Genco has won orphan designation from the FDA for its pediatric Tourette’s syndrome product candidate. KemPharm said it plans to use Genco’s nanoparticulate amphetamine technology to develop a prodrug used to treat Tourette’s syndrome when combined with ADHD.
“Today’s announcement of the license and assignment agreement with Genco provides KemPharm’s discovery and development team the opportunity to apply our prodrug expertise to a potential orphan-drug area of the ADHD market,” KemPharm president & CEO Travis Mickle said in prepared remarks. “In a subset of pediatric Tourette’s syndrome patients, there is a recognized problem of ADHD that requires additional treatment concurrent to treating the symptoms of Tourette’s.”
According to the deal, KemPharm will finance and manage product development in exchange for commercial ownership and the intellectual property of any product developed from the agreement.
Genco is eligible to earn certain milestone and royalty-based or value share payments, the companies said.
“KemPharm’s success at creating unique prodrug product candidates in multiple treatment areas allows us to see real potential for a prodrug to be successful as the basis for treating this rare pediatric disease,” Genco CEO Subhash Desai added. “By treating the underlying ADHD, we believe we can unlock the door to also treating tics and/or Tourette’s syndrome to provide an effective therapy for the unmet needs of those affected by this complex neurologic disorder.”
“Our goal is to discover and develop a prodrug-based therapy that can provide an appropriate and effective treatment for a rare pediatric disease while also successfully completing the FDA’s regulatory approval process, which may potentially allow us to seek a Priority Review voucher,” Mickle added.
“Uniquely, KemPharm’s proprietary LAT prodrug platform provides an opportunity to receive a voucher under the current guidelines which is an example of another way that prodrugs can be used to create value. Our agreement with Genco both builds on this platform and potentially adds significant assets to our development pipeline in ADHD.”