HMSL Hemosol (MM)

Hemosol Selects IGIV as its First Therapeutic Protein Product for Development TORONTO, July 13 /PRNewswire-FirstCall/ -- Hemosol Corp. (NASDAQ:HMSLNASDAQ: TSX:NASDAQ:HML) today announced that it has chosen Immune Globulin Intravenous 10% (IGIV) as the first protein product that the Company will advance through the clinical development and regulatory process in order to seek approval to commence commercial production. IGIV is comprised of naturally occurring antibodies that are normally produced in the human body, however, in some cases, patients cannot produce sufficient quantities of these antibodies and are required to receive IGIV infusions every 3 to 4 weeks to avoid infectious diseases. The North American market for IGIV in 2004 was approximately US$1.3 billion. The intended clinical development plan for Hemosol's IGIV protein product will begin with the U.S. Food and Drug Administration's acceptance of an Investigational New Drug application (IND), followed by a pivotal trial in patients diagnosed with Primary Immune Deficiency disease. Patients will be dosed for approximately 12 months and results will be compared to historical controls. This IND is expected to be filed in late 2005 or early 2006, followed by a Biologic License Application in the second half of 2007. The Company believes that, upon the successful completion of this regulatory program, a commercial product will be available for launch in 2008. Additional indications for this product will be sought subsequent to the first approval. "Our decision to go ahead with IGIV as the initial therapeutic product is another important step in our strategic plan to become a leading developer and manufacturer of plasma-derived therapeutic proteins," said Lee Hartwell, President & CEO, Hemosol Corp. "The billion dollar North American market for IGIV increased by more than 10% last year and growth of 7-10% per year is expected to continue. This rate of growth may increase if new indications currently being investigated for IGIV are approved." The first approvals for an intravenously administered immunoglobulin preparation occurred in the mid-1980s. Since then, several additional IGIV products have been approved for commercial sale in major markets. The well defined and longstanding record for seeking the approval of IGIV products combined with the availability of published guidance from leading regulatory authorities, provides Hemosol with a clearly defined clinical development and regulatory pathway. Following, IGIV, the Company also intends to pursue regulatory approval for two other key therapeutic protein products: Alpha 1 Proteinase Inhibitor (A1PI), and von Willebrand Factor/Factor VIII (vWF/FVIII). Hemosol expects to file INDs and commence pivotal trials for each of these additional drug candidates in 2006. As previously disclosed, Hemosol has completed pre-commercial pilot scale runs for the extraction of all three protein products at a 30-litre scale and results to date have demonstrated increased production yields of all three protein products ranging from 30-450% greater than current industry averages depending on the protein. Hemosol believes that these increased yields will position the company favourably to compete in the multi-billion dollar plasma products business. The Company is pursuing a number of strategic options with respect to generating the necessary capital required to execute its therapeutic protein initiative. These options include strategic and financial partners in addition to the capital markets. More About IGIV IGIV is currently used to treat Primary Immune Deficiency, Idiopathic Thrombocytopenia Purpura, some forms of cancer, certain autoimmune diseases, pediatric AIDS and during organ transplants. Early-stage research has demonstrated that IGIV may also be of importance in the treatment of multiple sclerosis, rheumatoid arthritis and Alzheimer's disease. Worldwide demand for IGIV is expected to increase by 7-10% on an annual basis for the next five years. In May 2005 the Advisory Committee on Blood Safety and Availability for the U.S. Department of Health and Human Services concluded that "there is a worsening crisis in the availability of and access to IGIV products that is affecting and placing patients' lives at risk (e.g. patients with immunodeficiency)". About Hemosol Hemosol is an integrated biopharmaceutical developer and manufacturer of biologics, particularly blood-related protein based therapeutics. The Company is deploying a novel technology, Plasma Protein Chromatography (PPC), which has the potential to change the business dynamics of the therapeutic plasma proteins sector. Hemosol also continues to develop its rich and diverse therapeutic pipeline that includes three technology platforms - Oxygen Therapeutics for the treatment of high volume blood loss; Drug Delivery for the treatment of Hepatitis C and liver cancer; and Cell Therapeutics for the treatment of chronic myelogenous leukemia and chemotherapy-induced anemia. For more information visit Hemosol's website at http://www.hemosol.com/. The Common Shares are listed on the NASDAQ Stock Market under the trading symbol "HMSL" and on the TSX under the trading symbol "HML". Certain statements concerning Hemosol's future prospects are "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and other applicable securities legislation. There can be no assurances that future results will be achieved, and actual results could differ materially from forecasts and estimates. Important factors that could cause actual results to differ materially from forecasts and estimates include, but are not limited to: Hemosol's ability to successfully implement the Cascade technology and commercialize products derived from that technology; Hemosol's ability to obtain additional financing which is critical to the implementation of the Cascade technology and to Hemosol's continued viability as a going concern; Hemosol's ability to obtain regulatory approvals for its products; Hemosol's ability to successfully complete clinical trials for its products; Hemosol's ability to enter into satisfactory arrangements for the supply of materials used in its manufacturing operations and the sale of resulting products to customers; technical, manufacturing or distribution issues; the competitive environment for Hemosol's products and services; the degree of market penetration of Hemosol's products; Hemosol's ability to attract and retain clients for its bio-manufacturing services; the risk that Hemosol may not become profitable; and other factors set forth in filings with Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission. These risks and uncertainties, as well as others, are discussed in greater detail in the filings of Hemosol with Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission. Hemosol makes no commitment to revise or update any forward-looking statements in order to reflect events or circumstances after the date any such statement is made. DATASOURCE: Hemosol Corp. CONTACT: Jason Hogan, Investor & Media Relations, (416) 361-1331, 1-800-789-3419, (416) 815-0080 fax, , http://www.hemosol.com/; To request a free copy of this organization's annual report, please go to http://www.newswire.ca/ and click on reports@cnw.

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