Corium Reports FQ3 Financial Results and Corporate Highlights

Corium International, Inc. CORI, +21.18% a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited financial results for the third fiscal quarter and the nine months ended June 30, 2018 and reported on recent corporate developments. Corium’s fiscal year ends on September 30.

Corporate Highlights

• Corplex(TM) Donepezil on track for filing — Corium has completed treatment in all of the ancillary clinical studies required for its New Drug Application (NDA) for Corplex Donepezil, a once-weekly patch that delivers the most commonly prescribed medication for Alzheimer’s patients. These studies included standard skin tolerability, alternative patch application site and heat effect studies. Corium remains on track to submit a Section 505(b)(2) NDA in the first quarter of calendar 2019. In addition, Corium reported clinical pharmacodynamic results at the Alzheimer’s Association International Conference [(R)] 2018 that provide additional validation of the therapeutic equivalence between Aricept [(R)] and Corplex Donepezil.
• First two key patents issued for Corplex Donepezil– In June and July, Corium announced the issuance of two U.S. patents, including composition elements, unique design features of the drug product and methods to achieve sustained, controlled and effective delivery of donepezil across the skin for a 7-day wear period. Eligible for listing in the FDA Orange Book, these patents establish the foundation of a strong IP portfolio for the transdermal delivery of donepezil and extend patent coverage of the product to at least July 2037. Corium has several additional pending patent applications relating to various features of Corplex Donepezil, as well as similar products.
• Pipeline advances in additional indications — Corium has progressed its development and feasibility evaluation of several pipeline product candidates, leveraging nonclinical and clinical studies that the company has already performed. The pipeline candidates include programs in several important disease areas including multiple sclerosis, Alzheimer’s and pain management. Corium anticipates advancing select programs into clinical pharmacokinetic and safety studies during fiscal 2019.
• Commercial production commenced using expanded capacity for P&G– Corium’s expanded commercial manufacturing capacity for Procter & Gamble’s Crest [(R) ] Whitestrips is now fully operational and in production. Part of an extended supply agreement with P&G, the additional production provides the companies with greater ability to meet significant increases in demand for Crest Whitestrips.

“We remain on track to file our Corplex Donepezil NDA in the first quarter of 2019 and look forward to delivering an important new treatment option for patients with Alzheimer’s disease and their caregivers,” said Peter D. Staple, President and Chief Executive Officer of Corium. “We are executing on our strategic plan to leverage our Corplex technology to expand our proprietary pipeline with the development of additional “first-in-patch” transdermal therapeutics. We’ve identified several promising candidates in therapeutic areas with significant unmet needs that, based on our initial formulation and feasibility work, meet our technical and commercial criteria for further development.”

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