Pierre Fabre Medicament Announces Submission of a Market Authorization Application for Milnacipran in Europe : New Data from European Phase III Fibromyalgia Study presented at EULAR congress
CASTRES, France, June 11, 2008 – Pierre Fabre Medicament today presented positive Phase III data from their milnacipran fibromyalgia (FM) study in adult patients. Pierre Fabre Medicament also announced that it has recently submitted a Market Authorization Application (MAA) to the European Medicines Agency (EMEA) for milnacipran, a unique dual-reuptake inhibitor for the treatment of fibromyalgia syndrome (FMS).
The results from a three month, double-blind, placebo-controlled European pivotal Phase III study of milnacipran in the treatment of FMS were presented today at the EULAR (European League Against Rheumatism) Congress in Paris, France.
FMS is a chronic rheumatological disorder characterized by widespread musculoskeletal pain, tenderness, fatigue, sleep disorders and is associated with a constellation of other symptoms such as cognition troubles, morning stiffness and mood disturbances.
Study Results This study recruited 884 patients from 83 study centers in 13 European countries (Czech Rep, Denmark , Finland, France, Germany, Italy, Norway, Poland , Portugal, Romania, Spain, Sweden, United Kingdom). Patients were randomized to receive either 200 mg per day (100 mg b.i.d.) of milnacipran (n=435) or placebo (n=449). The primary efficacy assessment was a composite responder rate based on:pain (= 30% reduction in pain from baseline in the 24-hour recall pain score recorded on an electronic diary) and patient global impression of change (PGIC,rating of 1 “very much improved” or 2 “much improved”). This composite responder analysis approach requires concurrent, clinically meaningful improvements in two outcomes for each patient, thus capturing in a single endpoint improvements in the multiple symptoms that comprise FMS. The Fibromyalgia Impact Questionnaire (FIQ) total score change from baseline was used as a key secondary criterion.
At the end of the 12-week fixed dose period, when compared with placebo, milnacipran showed a significantly greater improvement in the primary efficacy composite criterion (p=0.0003) and in the key secondary criterion, FIQ total score (p=0.015).The effects on pain were further confirmed by the statistical improvement in secondary parameters (24-hour recall pain and weekly pain ratings, Brief Pain Inventory). Patients’ overall improvement was confirmed by significant improvements in SF-36 (Mental and Physical components), Multidimensional Fatigue Inventory (MFI) total score, FIQ Physical function sub score, and the Multiple AbilitySelf-Report Questionnaire cognition total score (MASQ).
These trial findings consistently confirm, on all relevant parameters, that milnacipran is an effective treatment for the multiple symptoms of FMS including pain, physical function and symptoms affecting global well being, including fatigue.
Milnacipran was generally well tolerated, with most patient withdrawals occurring early in the trial. The most common adverse events that led to early withdrawal among the milnaciprantreated patients were nausea, hyperhidrosis, headache, and heart rate increase, each of which occurred at a rate of less than 5%. Milnacipran has a neutral effect on weight.
EMEA Submission The EMEA submission also includes efficacy data from two US pivotal Phase III trials involving a total of 2,084 patients (1,460 milnacipran, 624 placebo), in which milnacipran demonstrated improvement compared to placebo in treating FMS. Moreover, safety data collected from 2,209 patients (1,557 milnacipran, 652 placebo) during the US development program demonstrated that milnacipran was generally well tolerated with the majority of adverse events reported as mild to moderate in severity.
Pierre Fabre’s partners in the US, Forest Laboratories (FRX) and Cypress Bioscience (CYPB)submitted a New Drug Application (NDA) for milnacipran in the treatment of FM to the US Food and Drug Administration (FDA) around the end of 2007.The FDA accepted the milnacipran NDA for review in February 2008. The FDA Prescription Drug User FeeAct (PDUFA) target action date is expected to occur in October 2008.
About Pierre Fabre Medicament : The Pierre Fabre Group, the second largest independent laboratory in France, employs some 9500 people, and achieved 1.68 billion euros in sales in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands :Avène, Ducray, A-Derma, Galenic, Klorane and René Furterer. Pierre Fabre Médicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1400 employees dedicated to R&D, Pierre Fabre Médicament invests 25 % of its annual sales to R&D, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Médicament, with 50 % of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. For more information about Pierre Fabre Medicament , please visit Pierre Fabre website at www.pierre-fabre.com About Forest Laboratories Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and delivering products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
About Cypress CypressBioscience (CYPB) is committed to developing and commercializing pharmaceutical products and personalized medicine laboratory services that allow physicians to serve unmet medical needs. Cypress’ strategy involves evaluating various other potential strategic transactions, including the potential acquisition of products, product candidates, technologies and companies, and other alternatives.
Press contact : Caroline Perdrix Pierre Fabre Laboratories 45, place Abel Gance - 92654 Boulogne Billancourt Cedex e-mail :firstname.lastname@example.org
Posted: June 2008