Tuesday, 02 November 2010 03:34
AVANIR Pharmaceuticals (NASDAQ:AVNR) notified shareholders Friday that it had received FDA approval of AVP-923, now known as NUEDEXTA.
AVNR received FDA approval for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for the treatment of pseudobulbar affect (PBA). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries. We should note that the FDA approved only the 20/10mg formulation, not the 30/10mg. Additionally, there was no patient populations restrictions to MS or ALS patients only. Now that NUEDEXTA is approved, it also has the potential to be used off-label for diabetic peripheral neuropathy pain. This is a future indication AVNR will eventually be pursuing. Off-label use is likely to be negligible given that Medicare or insurance will not likely cover it. Ideally, AVNR will discuss the pricing for NUEDEXTA so that investors can begin modelling future revenue.
For sales of NUEDEXTA to reach some analyst’s estimates, AVNR will certainly have to push sales/advertising and hope insurance will cover NUEDEXTA. More recently, AVNR has stated AVNR has already been looking to hire 60+ new employees in Sales & Marketing and the sales team is being lead by Michael McFadden. He has an impressive career with over 20 years of pharmaceutical commercialization experience, most recently at Amylin Pharmaceuticals(AMLN). His sales team was consistently recognized as one of the leading managed markets teams in the industry.
One thing to keep in mind is that AVNR has a $75M shelf offering waiting to eventually be exercised; this shelf was made effective on October 28th.
We hope some subscribers used our extensive research to make an informed decision on AVNR. We felt the SPA provided AVNR with less regulatory risk and that they would be approved based on the safety/efficacy data available. We initially began in-depth coverage of AVNR starting back in July. Good luck trading out there!
Disclosure: Long AVNR
Initial Coverage - http://biomedreports.com/2010070746667/investors-warming-up-to-avnr.html
Recent Q&A about safety data - http://biomedreports.com/2010101958490/safety-data-explained-for-upcoming-fda-decision.html
AVNR Announces FDA Approval of NUEDEXTA - http://bit.ly/df686Y
NUEDEXTA FDA Approval Conference Call Webcast - http://bit.ly/bPEDHI
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