Impax Laboratories, Inc.
) announced the launch of its generic version of Fougera
Pharmaceuticals Inc.'s (now a wholly owned subsidiary of
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
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
) attention deficit hyperactivity disorder (ADHD) drug, Adderall
Impax currently carries a Zacks Rank #1 (Strong Buy).
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