• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Otsuka, Lundbeck partner in Japan

Otsuka, Lundbeck partner in Japan

November 1, 2013
CenterWatch Staff

H. Lundbeck and Otsuka Pharmaceutical said their existing alliance now also includes development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by the EMA as the first treatment for the reduction of alcohol consumption.

Nalmefene is a unique, dual-acting opioid system modulator, and acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence. Nalmefene is thought to reduce the reinforcing effects of alcohol, thereby reducing the urge to drink alcohol.

The harm of alcohol consumption affects individuals, their families, workplaces and society. It is estimated there are approximately 800,000 people in Japan who have been diagnosed with alcohol dependence; an estimated 8.6 million people consume alcohol at harmful drinking levels. In Japan, medical costs associated with alcohol consumption were estimated to be over $40.5 billion per year, of which the direct medical costs are estimated at $10 billion.

Lundbeck will receive an initial payment of $68.8 million upon signing. Lundbeck will finance the development costs and has an option to co-promote the product in Japan. Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milestones. If all milestones in the agreement are achieved, the total value of the agreement to Lundbeck would be approximately $137.6 million, plus royalties related to the revenue in Japan.

Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan. It is expected the first phase III study will be initiated during 2014.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing