Hemosol Provides Corporate Update
09 12월 2004 - 9:30PM
PR Newswire (US)
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.
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