Corium Announces Streamlined Bioequivalence Development Path for Transdermal Corplex™ Memantine
August 24 2016 - 8:00AM
Corium International, Inc. (Nasdaq:CORI), a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty transdermal products, today
announced receiving favorable written feedback from the U.S. Food
and Drug Administration (FDA) on the company’s Pre-Investigational
New Drug Application (PIND) submission for once-weekly transdermal
Corplex Memantine.
Following review of Corium’s pre-IND submission, which included
summary results from a Phase 1 pharmacokinetic (PK) study of the
product candidate, the FDA concurred with the company’s development
plans, including its proposal for pivotal studies based on the
demonstration of bioequivalence, or BE, between the Corplex
Memantine Transdermal Delivery System (TDS) and oral Namenda
XR® (memantine HCl) extended release capsules.
“We are pleased with the FDA’s positive feedback on our
bioequivalence-based clinical development plan,” said Peter D.
Staple, President and Chief Executive Officer of Corium.
“This guidance parallels the feedback that we received from the FDA
for Corplex Donepezil, and was well-supported by our clinical study
data. The bioequivalence approach enables the development of
these important new treatments with reduced risk, time, and cost,
compared to typical transdermal development programs.”
“We look forward to advancing our once-weekly Alzheimer’s
products through clinical trials, and pursuing a streamlined
regulatory pathway. These new transdermal therapeutics are
designed to deliver drugs that collectively address an estimated
90% of the current market, and have the potential to improve the
lives of patients and their caregivers.”
Corium recently reported results of studies on its optimized
formulation of Corplex Memantine, which demonstrated delivery of
the required dose of memantine over seven days in a pig study while
also indicating acceptable skin tolerability. In preparation
for a pilot BE trial, the company next plans to conduct a human PK
study of this optimized formulation in healthy subjects to confirm
skin tolerability and sustained delivery over one week.
Bioequivalence clinical studies are designed to assess the
biological equivalence of pharmaceutical products based on the
similarity of their PK profiles to those of already-approved drugs,
and are generally performed in healthy subjects. These
studies are relatively short in duration of treatment, and provide
a development path that is substantially less costly and more
streamlined compared to standard clinical development
programs.
A Section 505(b)(2) NDA is a new drug application in which the
FDA and applicant may rely on certain investigations of safety and
effectiveness that were previously conducted by someone other than
the applicant, and is applicable to an active drug substance that
has previously been approved in a different dosage form.
About Alzheimer's Disease and Memantine
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 5.1 million Americans
suffered from Alzheimer's disease in 2015; by 2025, this number is
estimated to reach 7.1 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.
Memantine (the active ingredient in Namenda®) is one of the most
widely prescribed medications for the treatment of moderate to
severe dementia of the Alzheimer’s type. Memantine is the
only FDA-approved N-methyl-D-aspartate (NMDA)-receptor antagonist
for use in Alzheimer’s and works by regulating the activity of
glutamate, a neurotransmitter in the brain involved in learning and
memory. Memantine is currently only available in once- and
twice-daily oral dosage forms, presenting compliance challenges for
family members and caregivers who cannot rely on patients to
consistently take their daily tablets.
Memantine and donepezil (the active ingredient in Aricept®)
together represent approximately 90% of the units sold for the
treatment of Alzheimer’s disease in the United States.
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 Endo
Pharmaceuticals 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 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 June 30, 2016, filed with the Securities
and Exchange Commission on August 12, 2016, 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 registered trademarks of Corium
International, Inc.Namenda® and Namenda XR® are registered
trademarks of Merz Pharma GmbH & Co. KGaA.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:
BCC Partners
Karen L. Bergman
kbergman@bccpartners.com
(650) 575-1509
Susan Pietropaolo
spietropaolo@bccpartners.com
(845) 638-6290
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