Forest Laboratories Announces Intention to Continue Marketing Both NAMENDA® TABLETS and Once-Daily NAMENDA XR® Into the Fall of 2014
Patient, Caregiver, Physician Acceptance of Benefits of NAMENDA XR® Strong
Initiatives to Ensure Robust and Reliable Product Supply Progressing
Final Conversion to NAMENDA XR® Anticipated Later this Year
Tuesday, June 10, 2014 4:01 pm EDT
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX), a leading, fully integrated, specialty pharmaceutical company, today announced that it intends to continue to market both its NAMENDA® (memantine HCl) 5 mg and 10 mg tablets and once-daily NAMENDA XR® (memantine HCl) extended-release capsules into the fall of 2014. The Company noted that patient and caregiver response to the NAMENDA XR® product has been exceptionally positive, with caregivers and physicians clearly recognizing the benefits of the single daily dosing regimen. Forest stated that its decision to defer final conversion to the NAMENDA XR® product later in the year will not affect the company's ability to meet its financial objectives for the product.
"The conversion to the single daily dose has exceeded our expectations with current scripts trending at approximately 40% for NAMENDA XR®," said Brent Saunders, Forest's CEO and President. "We have always maintained that the successful conversion to Namenda XR® is based on three things: Patient, caregiver and healthcare providers responding favorably to the benefits of the once-daily dosing of the NAMENDA XR® product; ensuring that we achieved appropriate levels of managed care coverage and formulary planning; and ensuring that we optimize the efficiency of our manufacturing capabilities to ensure adequate supply to support the ultimate conversion to the XR product. Conversion rates are demonstrating patient and payer acceptance of the benefits of the single daily dose, and we continue to make progress in improving manufacturing yield and efficiency. The success of the NAMENDA XR® conversion to date provides us with the option of adjusting the timing of the final conversion, while still meeting our financial commitments."
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
The recommended starting dose of NAMENDA XR® is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR® 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA® tablet. There is no study addressing the comparative efficacy of these 2 regimens.
It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA® tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA® tablet.
NAMENDA XR® should be administered with caution to patients with severe hepatic impairment.
A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).
IMPORTANT SAFETY INFORMATION
NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
Warnings and Precautions
NAMENDA XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels and a possible increase in adverse effects.
NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.
The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Please visit www.NamendaXR.com for more information and full prescribing information.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest's strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY. To learn more, visit www.frx.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
Frank J. Murdolo, 1-212-224-6714
Vice President, Investor Relations
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