Forest Files Memantine/Donepezil Fixed Combination For Alzheimer’s

Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.

For Forest Laboratories Inc., the fixed-dose combination of memantine and donepezil for Alzheimer’s disease will extend the life of its lucrative Namenda franchise, while royalty payments that start five years post-launch would support development of other projects in originator Adamas Pharmaceuticals Inc.’s CNS pipeline.

On March 4, Forest announced the NDA submission for the fixed-dose combination of extended-release memantine and immediate-release donepezil, two drugs...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By 

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By 

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By 

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

More from R&D

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.