the idea of approving another drug that might make people run off the road," said Funtleyder, in a note published this morning.


Wenn Pfizer die Partnerschaft wirklich beendet gehts ganz den Bach runter, also noch nicht einsteigen und an den Rebound glauben.

[-2GOOD4YOU-]

denke geht bei eröffnung 10-15%runter und dann gehts mindensten 10-20% up

[mfierke]

huuuuuu, die hat es ja böse runter gekloppt

[seppelbroker]

Antwort auf Beitrag Nr.: 21.620.383 von -2GOOD4YOU- am 17.05.06 12:59:24

so siehts aus

[weinicht]

Antwort auf Beitrag Nr.: 21.624.855 von seppelbroker am 17.05.06 17:11:29

Habe mich mal eingekauft...entweder 10 oder 25.

[seppelbroker]

Antwort auf Beitrag Nr.: 21.624.885 von weinicht am 17.05.06 17:13:04

Hopp oder Top!
sehe das genau wie du, und dafür, dass der Gesamtmarkt sch.... aussieht hält sich NBIX relativ gut.
Schaun mer mal was kommt

[weinicht]

Antwort auf Beitrag Nr.: 21.628.538 von seppelbroker am 17.05.06 20:30:51

Was is das denn??

13000 bei 16,00 im Bid??

[weinicht]

Oh....war nur ein Fake...jetzt sind es nur noch 12600.

[weinicht]

Antwort auf Beitrag Nr.: 21.635.925 von weinicht am 18.05.06 11:08:14

Boah...und bedient worden...das ist doch getürckt.

[seppelbroker]

Antwort auf Beitrag Nr.: 21.636.204 von weinicht am 18.05.06 11:24:18

11:21:26 16,00 13.000
11:10:54 16,01 400
10:16:59 15,60 320
09:42:10 15,53 500
09:04:05 15,63 62

[nkelchen]

heute für 7€ im Angebot!
Wahnsinn, wie die abschmieren.
nk

[nkelchen]

Antwort auf Beitrag Nr.: 22.244.172 von nkelchen am 23.06.06 13:18:20

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B0A3…

Neurocrine and Pfizer Terminate Collaboration Agreement for Indiplon

E-mail | Print | | Disable live quotes Last Update: 5:08 PM ET Jun 22, 2006


SAN DIEGO, June 22, 2006 /PRNewswire-FirstCall via COMTEX/ -- Neurocrine Biosciences, Inc. (NBIX : Neurocrine Biosciences Inc
News , chart, profile, more
Last: 13.81-0.03-0.22%

7:12am 06/23/2006

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NBIX13.81, -0.03, -0.2%) announced today that Neurocrine and Pfizer have agreed to terminate the collaboration agreement to develop and co-promote indiplon. As a result, Neurocrine will reacquire all worldwide rights for indiplon capsules and tablets and will independently develop indiplon for approval and commercialization. Neurocrine will meet with the Food and Drug Administration (FDA) to finalize development plans for the resubmissions of each indiplon NDA and plans to commercialize indiplon as quickly as possible upon approval. The Company plans to review various business and commercial alternatives to expedite successful commercialization of indiplon. As part of the termination provisions of the agreement, Pfizer will continue to support indiplon for a period of up to 180 days to ensure a smooth transition.
"While we are disappointed that we will not be working with Pfizer for the commercialization of indiplon, Neurocrine is fully committed and prepared to develop and commercialize this product. With the clinical, regulatory and commercial investment we have received from Pfizer coupled with our experience in conducting the indiplon clinical development program, we are well- positioned to complete development of this product to secure FDA approval and we anticipate a seamless transition of responsibility," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "Neurocrine will reacquire full worldwide rights to this product which we believe has significant commercial value and we will evaluate commercial alternatives throughout various worldwide markets once our resubmissions have been made. We believe that full rights to indiplon, together with our R & D pipeline which is advancing several Phase II products, provides additional value and partnering opportunities," added Lyons.
In December 2002 Neurocrine entered into an exclusive worldwide collaboration agreement with Pfizer to develop and commercialize indiplon.
Conference Call and Webcast Today at 5:30 PM Eastern Time
Neurocrine will host a live conference call and Webcast to discuss the plans for indiplon today at 5:30 PM Eastern Daylight Time (EDT)/ 2:30 PM Pacific Daylight Time (PDT). Participants may access the live Conference Call by dialing 1-800-540-0559 (U.S.) or 785-832-1508 (International) and using the Conference ID# "Neuro". The call can also be accessed via the Webcast through Neurocrine's website at < http://www.neurocrine.com/" target="_blank" rel="nofollow ugc noopener">http://www.neurocrine.com/ > or through a link provided by PRNewswire at < http://www.videonewswire.com/event.asp?id=34432 >
Participants may also access a replay of the Conference Call approximately one hour after the conclusion of the call by dialing 1-800-839-2461 (US) or 402-220-7219 (International). The call will be archived until Thursday, July 6, 2006.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties relating to Neurocrine's indiplon program that could cause actual results to differ materially from those indicated in the forward-looking statements. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to; risk that the Company will not be able to address issues and or requests set forth in the action letters from the FDA in a timely manner; risk that the Company will not be able to address issues and or requests set forth in the action letters from the FDA in a manner acceptable to the FDA; the risk that FDA may reject any future indiplon regulatory filings or find them incomplete or insufficient; risk that indiplon approval and subsequent commercialization may be significantly delayed; risks relating to availability of capital; and the other risks described in Neurocrine's annual report on Form 10-K for the year ended December 31, 2005 and quarterly report on Form 10-Q for the quarter ended March 30, 2006. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences, Inc.
Elizabeth Foster or Claudia Woodworth, both of Neurocrine Biosciences, Inc., [phone] http://www.prnewswire.com Copyright (C) 2006 PR Newswire. All rights reserved. ********************************************************************** As of Sunday, 06-18-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 03-28-2006 for NBIX @ $66.87. (C) 2006 Comtex News Network, Inc. All rights reserved.

