(RTTNews) -  Wednesday, biotechnology company Genzyme Corp. (GENZ: News ) said phase 2/3 study of its advanced phosphate binder, or APB, showed that APB did not exhibit a significant improvement in phosphate lowering compared to the company's Renvela, and hence it is not planning to pursue further clinical development of APB.

However, the company said, the trial met its primary end point, which was to show that the APB lowered phosphate levels effectively compared to placebo. In the study, Renvela and the APB both effectively lowered patients' phosphorus levels, the company noted.

The company is planning to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela.

The trial was a randomized, double-blind, placebo-controlled study that enrolled 349 adult hemodialysis patients with hyperphosphatemia. It included seven arms: low, medium and high dose APB; low, medium and high dose Renvela, and placebo. It included a two-week screening period, a two-week washout period, and a three-week treatment period.

Early this week, Genzyme revealed that the U.S. Food and Drug Administration has sought for resolution of deficiencies at its Allston Landing manufacturing plant, primarily related to fill/finish capabilities, before granting approval for Lumizyme, its alglucosidase alfa drug candidate for the treatment of Pompe disease. The company also revealed that Lumizyme is no longer produced at Allston, but at a larger facility in Belgium.
The Allston facility was shut down for a few weeks in June following a viral contamination in one of the six bioreactors used to develop Cerezyme and Fabrazyme, the two best-selling drugs of Genzyme. Sales of the two enzyme replacements were put on hold for more than a month following the virus detection.

Last month, Genzyme reported an 87% decline in profit for the third quarter from last year, reflecting the temporary shutdown and remediation of a key manufacturing facility in Boston that resulted in restricted supplies of the company's Gaucher disease drug Cerezyme and Fabry disease drug Fabrazyme.

The company also slashed its full-year adjusted earnings outlook, reflecting its decision to write of Cerezyme work-in-process material, cost of remediating the Allston plant, and management of customer-level inventories related to the Bayer transaction.

GENZ closed Tuesday's regular trading session at $50.32.

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by RTT Staff Writer

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