Genzyme Kidney Drug Failed, Too...What Could Possibly Happen Next?

Just when you thought it couldn’t get any worse for Genzyme, a disappointing Phase II/III clinical trial led the company to drop development of its next-generation kidney drug, advanced phosphate binder (APB), late last week.

APB actually met its endpoint of lowering phosphate levels compared to placebo, but the drug failed to improve on Genzyme’s existing kidney drugs. According to a BioWorld article:

Renvela and Renagel face patent expirations starting in 2014, though near-term bundling issues following the Centers for Medicare & Medicaid Services proposed rule on oral phosphate binders earlier this year could start eating at product sales as early as 2011.

The BioWorld article reports Robert W. Baird analyst Christopher Raymond calling the APB failure a “game-changer” for Genzyme, although Leerink Swann analyst Joshua Schimmer tried to look on the bright side:

“If anything, there may be a nice SG&A savings if the company winds down its nephrology sales force once Renagel/Renvela starts to go away,” he wrote in a research note.

This is, of course, only the latest in a series of blows Genzyme has suffered this year, including the FDA rejection Clolar for leukemia and Lumizyme for Pompe disease, manufacturing problems caused by viral contamination and garbage, lost revenues and monopolies due to said manufacturing issues, and now the news that activist investor Carl Icahn has upped his stake in the company.

What could possible go wrong next? Well, here’s a snapshot of Genzyme’s upcoming milestones (courtesy of recent analyst reports from Credit Suisse and Oppenheimer):

• Q1 2010: launch of osteoarthritis drug Jonexa
• H1 2010: Phase IIb data with muscular dystrophy drug ataluren
• H1 2010: Phase III data with mipomersen in severe hypercholesterolemia
• H1 2010: Phase III data with mipomersen in high-risk hypercholesterolemia