Acorda Therapeutics Announces Acquisition of Two Neuropathic Pain Assets
*Qutenza^® (capsaicin) 8% Patch FDA-Approved Therapy for Neuropathic Pain
Associated with Postherpetic Neuralgia
*Phase 3-Stage Product NP-1998 Being Assessed in Painful Diabetic
*Approximately $8 Million Payment for Rights in United States and Selected
ARDSLEY, N.Y. -- July 9, 2013
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has acquired
two neuropathic pain management assets from NeurogesX, Inc. (OTCBB: NGSX).
Qutenza^® is approved by the U.S. Food and Drug Administration (FDA) for the
management of neuropathic pain associated with postherpetic neuralgia. The
Company also acquired NP-1998, a Phase 3 ready, prescription strength
capsaicin topical solution, being assessed for the treatment of neuropathic
pain. NP-1998 was previously referred to as NGX-1998.
“The acquisition of Qutenza and NP-1998 enables us to expand into the area of
neuropathic pain management. We plan to support Qutenza with our existing
medical and commercial infrastructure, which includes one of the industry’s
best neurology sales forces,” said Ron Cohen, M.D., Acorda’s President and
CEO. “In addition, we will leverage our neurology expertise to evaluate
NP-1998 for the treatment of neuropathic pain, with an initial emphasis on
painful diabetic neuropathy. This adds another potentially important, late
stage product to our pipeline.”
Acorda made an approximately $8 million payment to acquire development and
commercialization rights for Qutenza and NP-1998 in the United States, Canada,
Latin America and certain other territories, including $7 million paid to
NeurogesX and approximately $900,000 for certain assumed accounts payable.
Acorda will also make up to $5 million in payments contingent upon the
achievement of certain regulatory and sales milestones related to NP-1998.
Astellas Pharma Europe Ltd. has exclusive commercialization rights for Qutenza
in the European Economic Area (EEA) including the 27 countries of the European
Union, Iceland, Norway, and Liechtenstein as well as Switzerland, certain
countries in Eastern Europe, the Middle East and Africa. Astellas also has an
option to develop NP-1998 in those same territories.
Qutenza ^ is a dermal patch containing 8% prescription strength capsaicin that
is applied once every three months for the management of neuropathic pain
associated with postherpetic neuralgia, also known as post-shingles nerve
pain. The drug was approved by the U.S. Food and Drug Administration in 2010,
and had net sales of $2.6 million in 2011. NeurogesX discontinued active
promotion of the product in March 2012; net sales were approximately $2.4
million through the end of the third quarter of 2012. Acorda plans to support
Qutenza in the United States using the Company’s existing commercial
organization, including its specialty neurology sales force of approximately
100 sales professionals, as well as its medical and safety reporting
NP-1998 is a topical solution containing 20% prescription strength capsaicin
under clinical development as a treatment for pain associated with neuropathic
pain conditions such as painful diabetic neuropathy (PDN).
Astellas is currently conducting clinical trials of Qutenza including a Phase
3 trial to assess its use in the treatment of pain associated with PDN. Under
the terms of the agreement, Acorda will have rights to review data from that
trial, and the companies may also collaborate and/or share costs of future
Postherpetic Neuralgia (PHN) or Post-Shingles Nerve Pain
Postherpetic neuralgia (PHN), also known as post-shingles nerve pain, is
chronic pain resulting from shingles, a viral infection caused by the same
virus that causes chickenpox. There are approximately one million new cases of
shingles in the United States each year.
Shingles is characterized by an outbreak of rash or blisters on the skin and
nerve pain that typically resolves within several weeks. However, up to
one-third of people who have a shingles outbreak experience PHN, which can
continue for months or years after the shingles rash has healed.
About Painful Diabetic Neuropathy (PDN)
Diabetes is a group of diseases marked by high levels of blood glucose
resulting from defects in insulin production, insulin action or both.
According to the National Institute of Diabetes and Digestive Kidney Diseases
(NIDDK), more than 23 million people in the U.S. have diabetes.
Painful diabetic neuropathy is a common complication of diabetes characterized
by chronic pain that results from damage to nerves due to poor circulation and
high blood sugar. People with diabetes can develop nerve problems at any time,
but risk rises with age and longer duration of diabetes. Diabetic neuropathies
also appear to be more common in people who have problems controlling their
blood glucose, as well as those with high levels of blood fat and blood
pressure, and those who are overweight.
Qutenza Important Safety Information
Qutenza^® is indicated for the management of neuropathic pain associated with
postherpetic neuralgia. Treatment with Qutenza must be performed only by a
healthcare provider. You should never apply or remove Qutenza yourself.
Warnings and Precautions:
*Qutenza is not for use near eyes or mucous membranes. Do not sniff or
inhale near the Qutenza patch as this may cause you to cough or sneeze.
*Do not touch the Qutenza patch with your hands. If you touch the patch, it
may cause burning and stinging; if this occurs, tell your healthcare
*Even though a numbing medicine is used on the skin before applying
Qutenza, some patients may still experience substantial pain during the
treatment. Tell your healthcare provider if you are experiencing pain; a
cool compress or medicine for the pain can be provided to help lessen your
*Qutenza can cause serious side effects including pain and increases in
blood pressure during or right after treatment.
*Your healthcare provider should check your blood pressure during treatment
*Patients who have high blood pressure that is not well controlled by
medicine, or who have had recent heart problems, stroke, or other vascular
problems, may be at increased risk and should discuss with their doctor
whether Qutenza is right for them.
*In clinical studies, the most common drug-related side effects of Qutenza,
which occurred in 5% or more of patients, included redness, pain, small
bumps, and itching. These side effects occurred at the patch application
*You should tell your doctor if any side effects bother you or do not go
These are not all the side effects of Qutenza. For more information, ask your
healthcare provider or pharmacist or visit www.qutenza.com.
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
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 Actavis, Inc.
under its agreement with Acorda.
Acorda has one of the leading pipelines in the industry 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 potential for 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, GGF2 for treatment of heart failure and
rHIgM22, a remyelinating monoclonal antibody, for the treatment of MS. GGF2 is
also being investigated in preclinical studies as a treatment for neurological
conditions such as stroke and peripheral nerve damage. Chondroitinase, an
enzyme that encourages nerve plasticity in spinal cord injury, is in
Acorda 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 or any other acquired or in-licensed programs;
we may not be able to complete development of, obtain regulatory approval for,
or successfully market Diazepam Nasal Spray 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
partnerBiogen Idecin 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 inAcorda Therapeutics'filings
with the Securities & Exchange Commission.Acordamay 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 release are made only as of the date hereof, and
Acorda disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of this
Felicia Vonella, 914-326-5146
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