Impax Laboratories, Inc. (IPXL) recently announced that it has launched its authorized generic version of AstraZeneca’s (AZN) 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 Apr 2013.
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 Rytary.
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 GlaxoSmithKline (GSK) 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, Santarus, Inc. (SNTS) in the pharma space looks more attractive with a Zacks Rank #1 (Strong Buy).
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