DUBLIN and LAVAL, Quebec, March
25, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) and
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX)
today announced that the U.S. Food and Drug Administration (FDA)
has approved the New Drug Application (NDA) for Metronidazole 1.3%
Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis
(BV). Actavis acquired the rights to Metronidazole 1.3% from
Valeant Pharmaceuticals International in April 2013.
Bacterial vaginosis is an infection caused by an imbalance in
the normal bacteria in the vagina. It is the most common
vaginal infection in women ages 15 to
44[i]. Metronidazole 1.3% provides a
convenient, single-dose treatment for BV that is packaged in a
pre-filled disposable applicator. The U.S. BV market is
valued at approximately $140 million
annually, according to IMS Health.
"The approval of Metronidazole 1.3% is a significant milestone
for Actavis and provides an important new option with a single-dose
treatment for women suffering from BV," said Fred Wilkinson, President, Actavis Global
R&D. "The expected launch of the product later this year
will establish a promising long-term opportunity for Actavis and
support the continued growth of our industry-leading Women's Health
franchise."
"Valeant is pleased that another internal R&D compound has
been approved by the FDA and will soon be available," said
Tage Ramakrishna, M.D. and Chief
Medical Officer, Valeant Pharmaceuticals. "Metronidazole 1.3% gives
health care providers and women a new safe and effective treatment
for bacterial vaginosis."
Under the terms of the agreement with Valeant, Actavis will
acquire the rights to Metronidazole 1.3% for up to $57 million in up front payments, milestone
payments and certain guaranteed royalty payments during the first
three years of commercialization depending on market
conditions. Actavis will also pay ongoing royalties to
Valeant after the first three years of commercialization.
The approval of Metronidazole 1.3% was based on the results of a
Phase III randomized, double-blind, placebo-controlled, multicenter
clinical trial, which found that the higher concentration
Metronidazole 1.3% was well tolerated, safe and efficacious.
Metronidazole 1.3% provides an alternative treatment option to
MetroGel-Vaginal® (metronidazole vaginal gel 0.75%) for
patients with bacterial vaginosis.
Indication and Usage
Metronidazole vaginal gel 1.3% is
a nitroimidazole antimicrobial indicated for the treatment of
bacterial vaginosis in non-pregnant women.
Metronidazole vaginal gel 1.3% should be administered once
intravaginally at bedtime. Not for ophthalmic, dermal or oral
use.
Selected Safety Information
Metronidazole vaginal gel
1.3% is contraindicated in patients with a history of
hypersensitivity to metronidazole, parabens, other ingredients of
the formulation, or other nitroimidazole derivatives. Metronidazole
vaginal gel 1.3% should not be used concomitantly with or within
2 weeks of disulfiram treatment. Patients should not to
consume alcoholic beverages and preparations containing ethanol or
propylene glycol during and for at least 24 hours after treatment
with Metronidazole vaginal gel 1.3%
Convulsive seizures and peripheral neuropathy have been reported
in patients treated with oral or intravenous metronidazole.
Treatment should be discontinued promptly if abnormal neurologic
signs develop. Metronidazole may interfere with certain serum
chemistry laboratory values.
Prolonged anticoagulant effects of warfarin and other coumarin
anticoagulants have been reported with co-administration of oral
metronidazole. Elevated plasma lithium concentrations have
been reported with oral metronidazole.
The most common adverse reactions observed in the clinical study
(incidence ≥1%) were vulvovaginal candidiasis, headache,
vulvovaginal pruritus, nausea, diarrhea, and dysmenorrhea.
The product and brand names mentioned herein are trademarks,
registered trademarks and/or service marks of their respective
owners.
About Actavis
Actavis plc (NYSE: ACT) is a global,
integrated specialty pharmaceutical company focused on developing,
manufacturing and distributing generic, brand and biosimilar
products. Actavis has global headquarters in Dublin, Ireland and U.S. administrative
headquarters in Parsippany, New
Jersey, USA.
Actavis develops and manufactures generic, brand, branded
generic, legacy brands and Over-the-Counter (OTC) pharmaceutical
products and has commercial operations in approximately 60
countries. The Company's North American branded
pharmaceuticals business is focused principally in the Women's
Health, Urology, Gastroenterology and Dermatology therapeutic
categories with a strong pipeline of products in various stages of
development. Actavis also has a portfolio of five biosimilar
products in development in Women's Health and Oncology.
Actavis Global Operations has more than 30 manufacturing and
distribution facilities around the world, and includes Anda, Inc.,
a U.S. pharmaceutical product distributor.
For press release and other company information, visit Actavis'
Web site at http://www.actavis.com.
About Valeant Pharmaceuticals International,
Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:
VRX) is a multinational specialty pharmaceutical company that
develops, manufactures and markets a broad range of pharmaceutical
products primarily in the areas of dermatology, eye health,
neurology and branded generics. More information about
Valeant can be found at www.valeant.com.
Actavis Forward-Looking Statement
Statements
contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that
reflect Actavis' current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Actavis disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Actavis' current expectations depending upon a
number of factors affecting Actavis' business. These factors
include, among others, the impact of competitive products and
pricing; market acceptance of and continued demand for Actavis'
products, including Metronidazole 1.3%; difficulties or delays in
manufacturing; the difficulty of predicting the timing or outcome
of FDA or other regulatory agency approvals or actions, if any;
patents and other intellectual property rights held by the Company
and the ability to successfully enforce such rights against third
parties; and other risks and uncertainties detailed in Actavis'
periodic public filings with the Securities and Exchange
Commission, including but not limited to Actavis plc's Annual
Report on Form 10-K for the year ended December 31, 2013. Except as expressly required
by law, Actavis disclaims any intent or obligation to update these
forward-looking statements.
Valeant Forward-Looking Statement
This press release
may contain forward-looking statements, including, but not limited
to, statements regarding a new safe and effective treatment for
health care providers and women. Forward-looking statements
may generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks and uncertainties discussed in the
Company's most recent annual or quarterly report and detailed from
time to time in Valeant's other filings with the Securities and
Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. Readers are
cautioned not to place undue reliance on any of these
forward-looking statements. These forward-looking statements speak
only as of the date hereof. Valeant undertakes no obligation
to update any of these forward-looking statements to reflect events
or circumstances after the date of this press release or to reflect
actual outcomes.
[i]
http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
CONTACTS:
|
Actavis:
|
|
Investors:
|
|
Lisa
DeFrancesco
|
|
(862)
261-7152
|
|
|
|
Media:
|
|
Charlie
Mayr
|
|
(862)
261-8030
|
|
|
|
David
Belian
|
|
(862)
261-8141
|
|
|
|
Valeant:
|
|
Laurie W.
Little
|
|
(949)
461-6002
|
|
|
Logo -
http://photos.prnewswire.com/prnh/20101025/LA87217LOGO
SOURCE Valeant Pharmaceuticals International, Inc.