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South Africa Approves Hemopure [Hemoglobin Glutamer -- 250 (Bovine)] For Treatment Of Acute Anemia

CAMBRIDGE, MA -- April 10, 2001 -- 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 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.

Biopure has contracted South Africa-based healthcare provider Network Healthcare Holdings Limited or "Netcare" 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.

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.

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.

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 percent 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.


SOURCE: Biopure Corporation

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