- Otsuka Pharmaceutical has acquired rights to Teva's investigational headache medication through a new licensing agreement, the Japanese pharma said Monday.
- The deal gives Otsuka, headquartered in Tokyo, exclusive rights to commercialize Teva's fremanezumab in Japan. In exchange, the Israeli drugmaker receives $50 million through a lump sum payment, as well as regulatory and sales milestones and royalties on future revenue. Otsuka is also responsible for the costs of additional clinical trials conducted in Japan.
- Fremanezumab is one of an emerging class of medications that work by thwarting a protein dubbed calcitonin gene-related peptide (CGRP), which research suggests plays a role in migraine development. Currently, the drug is in late-stage testing for a variety of headache conditions, including chronic and episodic migraines as well as cluster headache
An often-referenced national survey published in the journal Cephalalgia in 1997 found that, among a sample of more than 4,000 Japanese people ages 15 and up, 8.4% had experienced a migraine within the last year. Nearly three-fourths of those patients reported that migraine negatively affected their daily routine, yet a majority also never went to see a doctor about their ailment. About 60% were using over-the-counter medications to treat their severe headaches.
Twenty years later, there is still a need for more targeted migraine therapies in Japan, according to a May 15 statement from Otsuka. And with that in mind, Teva's drug represents a promising investment for Otsuka, which already has a strong track record rolling out its own neuroscience drugs.
In the first quarter of 2017 alone, the company's antipsychotic Abilify (aripiprazole) and its extended release version, major depressive disorder treatment Rexulti (brexpiprazole) and PsuedoBulbar Affect drug Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) brought in ¥49.7 billion ($448 million) in combined revenue.
Tatsuo Higuchi, Otsuka Pharma Co.'s president, said in a statement his company plans to use its expertise in neuroscience, as well as psychiatry, in relation to the licensing deal. That experience will come in handy, too, as fremanezumab faces a good amount of competition.
Novartis and Amgen are co-developing their own CGRP-inhibitor, erenumab, as a treatment for chronic and episodic migraine. In 2016, the drugmakers reported positive results from a Phase 2 trial of their candidate in the former indication and from two Phase 3 trials in the latter indication.
Eli Lilly has also worked to build out its pain pipeline, and has two late-stage prospects in lasmiditan and galcanezumab, another anti-CGRP agent.
Teva's has two Phase 3 studies testing two-doses of fremanezumab against placebo as treatment for chronic migraine and episodic migraine. The estimated enrollment for each trial is 878 patients, and primary completion dates for both are set for September.