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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