Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for ADLARITY® (donepezil transdermal system) for the Tr...
January 27 2020 - 7:30AM
Corium, Inc., a commercial-stage biopharmaceutical company leading
the development of novel transdermal healthcare products that are
intended to provide alternative treatment options for patients and
their families, today announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing the company’s New Drug
Application (NDA) for ADLARITY (donepezil transdermal system), its
lead investigational agent for the treatment of dementia of the
Alzheimer’s type in patients with mild, moderate, and severe
Alzheimer’s disease. FDA has set a Prescription Drug User Fee
Act (PDUFA) target action date of July 30th, 2020.
“We are thrilled with FDA’s acceptance of Corium’s NDA filing
for ADLARITY,” said Perry J. Sternberg, President and CEO
of Corium. “If approved, this product could represent the
first once-weekly transdermal formulation of donepezil for the
treatment of Alzheimer’s disease.”
“Unfortunately, very few treatments are currently available for
Alzheimer’s disease. ADLARITY could provide a meaningful new option
for patients living with this devastating disease, as well as their
caregivers,” said Richard Isaacson, M.D., associate professor of
neurology and director of the Alzheimer’s Prevention Clinic at
Weill Cornell Medicine, who has also served on an advisory board at
Corium.
About ADLARITY
ADLARITY (donepezil transdermal system) is an investigational,
once-weekly transdermal formulation of Pfizer’s Aricept® (donepezil
HCL) that leverages Corium’s proprietary CorplexTM technology
platform. Corplex technology enables the development of new
transdermal therapeutics incorporating small molecule drugs
previously thought to have been incapable of delivery through the
skin. The active ingredient, donepezil, is the most widely
prescribed medication in a class of Alzheimer's drugs known as
cholinesterase inhibitors and is currently approved by FDA for the
treatment of mild, moderate and severe forms of the disease.
Donepezil is currently only available in tablet or orally
disintegrating tablet form, each administered once daily, and is
known to cause gastrointestinal side effects.
Corium is seeking approval of ADLARITY under the 505(b)(2)
regulatory pathway, referencing Aricept data, for both a 5mg/day
and 10mg/day transdermal patch that would be applied to the skin
once weekly. Corium believes that ADLARITY has the potential to
improve the quality of life of patients and their caregivers by
promoting adherence to prescribed therapy with a less frequent once
a week dosing regimen. In clinical trials, ADLARITY also
demonstrated the potential to reduce gastrointestinal side effects
compared to the daily dosing of oral donepezil.
About Alzheimer’s Disease
Alzheimer's disease is a progressive brain disorder in which
brain cells degenerate and die, causing a steady decline in memory
and mental function. According to the Alzheimer’s Association, an
estimated 5.8 million Americans were living with Alzheimer's
disease in 2019; 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.
About Corium
Corium, 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 developed and is the sole commercial
manufacturer of seven prescription drug and consumer products with
partners including 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 November 2018, all of Corium’s
outstanding stock was acquired by an affiliate of Gurnet Point
Capital. For further information, please visit
www.coriumintl.com.
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare fund founded by
Ernesto Bertarelli and led by Chris Viehbacher, who, together, have
decades of expertise in an industry for which they share a passion,
both as Chief Executives and as investors. With an initial
allocation of $2 billion, GPC is investing long-term capital and
supporting entrepreneurs in building a new generation of companies.
Based in Cambridge, MA, its remit is global, encompassing life
sciences and medical technologies. The fund invests across all
stages of product development through to commercialization and does
so with an approach that is a hybrid of venture and private equity
investing strategies. www.gurnetpointcapital.com
ADLARITY®, Corplex™ and MicroCor® are registered trademarks of
Corium, Inc.Aricept® is a registered trademark of Eisai Inc.
Contact: Corium, Inc.Christina
Dickersonchristina@coriumtech.com(650) 298-8257
Source: Corium
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