By CBJ News Staff
KemPharm, Inc. announced today the U.S. Food and Drug Administration had accepted the New Drug Application for its investigational attention deficit hyperactivity disorder (ADHD) treatment, KP415.
The Florida-based specialty pharmaceutical company, with locations in Coralville and Virginia, said the action will trigger a regulatory milestone payment of $5 million from an affiliate of Gurnet Point Capital (GPC) within 30 days under a license agreement with the company.
In addition, KemPharm also announced that Corium, Inc. will lead all commercialization activities for KP415, if approved. Corium, led by President and CEO Perry Sternberg, is a portfolio company of GPC, focused on the development, manufacture and commercialization of specialty pharmaceutical products.
“We are pleased that the FDA has accepted the KP415 NDA, and we now look forward to working with the team at GPC to advance the regulatory review process towards a potential approval as early as March 2021,” said Travis C. Mickle, Ph.D., president and CEO of KemPharm, in a release. “In addition to the regulatory activities, we are thrilled to have the opportunity to benefit from Perry’s leadership and Corium’s commercialization expertise to bring this new treatment to market, following FDA approval.”
KP415 contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate, better known as Ritalin. Because SDX is a “new molecular entity,” FDA review guidance calls for 10 months between New Drug Acceptance and approval.
“The advances KemPharm is making in the treatment of ADHD are exciting,” Mr. Sternberg said. “There are several unmet needs with existing treatment options, which we believe KP415 has the potential to address, bringing meaningful benefits to physicians, patients and their families. The team at Corium is energized to be working with KemPharm to advance KP415 towards a potential approval and launch.”
Under KemPharm’s licensing agreement, GPC’s affiliate has exclusive worldwide rights to develop, manufacture and, if approved, commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484.
In addition to the $5 million regulatory milestone payment for acceptance of the KP415 NDA, the agreement also provides for a regulatory milestone payment within 30 days of its approval. CBJ