Corium Presents Clinical Results from Pilot Bioequivalence Study of Corplex™ Donepezil Transdermal System at Alzheimer's Association International Conference® 2017

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

Today’s poster presentation can be accessed at the Events & Presentations section of Corium’s website here.

As announced on May 11, 2017, data from the pilot BE study demonstrated that Corium’s Corplex Donepezil transdermal product candidate successfully met the criteria for bioequivalence to oral Aricept^® (donepezil hydrochloride) using primary pharmacokinetic (PK) endpoints previously established with the U.S. Food and Drug Administration (FDA).  Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer's disease.  

“These data support once-weekly Corplex Donepezil as a bioequivalent alternative to daily Aricept,” said Dr. Singh.  “Sustained and controlled transdermal delivery of donepezil over a seven-day period has the potential to simplify treatment, improve patient compliance, and reduce the GI side effects common to the oral dosage form.  We look forward to bringing this convenient therapeutic option to Alzheimer’s disease patients and their caregivers in the near future.”

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. 

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.   

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

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