MONTREAL, Jan. 4 /PRNewswire/ - Procyon Biopharma Inc. (TSE:PBP) announced today the signing of a licensing agreement with Biovail Corporation for the marketing rights in the United States to FIBROSTAT(R), a novel topical therapeutic for scar management. The culmination of this agreement follows an expanding relationship between both companies subsequent to an alliance for the Canadian marketing rights for FIBROSTAT(R) with Biovail Pharmaceuticals Canada (a division of Biovail Corporation) in February of last year and the co- development activities undertaken since then. Terms of the agreement include an investment of $4 million in preferred equity, $5 million as a licensing fee upon approval and commercialization of the product in the U.S., and double- digit royalties payable to Procyon upon the commercialization of the product. The deal also includes undisclosed payments by Biovail to Procyon specifically associated with the development of FIBROSTAT(R), subject to the attainment of certain milestones. "This is a tremendous step forward in the path to commercialization of FIBROSTAT(R) worldwide and is a further validation of the potential of this unique product. As well, this is a very important milestone for the Company. This sets the stage for licensing this product out in the rest of the world including Europe and Japan" said Mr. Hans J. Mader, CEO, President and Chairman of Procyon Biopharma Inc. "We are very pleased that our alliance for FIBROSTAT(R) now covers both the United States and Canada. This is in line with Biovail's enhanced emphasis on the U.S. market following the recent acquisition of a U.S. pharmaceutical sales and marketing organization and the Company's plans to add an additional 500 sales representatives to this organization," said Mr. Rolf Reininghaus, President of Biovail Ventures. FIBROSTAT(R) is a novel topical therapeutic for scar management in patients who have undergone dermal trauma, such as surgery. FIBROSTAT(R) has been proven to significantly reduce hypertrophic scarring in past clinical trials and is currently available in Canada under the Special Access Program of Health Canada. FIBROSTAT(R) is well advanced on the development path with commercial launch expected in 2004/2005 in North America. Currently, the product is undergoing final dose finding studies in Canada with Phase III trials slated to begin early next year. FIBROSTAT(R) is patented in the U.S, Canada, Japan and Australia, with patents allowed in Europe and is one of two late-stage products in Procyon's development pipeline. It was invented by Dr. Ken Dolynchuk, a plastic surgeon at the University of Manitoba, and has been exclusively licensed to Procyon. Procyon Biopharma Inc. is a publicly listed, Biopharmaceutical Company focused principally on advancing two powerful platform technologies that have the potential to diagnose and treat cancer. Procyon's non-pathogenic Antinucleosome Autoantibodies (ANAs) bind specifically to multiple cancer cell types strongly enhancing the immune response to cancer cells. Prostate Secretory Protein (PSP94) is a naturally occurring human protein that has the potential to treat prostate cancer by inhibiting abnormal prostate cell growth. In addition, the estimation of PSP94 levels in prostate cancer patients may have prognostic and diagnostic applications. Procyon also has two late-stage products: FIBROSTAT(R), a topical cream for the management of newly formed scars following surgery or burns and COLOPATH(R), a rapid, non-invasive screening test for colorectal cancer. Procyon's shares trade on the Toronto Stock Exchange under the ticker symbol, PBP. This release contains forward-looking statements that reflect the company's current expectation regarding future events. The forward- looking statements involve risk and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company's filings.
SOURCE Procyon Biopharma Inc.