[nkelchen]

http://www.investors.com/editorial/IBDArticles.asp?artsec=22…
Analysts: Neurocrine Can Seek Comfort From Unlikely Source
BY PETER BENESH

INVESTOR'S BUSINESS DAILY

Posted 6/30/2006

A few years ago it seemed unimaginable that ImClone Systems (IMCL) could serve as a model for another company. Today, some industry insiders say the once-troubled drug maker could teach some valuable lessons to Neurocrine Biosciences. (NBIX)

On May 16 Neurocrine watched its stock drop 62% after the Food and Drug Administration said the company's Indiplon insomnia drug had substandard clinical trial data. Neurocrine must now bring its trial data up to the FDA's requirements.

The bad news continued on June 22, when Pfizer (PFE) severed its partnership with Neurocrine over Indiplon. Neurocrine's stock sank 38% to 8.61 — down from a 52-week high of 73.13 on March 16.

In a June 23 conference call, Chief Executive Gary Lyons said the company will press on with development of Indiplon. He estimated the additional cost at $30 million.

If Neurocrine's recent problems sound familiar, think back a few years.

ImClone, (IMCL) maker of colorectal cancer drug Erbitux, was rocked by similar problems in 2001.

In December of that year the FDA said ImClone's clinical trial data for Erbitux were substandard. The drug was not approved for sale and had to be sent back for further research and development.

Seven months later ImClone was rocked by an insider trading scandal that sent then-Chief Executive Sam Waksal and lifestyle maven Martha Stewart to jail.

ImClone's stock bottomed out at 5.24 in September 2002 after trading above 75 less than a year earlier.

"The market reacted like it was a disaster, but it was not the end of the world," said analyst James Reddoch of Friedman, Billings, Ramsey, which seeks ImClone's business.

Indeed, ImClone went back to work on Erbitux and eventually resubmitted the data. The FDA approved Erbitux in February 2004.

By July 2004, ImClone's shares had rebounded to 87.24. They since have fallen back to near 40 due to questions surrounding Erbitux's potential as a blockbuster. Still, the company is in much better shape than it was five years ago.

Neurocrine could follow a similar path with Indiplon, says analyst Aaron Reames of A.G. Edwards.

The FDA approved two low-dose, quick-release versions of Indiplon, but not the more profitable high-dose, time-release version. The agency wants Neurocrine to run new data analyses of preclinical studies and clinical trials to justify approval of time-release Indiplon.

"Neurocrine had fiddled with the basic outline of its phase three study," Reames said.

Tough Road Ahead

Neurocrine must now decide whether to seek another partner or go it alone. Company officials — who refused to comment for this story — have asked for a meeting with FDA officials to find out what, exactly, the regulator didn't like.

The FDA has said it wants Neurocrine to reanalyze data — particularly regarding high-dose Indiplon's safety for the elderly. The worst news would be an FDA demand for additional clinical trials.

If the FDA asks only for reanalysis of data, Neurocrine could do that in a few months. But if the agency demands more clinical trials, that could take at least two years, says analyst Eun Yang of Jefferies & Co.

"The company must show convincing safety data," said Yang, whose employer has done business with Neurocrine.

Even if Indiplon gets FDA approval, it'll come up against some tough competition.

Sanofi-Aventis (SNY) has a new formulation of its Ambien sleep drug, called Ambien CR (for controlled release). In two years Ambien's original formulation will become generic, making it a cheap competitor in the annual $2 billion U.S. insomnia market.

Additional competition comes from Lunesta, an all-night sleep drug made by Sepracor. (SEPR)

Darkness, Light

Another potential nightmare for Neurocrine is if it has to take Indoplin's time-release version back to the lab.

"Reformulation would put them back many years," said Michael Shulman, editor of ChangeWave Biotech Investor.

So what does Neurocrine have on its side? Money, for one thing. At the end of the first quarter the company's balance sheet showed $264 million in cash.

In addition, Pfizer will maintain its support for 180 days, giving Neurocrine time to organize itself.

Neurocrine also should benefit from the FDA's desire to make more drugs available.

