Cyberonics - FDA Panel am 15.Juni - 500 Beiträge pro Seite

[Madawa]

Cyberonics hits record on optimism for depression
Reuters, 01.16.04, 12:01 PM ET


CHICAGO (Reuters) - Shares of Cyberonics Inc. rallied to a record on Friday, rising by more than 11 percent, amid growing optimism that the company`s pacemaker-like device will win U.S. regulatory approval to treat chronic depression, analysts said.

Investor enthusiasm for the company was underscored by Boston Scientific Corp.`s request to increase its stake in the company, they said.

Cyberonics earlier this week said it extended the time frame under which Boston Scientific could raise its investment to 20 percent from 15 percent until February 28.

Asked about the strength in the stock, Cyberonics chairman and chief executive Robert Cummins said, "Maybe the market has finally figured out that there may be 1.2 million shares of demand coming into the market in February."

In a telephone interview with Reuters, Cummins said the terms of the company`s agreement with Boston Scientific have not changed and that Boston Scientific`s interest is "purely as an investment."

Cummins said Cyberonics has no planned announcements at this time.

Boston Scientific was not immediately available to comment.

"I think investors see Boston Scientific putting a floor on (Cyberonics`) stock," First Albany Corp. analyst William Plovanic said.

He said the real driver of the rally was hopes that Cyberonics will win regulatory approval to use the device, currently used to treat epilepsy, for chronic depression, a market worth billions of dollars. The device shocks the Vagus nerve, the longest cranial nerve, which affects movement and is thought to be linked to depression and other disorders.

"You`re starting to see the potential for the depression market priced into the stock," Plovanic added.

Cummins, who earlier this month guided Wall Street`s earnings expectations lower for the next two quarters because of increased spending to launch the device to treat depression, said he expects the U.S. Food and Drug Administration to review its application in early April.

Citing a 2001 study conducted by market research firm Data Monitoring, Cummins said there are 4.4 million Americans who were depressed and did not respond to other treatments. That translates into a $66 billion market for Cyberonics, he said.

Cyberonics shares were up $3.67, or 11 percent, at $37.08, after scoring a fresh high at $37.20 in late morning trading on the Nasdaq. Volume was relatively heavy.

Options trader Paul Foster with Mercury Trading noted active bullish trading in Cyberonics options. He said the price of the calls, which gives investors the right to buy the shares at a certain price within a specific time frame, were up and higher than usual.

Copyright 2004, Reuters News Service


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FDA Website Confirms Cyberonics` Depression Panel Date
Monday April 26, 3:51 pm ET

HOUSTON, April 26 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that FDA confirmed on its website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfadvisory… 512 ) that a meeting of its Neurological Devices Advisory Panel will occur on June 15, 2004 to review Cyberonics` PMA-Supplement (PMA-S) seeking approval to market the VNS Therapy(TM) System "as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to two or more adequate antidepressant treatments."

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Die erste Meldung ist ja schon von Januar, da ging die Aktie auch ziemlich ab. Jetzt ist es etwas ruhiger geworden, aber vielleicht tut sich ja nach dem dem FDA Panel am 15. Juni was???

Was meint Ihr? Bin über weitere Meinungen dankbar!

[Madawa]

Reuters
UPDATE - Cyberonics` device safe for depression -experts
Tuesday June 15, 8:09 pm ET
By Susan Heavey



GAITHERSBURG, Md., June 15 (Reuters) - A Cyberonics (NasdaqNM:CYBX - News) device for epilepsy is safe enough to treat chronically depressed patients, despite concerns over how much relief it could provide, a U.S. Food and Drug Administration panel of outside experts said on Tuesday.

While data showed some impact for those most severely depressed, the panelists said muddled results made it difficult to determine if the pacemaker-like implant or other factors were at work.

But the device -- called VNS Therapy -- was safe despite "some annoying side effects," said panel chair Kyra Becker, a neurologist at the University of Washington in Seattle.

