Replies to post #144017 on Biotech Values

[north40000]

Bloomberg note on FDA staff concerns:

http://www.bloomberg.com/news/2012-06-18/onyx-s-cancer-drug-s-risk-may-outweigh-benefit-fda-says.html

Not an optimistic forecast at present time. That AC hearing should be contentious.

[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 .

[pcrutch]

I don't expect ONXX to get a positive vote or approval this time around. Likely wont be approved until 2014. Data doesnt support accelerated approval.

[genisi]

ORR in ITT population is 22.9% in the FDA analysis, and in the 'truly' unmet need (patients unresponsive or intolerant to approved agents) is above 20% in all subgroups, so I think the efficacy demand is met but seems it may not justify the risk for cardiotox in the FDA's view and chances are quite high they will want more data.