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FDA approves treatment protocol for Gaucher disease treatment

BY Alaric DeArment

NEW YORK The Food and Drug Administration has approved a treatment protocol for a drug to treat a rare but potentially deadly genetic disease.

Protalix BioTherapeutics announced the FDA’s approval of its treatment protocol plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease, currently in phase 3 studies.

The protocol is a multicenter, open-label trial that will allow healthcare providers to use prGCD to treat patients with Gaucher disease during an expected shortage of Genzyme’s Gaucher treatment, Cerezyme.

“We appreciate the guidance and vote of confidence provided by the FDA in establishing a treatment protocol for prGCD and are working closely with physicians and patient advocacy groups to allow Gaucher disease patients to gain access to our drug,” Protalix president and CEO David Aviezer said in a statement. “We expect to continue our phase 3 pivotal study next month and are looking forward to announcing top-line results from this study in October.”

According to the National Gaucher Foundation, Gaucher disease occurs in about one-in-20,000 live births and is particularly prevalent in people of Ashkenazi Jewish descent. Patients with the disease have a genetic lack of ability to produce glucocerebrosidase, or GCD, in their bodies, resulting in the buildup of fatty tissue that can lead to enlargement of internal organs and death.

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Drug Store News launches new magazine

BY Alaric DeArment

BOSTON An estimated 100 people gathered last Monday for the official launch of the latest member of The Drug Store News Group of publications.

Armada is a specialty pharmacy channel management organizationThe attendees, including some curious representatives of retail pharmacy chains, crowded into the Stone Room at the Westin Boston Waterfront for a reception to introduce Specialty Pharmacy magazine, which Drug Store News began printing under a partnership with specialty pharmacy channel management organization Armada Health Care.

“When people outside of the business ask me what specialty pharmacy is, I try to keep the answer as simple as possible: I tell them it’s about patients with complex, chronic conditions; I tell them it’s about extremely complex, high-cost drugs,” Drug Store News editor-in-chief Rob Eder said in a speech at the reception. “And because of that, every single touch point of the operation, from managing the network, the utilization management, formulary management, sourcing the drugs, the buy and bill, the benefit design, the dispensing and fulfillment, the claims adjudication, etc. — all of it is more complex. So, that is our mission: to make a very complex business easier for the people who make their living in that business.”

Associate publisher Wayne Bennett noted the drug-development environment that has helped contribute to the rapid growth of specialty pharmacy.

“Our new publication, Specialty Pharmacy, will add to the broad portfolio of pharmacy publications published by the Drug Store News Group,” Bennett said. “As three-quarters of all new drugs currently in the drug development pipeline are biotech products, and the market for these products will grow by $40 billion in just a few short years, Specialty Pharmacy will be the voice for all stakeholders in this rapidly growing area of pharmacy care. We will also be collaborating with Armada Health Care, who has led in providing innovative solutions to make the specialty pharmacy market work more efficiently.”

Specialty products — most of them biotech drugs — have experienced rapid growth lately, generating just under $60 billion in U.S. sales last year, Specialty Pharmacy reported in its inaugural issue, and growing by 8.8% year-over-year, compared to 4.4% for traditional drugs. Meanwhile, two specialty pharmacies — Swartz Creek, Mich.-based Diplomat Specialty Pharmacy and Fort Lauderdale, Fla.-based Commcare Pharmacy — made Inc. magazine’s list of the top 500 fastest-growing private companies in the country for 2009.

“My colleagues and I are very enthusiastic about our collaboration with Drug?Store News to launch Specialty Pharmacy magazine. We are confident that this publication will become the media voice for this emerging segment of health care, while fostering a better understanding of the value proposition that specialty pharmacies offer to such key stakeholders as Pharma/Biotech, payers, prescribers and most importantly patients,” said Lawrence S. Irene, RPh, CEO Armada Health Care.

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Warning label updated for immunosuppressant drug CellCept

BY Alaric DeArment

ROCKVILLE, Md. Reports of a type of anemia have prompted changes to the warning label of a drug used to prevent the immune system from rejecting transplanted organs.

The Food and Drug Administration announced Friday that patients using CellCept (mycophenolate mofetil) had reported cases of pure red cell aplasia, which causes selective reduction of red blood cell precursors in the bone marrow. Patients with PRCA may experience fatigue, lethargy and pale skin.

Swiss drug maker Roche manufactures CellCept, and several generic drug companies make their own versions.

In July, the FDA required changes to the labeling of several immunosuppressant drugs, including CellCept, following reports of opportunistic viral infections among patients using them.

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