PHARMACY

Study shows Sutent/high blood pressure link; experts say it’s worth the risk

BY Drew Buono

WALTHAM, Mass. According to a study published in the New England Journal of Medicine, the new anti-cancer drug Sutent can cause high blood pressure in patients with kidney cancer. This now relates to a study published last month that found the drug increased blood pressure and the risk of heart failure among patients with stomach cancer.

“Patients taking sutent and other similar [drugs] may experience increases in blood pressure of 15 percent to 25 percent,” said study author Michel Azizi, a professor of vascular medicine at Georges Pompidou European Hospital in Paris. Azizi thinks that, despite the increase in blood pressure, the cancer-fighting benefits of sutent outweigh the risks. Sutent and similar drugs are prescribed for patients with advanced malignancies and short life expectancies, he explained. Also, for patients with normal blood pressure, the increase caused by the drug is manageable with blood pressure-lowering drugs, he noted.

In a statement released in December for the The Lancet study, Sutent’s maker, Pfizer, agreed that these heart risks do exist. In the statement, Pfizer added that, “lower incidences of cardiovascular effects have been observed in subsequent randomized Phase III prospective sutent studies in both renal cell carcinoma and gastrointestinal stromal tumor[s].”

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Orion, Sun in patent fight over Stalevo

BY Drew Buono

HELSINKI, Finland Orion has extended a patent suit against Sun Pharmaceuticals, which is challenging the company on its Parkinson’s disease treatment drug Stalevo, according to published reports.

Orion is already suing Sun to prevent it from making a generic version of the drug, which is generically called carbidopa/levodopa. Sun has now amended its application to contain Paragraph IV challenges against three of Orion’s patents covering Stalevo.

The challenges mean Sun is either claiming Orion’s patents are invalid or that it would not be infringing on Orion’s patent rights by making a generic version.

Orion, which is evaluating its legal options together with Novartis, the company which exclusively markets Stalevo in the, said the application review process has only just begun and that generic competition is ‘neither certain nor imminent’.

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Forest, Cypress submit application to FDA for fibromyalgia treatment

BY Drew Buono

NEW YORK and SAN DIEGO Forest Laboratories and Cypress Bioscience have recently submitted a drug application to the Food and Drug Administration for milnacipran, a drug for treatment of fibromyalgia syndrome, according to published reports.

The submission includes efficacy data from two Phase III trials involving 2,084 patients, which showed that milnacipran demonstrated improvement compared to a placebo in treating fibromyalgia, the companies said.

Currently, only Pfizer’s Lyrica is approved in the U.S. to treat fibromyalgia, which affects up to 6 million Americans.

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