ANI Pharmaceuticals Acquires NDA for Testosterone Gel 1 Percent

ANI Pharmaceuticals Inc. (NASDAQ:ANIP) announced that it’s acquired the approved new drug application (NDA) for a testosterone gel 1 percent product. It was previously licensed to Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).

As quoted in the press release:

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 millionin 2014.

About the testosterone gel 1 percent 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).

Arthur S. Przybyl, president and CEO of ANI, commented:

We are pleased to acquire this NDA from Teva and will begin work immediately to maximize the value of this product.

Click here to read the full ANI Pharmaceuticals Inc. (NASDAQ:ANIP) press release.

ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) 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.