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[DewDiligence]

FDA Approves Nuvigil

[Nuvigil contains a single isomer of the active ingredient in Provigil and has a longer half-life than Provigil. However, the clinical benefit of Nuvigil relative to Provigil is marginal and Nuvigil was developed by CEPH as a way to extend the patent life of the franchise. Evidence of the above is that CEPH does not even intend to launch Nuvigil right away; this PR says the launch will be delayed until more clinical data can be collected but the real reason for the delay (IMO) is that there is no imperative for CEPH to launch Nuvigil until Provigil gets closer to its patent expiration. At that time, CEPH can begin the process of “switching” users from Provigil to Nuvigil.]

http://biz.yahoo.com/prnews/070618/nem030.html?.v=9

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Cephalon Receives FDA Approval of NUVIGIL™ for the Treatment of Excessive Sleepiness Associated with Three Disorders

Monday June 18, 6:55 am ET

FRAZER, Pa., June 18 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) today announced that it has received approval from the U.S. Food and Drug Administration to market NUVIGIL™ (armodafinil) Tablets [C- IV], a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD). In OSAHS, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. NUVIGIL is the single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL® (modafinil) Tablets [C-IV], which was approved by FDA in 1998 to improve wakefulness.

"FDA approval of NUVIGIL is a major accomplishment and the result of collaborative efforts with the scientific and regulatory communities," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We are excited about the future of NUVIGIL and we have initiated additional clinical work to explore its potential in a wide range of medical disorders."

Cephalon's clinical program will evaluate the use of NUVIGIL as a treatment for serious medical conditions such as bipolar depression, cognition associated with schizophrenia, excessive sleepiness in medical conditions such as Parkinson's disease, and fatigue in patients who are being treated for cancer. The company currently plans a commercial launch of NUVIGIL once additional clinical data has been amassed.

"The approval of NUVIGIL allows us to preserve our current leadership position in the area of wakefulness," said Frank Baldino, Jr., Ph.D., Chairman and CEO, Cephalon. "More importantly, we now have a longer-term opportunity to further characterize the utility of this compound beyond wakefulness." NUVIGIL is protected by a U.S. patent expiring in 2023.

The agency has approved final labeling for NUVIGIL, including a bolded warning, which is consistent with the draft labeling received by the company in March 2007. Full prescribing information will be available on the FDA website or on the company's website at: http://www.cephalon.com/newsroom/assets/Nuvigil_Prescribing_Information.pdf. As expected, the agency also has indicated that it will request similar language in the label for PROVIGIL.

About NUVIGIL

The active pharmaceutical ingredient in NUVIGIL, armodafinil, is the longer-lived r-enantiomer of modafinil, the active ingredient in PROVIGIL. The approval of NUVIGIL is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, NUVIGIL was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered a seven-year compound annual growth rate (CAGR) greater than 75% and 2006 revenue of $1.760 billion. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
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