Biotech Values

[DewDiligence]

Re: RBC report on GENR

I noticed some inaccuracies in the report:

>>In January 2005, the FDA selected Evizon for participation in the Continuous Marketing Application (CMA) Pilot 2 program. Each division of the FDA could select one investigational drug for inclusion in this program, which is designed to test whether more frequent and collaborative discussions between companies and the agency increased the success rate for innovative new products. The inclusion of Evizon in this program signals its novelty and potential importance to the agency…<<

This quaint notion has already been debunked on this message board. In fact, the main qualification for inclusion in the CMA program was simply applying for it.

>>Allergan will also pay up to $41 million ($6 million upfront in cash and an equity investment) to Entremed for rights to Panzem, a preclinical small molecular candidate for AMD.<<

This analyst apparently hasn’t checked facts in a while: the AGN-ENMD partnership to develop Panzem for AMD is essentially dead. (AGN has several other irons in the AMD fire, however.)

>>Even though Evizon is two or more years from the market, it is the most advanced systemic treatment in development and should therefore still command a high price with partners…<<

Only if prospective partners are in fact interested in a systemic treatment for AMD. Since Evizon is the only systemic treatment for AMD in clinical development out of roughly two dozen such treatments, there’s a legitimate question as to whether anyone besides GENR thinks this is a good way to go.

Moreover, Evizon is not “two or more years from market”—it is four or more years from market. The second phase-3 trial, which will take roughly a year to enroll and two years to complete once enrolled, has not yet opened for business.