Welcome!

News Feed Item

Actavis and Valeant Announce FDA Approval for Metronidazole 1.3%

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



Valeant Pharmaceuticals International, Inc.

Logo - http://photos.prnewswire.com/prnh/20101025/LA87217LOGO

SOURCE Valeant Pharmaceuticals International, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet and...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
910Telecom exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and exchanges.
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, discussed how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a practic...
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
WebRTC is about the data channel as much as about video and audio conferencing. However, basically all commercial WebRTC applications have been built with a focus on audio and video. The handling of “data” has been limited to text chat and file download – all other data sharing seems to end with screensharing. What is holding back a more intensive use of peer-to-peer data? In her session at @ThingsExpo, Dr Silvia Pfeiffer, WebRTC Applications Team Lead at National ICT Australia, looked at differ...
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.