PHARMACY

Biogen, Genentech announce positive results in Rituxan study

BY Drew Buono

SAN FRANCISCO & CAMBRIDGE, Mass. Biogen and Genentech have released the results of a Phase III clinical study of the arthritis drug Rituxan. The drug’s results were compared with a placebo study and, according to the American College of Rheumatology 20, scored significantly higher at six months than did the placebo. Both studies involved using the drug methotrexate in combination with the Rituxan and the placebo. The ACR 20 measures an improvement in arthritis on a scale of improvement by 20 percent or more.

In this study, titled SERENE, patients received a single treatment of two infusions of either 500 mg or 1000 mg of Rituxan in combination with a stable dose of methotrexate. Although the study was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both Rituxan doses. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

“While use of Rituxan with methotrexate is well-established in rheumatoid arthritis patients who have had an inadequate response to anti-TNF therapy, this is the first Phase III study demonstrating that Rituxan improved symptoms of rheumatoid arthritis in patients who had not previously been treated with a biologic therapy,” said Hal Barron, M.D., Genentech’s senior vice president, development and chief medical officer. “These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease.”

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Harvard program seeks to discourage doctors from prescribing pediatric antibiotics

BY Drew Buono

CAMBRIDGE, Mass. A program was conducted at the Harvard Medical School in an effort to change doctors’ prescribing habits for antibiotics and to educate parents of small children about the proper use of antibiotics, according to Reuters.

The program was initiated because of the emergence of microbes that are resistant to antibiotics because doctors prescribed the medications when they weren’t really needed.

Harvard Medical School’s Jonathan Finkelstein and colleagues conducted the program in 16 Massachusetts communities between 1988 and 2003. Finkelstein’s team measured changes in antibiotic prescribing rates among three groups of children: 3 to 24 months, 24 to 48 months, and 48 to 72 months.

By the end of the study, the intervention had not changed the rate of antibiotic use in the youngest group, but for children between 24 and 48 months, the rates decreased by 4.2 percent and for the oldest children, the rates decreased by 6.7 percent.

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Patent office rejects Gilead patents for Viread

BY Drew Buono

WASHINGTON The Patent and Trademark Office has tentatively rejected four patents for Gilead Sciences’ HIV drug Viread, according to published reports.

The Public Patent Foundation filed a petition in March seeking to revoke the patents for the drug because they felt the drug should never have been patented in the first place, as the technology used to make the drug had been previously disclosed publicly.

The PTO is now re-examining the patents. Industry experts have said that it is common for the federal agency to tentatively rule patents invalid after having been asked by a third party to re-examine them. What would be unlikely would be the patents being permanently revoked, which has only occurred about 10 percent of the time.

Gilead sells Viread under that name and in combination with other drugs as Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company.

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