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.
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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.
) 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
) 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
Forest Labs carries a Zacks Rank #2 (Buy). Last month,
) 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
) with a Zacks Rank #1 (Strong Buy).