PHARMACY

Sandoz starts two late-stage biosimilar trials

BY Alaric DeArment

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs’ eventual marketing in the United States.

The generics arm of Swiss drug maker Novartis announced the start of phase-3 clinical trials of filgrastim and pegfilgrastim, respectively biosimilar versions of Amgen’s Neupogen and Neulasta. Both drugs are used to prevent neutropenia, a side effect of some chemotherapy treatments that results in low counts of white blood cells, known as neutrophils, and can lead to dangerous infections.

"Sandoz is already the clear global leader in biosimilars overall and in each of our three marketed products, with approximately 50% total segment share in the highly regulated markets of North America, Europe, Japan and Australia," Sandoz global head Jeff George said. "These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline."

Sandoz already markets filgrastim under the brand name Zarzio in more than 30 countries outside the United States, where a large healthcare reform bill included the creation of a regulatory approval pathway for biosimilars. In addition, it markets the growth disorder drug Omnitrope (somatropin), a biosimilar of Pfizer’s Genotropin, in the United States under a special approval pathway that the Food and Drug Administration created in 2006.


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The Apothecary Shops receives distribution rights for Eylea

BY Alaric DeArment

PHOENIX — The wholesale arm of specialty pharmacy The Apothecary Shops has received distribution rights to a drug for treating age-related macular degeneration, the company said Thursday.

Apothecary Shops Wholesale has begun distributing Regeneron Pharmaceuticals’ Eylea (aflibercept) to physicians and patients. The drug is used to treat neovascular or "wet" AMD. The "wet" form usually leads to more serious vision loss.

"With over 17 years of ophthalmology practice experience, The Apothecary Shops are among the finest specialty pharmacies in the nation, particularly with regard to ophthalmological medications," Apothecary Shops national director of ophthalmology Jim Rehovsky said. "And to better serve our customers who are prescribed the Eylea injection, we have the ability to work directly with the administering physician and the insurance provider to give our customers broader access options."

Last week, Diplomat Specialty Pharmaceuticals also announced that it received distribution rights for the drug.

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Jazz Pharmaceuticals, Azur Pharma combine

BY Allison Cerra

DUBLIN — Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

The two said the it now will be a specialty biopharmaceutical company called Jazz Pharmaceuticals plc and will be based in Dublin.

"As Jazz Pharmaceuticals plc, we are a growing, profitable specialty biopharmaceutical company with a diverse portfolio of products in the central nervous system and women’s health areas," said Bruce Cozadd, chairman and CEO at Jazz Pharmaceuticals. "We now have a strengthened management team, a broader commercial organization and an efficient platform for further growth, with resources to build our product portfolio and a future pipeline."

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