Development, marketing agreement signed for milnacipran.

2004 FEB 5 - (NewsRx.com & NewsRx.net) -- Cypress Bioscience, Inc., (CYPB), Forest Laboratories, Inc., (FRX), and Pierre Fabre Medicament announced that the companies have entered into an agreement for the development and marketing for Cypress' product, milnacipran, licensed from the product's originator, Pierre Fabre Medicament, for indications in the United States market.

Milnacipran is currently being evaluated in a phase III program sponsored by Cypress for the treatment of fibromyalgia syndrome (FMS). Fibromyalgia is a frequent cause of chronic, widespread pain and is estimated to affect 6-12 million people in the United States. There are currently no products approved for the treatment of FMS.

Specific terms of the transaction were not disclosed but the total upfront and milestone payments to Cypress under the agreement could be between $200 and $250 million. In addition Forest will pay Cypress a royalty based on sales and will fund all continuing development activities, which will be managed jointly by both companies. Forest will be responsible for sales and marketing activities, with Cypress having the option to copromote up to 25% of the total physician details.

Cypress holds two patents covering the use of milnacipran for FMS, both expiring in 2021. As a new compound in the United States, milnacipran also qualifies for 5 years of marketing exclusivity upon marketing approval under the Hatch-Waxman legislation.

The current phase III program, which is designed to support registration of milnacipran for the treatment of FMS in the U.S., is based on the results of a controlled, randomized phase II study with 125 FMS patients. Data from the study demonstrated that milnacipran provided statistically significant improvements in multiple measures of clinical pain and many secondary symptoms, including fatigue, mood, and patient global status reports.

The phase III program consists of multiple randomized, placebo controlled clinical trials. Enrollment in the first study is underway and progressing on schedule at approximately 30 clinical sites in the U.S. The study includes male and female outpatients with a primary diagnosis of FMS who meet other entry criteria. The phase III program could possibly be completed in 2006 and, if successful, a new drug application for FMS could possibly be submitted later in that year.

Howard Solomon, chairman and CEO of Forest, said: "We are intrigued by the impressive results for the phase II study of milnacipran in FMS conducted by Cypress and its potential for other pain syndromes. We are also impressed by the safe and successful use of milnacipran in Europe where it has been developed and marketed by Pierre Fabre Medicament as a dual-acting agent for depression for several years." Solomon added: "We look forward to working with Cypress on the further development of milnacipran in the future."