Impax Laboratories, Inc. (IPXL) announced the launch of its generic version of Fougera Pharmaceuticals Inc.’s (now a wholly owned subsidiary of Novartis (NVS)) Solaraze gel. Fougera was acquired by Novartis' generic arm, Sandoz in Jul 2012. Solaraze gel is approved for the topical treatment of actinic keratoses (AKs).
We note that in Jun 2012, Impax entered into a development, supply and distribution deal with TOLMAR, Inc. Under the agreement, TOLMAR gave Impax an exclusive license to commercialize generic Solaraze in the U.S. TOLMAR will develop and manufacture the drug.
TOLMAR was the first company to file a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification and was the first to obtain approval in the U.S. The patent will expire in Aug 2015. On Oct 30, 2013, the U.S. Food and Drug Administration (FDA) granted final approval for the generic Solaraze gel.
According to IMS Health, Solaraze generated revenues of approximately $78 million in the 12 months ending Sep 2013 from the U.S.
We note that Global Pharmaceuticals, the generic unit of Impax performed impressively in the third quarter of 2013. Segmental revenues climbed 15.3% to $115.7 million during the quarter aided by the sales of new generic products launched this year. Growth was partially offset by lower sales of Impax’ authorized generic version of Shire’s (SHPG) attention deficit hyperactivity disorder (ADHD) drug, Adderall XR.
Impax currently carries a Zacks Rank #1 (Strong Buy). Investors may also consider Actelion Ltd. (ALIOF) which carries a Zacks Rank #1.
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