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Biotech / Medical : Northfield Lab(NFLD) -- Ignore unavailable to you. Want to Upgrade?

To: Merritt who wrote (66)	7/7/1998 6:18:00 PM
From: Vector1	Read Replies (1) \| Respond to of 148

Merrit, I have no problem with disagreement. The following is from a September Cowan report on the industry. It is dated but would imply that Biopure is much further along than you seem to believe. As regards the facility it is disucssed on the Biopure web site. i do know that the same standards apply for approval of a vet product facility as a human. -- 80 Transfusion Therapies September 1997 BIOPURE (Private) Biopure is developing a blood substitute derived from bovine hemoglobin. Unlike its competitors, Biopure is initially targeting the veterinary market with Oxyglobin. The product has completed clinical trials and could be launched by year end 1997 assuming marketing clearance is forthcoming. Biopure is also developing Hemopure, a blood substitute for the human market. Hemopure is currently in Phase III clinicals in Europe and should enter U.S. Phase III clinicals this fall - setting the stage for a PMA submission in mid-to-late '98. Biopure already has a manufacturing facility in place which is capable of making 500K patient doses, scaleable to 1.5MM doses. Although the loss of partner Pharmacia & Upjohn, may spook a few folks, we suspect Biopure is in the hunt for another marketing alliance given the cost of ongoing human clinicals and the possibility that initial sales to the vet market may carry subpar margins. q Biopure Going To The Dogs . . . Then To People Biopure recently completed Phase III clinical trials for its bovine-based hemoglobin product, Oxyglobin. As detailed below, Biopure is initially targeting the veterinary market, which lacks alternatives for the treatment of acute blood loss. A temporary oxygen carrier could buy valuable time until a blood donor can be identified. But the vet market is difficult to size and it is not clear if this price sensitive market will support a product with decent margins, particularly early-on in Biopure's production curve. And production may not be able to ramp to more economical levels until Biopure's human product (Hemopure) garners U.S. approval in 1999-2000. Hemopure is currently in Phase III clinicals in Europe, with U.S. trials set to start this fall. The company will be targeting Hemopure at the general surgery market (large blood loss procedures) and a PMA could be filed by mid-to-late '98. BIOPURE PRODUCT LINEUP Market Product(s) Comments Veterinary Oxyglobin - Recently completed Phase III clinical trials. - Approval expected by year-end for use with anemic dogs. - Estimated that just 6% of dogs that would benefit from a blood transfusion is actually administered one. Human Hemopure - Have initiated Phase III clinicals in Europe. - U.S. Phase III clinicals expected to begin this fall with 200 patients targeting general surgery (large blood procedures including cardiopulmonary bypass and orthopedics). - Major endpoint will be a reduction or elimination of allogeneic blood. - Expect Phase III trials will be completed in 6 months - setting the stage for a PMA submission in mid-'98 with U.S. approval expected in 1999. - Only blood substitute in development that is stable at room temperature.