Eli Lilly and Company (LLY) and Kowa Pharmaceuticals America, Inc. recently presented positive results on their cholesterol management drug, Livalo (pitavastatin) 4 mg, from a phase IV study.
The 12-week, randomized, double-blind, double-dummy, active-controlled, parallel-group, superiority study was conducted to evaluate the efficacy of Livalo compared to that of Bristol-Myers Squibb’s (BMY) Pravachol (pravastatin) 40 mg for the reduction of low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with high cholesterol (dyslipidemia).
Results showed that patients receiving Livalo experienced a significantly higher LDL-C reduction compared to patients on Pravachol (31% reduction vs 21% reduction). Meanwhile, the occurrence of treatment emergent adverse events was lower in the Livalo arm compared to Pravachol (61.1% vs 62.7%).
Eli Lilly and Kowa intend to analyze the results further. Livalo is currently approved for the treatment of high cholesterol. It has been available in the US since Jun 2010 and is approved in several other countries including Japan.
Eli Lilly currently carries a Zacks Rank #2 (Buy). The biggest near-term challenge for Eli Lilly will be to replace the revenues that will be lost to generic competition now that Zyprexa has lost US and EU exclusivity. The generic threat will continue to pose challenges for Eli Lilly with Cymbalta slated to lose patent protection in late 2013 and Evista in 2014. On the flip side, the Animal Health business and the diabetes franchise should provide some downside support. We are also pleased to see Eli Lilly pursuing small acquisitions and in-licensing deals to boost its pipeline.
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