KemPharm & Genco Sciences Announce Technology Licensing Agreement

KemPharm, Inc., a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, recently announced it has entered into a technology licensing and assignment agreement with Genco Sciences, LLC (Genco).

Utilizing Genco’s early research-stage proprietary nano-particulate amphetamine technology, KemPharm will focus on devising an unique prodrug to be developed as a treatment for pediatric Tourette’s syndrome when accompanied by ADHD (attention deficit hyperactivity disorder). Genco previously received an Orphan Designation letter from the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development for its product candidate for pediatric Tourette’s syndrome.

“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,” said Travis C. Mickle, PhD, President and Chief Executive Officer of KemPharm. “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.”

Under terms of the agreement, KemPharm will be responsible for financing and managing all product development. In exchange, KemPharm will retain full intellectual property and commercial ownership of any product developed as a result of this agreement, with Genco eligible to receive certain milestone and royalty-based or value share payments. Additional details about the agreement were not disclosed.

“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,” said Subhash Desai, PhD, Chief Executive Officer of Genco. “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,” Dr. Mickle continued. “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.”

Tourette’s syndrome is an inherited neuropsychiatric disorder with onset in childhood, characterized by the presence of motor and phonic tics – the treatment goal is managing symptoms to achieve optimum functioning, rather than eliminating symptoms; not all persons with Tourette’s require treatment, and there is no cure nor universally effective medication.

In 90% of cases, Tourette’s syndrome exists in conjunction with another disorder. The most frequent co-occurring condition in people with Tourette (63%) is ADHD, though the cause of this association is uncertain.

The Centers for Diease Control and Prevention published a series of statistics related to Tourette’s syndrome in its “A National Profile of Tourette Syndrome, 2011-2012.” The CDC profile is linked as follows: https://www.cdc.gov/ncbddd/tourette/data.html

KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT^TM (Ligand Activated Therapy) platform technology. KemPharm utilizes its proprietary LAT^TM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, Apadaz™, an immediate-release, abuse-deterrent acetaminophen/hydrocodone combination product candidate and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.

Genco is a privately held company developing proprietary products for the treatment of ADHD and Tourette’s/Tics.