Effient (prasugrel), an anti-clotting drug developed by Eli Lilly (LLY) and Daiichi Sankyo finally received U.S. FDA approval on July 10, 2009. The drug is approved for the reduction of the risk of blood clot formation in patients undergoing angioplasty, a common procedure to unblock a clogged coronary artery.
Effient’s approval has been long-awaited and is a major win for Eli Lilly. The company had filed the NDA for the product in December 2007.The final decision took a long time coming with the FDA pushing back the approval date twice during the 18-month review period.
The approval is based on data from a pivotal phase III study (TRITON), which showed Effient to be statistically superior to Sanofi’s (SNY)/Bristol-Myers’ (BMY) Plavix in reducing the occurrence of heart attack, stroke or cardiovascular death.
However, the Effient label comes with a black box warning, which is the FDA’s strongest safety label. This includes a warning, which alerts physicians that the drug can cause significant — sometimes fatal — bleeding. Effient should, therefore, not be used in patients with active pathological bleeding, a history of mini-strokes or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.
Although disappointing, the labeling does not come as a major surprise. In the phase III TRITON study, Effient was shown to significantly increase the risk of major bleeding and life-threatening bleeding. We believe the black box warning could make it challenging for Effient to take share from Plavix, which is the current standard of treatment. Eventually, we see Effient posting peak sales in the range of $1.5 billion.
We maintain a Hold rating on Eli Lilly with a price target of $36. While Effient’s approval is a major boost for the company, we remain skeptical about the overall potential of the pipeline relative to revenue-at-risk to patent expirations. We think the lack of a significant enough pipeline to grow sales longer-term will continue to weigh on the stock going forward.
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