Axcan Pharma Inc. Announces Third Quarter Results.MONTREAL--(BUSINESS WIRE)--Aug. 22, 1997--AXCAN PHARMA(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). ;ME AXP ) In announcing results for its third quarter ended June 30, 1997, Axcan Pharma Inc. indicated revenues of $4,662,000 compared to $4,220,000 for the corresponding period in the previous fiscal year. The Company ended the quarter with a net loss of $384,000, or $0.025 per share compared to net earnings of $34,000, or $0.003 per share for the quarter ended June 30, 1996. These quarterly results include results from Axcan Schwarz LLC, the Company's joint venture operation with Schwarz Pharma US which will launch URSO(R) in the United States when the product is approved by 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. . Pre-launch expenses for URSO(R) have resulted in an increase in selling and administration expenses to $2,141,000 for this quarter from $1,538,000 for the same period in the previous fiscal year. This trend will continue until URSO(R) is launched in the United States. Phase II study on URSO(R) for the treatment of hypercholesterolemia Axcan Pharma announced the beginning of a clinical development program to evaluate the efficacy and safety of URSO(R) (ursodiol) in hypercholesterolemia (types IIa or IIb). Axcan has received approval from the Food and Drug Administration (USA) for its IND (Investigational New Drug submission) related to the use of ursodiol for this purpose. Acquisition of VIOKASE(R) for the US market During this quarter, Axcan Pharma US Inc., a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Axcan Pharma Inc., signed a letter of intent with American Home Products Corporation whereby Axcan will acquire the US rights to VIOKASE(R), an oral pancrelipase formulation. VIOKASE(R) is a pancreatic enzyme preparation containing standardized lipase lipase (lī`pās), any enzyme capable of degrading lipid molecules. The bulk of dietary lipids are a class called triacylglycerols and are attacked by lipases to yield simple fatty acids and glycerol, molecules which can permeate the membranes , protease and amylase amylase (ăm`əlās'), enzyme having physiological, commercial, and historical significance, also called diastase. It is found in both plants and animals. Amylase was purified (1835) from malt by Anselme Payen and Jean Persoz. in fixed proportions. It is indicated for the treatment of patients with exocrine exocrine /exo·crine/ (ek´so-krin) 1. secreting externally via a duct. 2. denoting such a gland or its secretion. ex·o·crine adj. 1. pancreatic enzyme deficiency as is often associated with cystic fibrosis, chronic pancreatitis and post-pancreatectomy. VIOKASE(R) will be the second product that Axcan will have on the US market. Axcan intends to co-market VIOKASE(R) with Paddock Laboratories, MN, in the very near future and has relocated its US base of operations Noun 1. base of operations - installation from which a military force initiates operations; "the attack wiped out our forward bases" base air base, air station - a base for military aircraft army base - a large base of operations for an army in Minneapolis. The acquisition is subject to respective corporate approvals and due diligence provisions. Once completed, the transaction will allow Axcan to increase its total sales by more than 25 percent in the next fiscal year (1997-1998). Axcan to Market URSO(R) in Canada Axcan Pharma Inc. also announced that following the acquisition of Jouveinal Inc. by Parke-Davis, an agreement has been reached between Axcan and Jouveinal to terminate the licensing agreement concerning the ursodiol formulation marketed in Canada under the URSOFALK(R) trademark. Based on 10 months of sales, URSOFALK(R) will represent at least $3.0 million CAN in additional revenue for Axcan's fiscal year ending September 30, 1998. Axcan will take over distribution of URSOFALK(R) on November 30, 1997, at the latest. URSOFALK(R) was licensed in 1984 to Jouveinal Canada Inc. and launched in 1990 for the dissolution of gallstones Gallstones Definition A gallstone is a solid crystal deposit that forms in the gallbladder, which is a pear-shaped organ that stores bile salts until they are needed to help digest fatty foods. . Approval for the treatment of cholestatic liver diseases including 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 ) was obtained in 1996. Jouveinal has successfully marketed as URSOFALK(R) in Canada, at a time when Axcan did not have the resources to do so. With the planned launch of URSO(R) in the United States, Axcan will benefit from the spillover of US promotional activities. Axcan Pharma is a Canadian pharmaceutical company which specializes not only in the field of gastroenterology but also 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). CONTACT: Relations Axcan Pharma Inc. Bertrand Bolduc, 514/467-5138 514/464-9979 (FAX) http://www.axcan.com bbolduc@axcan.com |
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