BPUR -World's First Oxygen Therapeutic for Human Use Approved In South Africa to Treat Acute Anemia in Surgery Patients
Biopure Contracts Netcare and Community Healthcare To Introduce Hemopure(R)
as Blood Avoidance Technique
CAMBRIDGE, Mass., April 10 /PRNewswire/ -- In the world's first regulatory approval of an oxygen
therapeutic for human use, South Africa's Medicines Control Council (MCC) has approved Biopure
Corporation's (Nasdaq: BPUR - news) product Hemopure® [hemoglobin glutamer -- 250 (bovine)] for the
treatment of acute anemia and avoidance of red blood cells in adult surgery patients, the company announced
today. Biopure has contracted South Africa-based healthcare provider Network Healthcare Holdings Limited
or ``Netcare'' (JSE: NTC) and Community Healthcare Holdings Limited to exclusively market and distribute
the product in Sub-Saharan Africa.
``This approval culminates almost two decades of technological innovation and product development,'' said
Biopure's Chairman and Chief Executive Officer Carl W. Rausch, who co-founded the company with Vice
Chairman David N. Judelson in 1984. ``Hemopure's introduction in South Africa is the first step in our
worldwide commercialization strategy, and we are preparing to file a U.S. marketing application later this year
followed by filings in Europe and other countries.''
Hemopure is the first product approved for human use in a new class of intravenously administered
pharmaceuticals, called oxygen therapeutics, which can be used to deliver oxygen to the body's tissues as a
sterile alternative to red blood cell transfusion. The marketing application in South Africa included data from
20 human clinical trials conducted over the past nine years in the United States, Europe, South Africa and
Canada. These clinical data included three completed, advanced trials comparing Hemopure to red blood cell
transfusion in cardiac, vascular and general surgeries and additional supportive data.
``This unique oxygen carrier could profoundly impact public health issues in Africa as the product's purity,
compatibility with all blood types and two-year room temperature stability address many of the medical and
logistical problems surrounding the treatment of anemia with red blood cells,'' said Dr. Richard Friedland,
chief operating officer of Netcare, the largest private doctor and hospital network in South Africa. ``In these
respects, our distribution agreement with Biopure is consistent with our commitment to introduce innovative
technologies that provide the best possible healthcare to our patients.''
While stored blood is tested and screened for certain known pathogens, it cannot be pharmaceutically
processed to assure purity. Biopure's patented, 22-step pharmaceutical manufacturing process for Hemopure
incorporates raw material controls to prevent the introduction of pathogens and employs purification
techniques that have been validated to remove or inactivate potential infectious agents, including bacteria,
viruses such as HIV and hepatitis C, and transmissible spongiform encephalopathy (TSE) agents that cause
rare neurological diseases such as variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform
encephalopathy (BSE) or ``Mad Cow disease''.
Independent expert reports, including one submitted to the South Africa MCC and the European Medicines
Evaluation Agency, estimate the risk of TSE transmission through Biopure's proprietary process as less than
one in 100 million, or effectively nil. The company's ultra-pure veterinary product, Oxyglobin®, is a similar
oxygen therapeutic approved by the U.S. Food and Drug Administration in 1998 and the European
Commission in 1999 for the treatment of anemia in dogs.
South African Market
Hemopure is licensed in South Africa to Tshepo Pharmaceuticals Limited, a joint subsidiary of Netcare and
Community Healthcare. Tshepo will launch the product nationally in the first half of 2002 after Biopure
completes the expansion of its Cambridge, Mass. manufacturing facility to accommodate an annual
production capacity of 100,000 Hemopure units. In the interim, Biopure will supply product at no cost for
introduction on a limited basis at select Netcare hospitals, where patient outcomes data will be collected to
demonstrate the pharmaco-economic implications and cost effectiveness of this new treatment.
``Netcare has a national presence that ensures access to world-class medical specialists and facilities and a
blood conservation program that promotes blood avoidance techniques in medicine and surgery,'' says Dr.
Edward Jacobs, Biopure's senior vice president of Medical Affairs, who has been involved with the
development of Hemopure since 1984. ``The expertise of these doctors, many of whom were involved in our
clinical trials, provides a conduit for educating the medical community on patient management using an oxygen
carrier with physical and clinical attributes that are different than blood.''
Hemopure -- An Oxygen Therapeutic
Each unit of Hemopure consists of 30 grams of hemoglobin that has been extracted from bovine red blood
cells, ultra-purified, chemically cross-linked and formulated in 250 milliliters of a balanced salt solution. These
stabilized, non-cellular hemoglobin molecules circulate in plasma (the fluid part of blood) when infused and are
much smaller, have lower viscosity (resistance to flow) and more readily release oxygen to tissues than red
blood cells. Consequently, they can carry oxygen at low pressure and can carry oxygen through constricted
or partially blocked blood vessels to areas of the body that red blood cells cannot reach.
``Hemopure represents a new treatment approach for providing immediate oxygen-carrying support when
there is a need or preference to avoid red blood cell transfusion. When infused, the product acts as an
'oxygen bridge' to help stabilize anemic surgery patients until they manufacture their own red blood cells or
compatible red blood cells can be administered,'' said Dr. Lewis Levien, a leading vascular and general
surgeon at Milpark Hospital in Johannesburg, South Africa, and a clinical trial investigator of Hemopure.
Anemia is a shortage of red blood cells or hemoglobin, the oxygen-carrying protein within red blood cells,
which can cause an oxygen deficiency and lead to cell damage, organ dysfunction or, in severe cases, death.
Acute anemia, usually caused by blood loss, is the primary indication for red blood cell transfusion.
Biopure sources its raw material, the protein hemoglobin, from managed herds of U.S. beef cattle (an
abundant source in a BSE-free country) with documentation assuring the origin, medical history, feed (no
mammalian protein) and young age of the cattle. These ``safe sourcing'' controls are not and cannot be
applied to the human donor pool and, as such, represent additional safeguards compared to human blood
products. In addition, Hemopure is compatible with all blood types and is approved in South Africa as stable
over a broad temperature range, including room temperature, for two years. In contrast, refrigerated red
blood cells are type specific and have a maximum shelf life of 42 days.
Product Indication
Hemopure was approved in South Africa for the treatment of adult surgical patients who are acutely anemic
and for the purpose of eliminating, delaying or reducing the need for allogenic (donated) red blood cells. Up
to seven units of Hemopure may be used over the course of one to six days. Results from Biopure's
advanced, red blood cell controlled trials in cardiac, vascular and general surgery showed that a statistically
significant percentage of patients receiving Hemopure avoided red blood cell transfusion and exhibited
improved hemodynamic stability.
In these trials, side effects (greater than or equal to 5% increased incidence versus control group) included
abdominal pain, weakness, hypertension (mild to moderate), jaundice (associated with the conversion of
hemoglobin to bilirubin and not associated with liver dysfunction), nausea, rash and discolored urine. Transient
mild to moderate isolated increases in enzyme levels may occur and are not associated with clinical hepatitis
or pancreatitis. Hemopure should not be used in patients with uncontrolled hypertension, systemic
mastocytosis or a known hypersensitivity to bovine hemoglobin, and has not been evaluated for use in
children or pregnant women.
Netcare, Tshepo Pharmaceuticals and Community Healthcare
Network Healthcare Holdings (Pty) Limited, or ``Netcare'', is an investment holding company whose
subsidiaries are engaged in a wide range of medical and health-related services. These subsidiaries own and
manage 43 private hospitals with 7200 beds and 61 specialized medical facilities throughout South Africa.
The company's association with the National Hospital Network expands this network to 104 hospitals. Other
business operations include pre-hospital and emergency services, pharmaceutical procurement, medical
education and training, patient referrals from other African countries, healthcare insurance and e-commerce.
Netcare has won a host of awards, including Best Healthcare Marketing Organization and Best Private
Hospital Group in South Africa. The Netcare Group has twice been voted one of the top 49 companies to
work for in South Africa.
Tshepo Pharmaceuticals (Pty) Limited is a pharmaceutical distribution company jointly owned by Netcare
and Community Healthcare Holdings (Pty) Limited, a black-owned investment holding company that owns
several healthcare-related investments. Community Healthcare recently acquired the Montana Park Clinic in
Pretoria, South Africa, and is presently negotiating the acquisition of several private hospitals in Gauteng. The
executive directors of Community Healthcare are Dr. Anna Mokgokong, Joe Madungandaba and Dewald
Dempers.
Biopure Corporation
Biopure Corporation, headquartered in Cambridge, Mass., is the leading developer, manufacturer and
marketer of a new class of pharmaceuticals, called oxygen therapeutic solutions, which are intravenously
administered to deliver oxygen to the body's tissues. Hemopure® [hemoglobin glutamer - 250 (bovine)], or
HBOC-201, is approved in South Africa to treat acute anemia and avoid red blood cell transfusion in adult
surgery patients. The company expects to file a marketing application in the United States in 2001, followed
by an application in Europe. The product is also being developed for use in trauma, cancer and ischemic
events such as heart attack and stroke. Oxyglobin® [hemoglobin glutamer - 200 (bovine)], the only product
of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United
States for the treatment of anemia in dogs.
Biopure's U.S. and foreign patents cover the manufacture of ultra-pure and room temperature stable
hemoglobin solutions and their use as oxygen therapeutics. Key claims in the U.S. patents are not limited by
the hemoglobin source (e.g., animal, human or genetically derived).
Statements in this press release that are not strictly historical may be forward-looking statements. There can
be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic
products, that necessary regulatory approvals will be obtained, that any clinical trials will be successful, or that
any approved product will find market acceptance. Actual results may differ from those projected in
forward-looking statements due to risks and uncertainties that exist in the company's operations and business
environment. These risks include, without limitation, the company's stage of product development, history of
operating losses and accumulated deficits, and uncertainties related to clinical trials, regulatory approval,
manufacturing and market acceptance. The company undertakes no obligation to release publicly the results
of any revisions to these forward-looking statements to reflect events or circumstances arising after the date
hereof. A full discussion of Biopure's operations and financial condition, and specific factors that could cause
the company's actual performance to differ from current expectations, can be found in the company's filings
with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the
SEC Web site, www.sec.gov, or through the Investor section of Biopure's Web site, www.biopure.com .
CONTACT: Douglas Sayles, Associate Director, Corporate Communications of
Biopure Corporation, 617-234-6826, or IR@biopure.com; or
investors, Jonathan Fassberg of The Trout Group, 212-477-9007,
ext. 16 for Biopure, or media, Brad Miles of BMC Communications,
212-477-9007, ext. 17, for Biopure
SOURCE: Biopure Corporation |
