KemPharm Participates in KP415 Late-Cycle Communication Meeting with FDA


2020-12-03 01:33:20 BioSpace


CELEBRATION, Fla., Dec. 02, 2020 -- KemPharm, Inc.. , a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the Company participated in a late-cycle communication meeting on December 1, 2020, with the U.S. Food and Drug Administration regarding the ongoing review of the New Drug Application for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder . In the meeting, the FDA did not raise any substantive issues related to KP415’s safety and efficacy at this point in their review of the KP415 NDA. In addition, the FDA re-affirmed the PDUFA date for the KP415 NDA is March 2, 2021. KP415 is KemPharm’s investigational product candidate for the treatment of ADHD. KP415 consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. KP415 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. “The late-cycle review meeting with the FDA continued a series of productive meetings with the Agency, and sets the stage for the next phase of the NDA review process, including the potential for confidential discussions of the KP415 product label,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “With approximately three months until the KP415 PDUFA date, we remain optimistic about the potential outcome and, accordingly, have been working closely with Corium to plan for the potential commercialization of KP415, if approved. This topic will be a primary focus for this morning’s ‘KP415 Market Opportunity and Commercialization Strategy’ webcast.” 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 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, 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 of the PDUFA date and potential FDA approval of the KP415 NDA, the potential commercial launch of KP415, or the potential clinical benefits of KP415 or any of the Company’s 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, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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.
庆祝活动,佛罗里达州,2020年12月2日--KemPharm公司。这家专注于发现和开发专有前药的特种制药公司今天宣布,该公司参加了2020年12月1日与美国食品和药物管理局举行的关于KP415新药申请正在审查的后期周期沟通会议,KP415是KEMPHARM公司用于治疗注意力缺陷多动障碍的研究候选产品。在会议中,FDA在对KP415 NDA的审查中,在这一点上没有提出任何与KP415的安全性和有效性相关的实质性问题。此外,FDA重新确认KP415 NDA的PDUFA日期为2021年3月2日。 KP415是Kempharm公司用于治疗ADHD的候选研究产品。KP415由Kempharm的D-哌甲酯(d-MPH)的前药serdexmethylphenidate(SDX)与即刻释放的d-MPH共配制成。KP415旨在解决使用最广泛的哌甲酯ADHD治疗未满足的需求,包括更早的起效时间和更长的治疗时间,同时避免可能与不良事件相关的d-MPH浓度不必要的峰值。 Kempharm公司总裁兼首席执行官Travis Mickle博士说:“与FDA的后期审查会议继续与该机构举行了一系列富有成效的会议,并为NDA审查过程的下一阶段奠定了基础,包括可能对KP415产品标签进行保密讨论。距KP415 PDUFA日期大约还有三个月,我们对潜在的结果保持乐观,因此,我们一直在与Corium密切合作,为KP415获得批准后的潜在商业化进行规划。这个主题将是今天上午'KP415市场机会和商业化战略‘网络广播的主要焦点。“ 关于Kempharm: KemPharm是一家专业制药公司,专注于通过其专有的LAT®(配体激活疗法)技术发现和开发治疗严重医疗状况的专有前药。KemPharm公司利用其专有的LAT®技术来生产经FDA批准的药物的改进前药版本,以及生产可用于新疾病适应症的现有化合物的前药版本。Kempharm公司的前药产品候选管道集中在注意力缺陷多动障碍,或ADHD和兴奋剂使用障碍的高需求领域。Kempharm公司共同主导的治疗ADHD的临床开发候选药物KP415和KP484都是基于D-哌甲酯的前药,但具有不同的持续时间/效果曲线。此外,KemPharm公司还获得了FDA批准的阿帕达兹®,这是一种含有氢可酮的前体药物二苯羟考酮和对乙酰氨基酚的即刻释放联合产品。欲了解更多有关KemPharm及其前体药物候选产品的信息,请访问www.KemPharm.com或通过Twitter,LinkedIn,Facebook和YouTube与我们联系。 有关前瞻性陈述的警告: 本新闻稿可能包含基于经修订的1933年《证券法》第27A节和经修订的1934年《证券交易法》第21E节的安全港条款所作的前瞻性陈述。前瞻性陈述包括不完全涉及历史或当前事实的所有陈述,包括但不限于公司提议的开发和商业时间表,并且可以通过使用诸如“可能”,“将”,“预期”,“项目”,“估计”,“预期”,“计划”,“相信”,“潜在”,“应该”,“继续”或这些词语的否定版本或其他类似词语来识别。前瞻性陈述不是对未来行动或业绩的保证。这些前瞻性陈述,包括PDUFA日期的时间和FDA对KP415 NDA的潜在批准,KP415的潜在商业推出,或KP415或该公司任何候选产品的潜在临床益处,都是基于KemPharm目前可获得的信息及其当前计划或预期,并受到许多可能显著影响当前计划的不确定性和风险的影响。有关Kempharm业务的风险在Kempharm截至2019年12月31日的年度10-K表年度报告,Kempharm截至2020年9月30日的季度10-Q表季度报告以及Kempharm向证券交易委员会提交的其他定期和当前报告中有详细描述。KemPharm没有义务更新或更改其前瞻性陈述,也明确表示不承担任何此类义务,不论是由于新信息,未来事件或其他原因。