PropThink: Safety Concerns with Kynamro Battering ISIS Ahead of Advisory Panel Vote
(Thomson Reuters ONE) -
By Jake King
The FDA has raised safety concerns about tumors spotted in patients treated with
the developmental LDL-lowering therapy, Kynamro. The drug is under review after
a New Drug Application was accepted by the FDA in May of this year, and will go
before the Endocrinologic and Metabolic Drugs Advisory Committee on Thursday.
Kynamro is being developed by Isis Pharmaceuticals (NASDAQ:ISIS) and is
partnered with Sanofi's (NYSE:SNY) subsidiary Genzyme. On Tuesday morning,
shares of Isis gapped down 15% on fears that the advisory committee will either
delay Kynamro's commercialization through further trials, request a limiting
Risk Evaluation and Mitigation Strategy, or vote to deny the approval. The
injectable drug, called mipomersen, was filed as a treatment for homozygous
familial hypercholesterolemia (HoFH), a genetic disorder for which patients
already taking standard lipid lowering therapies are unable to maintain low
enough LDL-C levels.
The FDA's report, released ahead of a Thursday advisory panel meeting, raised
concerns about an imbalance in neoplasms (tumors), stating, "The incidence of
reported neoplasms (benign and malignant) was 3.1% (23/749) in mipomersen
treated patients versus 0.9% (2/221) in placebo-treated patients." The reviewer
ends by commenting, "There are several confounding factors that make it
difficult to conclude that mipomersen is playing a dominant role in this cancer
imbalance." There was no consistency, for instance, in the location of the
tumors. What that means for Kynamro's approval is not entirely clear, but the
neoplasm imbalance is news to shareholders, hence today's weakness. Already
Piper Jaffray lowered their ISIS target price from $18 to $10 and downgraded the
company to neutral. Thursday's advisory panel will also be considering Kynamro's
effects on the liver, an acknowledged problem, and will weigh the potential for
a risk-mitigation plan to accompany the drug's approval. As Isis' most advanced
candidate, the loss of Kynamro - a negative vote and negative approval outlook -
will have a major effect on the stock, regardless of the company's extensive
pipeline. Kynamro is already being partly discounted from ISIS' valuation today,
but the shares still have room to fall on any concrete news.
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Datum: 16.10.2012 - 18:59 Uhr
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