Astellas Pharma and Chromocell said today they will partner to develop and commercialize new drugs for neuropathic and other pain conditions, under a license and collaboration agreement that could generate more than $515 million-plus for Chromocell.
Astellas gained worldwide rights to commercialize Chromocell’s lead compound, CC8464, an oral, peripherally acting inhibitor of the NaV1.7 ion channel, which is involved in the transmission of pain.
NaV1.7 has been a target of interest to several drug developers. Most recently, on September 22, Purdue Pharma disclosed plans to accelerate development of its Nav1.7 compounds for chronic pain through a joint venture with AnaBios. And in July, XRpro Sciences acquired from Pfizer assets related to the ion channel biology platform that the pharma giant inherited by acquiring Icagen in 2011—a platform designed to identify small molecule inhibitors of Nav1.7 and other ion channels.
The companies said CC8464 has the potential to be effective in several “large unmet or poorly served chronic pain markets,” as well as undisclosed rare, currently untreated diseases. Chromocell anticipates filing an IND for CC8464 in early 2016, the companies said.
Astellas agreed to pay Chromocell $15 million upfront, more than $500 million tied to development and commercial milestones, as well as double-digit royalties on sales if CC8464 is successfully commercialized.
Chromocell agreed to conduct all development of CC8464 through the initial Phase IIa proof-of-concept clinical trial in neuropathic pain. Astellas will lead all further development activities through to commercialization of CC8464 for the treatment of peripheral neuropathic pain.
In addition, the companies said Chromocell may propose, and may initiate, studies for additional indications, such as rare diseases and non-oral formulations of the drug candidate. Astellas can opt-in for development for those indications, in return for making additional payments to Chromocell, and, in certain instances, U.S. co-promotion rights.
Under its license from Chromocell, Astellas also gained global rights to other unspecified “back-up” pain drug candidates that have been identified through Chromocell's Chromovert® technology platform. Chromovert is designed to enable identification of rare cells expressing therapeutic targets, and according to Chromocell has enabled the company to discover CC8464 and other promising drug candidates.
“Astellas expects to provide a new therapeutic option to neuropathic and other pain conditions with high unmet medical needs by the collaboration to develop CC8464, and to make further contributions to the treatment of patients with pain conditions,” Kenji Yasukawa, Ph.D., Astellas svp and chief strategy officer, said in a statement.
Chromocell CEO Christian Kopfli cited Astellas’ commitment to pain treatments within its neuroscience area of R&D focus. The company’s pain pipeline includes ASP8477, a neuropathic pain compound designed to inhibit central sensitization, and under Phase II study in Europe. Development of another neuropathic pain compound, the Phase I ASP9226, was discontinued as of May.
In addition to neurology, Astellas’ therapeutic areas of focus include immunology, nephrology, oncology, and urology.