Concert rethinks R&D plans after loss in Incyte patent case

Legal and regulatory issues
The ruling wiped 11% off Concert’s stock in premarket trading. (Image: iStock/BCFC)

Concert Pharmaceuticals is reassessing whether to expand CTP-543 into additional indications after its attempt to challenge an Incyte patent failed. The setback leaves Concert committed to taking the drug forward in alopecia areata but uncertain of its future beyond the indication.

Lexington, Massachusetts-based Concert filed a post grant review petition against Incyte in the summer in a bid to chip away at the scope of a patent covering ruxolitinib, a drug sold by Incyte as Jakafi. Concert’s CTP-543 is a deuterated form of ruxolitinib, meaning it features deuterium, not hydrogen, in certain locations but is otherwise the same molecule.

As Concert sees it, the ruxolitinib patent falls short of describing and enabling “the full scope of the vast genus of deuterated ruxolitinib analogs now claimed.” The Patent Trial and Appeal Board disagreed. 


How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

The ruling (PDF) wiped 11% off Concert’s stock in premarket trading. Concert could continue the fight, though. And either way it thinks CTP-543 can proceed in its lead indication unaffected by the ruling.

“This decision does not prohibit us from challenging the validity of the patent at a later time in federal court, and we will continue with our plans to develop CTP-543 for alopecia areata. We don’t expect any disruption to our clinical timelines,” Concert CEO Roger Tung said in a statement

The blow, as Conert sees it, relates to its ability to expand CTP-543 into other indications. With the board siding with Incyte, the management team at Concert is reassessing plans to broaden the scope of the CTP-543 R&D program into other indications. Concert had previously talked up the prospect of using the $160 million it received from Vertex last year to bankroll the expansion.

News of the setback was softened somewhat by the revelation that the FDA has awarded fast-track designation to CTP-543 in alopecia areata.

Suggested Articles

Medtronic has received FDA approval for a drug-coated balloon designed to clear the access points used by patients undergoing dialysis treatments.

J&J's DePuy Synthes division has launched a new fixation system to expand treatment options for patients with frail bones in the neck and upper back.

Horizon Therapeutics is expanding its U.S. footprint to the Bay Area—the company unveiled a new R&D and manufacturing site in South San Francisco.