Impax Laboratories, Inc.
) recently announced that it has launched its authorized generic
) Zomig (zolmitriptan) tablets and orally disintegrating tablets
(2.5 mg and 5 mg).
Zomig is approved for the acute treatment of migraine with or
without aura in adults. According to IMS Health, Zomig (2.5
mg and 5 mg) and orally disintegrating tablets generated US
revenues of approximately $196 million for the 12 months ending
Impax has a distribution, license, development and supply
agreement with AstraZanaca.
Meanwhile, the company is currently working with the US Food
and Drug Administration (FDA) on the appropriate next steps for
its lead candidate, Rytary. We remind investors that a New Drug
Application (NDA) for Rytary was filed in Dec 2011. However, in
Jan 2013, the FDA issued a complete response letter for
The company is looking to get Rytary approved for the
symptomatic treatment of adults suffering from idiopathic
Parkinson's diseases. In Mar 2013, when the FDA completed its
re-inspection of the company's manufacturing facility at Hayward,
it issued a new Form 483 with 12 observations. Impax is working
diligently on the issues noted by the FDAand expects to resolve
the matter quickly. However, the new Form 483 remains a major
overhang on the stock.
We remind investors that
) recently terminated its Rytary agreement with Impax. As per the
terms of the agreement, Glaxo was responsible for the development
and commercialization of the candidate outside the US and Taiwan.
Glaxo decided to return those rights to Impax, effective end Jul
2013, due to delays in regulatory approval and launch dates in
countries that Glaxo has rights to.
Following Glaxo's decision, Impax will be responsible for the
development of the candidate across the globe. The company will
look for a partner in ex-US markets.
Impax carries a Zacks Rank #3 (Hold). Other generic players
also carry a Zacks Rank #3. Currently,
) in the pharma space looks more attractive with a Zacks Rank #1
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