The content of the presentation at the Leerink Swann conference was quite different from the content presented the day before at BIO CEO. I encourage interested investors to listen to the recording on Arena's investor site.
Rather than following a prepared slide deck, Jack Lief and Dominic Behan, Arena's co-founders, responded to questions from a moderator. This gave them a great opportunity to reply to issues that have been raised in the popular press, but that weren't deemed valid or significant enough to be included in Arena's standard slide show.
Why didn't you follow the FDA's advice to do a 12-month prolactin study? They explained that this was never a recommendation -- it was suggested only if Arena couldn't detect the necessary signals in a shorter study, which they were able to acheive.
What do you expect from the adcom? We don't know the agenda yet, but we are expecting to cover the items in CRL and whatever else may be raised. Do you expect CV issues to be addressed? Lorcaserin has no effect on heart rate or blood pressure other than lowering it as a result of weight loss. So we don't expect any issues.
Do you find the FDA any more receptive to weight loss drugs due to pressure from congress? Can't say, but we have found the FDA to be much more communicative with us lately.
How do you view the market for lorcaserin? We are leaving that to Eisai. We're focused on provide a valuable treatment option. Doctors will evaluate which patients are right for lorcaserin treatment. Pricing? Roughly $5-$7/day maybe, based on Xenical, but that's just a guess.
Have you considered a lorc-phen combo? Lorcaserin has no chemical relationship to fenfluramine, which actually had greater selectivity for the receptors in the heart than for those that affect appetite. We'll consult with the FDA on the possiblility of any post-approval studies. We would talk to Eisai about sharing costs (they will pay 90% of the cost of studies required by the FDA post approval).
Partnership status for EU and ROW? We are in discussions but we will wait until after the FDA decision to move ahead with anyone. Has the EMA asked for comparator studies, which they often request? Hasn't come up in our discussions with them. We're confident that we've addressed their guidance. Will reimbusement be an issue without a comparator? We don't think so.
And more, including comments on the pipeline. Take a listen.