The device, which is surgically implanted to deliver electrical pulses to the brain, is already cleared for epilepsy. The FDA usually, but not always, follows the advice of its outside experts.

The panel`s 5-2 recommendation is vital to expanding Cyberonics` sales potential. Analysts say the chronic depression market could be as much as 10 times larger than the one for epilepsy.

"It is their growth opportunity for the future. This market may take a little time to develop but it will ultimately be a very attractive market for devices," said analyst Jan Wald of A.G. Edwards, adding it was "unclear that it`s going to be smooth sailing with the FDA."

Some panel members suggested the company conduct double-blind, randomized placebo studies to gain clearer data.

Psychiatrist John Rush of University of Texas Southwestern in Dallas, who conducted some depression studies for Cyberonics, said researchers were "now in a position where that could be done."

But such studies would yield little additional information and were not necessary, he said, adding they would deny chronically depressed patients immediate help.

Other panelists agreed the acute need to help those patients outweighed the data problems.

At the meeting, a number of patients told the panel through hoarse voices -- one of the most common side effects - how the device had given them hope to live.

In one group of 342 patients studied, 68 percent suffered voice problems while another 29 percent reported coughing. Other reactions included breathing difficulties and heart problems, studies showed.

FDA staff also told the panel the number of suicides or attempted suicides were "enough to make us concerned." In the same 324 patients, 3.5 percent tried to kill themselves.

Despite the risks, the patients said they were desperate for help. "I had nothing to lose," said patient Carmen McGuffy, explaining why she sought the surgical option that is already approved for depression in Europe and Canada.

The FDA outside experts agreed but recommended several conditions along with the approval, including proper education for surgeons, psychiatrists and other doctors as well as a patient registry to collect more data.

Panel members also said the device should only be used for patients who did not respond to at least four other types of therapy.

Cyberonics CEO Robert Cummins said the company was "not surprised at the conditions," calling them "fair." (additional reporting by Bill Berkrot in New York)

[lux2001]

LAST MATCH
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Volume 406,793


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As of 8:14:21.096

Salut

[Madawa]

Cyberonics soars on FDA panel decision

By CBS MarketWatch
Last Update: 10:04 AM ET June 16, 2004



SAN FRANCISCO (CBS.MW) -- Shares of Cyberonics surged as much as 64 percent Wednesday in response to a regulatory panel`s recommendation that the device maker`s implant system be approved as a depression therapy.


After being halted at $19.58 on Tuesday ahead of the panel`s decision, the Houston-based company`s shares rose as high as $32.15 and changed hands lately at $31.06, up $11.48, or nearly 59 percent.

Late Tuesday, Cyberonics (CYBX: news, chart, profile) said a Food and Drug Administration advisory panel recommended approval of its VNS system for patients suffering from treatment-resistant depression.

The device, similar to a pacemaker, is already used to treat patients with epilepsy.

While the recommendation is not binding, the full FDA typically follows the lead of its advisory panels.

"It`s a giant step forward toward approval," said Skip Cummins, chairman and CEO of Cyberonics.

Gaining marketing approval from the FDA for depression would make Cyberonics "the market leader in what`s considered by many to be the next frontier in medical devices," Cummins said.

Approximately 4.4 million Americans suffer from treatment-resistant depression, according to Cummins. That`s more than 10 times the size of the company`s current potential market for treatment-resistant epilepsy, he said.

The company believes the device may eventually be able to be used to treat other conditions as well, including Alzheimer`s disease, anxiety and chronic pain. The VNS system applies "mild, intermittent electrical pulses" to a nerve in the neck.

Patients in the company`s studies had suffered depressive illness for an average of more than 25 years, Cummins said.

[Paepstin]

Hörrlein
Autor: Hörrlein BioTech/NanoTech
14:41 | 15.06.04

Cyberonics – Heute ist die Entscheidung
Beratergremium der FDA gibt heute sein Votum ab


Auch chronisch depressive U.S. Bürger, die mit den herkömmlichen Medikamenten keine Besserung ihrer Beschwerden erreichen können, werden vielleicht schon bald auf eine ganze neue Form der Therapie hoffen können. Heute wird ein von der U.S. Gesundheitsbehörde (FDA) eingesetztes Gremium aus unabhängigen Experten nämlich über eine mögliche Zulassung eines Gerätes entscheiden, das als der Herzschrittmacher für das Gehirn bezeichnet wird.


Das Stoppuhr-große Gerät der Firma Cyberonics (NasdaqNM:CYBX; WKN: 893206) wird während eines operativen Eingriffes in die Brust implantiert, sendet aber im Gegensatz zum Herzschrittmacher seine elektrischen Impulse nicht an das Herz, sondern eben an das Gehirn. Von dem in die Brust der chronisch depressiven Patienten implantierten Gerät führt ein Draht zu einem Nerv in Höhe des Halses, welcher in das Gehirn führt und auf diese Weise die vom Gerät ausgesandten Impulse direkt in das Gehirn leitet.


Schon gestern stieg das Papier von Cyberonics im Vorfeld der heutigen Entscheidung um 6,5 Prozent. Die Chancen für ein positives Votum des Gremiums, das die Wahrscheinlichkeit einer Zulassung drastisch ansteigen lassen würde, stehen nicht einmal schlecht. Zur Therapie der Epilepsie ist das Gerät nämlich bereits zugelassen und konnte sich bei dieser Erkrankung als ausgezeichnete Therapie erweisen. In Europa und Kanada ist die unter dem Namen VNS Therapie bekannte Methode ebenfalls schon ein Standardverfahren.


Es gibt eine Vielzahl von verschiedenen depressiven Zuständen, einige von ihnen lassen sich mit den herkömmlichen Antidepressiva gut in Schach halten. Allerdings gibt es nicht wenige Menschen, bei denen eine Gesprächstherapie und medikamentöse Behandlungen nicht den gewünschten Erfolg zeigen. Genau für solche Fälle von Depressionen, die nicht einmal so selten sind, wäre das Cyberonics-Gerät eine gute Alternative.


Für Cyberonics ist die Zulassung der VNS Therapie bei Depressionen ein Schlüssel für sein weiteres Wachstum. Alexander Arrow, Analyst bei Lazard Freres, geht bei einer Zulassung des Gerätes von mindestens einer Verdreifach des Umsatzes aus. Dies scheint noch relativ moderat geschätzt, denn der Markt mit Antidepressiva ist nicht nur gigantisch, sondern erfreut sich zudem eines stetigen Wachstums. Sollte das Gremium heute die Zulassung des Gerätes empfehlen, dann könnte sich auch der Kurs von Cyberonics, der am vorletzten Handelstag vergangener Woche noch bei einem 14-Monatstief notierte, wieder deutlich erholen.


Die statistischen Daten sprechen dafür, dass die VNS Therapie beim Einsatz gegen Depressionen ein gigantisches Marktvolumen vorfinden wird. Bis 2010 gehen Schätzungen von einem U.S. Markvolumen bis zu einer Milliarde Dollar aus. In den USA leiden fast 10 Prozent der Bevölkerung an Depressionen, etwa einem Drittel kann mit Medikamenten keine Linderung verschafft werden, so die Statistiken der National Institutes of Health.


Im Gegensatz zur traditionellen Schockbehandlung, der ECT, die das gesamte Gehirn stimuliert, zielt die VNS Therapie auf einen ganz bestimmten Nerv, den so genannten Vagus. Andauernde schwache elektrische Impulse auf den Vagus Nerv senden Signale in die Bereiche des Gehirns, welche für die Stimmungen verantwortlich sind.


Simone A. Hörrlein


Gruß Päpstin