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news.ANI Pharmaceuticals (ANI) has acquired the approved new drug application (NDA) for a testosterone gel 1% product previously licensed to Teva Pharmaceuticals.
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Upon commercialization, ANI will pay Teva up to $5 million at a rate of 5% of the consideration received by ANI as a result of commercial sale of the product. According to IMS Health, the overall market for testosterone gel 1% was approximately $300 million in 2014.
Arthur S. Przybyl, President and Chief Executive Officer said, "We are pleased to acquire this NDA from Teva and will begin work immediately to maximize the value of this product."
Testosterone gel is an androgen indicated for replacement therapy in males for conditions associated with deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
ANI Pharmaceuticals is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.