CELEBRATION, Fla., Oct. 04, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare diseases, announced its support for Niemann-Pick Awareness Month, which is the month of October, and Global Niemann-Pick Awareness Day, which is October 19th. KemPharm recognizes the important role and dedication of patient organizations, such as the National Niemann Pick Disease Foundation (NNPDF), and the International Niemann Pick Disease Alliance (INPDA), in not only raising awareness of Niemann-Pick disease type C (NPC), but also in providing advice, information and education to those living with NPC, their families, other caregivers, and all involved in the management of this disease. KemPharm supports and unites with these groups in advocating for those affected by NPC and their families and in seeking new therapeutic options for NPC where no satisfactory alternative treatments currently exist.
“NPC is a devastating neurodegenerative disease that affects people of all ages and leads to progressive loss of mobility, cognition, speech, and swallowing, often resulting in premature death,” said Christal Mickle, Senior Vice President, Operations and Product Development at KemPharm, Inc. “Unfortunately, there is currently no approved treatment for NPC in the U.S., and diagnosis of the disease is challenging due to the wide range of possible disease presentations and variability in the timing of onset. This diagnostic complexity results in the disease frequently being unrecognized and misdiagnosed with diagnostic delays averaging four to five years in the U.S. For these reasons, KemPharm has become an active participant in the NPC community, and we applaud the tireless work conducted by patient advocacy organizations to offer support for those living with NPC, their families and caregivers.”
KemPharm is a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare diseases. KemPharm has a diverse product portfolio, combining a clinical-stage development pipeline with NDA-stage and commercial assets. The pipeline includes arimoclomol, an orally-delivered, first-in-class investigational product candidate for Niemann-Pick disease type C (NPC), and KP1077, which the Company is developing as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder, and narcolepsy. In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS®, a once-daily treatment for ADHD in patients age six years and older containing KemPharm’s prodrug, serdexmethylphenidate (SDX), which is being commercialized by Corium, Inc. in the U.S. The FDA has also approved APADAZ®, an immediate-release combination product containing benzhydrocodone, KemPharm’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S. For more information on KemPharm and its pipeline of product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Early access programs are made available by KemPharm, Inc. and its affiliates, and are subject to the Company’s Early Access Program (EAP) policy as published on its website at www.kempharm.com. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the discretion of the treating physician.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation and which can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue,” “could,” “intend,” “target,” “predict,” or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding the promise and potential impact of our preclinical or clinical trial data, including without limitation the timing and results of any clinical trials or readouts, the timing or results of any IND applications and NDA submissions, including the resubmission of the NDA for arimoclomol, the potential uses or benefits of arimoclomol or any other product candidates for any specific disease indication or at any dosage, the potential benefits of any of KemPharm’s product candidates, the sufficiency of cash to fund operations, our plans or ability to seek funding, and our strategic and product development objectives. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by the Quarterly Report on Form 10-Q for the three months ended June 30, 2022, and KemPharm’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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