Corium Reports Positive Progress in Pilot Bioequivalence Study of Once-Weekly Corplex™ Donepezil Patch
March 20 2017 - 8:30AM
Corium International, Inc. (Nasdaq:CORI), a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty transdermal products, today
reported on positive progress in the pilot bioequivalence (BE)
study of its Corplex Donepezil candidate, a once-weekly transdermal
patch for delivery of the most commonly prescribed treatment for
the symptoms of Alzheimer’s disease.
The pilot BE study is a three-period, randomized crossover study
comparing the steady-state pharmacokinetic (PK) profiles of
once-daily oral Aricept® (donepezil hydrochloride) with two Corplex
Donepezil transdermal patches that differ only in surface
area. Corium reported that the steady-state PK profiles of
the transdermal dosage forms measured in the second treatment
period, which includes partial crossover data, continue to exhibit
a close similarity with the oral PK results and were indicative of
bioequivalence. The Corplex transdermal systems continued to
be well tolerated, with favorable skin safety and gastrointestinal
side effect profiles.
The company reported that the pilot study is on track for
completion of the third and final treatment period in April and
expects to report on results from the entire study in
May.
The objective of the pilot study is to enable the company to
finalize key parameters, including patch surface area and number of
subjects, for a successful pivotal BE study. The primary
objective of the pivotal study will be the demonstration of
statistically similar PK profiles between the final transdermal
candidate and the oral dosage form. Corium is pursuing the BE
development and regulatory pathway based on written feedback
provided by the FDA in 2016.
“We are very encouraged with the positive progress in the
crossover clinical study of our lead Alzheimer’s program and the
continued low attrition rates,” said Peter D. Staple, President and
Chief Executive Officer of Corium. “With our extensive
experience in successfully conducting pilot and pivotal
bioequivalence studies, we are well-positioned for the upcoming
pivotal BE study. Preparations for the pivotal study,
expected to commence later in 2017, are well underway, and we look
forward to advancing this candidate towards an NDA filing in
2018. We believe Corplex Donepezil will provide an important
new treatment option to improve the lives of Alzheimer’s patients
and their caregivers.”
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. An estimated 5.5 million Americans
are living with Alzheimer's disease in 2017; by 2025, this number
is expected to exceed 7 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. Corplex advanced transdermal and
transmucosal systems are broadly adaptable for use in multiple drug
categories and indications, and have the potential to reduce
quantities of active ingredient utilized in transdermal products.
Additionally, Corplex transdermal patches can enable
efficient drug delivery, and adhere to either wet or dry surfaces
for an extended period of time. Corium's
Corplex technology has been successfully commercialized in
Procter & Gamble's Crest® Whitestrips products, and is
being utilized in several proprietary 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. 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.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 clinical
trial and regulatory timing and plans, the achievement of clinical
and commercial milestones, and the advancement of our technologies
and our 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, 2016, filed with
the Securities and Exchange Commission on February 14, 2017,
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 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.
Source: Corium
Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049
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