KemPharm Inc (NASDAQ:KMPH) investors should be smiling from ear to ear today following the news that the company’s Investigational New Drug (IND) application for KP415, an extended release (ER) d-threo-methylphenidate (d-MPH) prodrug for the treatment of attention deficit hyperactivity disorder (ADHD), has been accepted by the FDA.
KemPharm shares reacted to the news, rising nearly 15% to $5.05 in early trading Tuesday.
KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.
We are very pleased that the FDA accepted our IND request for KP415, our co-lead product candidate, and expect to advance this program through proof-of-concept before year-end and into human clinical trials,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “Based on our estimates, in 2015, methylphenidate accounted for approximately 19.7 million prescriptions and $4.2 billion in sales in the ADHD market.”
“However, patent expiration in the ADHD space is eroding the revenues of branded products,” Mickle continued. “We believe KP415 offers the opportunity to address this market dynamic with a prodrug technology that, in pre-clinical studies, has demonstrated both extended release properties and a pharmacokinetic profile that could enable a more predictable therapy compared with currently available, immediate-release d-MPH products.”
KemPharm anticipates submitting a New Drug Application (NDA) submission for KP415 as early as 2018. In preclinical studies of KP415, KemPharm observed features that it believes could provide significant benefits when compared with other FDA-approved and widely prescribed methylphenidate products. Pharmacokinetic data from those preclinical studies suggest that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is approximately three times longer compared to immediate release methylphenidate. As a prodrug that requires metabolism, KP415 may be able to deliver d-MPH more consistently than the current formulation based approaches. This improved delivery may provide more consistent therapy. (Original Source)
On the ratings front, KemPharm has been the subject of a number of recent research reports. In a report issued on August 10, Canaccord Genuity analyst John Newman reiterated a Buy rating on KMPH, with a price target of $34.00 which represents a potential upside of 673% from where the stock is currently trading. Separately, on June 14, Oppenheimer’s Rohit Vanjani reiterated a Buy rating on the stock and has a price target of $11.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Newman and Rohit Vanjani have a total average return of -11.5% and 10% respectively. Newman has a success rate of 35% and is ranked #4067 out of 4184 analysts, while Vanjani has a success rate of 54% and is ranked #292.
KemPharm, Inc. is a clinical-stage pharmaceutical company, which engages in the discovery and development of proprietary prodrugs. Its products include KP201/APAP, KP511/ER, KP606/ER, KP415 and KP303 which are used for treatment of deficit/hyperactivity disorder, pain and cardiovascular disease.