Corium Announces Publication of Promising Data for Needle-Free Transdermal Influenza Vaccine

By Amirah Al Idrus May 21, 2015 8:58am

MENLO PARK, Calif., May 18, 2015 (GLOBE NEWSWIRE via COMTEX) --

Corium International, Inc. CORI, +7.04% a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the publication of promising data on the use of its needle-free transdermal system to deliver influenza vaccine in the June 9, 2015 issue of Vaccine, a pre-eminent publication on vaccines and vaccination. The manuscript, entitled "Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," details results of a preclinical study conducted by Novartis Vaccines and Corium. Importantly, the results demonstrate the compatibility of Corium's MicroCor® needle-free transdermal system with cell culture-derived influenza vaccines, and establish its potential as a next-generation vaccine delivery system.

In the study, trivalent seasonal influenza cell culture-derived antigens were successfully fabricated for in vivo administration using the MicroCor system and resulted in immunization results comparable to the control vaccine delivered by intramuscular injection. In addition, preliminary data related to the incorporation of influenza antigens within the polymer matrix indicate stability of the antigens in the dried state, suggesting potential for longer-term stability at room temperature. Authors of the paper conclude that "taken together, utilization of cell culture-based production of influenza vaccines along with microstructure delivery could potentially change the way vaccines are administered, particularly in the event of a pandemic."

"There is a significant unmet need for improving influenza vaccine accessibility by providing easy to use and needle-free delivery systems," said Parminder "Bobby" Singh, Ph.D., Chief Technology Officer and Vice President, R&D at Corium and a co-author of the paper. "We believe that use of our MicroCor technology to deliver influenza vaccine could provide significant benefit through improved immunization outcomes and more convenient vaccine delivery based on the results of this study."

About the MicroCor® Transdermal Delivery System

Corium's MicroCor system is a clinical-stage technology utilizing biodegradable microstructures for safe, effective and convenient transdermal delivery of small molecules and biologics, including vaccines, peptides and proteins. The system integrates active agents directly into arrays of solid-state biodegradable microstructures, or "microneedles," that penetrate the outer layers of the skin to release peptides, proteins or vaccines for local or systemic absorption. The solid-state nature of the MicroCor system enables room-temperature stability, simplifying handling, storage and reducing wastage. 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.

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 advanced transdermal and transmucosal delivery systems. Corium has developed and is the sole commercial manufacturer of six 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 co-developed with Teva. Corium has multiple proprietary programs in preclinical and clinical development for the treatment of osteoporosis and neurological disorders. For further information, please visit www.coriumgroup.com.

About Vaccine

Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society, The International Society for Vaccines and The Japanese Society for Vaccinology and is published by Elsevier. www.elsevier.com/locate/vaccine

Copies of this paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at [email protected] or +31 20 4853564.

"Fabrication of cell culture-derived influenza vaccine dissolvable microstructures and evaluation of immunogenicity in guinea pigs," by Amanda Bonificio, Esi Ghartey-Tagoe, Simona Gallorini, Barbara Baudner, Guohua Chen, Parminder Singh, Derek T. O'Hagan, Sushma Kommareddy. DOI: http://dx.doi.org/10.1016/j.vaccine.2015.04.059. The article appears in Vaccine, Volume 33, Issue 25, pp. 2930-2938, 2015, published by Elsevier.

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 plans and the advancement of our technologies and our proprietary 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 financial results are detailed in Corium's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission on May 8, 2015, 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 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.