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Forest Labs/Adamas Seek FDA Approval

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Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of new drug applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

With the commencement of 2014, several companies have been providing updates on the regulatory front and their future developmental plans. Earlier this week, Forest Laboratories, Inc. (FRX) and partner Adamas Pharmaceuticals Inc. provided an update on the regulatory front. Forest Labs and Adamas said that they have filed a New Drug Application (:NDA) for their fixed-dose combination (:FDC) of Namenda ER (memantine HCl extended release (:ER)) and Pfizer’s (PFE) Aricept (donepezil HCl) for the treatment of moderate-to-severe dementia of the Alzheimer’s type.

The FDC, if approved, will simplify the therapy for moderate-to-severe dementia of the Alzheimer’s type. It is an oral capsule (once-daily dose) that offers the advantage of both Namenda ER and Aricept and can replace the current dosing regimen of three pills twice daily dose by one pill once daily.

Forest Labs and Adamas have filed the NDA for two dosages of the FDC capsule − 28mg/10mg (Namenda ER/Aricept) and 14mg/10mg (Namenda ER/Aricept). They are looking to launch the FDC in 2015, before generic versions of Namenda IR enter the market.

Meanwhile, data from a pediatric program on Namenda IR is under FDA review. Forest Labs expects a feedback from the FDA in the third quarter of calendar 2014. Pediatric approval will extend Namenda IR’s exclusivity to Oct 11, 2015.

Developing and licensing late-stage candidates are important for Forest Labs considering the generic cliff being faced by the company. Lexapro is already facing stiff generic competition and generic versions of Namenda are expected to hit the market in early 2015.

Forest Labs carries a Zacks Rank #2 (Buy). Last month, Actavis, Inc. (ACT) announced its intention to acquire Forest Labs for a cash and equity transaction valued at about $25 billion. The deal is expected to close in mid-2014.

A better-ranked stock in the healthcare sector is Shire plc (SHPG) with a Zacks Rank #1 (Strong Buy).

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