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Share Name | Share Symbol | Market | Type |
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Allergan plc | NYSE:AGN | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 193.02 | 0 | 01:00:00 |
DUBLIN, May 22, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that a panel of the U.S. Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014 preliminary injunction requiring the Company to continue distribution of NAMENDA® (memantine HCl) immediate-release tablets.
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"While we are disappointed by the Court's decision to uphold this ruling, we intend to continue our strong efforts to convey the significant benefits of NAMENDA XR® to physicians, patients and caregivers," said Brent Saunders, CEO and President of Actavis. "Patient demand for NAMENDA XR® is currently trending at more than 50 percent of the total product line's days of therapy and growing, underscoring the strong physician, patient and caregiver demand for our once-daily product."
"We have also recently launched once-daily NAMZARIC®, a fixed-dose combination of NAMENDA XR® and donepezil that provides another treatment option for patients with moderate to severe Alzheimer's disease. Since the launch of NAMENDA XR® in 2013, the two medications, NAMENDA XR® and donepezil, have been commonly prescribed in combination with one another to treat the symptoms of moderate to severe Alzheimer's disease. NAMZARIC® offers an option with the benefits of both treatments, while reducing the number of pills a patient and their caregivers need to administer each day, to treat this disease."
Actavis noted that the Company will continue to manage sales and R&D expenses to ensure that the Appeals court's decision will have minimal to no impact on its 2015 NAMENDA® franchise contribution to earnings and longer term company earnings aspirations.
About NAMENDA XR®
NAMENDA XR® (memantine HCl) extended release capsules are a higher dose, once-daily formulation of NAMENDA® immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Its mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of NAMENDA XR® was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).
NAMENDA XR® 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician's Interview-Based Impression of Change Scale (0.3. unit mean difference).
There is no evidence that NAMENDA XR® or an AChEI prevents or slows the underlying disease process in patients with Alzheimer's disease.
Dosing and Administration
Special Populations
IMPORTANT SAFETY INFORMATION
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Please visit www.NamendaXR.com for more information and full prescribing information.
About NAMZARIC™
NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. NAMZARIC will be available in two dosage strengths, 28/10 mg (memantine HCl extended-release/donepezil HCl) and 14/10mg (memantine HCl extended-release/donepezil HCl) for patients with severe renal impairment. Memantine hydrochloride extended-release is the active ingredient in the currently marketed NAMENDA XR®, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in ARICEPT® (donepezil hydrochloride), which is indicated for the treatment of mild to severe dementia of the Alzheimer's type. Actavis and Adamas collaborated on the development of the fixed-dose combination and Actavis will have exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
DOSAGE AND ADMINISTRATION
About Actavis
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.
For more information, visit Actavis' website at www.actavis.com.
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 difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Actavis
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
David Belian
(862) 261-8141
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/actavis-confirms-appeals-court-ruling-requiring-continued-distribution-of-namenda-ir-300088026.html
SOURCE Actavis plc
Copyright 2015 PR Newswire
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