Allergan Enters Into Licensing Agreement with Merck to Obtain Exclusive Worldwide Rights to CGRP Migraine Development Program
Allergan and Merck (MSD outside the US and Canada) have entered into an agreement under which Allergan will acquire the exclusive worldwide rights to Merck's investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine, subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR).
Under the terms of the agreement, Allergan will acquire these rights for an upfront payment of $250 million, $125 million of which is payable upon HSR clearance and $125 million of which is payable in April of 2016. Merck will additionally be entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs. Allergan will be fully responsible for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products. Allergan said its 2015 earnings-per-share forecast provided on 11 May 2015 is unchanged as a result of the acquisition. Allergan remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.
The agreement gives Allergan rights to two CGRP receptor antagonists:
• MK-1602, an oral small molecule antagonist for the acute treatment of migraines. A Phase II study of MK-1602 has been completed and end of Phase II discussions with FDA are planned prior to initiating Phase III. A Phase III study is expected to begin in 2016.
• MK-8031, an oral small molecule antagonist for the prevention of migraines. A Phase II study of MK-8031 is expected to begin in 2016.
In July 2011, Merck announced that it had discontinued clinical development of an earlier investigational oral CGRP antagonist, Telcagepant (MK-0974), after some patients showed evidence of liver toxicity. The MK-1602 & MK-8031 molecules belong to a different chemical series than Telcagepant, and in clinical trials to date have not shown evidence of liver toxicity. The potential of the CGRP antagonist mechanism has received validation from episodic and chronic migraine studies of injectable candidates in development.
"The agreement to acquire exclusive worldwide rights to Merck's CGRP migraine development program builds on our existing strength in neurosciences and helps position Allergan as a potential leader in the acute treatment of migraine and prevention of migraine for millions of patients," said David Nicholson, Executive Vice President, Global Brands Research and Development at Allergan. "With two novel oral therapies in development for treating and preventing migraines, we have the opportunity to provide therapies that could alleviate an intensely debilitating and immobilizing condition for patients worldwide. We look forward to supporting the continued development of these programs and to potentially bringing these new therapies to market."
"We are pleased that this agreement will enable Allergan to advance these promising molecules for the potential benefit of migraine sufferers, and that Merck will be able to continue to further focus our research and development resources on our priority therapeutic areas," said Iain D. Dukes, Senior Vice President of Business Development & Licensing, Merck Research Laboratories.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance