ProMetic Life Sciences Inc.
TSX : PLI

ProMetic Life Sciences Inc.

December 11, 2009 06:00 ET

ProMetic Validates Its Regulatory Pathway for PBI-1402 With the FDA

MONTREAL, QUEBEC, CANADA--(Marketwire - Dec. 11, 2009) - ProMetic Life Sciences Inc. (TSX:PLI)

- Key milestone achieved for partnering

- PBI-1402 acknowledged as a novel, first-in-class drug that differs from existing medications (ESAs) approved for the treatment of anemia

- Unlike ESAs, PBI-1402 reduces tumor growth and does not elevate hemoglobin to potentially dangerous levels

ProMetic Life Sciences Inc. (TSX:PLI) met earlier this week with the U.S. Food and Drug Administration's ("FDA") Division of Medical Imaging and Hematology Products to discuss the regulatory pathway for the development of PBI-1402.

"We are very excited by the outcome of this meeting" indicated Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. "The Division of Medical Imaging and Hematology Products acknowledged that PBI-1402 is a novel, first-in-class drug that differs, via its mechanism of action, from existing medications approved for the treatment of anemia, such as the marketed erythropoiesis-stimulating agents (ESAs). This represents the achievement of a key milestone for our partnering discussions and strategic decisions as it creates a clear path for PBI-1402 and analogues to address unmet medical needs", Mr. Laurin added.

The guidance and recommendations provided by the FDA, corroborates ProMetic's strategy for the global development of PBI-1402 and its analogues for the treatment of anemia in cancer patients and in patients with chronic kidney disease.

The FDA sought recommendations from the Oncologic Drugs Advisory Committee in March 2008 based on increased evidence of ESAs' effect on patient survival, tumor progression and thrombotic events. Consequently, in December 2008, the FDA published a Medication Guide for ESAs warning that serious adverse events, including death, were more likely to occur if patients undergoing treatment with ESAs had cancer. Additionally the risk of these serious adverse events occurring would be greater if the hemoglobin target was greater than 12 g/dL.

ProMetic scientists have demonstrated that PBI-1402 differs from ESAs by virtue of a unique mechanism of action. Several studies to date indicate that PBI-1402 reduces tumor growth and does not elevate hemoglobin to potentially dangerous levels.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. ("ProMetic") (www.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand™ technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the U.S., Europe, Asia and in the Middle-East.

Forward Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 25 of ProMetic's Annual Information Form for the year ended December 31, 2008, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

Contact Information

  • ProMetic Life Sciences Inc.
    Pierre Laurin
    President and CEO
    +1-514-341-2115
    p.laurin@prometic.com
    or
    ProMetic Life Sciences Inc.
    Anne Leduc
    Manager, Investor Relations & Communications
    +1-514-341-2115
    a.leduc@prometic.com