PHARMACY

ACC speaks out in favor of waiting for results of further Vytorin trials

BY Drew Buono

WASHINGTON With all the fallout from the ENHANCE trial regarding Merck and Schering-Plough’s cholesterol drug Vytorin, there is one positive show of support for the drug and it comes from the American College of Cardiology, according to published reports.

The ACC issued a statement saying that “major clinical decisions [should] not be made on the basis of the ENHANCE study alone [as it deserves] serious thought and follow-up.” The overall incidence rates of cardiac events were nearly identical between both treatment groups and both were generally well tolerated, the statement said, so “there should be no reason for patients to panic.” It added that the ENHANCE trial “is an imaging study and not a clinical-outcome study,” and that conclusions should not be made until three large clinical-outcome trials are presented within the next two to three years.

But, there are still many who feel the drug is unsafe and has been since it was put on the market. Sidney Wolfe, director of Health Research Group at Public Citizen, said that “we first warned against using Vytorin in December 2004” and suggested people should wait at least seven years before taking the treatment as it was not a “breakthrough” drug.

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PHARMACY

Zydus, Prolong sign deal to develop anemia treatment

BY Drew Buono

AHMEDABAD, India Zydus Cadila and Prolong Pharmaceuticals have signed a development deal for a therapeutic protein, PEG-EPO, for the treatment of severe anemia, according to published reports.

Under the terms of the deal, both companies will use Prolong’s PEGylation technology to make PEG-EPO.

Severe anemia is a condition where the hemoglobin level or number of circulating red blood cells is significantly reduced. This is common in chronic renal failure, cancer patients undergoing chemotherapy, chronic inflammatory diseases, heart failure, and critically ill patients.

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GSK, TB Alliance renew partnership for tuberculosis treatment

BY Drew Buono

LONDON and NEW YORK GlaxoSmithKline and the Global Alliance for TB Drug Development have renewed their joint research program that is designed to improve the treatment of tuberculosis. The collaboration began in 2004 and currently includes some projects that may produce new medicines to attack Mycobacterium tuberculosis, which causes tuberculosis.

The deal has been extended for an additional three years to research tuberculosis and malaria. So far under the deal, the collaboration has seen two drug discovery projects, out of five, in non-clinical studies to have potential benefits in fighting persistent forms of mycobacterium tuberculosis and thereby offer better chances of shortening treatment duration, which currently takes about six months to complete.

“We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline,” said Mel Spigelman, TB Alliance director of research and development. “This collaboration is advancing the TB Alliance’s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease.”

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