- Teva Pharmaceutical Industries Ltd. has terminated a licensing and drug discovery pact with Heptares Therapeutics, handing back all rights to a preclinical small molecule CGRP inhibitor which was set to enter Phase 1 testing for migraine this year.
- Sosei Group, which wholly owns Heptares, said Tuesday it will conduct a "detailed review" of the preclinical data generated by Teva before issuing new guidance on when clinical study might begin.
- Teva paid $10 million upfront back in 2015 to secure a global license to Heptares' program, a move it described at the time as complementary to development of its more advanced CGRP blocker fremanezumab.
Battered by falling generic prices in the U.S. and unproductive efforts in specialty R&D, Teva announced in December it would conduct a review of its entire R&D portfolio in an attempt to winnow out programs unlikely to yield future returns.
"We ... have taken a very close look at all our R&D programs. In the specialty area, we have cut roughly 27% of our programs," explained Teva CEO Kåre Schultz on a February earnings call with investors. "Basically these are programs that fall outside our core expertise area and where it's very speculative whether we would be able to return a profitable investment out of these programs."
While Sosei's announcement doesn't indicate when Teva decided to end the collaboration with Heptares, it seems likely the preclinical CGRP blocker was flagged in the R&D reshuffle.
Teva's fremanezumab, a large molecule, inhibits the same pathway and is currently under review by the Food and Drug Administration for potential approval as a treatment of migraine. In addition, the market for anti-CGRP drugs looks to be highly competitive. Amgen Inc. and Novartis AG, as well as Eli Lilly & Co., are awaiting FDA decisions on their respective drugs, while Alder BioPharmaceuticals Inc. is advancing its own candidate out of late-stage development.
Slightly farther back, Allergan plc is testing two small molecule CGRP inhibitors for treatment of chronic and acute migraine.
Moving another similar drug through the entire gamut of clinical testing, then, probably didn't meet Teva's bar for programs likely to earn a return on investment.
Unfortunately for Teva, the Israeli drugmaker has run into a potentially costly roadblock with fremanezumab. Earlier this year, the FDA issued a warning letter to South Korean drug manufacturer Celltrion Inc., which happens to be Teva's single source of active pharmaceutical ingredient for framanezumab.
The FDA had been expected to decide whether to approve fremanezumab by June 6, but now a verdict on the drug is likely to be delayed, according to Teva.
Any delay would sting all the more because Teva used a coveted priority review voucher — which it paid $150 million to acquire last year — to accelerate the FDA's review of its Biologics License Application.
Teva's CEO said the long-term plan is to have two suppliers for fremanezumab API. In the meantime, however, the Israeli drugmaker could be left on the outside looking in as its competitors move to market.