In the ongoing phase II study, Celldex enrolled 120 patients with advanced breast cancer that over-expresses GPNMB (confirmed by an independent test). The patients, all of whom no longer respond to currently approved treatments, are then randomized to receive either CDX-011 or a physician's choice of treatment. The primary endpoint of the study is overall response rate.
Celldex CEO Anthony Marucci told me last week that a meaningful and positive response rate in the study would be 12% to 15% with a progression-free survival of greater than 12 weeks. Celldex is developing CDX-011 with a companion diagnostic that measures levels of GPNMB. As I said above, data from the phase II study is expected this spring at the American Society of Clinical Oncology annual meeting. It's a very important catalyst for Celldex.
Gary D. asks, "Do you feel any better about Avanir Pharmaceuticals (AVNR) yet or is 2012 going to be a repeat of 2011? They really blew it on having enough insurance coverage for patients who wanted to use Nuedexta but couldn't afford it or their insurance or Medicare didn't cover it, but as of January 1st, it looks a lot better. They turned their focus to long-term care facilities which should help, and of course with almost a year under their belt they should have got through some of the bumps and bruises."
Avanir had a rough year, no doubt. The launch of Nuedexta for pseudobulbar affect (PBA) disappointed, with fiscal 2011 net sales of $6.1 million well below expectations. Avanir shares lost half of their value as a result.This year has to be better for Avanir. Could it be any worse? The company appears to have learned some hard lessons and is making changes like adding sales reps to target long-term care facilities and assisting patients with reimbursement and co-payment issues which should help grow Nuedexta sales this year. Expectations have come down to more sensible levels. Short sellers, at least the few I know who were involved in the stock last year (profitably), have moved on.