Acorda Therapeutics Announces Completion of Neuronex, Inc. Acquisition
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the
Company has completed the acquisition of Neuronex, Inc., a privately
held company developing a nasal spray formulation of diazepam. Under the
terms of the agreement, Acorda paid $6.8 million to Neuronex to complete
the acquisition.
“Diazepam Nasal Spray is an important addition to our pipeline and
aligns with our core strategy to develop and commercialize products that
offer unique benefits to people with neurological diseases,” said Ron
Cohen, M.D., Acorda’s President and CEO. “This product leverages our
existing sales, marketing and medical organizations, which have proved
highly successful in bringing novel neurological therapies to market.”
Diazepam Nasal Spray is a proprietary formulation of diazepam that
Acorda is developing as a treatment for the management of selected,
refractory patients with epilepsy, on stable regimens of antiepileptic
drugs (AEDs), who require intermittent use of diazepam to control bouts
of acute repetitive seizures (ARS). Currently, the only approved
outpatient treatment option for people who experience this type of
seizure activity is DIASTAT® AcuDialTM (diazepam
rectal gel), a rectally administered gel formulation of diazepam. The
nasally administered formulation potentially offers patients and
caregivers a more practical and socially acceptable treatment option.
“There are up to 175,000 people in the U.S. who suffer from acute
repetitive seizures despite being on stable regimens of antiepileptic
medications. These seizures can occur at any time and have a profound
impact on a person’s life,” said Enrique Carrazana, M.D., Acorda’s Chief
Medical Officer. “As an epileptologist, I am very excited that we are
developing a product which, if approved, will represent a major
contribution to patient care.”
In addition to the closing payment to Neuronex, Acorda will provide
additional payments of up to $18 million based on achievement of certain
regulatory and manufacturing-related milestones, and up to $105 million
based on specified sales milestones. Tiered upper single-digit to lower
double-digit royalty-like earnout payments on sales will be paid if the
product is approved. In addition, Acorda will assume responsibility for
regulatory and sales milestone payments of up to $11 million and
single-digit royalties to third parties, based on existing Neuronex
licensing agreements.
Acorda made an initial option payment of $2.0 million to Neuronex in the
first quarter of 2012, and provided $1.5 million in ensuing quarters to
support certain research and development activities conducted by
Neuronex prior to completing the acquisition.
Acorda plans to submit a 505(b)(2)-type New Drug Application (NDA) for
Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) in
2013. A 505(b)(2) application allows for an NDA that relies on medical
literature and FDA’s finding of safety and effectiveness for a
previously approved drug product.
About Epilepsy and Acute Repetitive Seizures (ARS)
Epilepsy is a neurological condition that produces seizures affecting a
variety of mental and physical functions. Seizures are symptoms of
abnormal brain activity, and occur when a brief, strong surge of
electrical activity affects part or all of the brain. The Centers for
Disease Control and Prevention (CDC) estimates that approximately 2.3
million Americans have active epilepsy.
Acute repetitive seizures (ARS) are characterized by recognizable,
recurring episodes of seizure clusters.
About Acorda
Therapeutics
Acorda Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people with MS,
spinal cord injury and other neurological conditions.
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the United
States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking
speed. AMPYRA is marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda. AMPYRA and FAMPYRA are manufactured under license
from Alkermes Pharma Ireland Limited.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES distributed by Watson
Pharmaceutics, Inc. under its agreement with Acorda.
Acorda has an industry-leading pipeline of novel neurological therapies.
The Company is developing Diazepam Nasal Spray for treatment of certain
epileptic seizures. It is also studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its use in other
neurological conditions, including cerebral palsy and post-stroke
deficits. In addition, Acorda is developing clinical stage compounds
AC105 for acute treatment of spinal cord injury and GGF2 for treatment
of heart failure. GGF2 is also being investigated in preclinical studies
as a treatment for neurological conditions such as stroke and spinal
cord injury. Additional development programs include rHIgM22, a
remyelinating monoclonal antibody for the treatment of MS, and
chondroitinase, an enzyme that encourages nerve plasticity in spinal
cord injury.
Forward-Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects should be
considered forward-looking. These statements are subject to risks and
uncertainties that could cause actual results to differ materially,
including our ability to successfully market and sell Ampyra in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of unfavorable
results from future studies of Ampyra or from our other research and
development programs, including Diazepam Nasal Spray (“DZNS”) or any
other acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully market
DZNS or other products under development; the occurrence of adverse
safety events with our products; delays in obtaining or failure to
obtain regulatory approval of or to successfully market Fampyra outside
of the U.S. and our dependence on our collaboration partner Biogen
Idec in connection therewith; competition, including the impact of
generic competition on Zanaflex Capsules revenues; failure to protect
our intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property licenses
needed for the commercialization of our products; failure to comply with
regulatory requirements could result in adverse action by regulatory
agencies; and the ability to obtain additional financing to support our
operations. These and other risks are described in greater detail
in Acorda Therapeutics' filings with the Securities and Exchange
Commission. Acorda Therapeutics may not actually achieve the goals or
plans described in its forward-looking statements, and investors should
not place undue reliance on these statements. Forward-looking statements
made in this press release are made only as of the date hereof, and
Acorda Therapeutics disclaims any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this press release.