Corium Announces Issuance of Key U.S. Patent Covering Corplex™ Donepezil Transdermal System for Alzheimer’s Disease
June 13 2018 - 7:30AM
Corium International, Inc. (NASDAQ:CORI), a commercial stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty transdermal products, announced
today that the United States Patent and Trademark Office (PTO) has
issued a cornerstone patent related to the company’s Corplex
Donepezil Transdermal Delivery System (TDS), a once-weekly patch
that delivers the most commonly prescribed medication for
Alzheimer’s patients. U.S. Patent No. 9,993,466 provides coverage
of the drug product and its unique design features, including
composition elements that achieve a sustained, controlled and
effective delivery of donepezil across the skin for the 7-day wear
period. In addition, the PTO recently issued a notice of
allowance on another patent related to methods of transdermal
delivery of donepezil using the product described in U.S. Patent
No. 9,993,466. As previously announced, the Corplex Donepezil
TDS has achieved positive results in clinical bioequivalence
testing, and Corium is preparing to file a New Drug Application for
the product based on these results.
"Our novel Corplex TDS design and formulation technologies were
enabling for the once-weekly transdermal delivery of Donepezil,"
said Parminder "Bobby" Singh, Ph.D., Chief Technology Officer and
Vice President, R&D at Corium, and a co-inventor on the patent.
"The issuance of this patent highlights our innovation in the
transdermal delivery of molecules such as donepezil that have
previously been very challenging to transport across the skin with
traditional patch technologies."
The new patent is eligible for listing in the U.S. FDA Orange
Book, and its life extends at least to July 2037. It is the
first to issue of a series of pending Corium patent applications
relating to various aspects of Corplex Donepezil, as well as
similar products.
About Alzheimer's Disease and Donepezil
Alzheimer's disease is a progressive brain disorder in which the
brain cells degenerate and die, causing a steady decline in memory
and mental function. According to the Alzheimer’s
Association, an estimated 5.7 million Americans are living with
Alzheimer's disease in 2018; by 2050, this number is projected to
rise to 13.8 million. Alzheimer's disease is the most common
cause of dementia among older adults. Dementia ranges in
severity from mild, when it is just beginning to affect a person's
functioning, to moderate, and severe, when the person must depend
on others for the basic activities of day-to-day life.
Donepezil (the active ingredient in Aricept®) is the most widely
prescribed medication in a class of Alzheimer's drugs known as
cholinesterase inhibitors, and is approved for the treatment of
mild, moderate and severe disease. Donepezil is currently
only available in tablet or orally disintegrating tablet form, each
administered once daily, presenting compliance challenges for
family members and caregivers who cannot rely on patients to
consistently take their daily tablets, and is known to cause
gastrointestinal side effects, including nausea, vomiting and loss
of appetite.
About Corplex
Corium's Corplex system is a novel commercial-stage platform
technology designed to broadly enable the transdermal delivery of
small molecules, many of which have not previously been amenable to
transdermal delivery. Corium's Corplex technology has been
successfully commercialized in Procter & Gamble's Crest®
Whitestrips products, and is being utilized in therapeutic products
under development.
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.coriumintl.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 products, intellectual
property rights and portfolio, regulatory pathway, timing and
plans, and the advancement of our technologies, 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, 2018, filed with the Securities and Exchange Commission (SEC)
on May 15, 2018, 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 trademarks of Corium International,
Inc.Aricept® is a registered trademark of Eisai R&D
Management Co, Ltd.Crest® Whitestrips is a registered
trademark of The Procter & Gamble Company.
Investor and Media Contact:SMP CommunicationsSusan M.
Pietropaolosusan@smpcommunications.com(201) 923-2049
Source: Corium
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