Forest and Cypress Announce FDA Acceptance for Review of New Drug Application for Milnacipran for the Treatment of Fibromyalgia
February 21, 2008: 08:00 AM EST
Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (NASDAQ: CYPB) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milnacipran for the treatment of fibromyalgia. With a standard 10-month review timeline, the FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur by the end of October 2008.
The Companies submitted their NDA for milnacipran for the treatment of fibromyalgia syndrome based on results from a composite responder analysis requiring that each patient experienced concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function. The FDA advised that they are moving toward class labeling for drugs used to treat fibromyalgia, with any distinctions among therapies reflected in specific product labels instead of differences in the approved indications.
Milnacipran is a unique dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for a non-pain condition in over 50 countries, with real-world commercial experience outside the U.S. for 10 years. Milnacipran is jointly being developed for fibromyalgia in the United States market by Forest and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed by and is sold outside of the U.S. by Pierre Fabre Medicament. Fibromyalgia is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company dedicated to identifying, developing and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes LexaproÂ® (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; NamendaÂ® (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; CampralÂ®* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation, and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking agent indicated for the treatment of hypertension. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products BenicarÂ®* (olmesartan medoxomil), an angiotensin receptor blocker, Benicar HCTÂ®* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, and Azor(TM)* (amlodipine and olmesartan medoxomil) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Cypress is committed to being an innovator and leader in providing products for the treatment of patients with fibromyalgia. As part of its business development strategy, the company evaluates a number of Proof of Concept stage opportunities that leverage its repurposing experience and innovative approach to clinical trial design and regulatory strategy, and intend to continue to do this on an ongoing basis. The company continues to evaluate various other potential strategic transactions, including the potential acquisition of products, product candidates, technologies and companies.
For more information about Cypress, please visit Cypress' website at www.cypressbio.com.
This press release, as well as Cypress' SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the timing of the PDUFA target action date, whether the FDA will implement class labeling for drugs used to treat fibromyalgia, the potential of milnacipran to treat fibromyalgia, the NDA filing for milnacipran and Cypress' evaluation of potential strategic alternatives. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that more detailed analysis of the milnacipran trial results may not be favorable or may lead to different conclusions; that the milnacipran NDA may not be approved by the FDA or that the FDA's review of the NDA could be delayed, that we may not be able to protect our milnacipran patent portfolio and that milnacipran may never be approved as a drug by the FDA.