Corium Presents Additional Positive Clinical Results at Alzheimer's Association International Conference® 2018
25 Juillet 2018 - 4:30PM
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, presented
positive pharmacokinetic (PK) and pharmacodynamic (PD) clinical
results from the company's bioequivalence study of Corplex
Donepezil in a poster presentation today at the Alzheimer's
Association International Conference 2018 (AAIC) in Chicago, IL.
Today's poster presentation can be accessed at the Events &
Presentations section of Corium's website here.
Corium had previously reported positive PK bioequivalence data
comparing once-weekly Corplex Donepezil and daily oral Aricept at
steady state. In the poster results
presented today, these bioequivalence results were further
supported by equivalent pharmacodynamics of Corplex Donepezil and
oral Aricept, characterized by the relationship between plasma
donepezil concentrations and red blood cell acetylcholinesterase
inhibition, which is an important biomarker of the pharmacodynamic
response to donepezil.
The results also demonstrated that donepezil exposure over the
7-day wear duration was dose proportional for the two intended
product strengths, 5 mg/day and 10 mg/day. Further, the
pharmacokinetics were independent of age, indicating no dose
adjustment is required for Corplex Donepezil based on age.
"The close match of the pharmacodynamic response for
bioequivalent oral and transdermal regimens further supports
therapeutic equivalence between Aricept and Corplex Donepezil,"
said Dr. Singh. "We remain on track to file a 505(b)(2) New
Drug Application (NDA) for the product candidate in early 2019 and
look forward to bringing this important new therapeutic option to
Alzheimer's disease patients and their caregivers in the near
future."
The bioequivalence study was a six-month, three-period,
randomized crossover study comparing the steady-state PKPD profiles
of once-daily oral Aricept with Corplex Donepezil.
Corplex Donepezil is a proprietary once-weekly transdermal patch
for delivery of the most commonly prescribed treatment for all
stages of Alzheimer's disease.
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 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. 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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