Navigation Links
Adamas Pharmaceuticals Earns $40 Million in Milestone Payments from Forest Laboratories for MDX-8704
Date:1/9/2014

EMERYVILLE, Calif., Jan. 9, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. announced today that it has received $40 million in milestone payments from Forest Laboratories Holdings Limited (NYSE: FRX) for MDX-8704.  MDX-8704 is a fixed dosed combination (FDC) of Namenda XR® (memantine HCl extended release capsules) and donepezil HCl being developed as a once daily therapy for the treatment of moderate-to-severe dementia of the Alzheimer's type in the United States.

The milestone payments are for the successful completion of studies that support the planned New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for MDX-8704 by Forest in the first half of 2014.  These studies are based on a development plan agreed to by Adamas and the FDA prior to its license agreement with Forest.  Leveraging Adamas' know-how and intellectual property, the companies are collaborating on the development of the FDC, for which Forest has exclusive US commercialization rights.  Forest is responsible for all regulatory-related activities.  MDX-8704 is covered by multiple Adamas and Forest patents that extend to 2029.

Pursuant to their license agreement for development and commercialization of MDX-8704, Forest paid Adamas $65 million upfront in November 2012, and these $40 million payments are part of up to $95 million in subsequent development and regulatory approval milestones.  In addition, under the terms of the license agreement, Adamas will receive royalties beginning five years after launch on US net sales of FDC products and any additional memantine products for which Adamas' patents are listed in the FDA's Orange Book.

About Adamas Pharmaceuticals, Inc.

Adamas Pharmaceuticals is dedicated to improving the lives of those affected by central nervous system (CNS) disorders by enhancing the pharmacokinetic profiles of approved drugs to create novel treatments for use alone and as components of fixed-dose combination products.  The Company is currently advancing a pipeline of aminoadamantane-based drug candidates for the treatment of Parkinson's disease, Alzheimer's disease, and other CNS disorders.  The Phase 2/3 EASED study investigating ADS-5102 (amantadine HCl ER) for the treatment of levodopa-induced dyskinesia in Parkinson's disease has been completed and met its primary endpoint.  MDX-8704 (memantine HCl ER/donepezil) is a fixed-dose combination product candidate in late-stage investigation for the treatment of dementia associated with Alzheimer's disease.  In November 2012, Adamas entered into an agreement with Forest Laboratories, Inc. for the development and commercialization of MDX-8704 in the United States.  Adamas plans to advance its product candidates through approval and to commercialize approved products in the United States through a specialty CNS sales force.  For more information about Adamas, please visit www.adamaspharma.com.


'/>"/>
SOURCE Adamas Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Adamas Pharmaceuticals Presents Positive Clinical Data For ADS-5102, A Treatment For Levodopa-Induced Dyskinesia, At The World Parkinsons Congress
2. Adamas Pharmaceuticals presenta datos clínicos positivos para ADS-5102, un tratamiento para la disquinesia inducida por levodopa, en el Congreso Mundial del Parkinson
3. Adamas Pharmaceuticals Presents Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia (LID) In Parkinsons Disease
4. Adamas Pharmaceuticals To Report Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia In Parkinsons Disease
5. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
6. Novartis Pharmaceuticals Corporation stands behind medication adherence activities and reaffirms commitment to patient safety
7. Upcoming Conferences, Share Price Updates, and Leadership Changes - Research Report on Lilly, Allergan, Waters, Novavax, and Supernus Pharmaceuticals
8. Auxilium Pharmaceuticals, Inc. To Present At The J.P. Morgan 32nd Annual Healthcare Conference
9. Questcor Pharmaceuticals to Present at the J.P. Morgan Healthcare Conference
10. Study Updates, Notices, Quarterly Reports, and Revenue Guidance Updates - Research Report on NPS Pharmaceuticals, Oramed, PAREXEL, PhotoMedex, and Cell Therapeutics
11. Bellicum Pharmaceuticals Raises $34.4 Million in a Series B Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... 2017 Global Health Intelligence (GHI), the ... , published its 2017 ranking of the Best-Equipped ... extensive data analysis from GHI,s hospitals database for Latin ... the region. The GHI database covers 86% of the hospitals ... 130 data points for each institution in key areas such ...
(Date:5/9/2017)...  Demonstrating its commitment to representing research- based ... Pharmaceutical Research and Manufacturers of America (PhRMA) today ... now have to meet new research and development ... join PhRMA. "By putting in place ... clear message that being a member of PhRMA ...
(Date:5/6/2017)... , May 5, 2017   Provista , a ... more than 200,000 customers, today announced Jim Cunniff ... wealth of executive and business experience to Provista, including most ... pharmacy in California . He assumed his ... "Jim is a great fit for Provista," says Jody ...
Breaking Medicine Technology:
(Date:5/26/2017)... ... May 26, 2017 , ... ... a new educational seminar to focus on current legislative activity and the latest ... begin at 1 p.m. Sunday, Sept. 10, and will continue through Monday, Sept. ...
(Date:5/26/2017)... ... May 26, 2017 , ... A new analysis of community ... healthiest seniors are located in the Midwest. With the average cost of healthcare rising ... are concerned with both the quality and affordability of where they live. An annual ...
(Date:5/26/2017)... BOSTON, MA (PRWEB) , ... May 26, 2017 , ... ... Care Act (AHCA), which narrowly passed the U.S. House on May 4, would result ... would be expected under continued implementation of the 2010 Patient Protection and Affordable Care ...
(Date:5/26/2017)... ... 2017 , ... Silver Birch of Hammond, a new assisted lifestyle community, has ... acres of land at 5620 Sohl Avenue in Hammond, serves older adults who need ... studio and one-bedroom apartments. Each of the private apartments at Silver Birch features a ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: a poignant story ... published author Laura Weigel Douglas, an avid reader who lives in the Pacific Northwest ... feels like Green Hills Adventure Camp. She couldn’t be more grateful. , Twelve-year old ...
Breaking Medicine News(10 mins):