Biotech Values

[DewDiligence]

The other drug being reviewed by ODAC on Wednesday is SNY’s semuloparin (f/k/a AVE5026), an anticoagulant that SNY once billed as the successor to Lovenox:

http://in.reuters.com/article/2012/06/18/us-fda-sanofi-idINBRE85H0XK20120618

The Food and Drug Administration staff said only a small number of people in the clinical trials for semuloparin actually had issues with clotting, and most people died from other problems. "These findings call into question the clinical value of semuloparin in the proposed clinical setting," the FDA reviewers said in documents posted online on Monday.

… Sanofi has said cancer patients getting chemotherapy have a 6.5 times higher risk of getting blood clots than patients without cancer. But the FDA staff said data showed the rate was still very low, as only 3.4 percent of people who took a placebo during the clinical trial had a blood clot.

When Chris Viehbacher took over as CEO of SNY in 2008, semuloparin was one of the programs that was scaled back substantially; instead of seeking a general-purpose successor to Lovenox, SNY positioned semuloparin as an antocoagulant for the chemotherapy market, specifically (#msg-41018456, #msg-63888132)

The FDA briefing docs for semuloparin are at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM308561.pdf .