Filter News

Corium International, Inc. To Present Clinical Results From Pilot Bioequivalence Study Of Once-Weekly Corplex Donepezil Transdermal System At Alzheimer's Association International Conference 2017

Published: Jul 06, 2017

MENLO PARK, Calif., July 06, 2017 (GLOBE NEWSWIRE) -- Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced that Parminder "Bobby" Singh, Ph.D., Corium's Chief Technology Officer and Vice President, Research and Development, will present the clinical results from a bioequivalence (BE) study of Corium's once-weekly Corplex Donepezil product candidate at the Alzheimer's Association International Conference 2017 (AAIC) in London, UK, on July 18, 2017.

The pilot BE study was a six-month, three-period, randomized crossover study comparing the steady-state pharmacokinetic profiles of once-daily oral Aricept® with two Corplex Donepezil transdermal patches that differed only in size. Preliminary results from this study were reported on May 11, 2017.

Corium is planning to start its pivotal BE study later this year and remains on track to file a Section 505(b)(2) New Drug Application (NDA) for the product candidate in 2018. The pivotal study will be a simpler, two-way crossover design compared to the three-way crossover pilot study.

Poster Presentation Details:

Steady-State Clinical Pharmacokinetics Demonstrating Once-weekly Corplex Donepezil Transdermal System as a Therapeutic Alternative to Daily Oral Aricept

  • Tuesday, July 18, 2017, 9:30 AM-4:15 PM
  • Location: The ExCeL London, S8
  • Session: P3-01 Therapeutics: Clinical
  • Poster #16129

About Corium

Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company's broad experience with advanced transdermal and transmucosal delivery systems. Corium has multiple proprietary programs in preclinical and clinical development, focusing primarily on the treatment of neurological disorders, with lead programs in Alzheimer's disease. Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Mayne Pharma and Procter & Gamble. The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins. In addition to its proprietary Alzheimer’s program, the company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics and additional transdermal products that are being developed with other partners. For further information, please visit www.coriumgroup.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding our proprietary products and product candidates. Forward-looking statements are based on management's current expectations and projections and are subject to risks and uncertainties, which may cause Corium's actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect Corium's business and its results are detailed in Corium's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission (SEC) on May 12, 2017, and other reports as filed from time to time with the SEC. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial or operating performance, which speaks only as of the date they are made. Corium undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

Corplex™ and MicroCor® are registered trademarks of Corium International, Inc. Aricept® is a registered trademark of Eisai R&D Management Co., Ltd.

Source: Corium

Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049

Back to news