Hemosol (NASDAQ:HMSL)
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Hemosol Provides Corporate Update
- Company to focus on significant plasma-based therapeutic protein opportunity
-
TORONTO, Dec. 9 /PRNewswire-FirstCall/ -- Hemosol Corp. (NASDAQ:HMSLNASDAQ:
TSX:NASDAQ:HML) today announced that the Company is expanding its efforts and
resources being directed to the commercialisation of three key therapeutic
protein products: - Intravenous Immunoglobulins (IVIG), Alpha 1 Proteinase
Inhibitor (A(1)PI), and von Willebrand Factor/Factor VIII (vWF/FVIII), a
product used by hemophiliacs - all of which will be isolated using the Cascade
technology for which Hemosol is the exclusive North American licensee.
Hemosol believes that these initial products collectively represent the best
market opportunity for products isolated using the Cascade. "The Cascade
significantly increases protein recovery, which greatly reduces processing
time, production costs and provides us with a competitive advantage," said Lee
Hartwell, President and CEO, Hemosol Corp. "By using the Cascade to augment our
expertise in blood protein development and manufacturing, we look to become a
significant supplier of these valuable products."
Hemosol staff have completed training at the American Red Cross facility on the
Cascade technology and are in the process of implementing the technology at
Hemosol's facility. As expected, significantly higher target protein yields
compared to current technology have been met or exceeded at the four-litre
development scale and engineering runs on a limited scale will begin at
Hemosol's facility in the coming weeks. Hemosol's facility was originally
designed for the asceptic processing of blood products, is cGMP compliant and
has the capacity to process 500,000 litres of plasma annually using the Cascade
at commercial scale - with room for expansion.
The Company expects that Investigational New Drug applications for all three
products will be prepared for filing with the US Food and Drug Administration
(FDA) towards the end of 2005 with clinical development activity and commercial
scale-up of Hemosol's manufacturing facility commencing thereafter. After
completion of successful clinical trials, the Company expects that New Drug
Applications could be filed with the FDA in 2007. Hemosol plans to begin
commercial production following the appropriate regulatory approvals.
Hemosol is collaborating with the American Red Cross (ARC) and Prometic Life
Sciences (Prometic) on the commercial launch of products mentioned above in
addition to other products which could be isolated using the Cascade
technology. Each group possesses valuable experience and knowledge in the
field, and will collaborate on product development and clinical evaluation.
Hemosol is currently in discussions with the ARC for the supply of raw plasma
and the purchase of finished materials. The Company is also in early-stage
discussions with other potential plasma suppliers and product distributors.
Oxygen Therapeutic Program Update
As previously disclosed, Hemosol conducted a series of non-clinical studies on
HEMOLINK(TM) (hemoglobin raffimer), to determine the mechanism that caused
certain adverse cardiovascular related events observed in an earlier U.S.
clinical trial. Based on the data derived from these non-clinical studies
Hemosol believes that certain relatively simple modifications related to
eliminating low molecular weight components of HEMOLINK may be effective. At
this time however, the Company believes the resources required to pursue the
clinical development of a modified HEMOLINK would be better invested in the
significant, more immediate plasma-based therapeutic protein opportunity
discussed above. As a result Hemosol will defer further clinical development of
HEMOLINK at the present time.
The Company continues to believe that the market opportunity for HEMOLINK and
its broader oxygen therapeutics portfolio is significant and will continue to
pursue avenues for their development, including potential partners, which can
provide additional resources. Hemosol has invested considerable intellectual
capital in these products and believes that there may be potential for value
creation in the longer term.
In addition to its portfolio of oxygen therapeutics, Hemosol is developing a
pipeline of protein-based therapeutics to treat certain infectious diseases,
cancers and anemia. The Company plans to continue its efforts on establishing
proof of concept and preparing the most promising new drug candidates within
the portfolio for pre-clinical development and to further generate shareholder
value through active partnering and licensing initiatives.
More about the Cascade Process
The Cascade process is the first major technological improvement for the
extraction of valuable therapeutic products from plasma since the Cohn cold
ethanol fractionation process was originally developed for the manufacture of
albumin in the 1940's. This novel process based on affinity chromatography,
increases protein yields that allow for significant increases in profitability
per litre of plasma versus the established methods currently in use. The
Cascade process involves passing plasma through a series of affinity
chromatography columns that are each highly specific and selective for a
different plasma protein. The proteins of interest are captured on each of the
different resins, while the unbound plasma components flow through the column
and form the feed to the next affinity column. This process allows the
individual proteins of interest to be eluted off the affinity columns for
subsequent viral inactivation and downstream processing and polishing.
Essentially, the Cascade process replaces the backbone of the alcohol
fractionation scheme.
The enabling technology behind the Cascade provides the ability to rapidly
custom tailor robust chromatography resins to purify specifically targeted
proteins/biomolecules from complex solutions, through mimetic ligand screening
techniques, developed by Prometic.
About Hemosol
Hemosol is a biopharmaceutical company focused on the development and
manufacturing of biologics, particularly blood-related proteins. Hemosol has a
broad range of novel therapeutic products in development, including oxygen
therapeutics and protein-based therapeutics to treat certain infectious
diseases, cancers and anemia.
For more information visit Hemosol's website at http://www.hemosol.com/.
Hemosol'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" 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 there from;
Hemosol's ability to obtain additional financing; 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; 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,
(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.