Cypress Bioscience Inc. Phase II Milnacipran Data Presented at CINP Congress in Paris.SAN DIEGO -- Cypress Bioscience Inc. (Nasdaq:CYPB) announced that Dr. Olivier Vitton, a visiting clinician to Cypress from Pierre Fabre Medicament me·dic·a·ment n. An agent that promotes recovery from injury or ailment; a medicine. medicament a medicinal agent. , presented the milnacipran Phase II Fibromyalgia Syndrome trial data at the XXIVth CINP CINP Collegium Internationale Neuro-Psychopharmacologicum (International College of Neuropsychopharmacology) CINP Channel Islands National Park (US National Park Service) congress (Collegium col·le·gi·um n. pl. col·le·gi·a or col·le·gi·ums 1. An executive council or committee of equally empowered members, especially one supervising an industry, commissariat, or other organization in the Soviet Union. Internationale Neuro-Psychopharmacologicum, www.cinp2004.com) in Paris on June 20, 2004. The presentation, entitled, "Double-Blind Placebo Controlled Trial of Milnacipran in the Treatment of Fibromyalgia," was part of a satellite symposium entitled "Taking the Pain out of Depression -- Dual Action Antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics in the Relief of Pain in Depression, Fibromyalgia and Other Chronic Pain Syndromes." The symposium was chaired by Professor Jean-Pierre Olie from the Centre Hospitalier Sainte-Anne in France and Professor Simon C. Wessely from Kings College in the UK. Other presenters included Professor Jean-Pierre Lepine from the Hopital Lariboisiere Fernand Widal in France, Dr. Steven Stahl of the Neuroscience Education Institute in California and Dr. Mochizucki of Asahi Kasei Pharma in Japan. This symposium reflects the increasing attention that fibromyalgia is now receiving as a potential therapeutic target in Europe as well as the United States. Earlier this year Cypress Bioscience Inc. (NASDAQ:CYPB) and Forest Laboratories Inc. (NYSE NYSE See: New York Stock Exchange :FRX FRX Frame Relay Exchange (provides backbone connectivity for HUB sites) FRX Frequently Repeated Line FRX Fox Pro Report ) announced that they entered into a collaboration 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 that was commenced in October 2003 for the treatment of Fibromyalgia Syndrome (FMS FMS - Flexible Manufacturing System (factory automation). ). FMS is a frequent cause of chronic, widespread pain, and there are currently no products approved for the treatment of FMS. About Milnacipran Milnacipran is a novel compound which exerts its effect by inhibiting the reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. of both norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system. and serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by more than 3 million patients during more than six years of commercial availability outside the U.S. About Fibromyalgia Fibromyalgia is considered one of a group of related chronic pain syndromes characterized by both physical and psychiatric symptoms that include conditions such as irritable bowel syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence. (IBS IBS Irritable bowel syndrome, see there ), chronic tension headache, non-cardiac chest pain non-cardiac chest pain Internal medicine Chest pain that simulates cardiac nosologies, but is unrelated to cardiovascular disease; 50% of Pts with NCCP have known reflex and may have postprandial or noctural Sx. See Gastroesophageal reflux disease. and certain types of lower back pain. The use of milnacipran in these other chronic pain syndromes may also be explored under the agreement with Forest. FMS is estimated to affect six to 12 million people in the United States. FMS is most often diagnosed in the primary care setting and in addition is the second most commonly diagnosed condition in rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. clinics in the United States after osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. . For more information about FMS, please visit www.FMSresource.com. About Cypress Bioscience Inc. Cypress is committed to be the innovator and leader in providing products that improve the treatment of Functional Somatic Syndromes, including Fibromyalgia Syndrome (FMS), and other related pain and central nervous system conditions. Cypress' strategy involves acquiring/in-licensing central nervous system active compounds and developing them for new indications. In August 2001, Cypress licensed from Pierre Fabre Medicament its first product for clinical development, milnacipran. The license agreement provides Cypress with an exclusive license to develop and sell any products with the compound milnacipran as an active ingredient for any indication in the United States and Canada. On January 9, 2004, Cypress entered into a collaboration agreement with Forest Laboratories for the development and marketing of milnacipran. In October 2003, Cypress began initiating its Phase III clinical trials for the use of milnacipran as a potential treatment for FMS. We are continuing to evaluate various potential strategic transactions, including the potential acquisition of products, technologies and companies and other alternatives that we believe may enhance stockholder value. For more information about Cypress, please visit the Company's Web site at www.cypressbio.com. This press release, as well as Cypress' SEC filings and Web site at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 including statements about the potential of milnacipran to treat FMS and other related Functional Somatic Syndromes, the potential development of milnacipran for other chronic pain syndromes and entering into a strategic transaction. 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. In addition, there is the risk that we and Forest Laboratories may not be able to successfully develop or market milnacipran or any other products for the treatment of FMS and other related Functional Somatic Syndromes, and, as a result, would not receive any milestone or royalty payments from Forest Laboratories; that we and Forest Laboratories may encounter regulatory or other difficulties in the development of milnacipran for FMS, including delays in completing Phase III trials; that we may not be able to protect our patents or proprietary technology; that milnacipran may not significantly improve the treatment of FMS or any other related Functional Somatic Syndrome; that we may not be successful in identifying, licensing and developing any additional products, technologies or companies and even if we complete any such transaction, it may not enhance stockholder value. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. |
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