Debiopharm Submits Response to the FDA
LAUSANNE, Switzerland, November 4 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that Debiovision Inc., its Canadian affiliate, filed its Complete Response to the approvable letter received from the United States (U.S.) Food and Drug Administration (FDA) for Sanvar(R), or Debio 8609 (vapreotide acetate). The immediate release formulation of Sanvar(R), a somatostatin analogue, is used in the treatment of acute esophageal variceal bleeding (EVB).
"This is an important step towards completing the U.S. registration of our drug. Sanvar(R) has demonstrated therapeutic benefit in the control of acute variceal bleeding prior to endoscopic treatment, an indication for which, to this day, no product has been approved by the FDA," said Rolland-Yves Mauvernay, president and founder of Debiopharm Group.
"Last summer, we completed a confirmatory phase III study in the U.S. Our study took place in over 20 centers and enrolled 103 patients including 70 that qualified for the intention-to-treat (ITT) analysis. Debioclinic S.A., the Group's French affiliate, participated with the statistical analysis of our study. The results of this study were an important component of the Complete Response and were submitted to the FDA on September 30th," added Jacques Guertin, president and CEO of Debiovision Inc.
Debiopharm has already signed license agreements for the sales and marketing of Sanvar(R), with several commercial partners that include Salix Pharmaceuticals in the U.S., Ranbaxy Laboratories Ltd in India, EMS Sigma Farma in Brasil, LG Life Sciences in Korea, Tzamal Bio-Pharma Ltd in Israel, and Medical Futures in Canada.
Sanvar(R) is used prior to endoscopic intervention to control
haemorrhage and prevent re-bleeding during the critica
|SOURCE The Debiopharm Group|
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