Health Canada Responds to Hemolink(TM) New Drug Submission

Apr 26, 2001, 01:00 ET from Hemosol Inc.

    TORONTO, April 26 /PRNewswire/ - Hemosol Inc. (NASDAQ:   HMSL, TSE: HML)
 today announced that Health Canada's Biologics and Genetic Therapies
 Directorate (BGTD) has completed its first review of the Company's New Drug
 Submission (NDS) to market its human hemoglobin-based oxygen carrier
 Hemolink(TM) in Canada.
     The BGTD has provided Hemosol with a comprehensive set of questions
 related to the Hemolink(TM) New Drug Submission. In order to receive
 authorization to market Hemolink(TM) in Canada, the Company is expected to
 answer the questions to the satisfaction of the agency within 90 days. Hemosol
 expects to be able to satisfactorily respond to the questions in the required
 time.
     "We are confident in our ability to respond to Health Canada's questions
 with existing information from completed product validation, pre-clinical and
 clinical studies combined with data from our ongoing programs," stated John W.
 Kennedy, President and CEO of Hemosol Inc.
     Following Hemosol's response Health Canada will have 45 days to screen
 the response for completeness, which will be followed by a 90 day technical
 review period. Assuming a positive response upon a final review, the Company
 expects to be in a position to market Hemolink(TM) in Canada late in 2001.
     The NDS, filed on July 31st, 2000 seeks approval to market Hemolink(TM)
 in Canada to avoid or reduce the use of donor red blood cells in scheduled
 surgery such as coronary artery by-pass grafting surgery. In August of 2000,
 the BGTD granted Priority Review status to the Hemolink(TM) New Drug
 Submission. Priority Review status is granted to a small number of potentially
 important new products and provides a review timeframe that is significantly
 shorter than for non-priority products.
 
     About Hemosol Inc.
     Hemosol is an integrated biopharmaceutical company focused on the
 development of a portfolio of products for the treatment of hemoglobin
 deficiencies. Hemosol has a broad range of products in development which
 include: hemoglobin-based oxygen carriers, including Hemolink(TM); hemoglobin
 therapeutics to treat a variety of diseases such as hepatitis C and cancers of
 the liver; and cell therapy for possible therapeutic use to treat cancer, HIV-
 infection and auto-immune diseases. Hemolink(TM), Hemosol's flagship product,
 is a highly purified human-derived hemoglobin replacement product that is
 designed to provide immediate and safe oxygen delivery to vital organs and
 tissues. Potential benefits of Hemolink(TM) include significantly reduced risk
 of transmission of infectious diseases and adverse immune reactions,
 elimination of blood type mismatch and an extended storage life of at least
 two years compared with 42 days for donor blood. Hemosol is also developing
 methods to harvest hemoglobin from cells grown and expanded under controlled
 manufacturing conditions outside the human body.
     Hemosol Inc's common shares are listed on The Nasdaq Stock Market under
 the trading symbol "HMSL" and on the Toronto Stock Exchange under the trading
 symbol "HML".
 
     Certain statements concerning Hemosol's future prospects are
     "forward-looking statements" under the United States Private
     Securities Litigation Reform Act of 1995. 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 obtain regulatory approvals
     for its products; Hemosol's ability to successfully complete
     clinical trials for its products; technical or manufacturing
     or distribution issues; the competitive environment for
     Hemosol's products; the degree of market penetration of
     Hemosol's products; 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.
 
 

SOURCE Hemosol Inc.
    TORONTO, April 26 /PRNewswire/ - Hemosol Inc. (NASDAQ:   HMSL, TSE: HML)
 today announced that Health Canada's Biologics and Genetic Therapies
 Directorate (BGTD) has completed its first review of the Company's New Drug
 Submission (NDS) to market its human hemoglobin-based oxygen carrier
 Hemolink(TM) in Canada.
     The BGTD has provided Hemosol with a comprehensive set of questions
 related to the Hemolink(TM) New Drug Submission. In order to receive
 authorization to market Hemolink(TM) in Canada, the Company is expected to
 answer the questions to the satisfaction of the agency within 90 days. Hemosol
 expects to be able to satisfactorily respond to the questions in the required
 time.
     "We are confident in our ability to respond to Health Canada's questions
 with existing information from completed product validation, pre-clinical and
 clinical studies combined with data from our ongoing programs," stated John W.
 Kennedy, President and CEO of Hemosol Inc.
     Following Hemosol's response Health Canada will have 45 days to screen
 the response for completeness, which will be followed by a 90 day technical
 review period. Assuming a positive response upon a final review, the Company
 expects to be in a position to market Hemolink(TM) in Canada late in 2001.
     The NDS, filed on July 31st, 2000 seeks approval to market Hemolink(TM)
 in Canada to avoid or reduce the use of donor red blood cells in scheduled
 surgery such as coronary artery by-pass grafting surgery. In August of 2000,
 the BGTD granted Priority Review status to the Hemolink(TM) New Drug
 Submission. Priority Review status is granted to a small number of potentially
 important new products and provides a review timeframe that is significantly
 shorter than for non-priority products.
 
     About Hemosol Inc.
     Hemosol is an integrated biopharmaceutical company focused on the
 development of a portfolio of products for the treatment of hemoglobin
 deficiencies. Hemosol has a broad range of products in development which
 include: hemoglobin-based oxygen carriers, including Hemolink(TM); hemoglobin
 therapeutics to treat a variety of diseases such as hepatitis C and cancers of
 the liver; and cell therapy for possible therapeutic use to treat cancer, HIV-
 infection and auto-immune diseases. Hemolink(TM), Hemosol's flagship product,
 is a highly purified human-derived hemoglobin replacement product that is
 designed to provide immediate and safe oxygen delivery to vital organs and
 tissues. Potential benefits of Hemolink(TM) include significantly reduced risk
 of transmission of infectious diseases and adverse immune reactions,
 elimination of blood type mismatch and an extended storage life of at least
 two years compared with 42 days for donor blood. Hemosol is also developing
 methods to harvest hemoglobin from cells grown and expanded under controlled
 manufacturing conditions outside the human body.
     Hemosol Inc's common shares are listed on The Nasdaq Stock Market under
 the trading symbol "HMSL" and on the Toronto Stock Exchange under the trading
 symbol "HML".
 
     Certain statements concerning Hemosol's future prospects are
     "forward-looking statements" under the United States Private
     Securities Litigation Reform Act of 1995. 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 obtain regulatory approvals
     for its products; Hemosol's ability to successfully complete
     clinical trials for its products; technical or manufacturing
     or distribution issues; the competitive environment for
     Hemosol's products; the degree of market penetration of
     Hemosol's products; 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.
 
 SOURCE Hemosol Inc.