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Corium Announces Positive Preclinical Results with Long-acting Potent GLP-1 Analog Delivered in MicroCor® Transdermal Patch

MENLO PARK, Calif., March 29, 2016 (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 the publication of a paper in the Early Edition of the Proceedings of the National Academy of Sciences (PNAS), titled “Long-acting Potent GLP-1 Analog Delivered in Microstructure-based Transdermal Patch”. The results demonstrate that the combination of MicroCor transdermal system with E6, a new GLP-1R agonist, resulted in improved peptide effectiveness by increasing plasma stability and providing sustained glucose control in a preclinical proof-of-concept study.

The research was conducted in partnership with the California Institute for Biomedical Research (Calibr) and the Scripps Research Institute (TSRI). In the study, E6, which was developed using a novel peptide engineering strategy, was formulated in Corium’s dissolving microstructure transdermal delivery system. A single five-minute application of the MicroCor system resulted in bioavailability comparable to subcutaneous injection, with corresponding improvements in glucose tolerance sustained for up to four days.

The MicroCor transdermal delivery approach has the potential to offer a safe, effective, convenient and needle-free alternative to currently marketed GLP-1 injectables for the treatment of diabetes and obesity. The MicroCor system has been clinically validated with parathyroid hormone, and the results published today with GLP-1 continue to support broader applications, including other therapeutic peptides and proteins, and vaccines.

"These results represent important progress in demonstrating the promise of Corium’s MicroCor transdermal system as an alternative delivery system for treatments requiring chronic injections,” said Parminder "Bobby" Singh, Ph.D., Chief Technology Officer and Vice President, R&D at Corium. “We are pleased to collaborate with the talented research teams at Calibr and TSRI on a transdermal form of E6. The painless needle-free delivery of a long-acting GLP-1 would be an important advance in the treatment of patients with diabetes and obesity.”

About the MicroCor® Transdermal Delivery System

Corium's MicroCor system is a clinical-stage platform technology utilizing dissolving microstructures (also referred to as microneedles or microprotusions) for the safe, effective and convenient transdermal delivery of small molecules and biologics, including vaccines, peptides and proteins. Corium's drug-in-tip technology directly integrates active therapeutic agents with proprietary polymer combinations to create arrays of solid-state biodegradable microstructures to optimize the delivery of therapeutic or prophylactic agents either locally or systemically. MicroCor is designed to penetrate the superficial layers of the skin and dissolve or biodegrade upon application, eliminating bleeding and the discomfort associated with traditional injections. Unlike liquid injectable formulations, the solid-state nature of the MicroCor system enables room-temperature stability, simplifying handling and storage, and reducing spoilage. In addition, there are no needles or sharps left behind after use, providing a safer delivery system for healthcare workers and caregivers. Corium has established GMP manufacturing facilities and quality systems for scale-up, and has developed cost-effective manufacturing processes to support early-stage through clinical development programs.

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 developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Teva Pharmaceuticals, Par Pharmaceutical 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. The company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics that is currently in Phase 3 trials, and additional transdermal products that are being developed with other partners. Corium has multiple proprietary programs in preclinical and clinical development for the treatment of osteoporosis, and neurodegenerative and neurological disorders. 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 business strategy, clinical trial timing and plans, the achievement of clinical and commercial milestones, and the advancement of our technologies and our proprietary, co-developed and partnered 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 December 31, 2015, filed with the Securities and Exchange Commission on February 12, 2016, and other reports as filed from time to time with the Securities and Exchange Commission. 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.

Investor and Media Contact: BCC Partners Karen L. Bergman kbergman@bccpartners.com (650) 575-1509 Susan Pietropaolo spietropaolo@bccpartners.com (845) 638-6290

Source:Corium International, Inc.