Avanir Files NDA for AVP-825 - Analyst Blog

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.

Avanir Pharmaceuticals, Inc. 's ( AVNR ) pipeline looks promising with candidates like AVP-825, AVP-786 and Nuedexta (label expansion). Recently, Avanir submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its migraine candidate, AVP-825.

AVP-825 is being developed using OptiNose's novel Breath Powered intranasal delivery system, which includes low dosages of GlaxoSmithKline plc 's ( GSK ) Imitrex for the treatment of acute migraine.

The NDA was filed on the basis of a pivotal phase III trial on AVP-825 and a phase II trial along with two pharmacokinetic studies.

We note that Avanir joined forces with OptiNose for the development and commercialization of AVP-825 for the treatment of acute migraine on Jul 2, 2013.

Avanir's sole marketed product Nuedexta is expected to grow around 13% sequentially to $31.3 million in the first quarter of fiscal 2014 (year ending in Sep 2014). The approval of AVP-825 will reduce Avanir's dependence on a solitary product. Once approved, AVP-825 will be the first and only fast-acting, dry-powder intranasal form of Imitrex.

Avanir currently carries a Zacks Rank #3 (Hold). Some better-ranked players in the pharma industry include Actelion Ltd. ( ALIOF ) and Endocyte Inc. ( ECYT ). Both the stocks carry a Zacks Rank #1 (Strong Buy).



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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , AVNR , ECYT , GSK

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