"Wall Street doesn't get that the FDA wants to approve valuable drugs," Shulman said.

Neurocrine has other candidate drugs, but none will be ready soon. For now, it's a one-product firm.

Meanwhile, ImClone — which also declined to comment — is looking to find a new home. The company hired investment bank Lazard to auction it off.

Will Neurocrine travel a similar path?

It could happen, Reames says. His likely candidate, Johnson & Johnson, (JNJ) might be interested not necessarily for Indiplon alone, but for the five other drugs in Neurocrine's pipeline.

Another option: Neurocrine could put all its effort into its pipeline or acquire a valuable product from another biotech, says analyst Andrew McDonald, analyst with ThinkEquity.

"They might become a completely different company," he said.

Related Resources:

Search for previous IBD articles on this topic in the IBD Archives.

Read about innovative companies with promising futures in The New America.

Keep tabs on new products, innovations and market-moving trends with our Internet & Technology section.

[nkelchen]

Form 8-K for NEUROCRINE BIOSCIENCES INC


--------------------------------------------------------------------------------

6-Jul-2006

Termination of a Material Definitive Agreement



Item 1.02 Termination of a Material Definitive Agreement
On July 1, 2006, Neurocrine Biosciences, Inc. (the "Company") terminated the Amended and Restated Employee Stock Purchase Plan (the "Plan"). The termination was a result of a review of the plan's effectiveness in providing long-term share ownership to Neurocrine employees. In addition, the Plan had an insufficient amount of shares available to allow full participation by employees. Prior to its termination, the Plan provided employees an opportunity to purchase common stock of the Company at a price equal to 85% of the fair market value of the Common Stock on the exercise date. Item 8.01. Other Events.
The Company's Annual Meeting of stockholders was held on June 30, 2006. At the Annual Meeting, stockholders voted on five matters: (i) the election of three Class I Directors for a term of three years expiring in 2009, (ii) the approval of an amendment to the Company's Certificate of Incorporation, as amended, to increase the authorized number of shares of common stock from 50,000,000 shares to 110,000,000 shares, (iii) the approval of an amendment to of the Company's 2003 Incentive Stock Plan, as amended, and the reservation of 4,300,000 shares of common stock for issuance thereunder, (iv) the approval of an amendment to the Company's Amended and Restated Employee Stock Purchase Plan and the reservation of an additional 725,000 shares of common stock for issuance thereunder, and (v) the ratification of the appointment of Ernst & Young LLP as the Company's registered independent public accounting firm for the fiscal year ending December 31, 2006. The Stockholders approved all five matters and the voting results were as follows:
• Election of three Class I Directors

Joseph A. Mollica, Ph.D. For 30,453,120 Withheld 970,560
Wylie W. Vale, Ph.D. For 30,753,210 Withheld 670,470
W. Thomas Mitchell For 30,672,705 Withheld 750,975




• Approval of an amendment to the Company's Certificate of Incorporation, as amended, to increase the authorized number of shares of common stock from 50,000,000 to 110,000000


For 25,351,239 Against 4,560,323 Abstain 1,512,117
• Approval of an amendment to the Company's 2003 Incentive Stock Plan, as amended, which increased the number of shares of common stock reserved for issuance from 3,300,000 to 4,300,000 shares


For 16,581,535 Against 8,126,338 Abstain 1,483,368
• Approval of an amendment to the Company's Amended and Restated Employee Stock Purchase Plan, which increased the number of shares of common stock reserved for issuance from 625,000 to 725,000


For 23,537,041 Against 1,173,348 Abstain 1,480,852
• Ratification of the appointment of Ernst and Young LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2006


For 29,364,431 Against 554,161 Abstain 1,505,087

[nkelchen]

Antwort auf Beitrag Nr.: 22.450.582 von nkelchen am 07.07.06 14:14:10

http://biz.yahoo.com/prnews/060711/latu030.html?.v=60

Neurocrine Biosciences Announces Conference Call and Webcast to Present Second Quarter 2006 Financial Results
Tuesday July 11, 9:00 am ET


SAN DIEGO, July 11 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today that the Company will report second quarter 2006 financial results after the Nasdaq market closes Monday, July 17, 2006. A live conference call and webcast will follow at 5:00 p.m. Eastern/2:00 p.m. Pacific. Participants can access the live conference call by dialing 800-540-0559 (US) or 785-832-0326 (International) using the conference ID# NBIX. The call can also be accessed via the webcast through the Company's website at http://www.neurocrine.com
ADVERTISEMENT


If you are unable to attend the Webcast and would like further information on this announcement please contact Claudia Woodworth or Elizabeth Foster in the Investor Relations Department at Neurocrine Biosciences at [phone]. A replay of the Conference Call will be available approximately one hour after the conclusion of the call by dialing 877-710-5301 (US) or 402-220-1604 (International). The call will be archived until Monday, July 31, 2006.

Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. The product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com




--------------------------------------------------------------------------------
Source: Neurocrine Biosciences, Inc.

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von 6,50 auf 10,50
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