FDA to Review Sanofi's Lemtrada

Sanofi’s (SNY - Analyst Report) subsidiary, Genzyme, recently announced that the US Food and Drug Administration (FDA) has accepted the marketing application of Lemtrada (alemtuzumab). The company is looking to get Lemtrada approved for the treatment of relapsing multiple sclerosis (RMS). FDA’s decision regarding the approval of Lemtrada is expected in the second half of 2013.

We remind investors that in Aug 2012, the FDA issued a refuse-to-file letter in relation to Lemtrada’s marketing application. Lemtrada is also under review for the same indication in the EU. The Committee for Medicinal Products for Human Use (CHMP) is expected to render an opinion on the approval of Lemtrada in the second quarter of 2013.

Lemtrada’s marketing application includes data from two phase III trials, which were completed in 2011. In the first study, CARE-MS I, Lemtrada met the first primary endpoint. Results showed that treatment with two annual cycles of Lemtrada resulted in a 55% reduction in relapse rate compared to Pfizer/Merck KGaA’s (PFE - Analyst Report)/(MKGAF) Rebif over the two-year span of the study. However, Lemtrada failed to achieve statistical significance for the second primary endpoint. Results showed that 8% of patients treated with Lemtrada had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) compared to 11% of patients on Rebif.

In the second study, CARE-MS II, Lemtrada met both the primary endpoints. Results showed that treatment with Lemtrada resulted in a 49% reduction in relapse rate compared to Rebif, over a two-year period. Additionally, Lemtrada showed a 42% reduction in the risk of sustained accumulation (worsening) of disability.

We are pleased with Sanofi’s efforts to develop its pipeline, which should make significant revenue contributions upon approval. However, we note that Sanofi’s biggest challenge is the generic threat that is faced by several of its products.

Sanofi carries a Zacks Rank #2 (Buy) in the short run. Valeant Pharma (VRX - Snapshot Report) is an example of a pharma stock which is more favorably placed. The company carries a Zacks Rank #1 (Strong Buy).