Forest Labs/Adamas Seek FDA Approval - Analyst Blog
March 07 2014 - 6:00PM
Zacks
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).
ACTAVIS PLC (ACT): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
SHIRE PLC-ADR (SHPG): Free Stock Analysis Report
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