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Print Edition StoriesThursday, November 19, 2009
Genzyme halts kidney treatment development
By Mass High Tech staff
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Following a combined Phase 2 and 3 study for its advanced phosphate binder (APB), Genzyme Corp. is no longer pursuing development of its chronic kidney disease treatment, intended as a more effective version of its current Renvela drug.
The study returned positive results in lowering phosphate levels, as compared to placebo — its intended goal — but it did not offer a significant enough difference in phosphate reduction from Genzyme’s Renvela treatment, company officials reported Wednesday. Genzyme intended to develop a more potent drug than Renvela.
The study, which tested 349 adult hemodialysis patients, had returned mild side effects, including gastrointestinal disorders, from APB.
Genzyme was hit earlier this week by news of the U.S. Food and Drug Administration’s second rejection of its Lumizyme treatment of Pompe disease. The company got its initial rejection of the drug in March. The rejection related to Genzyme’s Allston plant’s finishing capabilities, which the company said it will address by adding internal controls, updating the filling and finishing capabilities in Allston, and using contract manufacturers and Genzyme’s own Ireland manufacturing plant.
Genzyme has continued to battle the consequences of a forced shut down at its Allston manufacturing facility in the summer due to the discovery of a virus.
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