Axcan's URSO(R) approvable -- Axcan receives approvable letter from FDA for Urso(R) in the treatment of PBC.MONTREAL--(BUSINESS WIRE)--March 25, 1997--Axcan Pharma Inc. (TSE/ME:AXP The brand name Digital gave to its first family of Alpha-based computers. In 1998, Digital was acquired by Compaq. See Alpha. .) has crossed a major threshold towards obtaining final approval to market URSO URSO University Radiation Safety Officer (assesses radiation hazards on campus) (Ursodiol) in the United States for the treatment of primary biliary cirrhosis Primary Biliary Cirrhosis Definition Primary biliary cirrhosis is the gradual destruction of the biliary system for unknown reasons. Description (PBC PBC 1 Peripheral blood cells 2 Primary biliary cirrhosis, see there ). The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has issued an approvable letter which is the last step before final approval in the United States. This letter lists the conditions which Axcan must satisfy prior to launching URSO in the United States. "Axcan sees no problem in satisfying these conditions and expects to do so within 4 months," stated Leon Gosselin, president and chief executive officer of the company. Primary Biliary Cirrhosis PBC is a chronic, progressive cholestatic liver disease of unknown origin. Some 50,000 people in the United States have the disease. After diagnosis, patients currently survive an average of 10 years. Liver transplant is the only alternative treatment for end-stage patients. Findings indicate that URSO is the only effective and safe drug for the treatment of PBC. It improves the survival rate of patients and delays liver transplantation. Axcan Pharma, Tokyo Tanabe and the Mayo Clinic are working together to develop several other new and important indications for URSO. These other indications pursued by Axcan target much larger disease populations, which would represent several million patients in the United States. Axcan-Schwarz LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control Axcan Pharma Inc. and Schwarz Pharma Inc. of Milwaukee have formed Axcan Schwarz LLC, a Delaware limited liability company which will market and distribute URSO ursodiol tablets in the United States , initially for the treatment of Primary Biliary Cirrhosis (PBC) and later for other indications as well, once they are approved by the FDA. Axcan and Schwarz each have a 50 percent ownership interest in Axcan Schwarz. As previously announced, Axcan will receive milestone payments for new URSO(R) indications once the FDA approves them. The net amount of these payments are US $20 million for the prevention of colorectal cancer, US $10 million for the treatment of hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. , US $5 million for adjunctive treatment of Hepatitis "C" and US $10 million for non-alcoholic steatohepatitis. Axcan Pharma is a pharmaceutical company which specializes in the field of gastroenterology and is also active in contraception, the prevention of sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely and hemodialysis. Founded in 1983, its head office is located in Mont-St-Hilaire (Quebec), and it has other offices and subsidiaries in Laval (Quebec), Calgary (Alberta), and Plattsburg (New York). CONTACT: Axcan Pharma Inc. Leon F. Gosselin, 514/467-5138 or Axcan Pharma Inc. Bertrand Bolduc, 514/467-5138 514/464-9979 (Fax) bbolduc@axcan.com |
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