Teva Pharmaceutical Industries Ltd. and Heptares Therapeutics (Heptares), a wholly owned subsidiary of Sosei Group Corporation (Sosei) have entered into a licensing and drug-discovery agreement under which Teva will receive exclusive global rights to develop, manufacture and commercialise novel, small-molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine.

Under the terms of the agreement, Heptares will receive an upfront payment of $10 million, research funding, and is eligible to receive additional research, development and commercialisation milestone payments of up to $400 million. In addition, Heptares will be eligible to receive royalties on net sales of products resulting from the alliance.

“We are delighted to begin this partnership with Heptares, which through its industry-leading, structure-based design approach has generated novel CGRP antagonists with significant promise for treating migraine,” said Michael Hayden, MD, PhD, president of global R&D and chief scientific officer at Teva.

“CGRP antagonism represents an exciting opportunity to treat migraine. We believe small-molecule CGRP antagonists offer further opportunities that are highly complementary to our promising candidate, TEV-48125, an anti-CGRP antibody.”

“This agreement is an exciting development for our CGRP antagonist program,” added Malcolm Weir, chief executive officer of Heptares.

“Teva brings world-leading clinical and commercial expertise in migraine to advance this program based on differentiated small-molecule CGRP antagonists discovered using our novel structure-based drug design technologies. The commitment Teva is making allows us to expand this promising programme.”

Approximately 36 million people in the United States and 8 million people in Japan suffer from migraine. Migraine is three times more common in women than in men and affects more than 10 percent of people worldwide. Migraine is defined as recurring attacks of moderate to severe headache pain. The International Headache Society defines chronic migraine as more than 15 headache days per month over a three-month period of which more than eight are migraines, in the absence of medication over use. Episodic migraine is the other migraine sub-type, which is defined as less than 15 headache days per month. During migraines, people can experience varying characteristics such as being very sensitive to light and sound and may also experience nausea and vomiting. There is no absolute cure for migraine since its pathophysiology has yet to be fully understood.

Calcitonin gene-related peptide (CGRP) is released during migraine attacks and can trigger migraine in patients. CGRP is found in small to medium-sized neurons in the trigeminal ganglion and mediates its activity through G protein-coupled receptors located throughout the body. Elevated levels of CGRP are found in migraineurs during an attack and blocking CGRP activity is a validated mechanism of action for relieving pain, and also for preventing migraine.