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Pfizer takes new direction with Protalix pact.

NEW YORK -- Pfizer Inc. has licensed global rights to a treatment for Gaucher's disease from Protalix.

The transaction signals Pfizer's entry into the market for extremely expensive medications for rare diseases, a step that has been taken by several other traditional pharmaceutical firms. Pfizer's agreement with Protalix, an Israel-based biotechnology company, places it into competition with Cerezyme, Genzyme Inc.'s biggest-selling product.

Protalix will receive $60 million initially and up to $55 million later under the agreement. The companies will split expenses to market the drug and revenue on a 60/40 basis, with Pfizer having the larger share. Protalix is close to filing its application for Food and Drug Administration approval of the drug. The product, Uplyso (also called taliglucerase alfa), could reach the market next year.

Shire Pharmaceuticals PLC is also seeking approval in the United States to sell a drug for Gaucher's disease.

Although large pharmaceutical companies once tended to disregard rare diseases, slower sales growth and patent expirations for older blockbusters (including treatments for high cholesterol and diabetes) have forced such companies to venture into the specialized drug sector.

For example, in October, GlaxoSmithKline PLC announced a deal with Prosensa, a Dutch company, to develop drugs for Duchenne muscular dystrophy, a rare disease.

Earlier, Novartis AG received FDA clearance to sell its drug Ilaris as a treatment for cryopyrin-associated periodic syndrome. Only about 300 Americans suffer from that syndrome, an inflammatory condition caused by a gene mutation.

Gaucher's disease is an enzyme deficiency that can cause an enlarged liver and spleen, anemia, frequent bleeding and bone weakness. Although fewer than 6,000 people worldwide are believed to be under treatment with Genzyme's Cerezyme, the financial implications are enormous. The medication reportedly costs about $200,000 per patient per year; thus sales surpassing $1 billion annually can be supported with even this small patient population.

Protalix's drug is made in genetically engineered carrot cells. The cells are grown in plastic bags rather than through the typical biopharmaceutical approach, which employs stainless steel vessels. Protalix says that its method significantly reduces production costs.

Protalix completed a late-stage trial of Uplyso in October. The drug was granted an orphan drug designation and a fast-track status by the federal regulators.

"We are excited about this collaboration, which represents a significant step toward bringing--for the first time--a plant-based enzyme replacement treatment option to patients affected by Gaucher's disease," comments Dr. David Aviezer, president and chief executive officer of Protalix.

"By joining our advances in biologics manufacturing and protein development with Pfizer's global strengths in patient services and reimbursement, we expect to help make taliglucerase alfa an important and cost-effective treatment choice for Gaucher's patients throughout the world."

David Simmons, president and general manager of Pfizer's established products business unit, adds that Pfizer and Protalix expect to quickly deliver the alternative treatment for people suffering from Gaucher's disease. "This agreement supports our goal to meet the needs of many patient populations, including those affected by rare diseases, and brings the best minds together to challenge the most feared diseases of our time," he says.

The Pfizer/Protalix pact is also applauded by Peter Saltonstall, president and CEO of the National Organization for Rare Disorders (NORD), a patient advocacy group.

"NORD is always pleased when treatment options are expanded for people with rare diseases," Saltonstall says. "We welcome Pfizer's commitment to the rare disease arena and look forward to working with Pfizer and Protalix in support of increased options for patients and families affected by rare diseases."
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Title Annotation:Focus
Publication:Chain Drug Review
Date:Dec 7, 2009
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