New Patent Issuance Extends SDX Patent Life for an Additional Five Years until 2037

CELEBRATION, Fla., July 28, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the United States Patent and Trademark Office (USPTO) has recently issued two (2) new patents to KemPharm governing methods of use and composition of matter for methylphenidate-based prodrugs. These newly-issued patents have an expiration date of December 9, 2037, which is an extension of approximately five (5) years past the previously-issued patents generally describing compositions based on a prodrug of d-methylphenidate (serdexmethylphenidate or SDX). KP415 and KP484, KemPharm’s clinical development candidates for the treatment of attention deficit hyperactivity disorder (ADHD), are both SDX-based formulations.

In September 2019, KemPharm entered into the License Agreement with an affiliate of Gurnet Point Capital (GPC) for the exclusive worldwide rights to develop, manufacture and commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484. GPC’s portfolio company, Corium, Inc. (Corium), will lead all commercialization activities for KP415.

The first patent (US 10,584,112) generally describes a specific stereoisomer compound of SDX and various other compositions. The second patent (US 10,584,113) generally describes compositions comprising unconjugated d-methylphenidate in combination with a specific stereoisomer compound of SDX.

“Issuance of these U.S. patents significantly strengthens the intellectual property portfolio governing KemPharm’s SDX-based product candidates, including our ADHD franchise, which is led by KP415,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “The additional five years of patent protection afforded by the issuance of these patents is well-aligned with the ongoing effort by GPC and Corium to prepare KP415 for potential commercialization, if approved. Based on previous communications from FDA, the anticipated PDUFA date for KP415 is March 2, 2021.”

“We are pleased that these two additional patents have been issued for SDX, extending the potential life cycle of the product candidates, KP415 and KP484, to 2037,” said Dr. Sophie Kornowski, Senior Partner at GPC. “The extension of time significantly enhances the overall value of these innovative ADHD treatments and further supports the investment thesis for our partnership with KemPharm.”

About KP415 and KP484:

KP415 consists of SDX co-formulated with immediate-release d-MPH and is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. In addition, results from the various Human Abuse Potential trials for the SDX component of KP415 suggest that the prodrug alone may have lower abuse potential than relevant d-MPH comparators.

KP484 is KemPharm’s co-lead clinical development candidate being developed for the treatment of ADHD in patients that respond best when a very long duration of therapy is required. Similar to KP415, KP484 is based on SDX. Preclinical and clinical studies of KP484 have demonstrated that the prodrug may produce a longer duration release of d-MPH compared to the most prescribed methylphenidate products. KP484 has the potential to be the first new methylphenidate-based product being developed with the intent to address the specific needs of the adult ADHD population.

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT^® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT^® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ^®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

About Gurnet Point Capital:

Gurnet Point Capital is a unique healthcare fund founded by Ernesto Bertarelli and led by Christopher Viehbacher, who, together, have decades of expertise in an industry for which they share a passion, both as Chief Executives and as investors. With an initial allocation of $2 billion, GPC is investing long-term capital and supporting entrepreneurs in building a new generation of companies. Based in Cambridge, MA, its remit is global, encompassing life sciences and medical technologies. The fund invests across all stages of product development through to commercialization and does so with an approach that is a hybrid of venture and private equity investing strategies. www.gurnetpointcapital.com.

Caution Concerning Forward Looking Statements:

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing and probability of potential FDA approval of the KP415 NDA, the potential commercial launch of KP415, the potential product life cycle of KP415 or KP484. The potential clinical benefits of KP415 or any of our product candidates, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

KemPharm Contacts:

Jason Rando/Maureen McEnroe
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664
jrando@tiberend.com
mmcenroe@tiberend.com