Allergan will buy exclusive worldwide rights from Merck & Co. to two clinical-phase migraine drug candidates for $250 million, plus milestone payments and royalties, the companies said today.
The agreement gives Allergan rights to two small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists. Furthest along clinically is MK-1602, for which a Phase II study has been completed. The company said it is planning end of phase II discussions with FDA before it launches a Phase III study of MK-1602, expected to begin in 2016.
The other compound being sold by Merck is MK-8031, which is expected to begin a Phase II study next year.
Both compounds are of a different chemical series and have not shown evidence of liver toxicity in clinical trials—unlike an earlier oral CGRP antagonist that Merck sought to develop a few years back. Merck ended its development program for Telcagepant (MK-0974) in 2011 after some patients in a clinical trial showed evidence of liver toxicity.
In pursuing approval of CGRP drugs for migraines, Allergan is competing with drug developers that have trumpeted promising results in recent weeks:
- Amgen reported on June 19 that patients receiving its AMG 334 (70 mg dose) experienced an average of a 4.9-day reduction in monthly migraine days after 52 weeks of treatment, from a baseline of 8.7 mean monthly migraine days.
- A day earlier, Teva Pharmaceutical Industries said its TEV-48125 yielded statistically significant reductions in migraine days—53% of patients given the 225 mg dose and 59% given 675 mg, compared with 28% receiving placebo. And on June 17, Eli Lilly said its LY2951742 met its primary endpoint in a Phase IIb study in episodic migraine.
Allergan agreed to pay $125 million upon expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and the other $125 million in April 2016. Merck will also be eligible for potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs.
Allergan has agreed to full responsibility for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products.
Merck said the deal will allow it to focus on priority therapeutic areas—which the company has identified as being oncology, diabetes, acute hospital care, and vaccines. The deal is also intended to raise the migraine drug presence of Allergan—fresh off its $70.5 billion acquisition by Actavis, in a deal announced last year.
Just over a year ago, the pre-merger Allergan saw its inhalable migraine therapy Semprana (dihydroergotamine; formerly trade-named Levadex) rejected by the FDA for a third time. The agency in June 2014 issued a Complete Response Letter citing concerns about “specifications around content uniformity on the improved canister filling process and on standards for device actuation,” pre-merger Allergan stated at the time.
The company emphasized that the FDA raised no questions about the safety or efficacy of Semprana, which Allergan inherited by acquiring MAP Pharmaceuticals in 2013 for $958 million.
“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,” David Nicholson, evp, global brands R&D at Allergan, said in a statement.
Neurosciences is among new Allergan’s areas of therapeutic focus, as are eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular, and anti-infective therapeutic categories. The company also operates the world's third-largest global generics business.
Allergan has sought to bolster several of those specialties through a flurry of recent deals. Just yesterday, the company shelled out $125 million in upfront cash to acquire Oculeve, and agreed to pay additional commercialization milestone payments related to Oculeve's lead development program OD-01. As part of the deal, Allergan also bought an additional earlier-stage dry eye device development program.
Last month, Allergan agreed to acquire Kythera Biopharmaceuticals for about $2.1 billion in cash and stock, adding to its portfolio Kybella™ (deoxycholic acid), the first non-surgical treatment for double chins.
