Orphan gestern in der USA +30% - 500 Beiträge pro Seite

[gony]

Die Aktie der Pharma Firma Orphan hat lt. Stockworld gestern in den USA ca 30 % zugelegt.
Bei der Comdirect gibt es keinen US Kurs und auch nichts von heute.

Es geht wohl um die Zulassung eines Medikamentes!

Hat jemand Infos?

[orkadian]

ORPH wurde gestern in USA gar nicht gehandelt.

[Predo]

Thursday June 7, 7:01 am Eastern Time
Press Release
SOURCE: Orphan Medical, Inc.
Orphan Medical Announces FDA Advisory Committee Finds Xyrem(R) Effective for Treating Cataplexy Associated with Narcolepsy
MINNEAPOLIS, June 7 /PRNewswire/ -- ORPHAN MEDICAL, INC. (Nasdaq: ORPH - news) announced today that the Peripheral and Central Nervous System Advisory Committee of the U.S. Food and Drug Administration (FDA) voted today that Xyrem® (sodium oxybate) oral solution is an effective treatment for cataplexy (sudden loss of muscle tone) associated with narcolepsy.

The Advisory Committee voted 6 to 3 that Xyrem, whose active ingredient is gamma hydroxybutyric acid or GHB, is effective in treating cataplexy at a dose of 9 grams per day. It voted 5 to 4 that it is also effective at a dose of 6 grams per day. The committee voted 4 to 4, with one abstention, on the issue of safety, and 8 to 1 that a risk management plan is necessary for the safe use of Xyrem, as Orphan Medical had recommended.

``We are encouraged by the outcome of the committee`s deliberations, even though the voting was not unanimous, and we`re pleased by the committee`s general view that new therapies are needed for cataplexy associated with narcolepsy. We will meet promptly with the FDA and feel confident we can address the clinical issues discussed by the committee,`` said John Bullion, CEO of Orphan Medical. ``Xyrem is now one step closer to approval and helping physicians better manage narcoleptic patients with cataplexy. We remain committed to the value of this drug in an under-served population.``

Narcolepsy is a chronic neurological sleep disorder affecting 100,000 to 125,000 individuals in the U.S. Its primary symptoms are excessive daytime sleepiness, often accompanied by cataplexy. Cataplexy is a sudden loss of muscle tone in response to strong emotional reactions, often causing the patient to collapse unexpectedly during waking hours. If approved, Xyrem would be the only treatment approved by FDA as effective in managing cataplexy in those afflicted with narcolepsy.

Xyrem was designated by the FDA for a priority review in October 2000. In addition to the clinical issues raised by the committee, the Company also will address with FDA issues regarding product labeling, the distribution system proposed by the Company to assure safe use, and manufacturing controls to assure compliance with FDA`s Good Manufacturing Practice regulations.

Orphan will host a conference call on Thursday, June 7th, at 9:30am EDT, for the financial community. Senior management will be available to discuss the recommendations of the FDA advisory committee and the company`s outlook for the remainder of the year. The telephone number is 877-278-2458 or you may access the audio webcast at http://acc.activate.net/teleconferenceregister/Intercall/.

Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases. The Company serves three strategic therapeutic market segments that are characterized by well-defined patient populations and served by physician specialists: oncology support, antidotes and sleep disorders. Orphan Medical`s Internet Web site address is http://www.orphan.com

The information in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation reform Act of 1995. A number of factors could cause actual results to differ materially from the Company`s assumptions and expectations. These are set forth in the cautionary statements included in Exhibit 99 to Orphan Medical`s most recent Form 10-Q or Form 10-K filed with the Securities and Exchange Commission. (These documents can be accessed through the Orphan Medical Web site at http://www.orphan.com). All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements.


Orphan Medical Noonan/Russo Communications
John Howell Bullion (CEO) Glenn Silver (media), ext. 271
Tim McGrath (CFO) David Walsey (investors), ext. 230
[phone] [phone]

SOURCE: Orphan Medical, Inc.

[JSK]

Sollte mal wieder nach vorne !

Chancen von 15 $ auf 40 $ und mehr, sobald Zulassung erfolgt, steht kurz bevor !!