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:9/12/2017)... reviews on the independent review site Consumer Affairs have ... hearing aids, ranking it higher than Miracle Ear ™, Beltone™, ... ... Aids ... that provides high performance, state-of-the-art, German-engineered hearing aids directly to consumers ...
(Date:9/7/2017)... Sept. 7, 2017  Eli Lilly and Company ... to streamline operations to more efficiently focus resources ... cost structure. Global workforce reductions, including those from ... to impact approximately 3,500 positions. ... annualized savings of approximately $500 million that will ...
(Date:9/7/2017)... --  BioLife Solutions , Inc. (NASDAQ: BLFS ), ... cell and tissue hypothermic storage and cryopreservation ... President and CEO, will be presenting at two investment conferences ... 19 th Annual Global Investment Conference on Tuesday, September ... The conference is being held at the New York Palace ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... September 22, 2017 , ... After a ... senior finds a new lease on life with assistance from CreditAssociates. CreditAssociates provides ... their problem with unsecured debt. The senior is one of the satisfied clients ...
(Date:9/22/2017)... ... , ... “Cursed with a Curse: The Truth about Tithing”: ... experienced when breaking free from this misconception. “Cursed with a Curse: The Truth ... by Christian Faith Publishing, Lysa M. Harrison’s new book is a powerful and ...
(Date:9/22/2017)... ... September 22, 2017 , ... “Fruit of the Spirit: “Love””: ... exploring nature that God has created. “Fruit of the Spirit: “Love”” is the creation ... a devoted wife and mother of five. Halimah is an avid writer, her inspiration ...
(Date:9/21/2017)... ... ... With ProSlideshow Portrait from Pixel Film Studios creating a stylistic portrait slideshow ... to two layers of subject matter along with fully customizable backdrop animation, key-frameless animation, ... Pro X. , With ProSlideshow Portrait each user are given the tools and ...
(Date:9/21/2017)... ... September 21, 2017 , ... Promotional Communication:, Keeping Up ... , In the competitive world of drug and device marketing and promotion, drug ... FDA rules. , The FDA has issued two draft guidances that are the ...
Breaking Medicine News(10 mins):