{"id":449095,"date":"2021-03-02T23:34:56","date_gmt":"2021-03-03T04:34:56","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=449095"},"modified":"2021-03-02T23:34:56","modified_gmt":"2021-03-03T04:34:56","slug":"kempharm-announces-fda-approval-of-azstarys-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-cii-a-new-once-daily-treatment-for-adhd","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kempharm-announces-fda-approval-of-azstarys-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-cii-a-new-once-daily-treatment-for-adhd\/","title":{"rendered":"KemPharm Announces FDA Approval of AZSTARYS\u2122 (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD"},"content":{"rendered":"
\n

\n Conference Call and Live Audio Webcast Scheduled for Tomorrow, Wednesday, March 3, at 8:30 a.m. ET<\/em>\n <\/p>\n

CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS\u2122 (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm\u2019s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.\u00a0\u00a0<\/p>\n

Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement (the \u201cLicense Agreement\u201d) between KemPharm and an affiliate of GPC. Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021.<\/p>\n

\u201cThe FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,\u201d said Travis C. Mickle, Ph.D., President and CEO of KemPharm. \u201cToday\u2019s approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT\u00ae<\/sup> platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug. We look forward to continuing our support of Corium as they forge ahead with the commercial launch of AZSTARYS.\u201d<\/p>\n

\u201cToday\u2019s approval by the FDA is met with great excitement for this innovative new ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults,\u201d said Perry Sternberg, CEO of Corium. \u201cOur team is mobilized to put our commercial plans into action as the approval of the AZSTARYS NDA now enables us to finalize our preparations for commercial launch as early as the second half of this year.\u201d<\/p>\n

Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine and an investigator in the AZSTARYS clinical trial, commented: \u201cThe ADHD industry, and specifically the MPH space, has seen little innovation in recent years, leaving prescribers and patients desiring new treatment options. In my research and practice, three properties are repeatedly cited by patients and their caregivers as being underserved by current ADHD medications: onset of action, duration of effect and consistency of therapy. Having investigated AZSTARYS and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.\u201d<\/p>\n

As a result of the FDA\u2019s approval of the AZSTARYS NDA, KemPharm has earned a regulatory milestone payment following FDA approval as provided under the License Agreement, and KemPharm is working with GPC to evaluate the related provisions and amounts. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S.<\/p>\n

The complete label for AZSTARYS, including prescribing information and important safety information, may be found at www.kempharm.com\/pipeline-products\/#kp415<\/a>. <\/p>\n

The complete label may also be downloaded in PDF format here:\u00a0http:\/\/ml.globenewswire.com\/Resource\/Download\/4f63af91-9427-40da-b881-82a5e22a0315<\/a>.<\/p>\n

\n Conference Call Information:<\/strong>\n <\/p>\n

KemPharm will host a conference call and live audio webcast with slide presentation tomorrow, Wednesday, March 3, 2021, at 8:30 a.m. ET, to discuss FDA approval of the AZSTARYS NDA.\u00a0\u00a0 Interested participants and investors may access the conference call by dialing either:<\/p>\n