Actavis' Women Health Biz Update - Analyst Blog
31 12월 2013 - 4:51AM
Zacks
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.
Last week, Actavis plc (ACT) 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.
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.'s (MRK)
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. (RDY) and Vanda Pharmaceuticals,
Inc. (VNDA). Both stocks carry a Zacks Rank #1 (Strong
Buy).
ACTAVIS PLC (ACT): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
DOCTOR REDDYS (RDY): Free Stock Analysis Report
VANDA PHARMACT (VNDA): Free Stock Analysis Report
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Vanda Pharmaceuticals (NASDAQ:VNDA)
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