Avanir Pharmaceuticals, Inc.
) soared 45.6% after the company announced that the U.S. District
Court for the District of Delaware has ruled the patent
infringement lawsuit against Par Pharmaceuticals, Inc. and
Impax Laboratories, Inc.
) in its favor. Par Pharma and Impax Labs had filed abbreviated
new drug applications (ANDAs) to get their generic versions of
Avanir's Nuedexta approved.
We note that
) generic arm Sandoz,
), Wockhardt, Par Pharma and Impax Labs had all filed ANDAs for
their generic versions of Nuedexta. Avanir settled its Nuedexta
patent litigation with Sandoz, Actavis and Wockhardt in August
and September 2013. Sandoz, Actavis and Wockhardt can now sell
their generic versions of Nuedexta from Jul 30, 2026.
The favorable decision from the court regarding the lawsuit
against Par Pharma and Impax has resulted in Nuedexta gaining
market exclusivity through 2026.
We note that Nuedexta was launched in the U.S. in Jan 2011 for
the treatment of pseudobulbar affect (PBA). Net Nuedexta revenues
grew 56.6% year over year to $23.3 million in the first quarter
of fiscal 2014 ending Dec 2013. This was the eleventh consecutive
quarter of double-digit sales growth for Nuedexta.
Avanir is looking to expand Nuedexta's label. Nuedexta is
currently being studied for two additional indications in phase
II, one for the treatment of agitation in Alzheimer's disease
(top-line data, second half of calendar 2014) and the other for
levodopa induced dyskinesia (LID) in patients suffering from
Parkinson's disease (second half calendar 2014). Avanir enrolled
the first patient in a proof-of-concept phase II study in
Avanir carries a Zacks Rank #3 (Hold). Some better-ranked
stocks include Impax Labs and Actavis, both carrying a Zacks Rank
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