Forest Laboratories Nabs Pediatric Exclusivity for Namenda

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Forest Laboratories, Inc. (FRX) will now enjoy an additional six months of exclusivity in the U.S. for its Alzheimer’s disease drug, Namenda (memantine hydrochloride). This covers both Namenda IR and Namenda XR.

Forest Labs has settlement agreements with quite a few generic companies regarding the launch of generic versions of Namenda IR. Under these agreements, these companies are entitled to launch their generic versions of Namenda IR three months before U.S. Patent No. 5,061,703 expires including any extensions and/or pediatric exclusivities. With the ‘703 patent scheduled to expire on Apr 11, 2015, generics were earlier expected to enter the market in Jan 2015. However, now that pediatric exclusivity has been obtained, generics can enter the market in Jul 2015.

Forest Labs is exploring all avenues to extend the Namenda franchise’s life-cycle. The company is currently switching patients on Namenda IR to Namenda XR, which was launched in Jun 2013. Namenda XR, a 28mg once-daily, extended-release formulation of Namenda IR, delivered sales of $135.8 million in fiscal 2014.

Meanwhile, Forest Labs along with partner, Adamas Pharmaceuticals (ADMS), is currently seeking FDA approval for a fixed dosed combination of Namenda XR and Aricept for the once-daily treatment of moderate to severe dementia of the Alzheimer’s type. The plan is to launch this combination (provided FDA approval is gained) before the entry of generic versions of Namenda IR in 2015. The pediatric exclusivity provides the company with more time to execute its plans for the extension of the Namenda life cycle.

Forest Labs is a Zacks Rank #2 (Buy) stock. The company has an agreement with Actavis plc (ACT) under which Actavis will acquire Forest Labs for about $25 billion (cash and equity). The acquisition is expected to close shortly.

A better-ranked stock in the health care sector is Gilead Sciences (GILD), a Zacks Rank #1 (Strong Buy) stock.

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