Upcoming FDA Advisory Committee (AdCom) meeting: Nov 13, 2013 - Sanofi (Genzyme) - Lemtrada (Alemtuzumab) for the treatment of Multiple Sclerosis

Developer company name:	Genzyme, now Sanofi (NYSE:SNY)
Indication:	Relapsing Multiple Sclerosis
Drug:	Lemtrada (Alemtuzumab)
Scheduled FDA AdCom date:	Nov 13 2013
Scheduled FDA PDUFA date:	Q4 2013
Type of application:	Supplemental BLA (sBLA); first submission for this indication

Sanofi (NYSE:SNY) is awaiting an FDA Advisory Committee meeting on Nov 13 2013 which will focus on the company's NDA for Lemtrada (alemtuzumab) indicated for Relapsing Multiple Sclerosis.

Alemtuzumab is a humanized monoclonal antibody already approved for the treatment of of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma under the trade name Campath.

In 2012 Sanofi permanently pulled all stocks of Campath off the shelves in anticipation of the market release of the higher-priced Lemtrada (MS patients require a fraction of the CLL drug, which would see Campath sell at 1/10 of its 60,000 annual cost if it stayed on the shelves and was mis-prescribed). Lemtrada is expected to rake in nearly 8 times more than the $76-million-a-year Campath.

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Sanofi acquired alemtuzumab in February 2011 as part of its acquisition of Genzyme. At the time the two companies disagreed on the perceived value of alemtuzumab, with Sanofi valuing it at $700 million, against Genzyme's $3.5 billion. The dispute resulted in the issuance of Contingent Value Rights (CVR) - a type of stock warrant which pays a dividend only if certain conditions relating to Lemtrada FDA approval are met. The CVR securities now trading on the NASDAQ-GM market with the ticker symbol GCVRZ. 

The milestones achieved by Lemtada will trigger a dividend payout of $1 - $4:

Event	Payout	Timing
FDA Approval	$1	2H2013
Sales over $400mil	$2	2014
Sales over $1.8 bil	$3	Anytime until 2020
Sales over $2.3 bil	$4	Anytime until 2020
Sales over $2.8 bil	$3	Anytime until 2020
Total	$14

Source

Although positive outcome of Lemtrada's AdCom on Nov 13 may not significantly move Sanofi's stock, the CVR stock will react heavily. Based on preliminary clinical trials results, and on the fact that Sanofi is so certain of approval it withdrew all other alemtuzumab brands off the shelves, the AdCom meeting is likely to end on a positive note for the company.

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