Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. Consequently,
pipeline-related setbacks have the potential to put a stock
behind the pack.
) suffered a setback when the U.S. Food and Drug Administration
(FDA) issued a complete response letter (CRL) for the New Drug
Application (NDA) of its oral contraceptive candidate. The
company is looking to get its progestin-only transdermal
contraceptive patch (norethindrone transdermal delivery system)
approved for the prevention of pregnancy.
The U.S. regulatory body has asked for more data on Actavis'
contraceptive patch. The FDA raised questions primarily on the
differences in size and formulation of the transdermal patch used
in the studies and the to-be-marketed product.
Actavis now intends to discuss the issues raised in the CRL
with the FDA. The NDA was submitted on Feb 26, 2013, and included
data from a 12-month, multi-center, open-label study. The CRL
comes as a huge blow to the company's efforts to strengthen its
women's health business.
ACTAVIS PLC (ACT): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis
DOCTOR REDDYS (RDY): Free Stock Analysis
VANDA PHARMACT (VNDA): Free Stock Analysis
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Meanwhile, Actavis filed an Abbreviated New Drug Application
(ANDA) for its ethinyl estradiol and etonogestrel vaginal ring
with the FDA last week. Ethinyl estradiol and etonogestrel
vaginal ring is the generic version of
Merck & Co.
) NuvaRing, which is an estrogen/progestin combination hormonal
contraceptive approved for the prevention of pregnancy.
Actavis believes that it is the first to file an ANDA for the
generic version of NuvaRing. Consequently, it should enjoy 180
days of marketing exclusivity. As per data released by IMS
Health, NuvaRing grossed total U.S. sales of around $560 million
for the 12 months ending Oct 31, 2013.
We note that Merck has filed a lawsuit (under the provisions of
the Hatch-Waxman Act) against Actavis seeking to prevent the
latter from commercializing its generic version of NuvaRing
before the expiration of U.S. Patent No 5,989,581.
Actavis currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
Dr. Reddy's Laboratories Ltd.
Vanda Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).