Actionable news
All posts from Actionable news
Actionable news in KMPH: KemPharm Inc,

KemPharm, Inc. Reports First Quarter 2016 Results

May 12, 2016 (GLOBE NEWSWIRE via COMTEX) --

Recent Clinical Development & Regulatory Highlights:

  • Introduced Apadaz(TM) as the proprietary name for KP201/APAP
  • FDA Advisory Committees voted 16 to 4 in support of Apadaz approval; voted 18 to 2 against inclusion of abuse deterrent labeling
  • Granted "Fast Track" designation for, and received clearance from FDA to initiate human clinical trials, of KP511, KemPharm's prodrug of hydromorphone

Recent Corporate and Financial Highlights:

  • Expanded senior leadership team with the appointment of Daniel L. Cohen, Executive Vice President, Government and Public Relations, and Rene A. Braeckman, Ph.D., Vice President, Clinical Development
  • Granted a fee waiver and received the refund of the full user fee amount of $2.4 million for the Apadaz NDA
  • Net loss of $0.20 per basic and diluted share for the quarter ended 3/31/2016
  • Cash, cash equivalents and marketable securities balance was $111.0 million at 3/31/2016, an increase of $59.7 million from 12/31/2015

CORALVILLE, Iowa, May 12, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. KMPH, -7.42% a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today reported its corporate and financial results for the first quarter ended March 31, 2016.

"This has been a significant period for KemPharm. Last week's joint advisory committee meeting with the FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management committees voted in support of approving Apadaz for the management of acute pain that requires an opioid, yet recommended against including abuse deterrent labeling for the product," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "While the committees' advice regarding potential product labeling is disappointing, we continue to work collaboratively with the FDA as it continues its priority review of Apadaz as we look ahead to the target action date on June 9, 2016."

"Earlier this week we received Fast Track designation by the FDA for KP511, our prodrug of hydromorphone, for the treatment of moderate-to-severe pain where an opioid is appropriate, and we now anticipate sharing proof-of-concept study data of KP511 as early as the second quarter of 2016. We believe these are positive steps forward with this program and demonstrate the continued development of our pipeline of proprietary prodrugs. Our plan is to develop KP511 as an extended-release prodrug product candidate - KP511/ER - that could offer the potential to deter certain methods of abuse while providing the same pharmacokinetic and therapeutic effect as existing hydromorphone products when taken as intended."

"Lastly, we anticipate achieving several milestones in 2016 in the development of KP201/IR, our acetaminophen-free hydrocodone prodrug," Dr. Mickle concluded. "We expect to progress this program into a potential NDA filing during 2017 as we continue to advance our pipeline in a planned effort to submit at least one new NDA each year through 2019."

Q1 2016 Financial Results:
KemPharm's net loss for the quarter ended March 31, 2016, was $2.9 million, or $0.20 per basic and diluted share, compared to a net loss of $6.0 million, or $2.50 per basic and diluted share, for the same period in 2015. The decrease in net loss period-to-period is primarily due to a $6.9 million increase in total other income (expense) primarily related to an increase...