Merck & Co. and Japan Tobacco Inc. Sign Licensing Agreement for Osteoanabolic Drug Candidate

Merck & Co., Inc. and Japan Tobacco Inc. (JT) have announced a worldwide licensing agreement to develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth stimulating) agent for the treatment of osteoporosis, a disease which reduces bone density and strength and results in an increased risk of bone fractures.

Under the terms of the agreement, Merck gains worldwide rights, except for Japan, to develop and commercialize JTT-305. JT will receive an upfront payment and is eligible to receive additional cash payments upon achievement of certain milestones associated with the development and approval of a drug candidate covered by this agreement. JT will also be eligible to receive undisclosed royalties from sales of any drug candidates that receive marketing approval.

“Through this agreement with Merck, JT is well positioned to maximize the therapeutic potential for JTT-305 as a possible future option for patients with osteoporosis,” said Noriaki Okubo, President of JT’s Pharmaceutical Business.

JTT-305 is an investigational oral calcium sensing receptor (CaSR) antagonist that is currently being evaluated by JT in Phase II clinical trials in Japan for its effect on increasing bone density and is in Phase I clinical trials outside of Japan.

Most current available osteoporosis therapies reduce fracture risk by slowing bone loss – or bone resorption. Osteoanabolic drugs, such as JTT-305, may reduce fracture risk by stimulating the growth of new bone and thereby increasing bone density.