Daiichi axes $650M pain pact 7 months after FDA setback

Daiichi Sankyo has cut and run from its $650 million pain alliance with Charleston Laboratories. The decision comes seven months after the FDA knocked back a request for approval of the collaboration’s top prospect.

When Daiichi received the CRL for the fixed-dose combination of hydrocodone, promethazine and acetaminophen in February, it committed to working with Charleston and the FDA to resolve the problems with the filing. However, following a review of its portfolio and the U.S market, Daiichi has decided to cut its losses and return the rights to CL-108 and other products to Charleston.

That decision will have financial consequences for Daiichi. The Japanese drugmaker handed over $100 million upfront to team up with Charleston in 2014. A further $100 million payment was tied to a near-term milestone. That left $450 million linked to the regulatory filing and approval, some of which Daiichi is paying despite abandoning the drug. Daiichi will take a $250 million impaired loss reflecting payouts to Charleston.

To hear Charleston tell it, Daiichi has opted to take these financial hits despite CL-108 nearly being ready to go back before the FDA. The Jupiter, FL-based specialty pharma company plans to refile its NDA in the coming weeks. Charleston, which already had the rights to co-promote CL-108, created a U.S. commercial subsidiary earlier this year.

Daiichi released news of its decision at the same time as an update about a phase 3 diabetic peripheral neuropathic pain trial of mirogabalin. The 750-patient study linked the calcium channel drug to a statistically significant improvement in average daily pain scores over placebo after 14 weeks. Daiichi said an early look at the safety data uncovered no major safety concerns.

The release of the top-line data comes two months after Daiichi reported a similar success in a trial involving patients with post-herpetic neuralgia. The trials form part of a phase 3 program Daiichi hopes will establish mirogabalin as a rival to the similar pain drug Lyrica, which racked up sales of close to $5 billion for Pfizer last year despite losing patent protection in some markets.