KemPharm, Inc. (NASDAQ: KMPH) on March 02, 2021, announced that the company got approval from FDA for the new drug AZSTARYS which is used for the treatment of ADHD and it’s a once Daily medicine for patients six-year and older. In pre-market trading on Wednesday, the stock was up 75.61% after the news.
The new approved medicine AZSTARYS is made up of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
The new medicine AZSTARYS will be commercialized by the Corium, Inc. which is a portfolio company of Gurnet Point Capital (GPC). There is a license agreement has been signed between Corium and KemPharm and it is expected that the AZSTARYS will be available commercially in the U.S in the 2nd half of 2021.
The complete information about the AZSTARYS is available on KemPharm website. The complete product label is also available in PDF format.
What is Attention Deficit Hyperactivity Disorder (ADHD):
ADHD is one of the most common neurodevelopmental disorders of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviours (may act without thinking about what the result will be), or be overly active.
KemPharm® is a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs that are designed to be improved versions of widely prescribed, approved drugs. The company corporate headquarter is located in celebration, Florida, USA. The company is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder.
The president and CEO of KemPharmTravis C. Mickle said that FDA approval is an important event for the company and an important milestone in the treatment of ADHD. He further said that he is looking forward to continuing their support for Corium for the commercial launch of AZSTARYS.
On this occasion, the CEO of CoriumPerry Sternberg said that the FDA approval is great excitement for ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults. He assured that the Corium is prepared for the commercial launch of AZSTARYS in the 2nd half of 2021.
The President of the Center for Psychiatry and Behavioral Medicine and an investigator in the AZSTARYS clinical trialAnn Childress, M.D said that she believes this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.
The financial impact of AZSTARYS approval on KemPharm
The recent FDA approval enablesKemPharm to earned a regulatory milestone payment following. As KemPharm is working with GPC, under the license agreement the KemPharm may be eligible for up to $468 million in regulatory and sales milestone paymentsas 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.
The ADHD market generated $17.9 billion in revenue in 2019 with a prescription growth rate of 4%. The branded portion generated only $7.4 billion while the rest was extended-release products which generated 9% of the revenue.
Conference Call Information:
The company is going to make a conference call and live audio webcast with slide presentation tomorrow, Wednesday, March 3, 2021, at 8:30 a.m. ET regarding FDA approval.Interested participants and investors may access the conference call by dialling either:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 4272912