CELEBRATION, Fla., Dec. 13, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that it has been named the 2021 David J. Gury Company of the Year by BioFlorida. The award, presented during the 2021 BioFlorida Annual Conference, is in recognition of the U.S. Food and Drug Administration’s (FDA) approval of AZSTARYS® for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older, and other important milestones achieved by KemPharm over the past year. Corium, Inc. is leading all commercialization efforts for AZSTARYS in the U.S.
The David J. Gury Company of the Year Award recognizes a Florida-based life sciences company that has demonstrated significant, quantifiable achievements in financing deals, partnering agreements, research discoveries, grants, clinical trials, approvals, product development or commercialization milestones. Winners must also demonstrate a history of service to the BioFlorida mission to advance the life sciences industry in Florida. BioFlorida represents over 6,700 establishments and research organizations in the biopharmaceuticals, medical technology, health IT and bio-agriculture sectors.
“We're excited to recognize KemPharm as the BioFlorida’s 2021 David J. Gury Company of the Year and celebrate their growth and efforts with their recent FDA approval of an innovative new ADHD therapy and the potential it holds to meet the unmet needs of this patient population,” said Nancy K. Bryan, President and CEO of BioFlorida. “The KemPharm team has a personal passion for ADHD understanding both what it is like to live with it and parent those living with ADHD. The team uses this passion to continue to push for better products for patients and are poised for continued success in the future.”
KemPharm harnesses its LAT® technology to develop proprietary prodrugs for serious medical conditions. 2021 was highlighted by Corium’s U.S. commercial launch of AZSTARYS®, a new once-daily treatment for ADHD in patents age six years and older. Additionally, during 2021, KemPharm was able to complete an extensive financial restructuring, which enabled the company to eliminate all of its debt, add significant cash to its balance sheet, and re-emerge as a Nasdaq-listed company. Most recently, KemPharm announced the uplisting of the company’s stock to The Nasdaq Global Select Market, which is recognized as having the highest initial listing standards of any exchange in the world and is considered a mark of achievement and stature for qualified companies.
“2021 has been a year of significant achievement for KemPharm, and the company is now well positioned for continued growth in 2022 and beyond,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “The launch of AZSTARYS and approval of the drug by the FDA earlier this year were seminal events in KemPharm’s history, validating the company’s LAT technology and approach to prodrug development. Dovetailing this success was the revitalization of KemPharm’s business and finances, which has resulted in the company having clean balance sheet and strong cash position.”
Dr. Mickle concluded, “I would like to express my sincerest gratitude to BioFlorida for naming KemPharm the 2021 David J. Gury Company of the Year. This is a tremendous honor for our company, especially given how much the Florida biotechnology industry, as championed by BioFlorida, has grown over the past several years.”
AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH. Corium, Inc. is leading all commercialization efforts for AZSTARYS in the U.S.
The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
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, stimulant use disorder (SUD) and CNS rare diseases, including idiopathic hypersomnia (IH). In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS®, a once-daily treatment for ADHD in patents age six years and older containing KemPharm’s prodrug, serdexmethylphenidate (SDX), and APADAZ®, an immediate-release combination product containing benzhydrocodone, KemPharm’s 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.
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 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 continued commercialization of AZSTARYS® and the further development of KemPharm’s pipeline of 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and KemPharm’s other filings 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.
Tiberend Strategic Advisors, Inc.
Jason Rando/Maureen McEnroe, CFA
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