Biotechnology companies Isis Pharmaceuticals Inc. and Genzyme Corp. said Friday approval of their cholesterol drug candidate mipomersen will face at least a one-year delay, now that the Food and Drug Administration has asked for more study data.
The drug candidate is in late-stage development, but the FDA said it will require data from two ongoing preclinical studies testing whether or not mipomersen causes cancer. The companies anticipate filing an application with the FDA in 2010.
Isis shares plunged $4.81, or 29 percent, to close at $11.99. The stock has traded between $8.79 and $20.15 over the last 52 weeks. Meanwhile, shares of Genzyme fell 85 cents to close at $72.49.
Mipomersen is being developed to treat a condition called homozygous familial hypercholesterolemia, which is a severe form of high cholesterol. In a statement, the companies said they will speed up plans for an outcomes trial based on FDA guidance.
"Conducting an outcome study in parallel with our continued evaluation of the effects of mipomersen on atherogenic lipids will allow us to submit a much stronger NDA (application) for high risk patients," said Isis Chairman and Chief Executive Dr. Stan Crooke, in a statement.
Cowen and Co. analyst Eric Schmidt suggested the postponement and FDA guidance could impact financial terms of the deal between Isis and Genzyme. The partners are expected to finalize their partnership later in the quarter.
He downgraded shares of Isis to "Neutral" from "Outperform", adding that the postponement and a lack of milestones make for a less optimistic outlook on the stock's near-term performance.
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