Biotech Values

[DewDiligence]

Re: GENR Evizon timeline

>>even if all goes OK, you are looking at commercialization no sooner than 1H09.<<

2009 is the best-case scenario assuming that GENR’s NDA submission is based on the two-year data. If enrollment in the phase-3 trials is slow, 2010 is more likely.

The timeline depends to a great extent on the trial sites that will be set up internationally. Clearly, GENR is emphasizing international recruitment—it will be very difficult to enroll U.S. patients into a placebo-controlled trial now that these patients have the option of taking Macugen commercially and getting reimbursed.

Macugen was accepted for FDA review based on only one-year data, but it is administered locally. Given the potential for a systemically-administered anti-angiogenic drug such as Evizon to cause systemic harm, I highly doubt that the FDA will allow GENR shave a year off the submission timeline as they did with Macugen.

Moreover, there is less of an unmet medical need now than there was when the Macugen NDA was submitted. (Macugen is the only drug approved by the FDA for all forms of wet AMD.)

In summary: 2009 is the best-case scenario for an Evizon approval; 2010 is perhaps more realistic.