Alnylam Pharmaceuticals Inc. (ALNY) recently announced the completion of patient enrollment in a phase I trial of its liver cancer pipeline candidate ALN-VSP. The phase I trail is a multi-center, multinational, open-label dose escalation study. The main objective of the study is to evaluate the safety and tolerability of multiple doses of ALN-VSP ranging from 0.1-1.7 mg/kg.
Alnylam expects to present data from the trial at the American Society of Clinical Oncology meeting in June 2011. Moreover, Alnylam plans to find a partner for the program before initiating phase II studies which are expected in 2012.
Liver cancer affects a large number of patients in the world with more than 600,000 people diagnosed with primary liver cancer or hepatocellular liver cancer and more than 500, 000 people diagnosed with secondary liver cancer or metastatic liver cancer annually. Liver cancer is associated with the worst survival rates among other cancers and therefore has large clinical need that needs to be met.
We believe that if the ALN-VSP is successfully developed and commercialized then it would boost the top line at Alnylam since the market has a huge unmet need.
Our Recommendation
We currently have a Neutral recommendation on Alnylam, which is supported by a Zacks #3 Rank (short-term Hold rating). We like the company’s newly launched “5X15” initiative and are pleased with the progress of the company’s pipeline. Alnylam’s balance sheet is also very strong.
However, with the end of two major deals with Novartis AG (NVS) and Roche Holdings Ltd (RHHBY) in the recent past, we prefer to remain on the sidelines as the company could lose out on major milestone payments and royalties. We also await further visibility on the clinical progress of the pipeline as well as Alnylam’s ability to enter into large partnerships.
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