"
About MAP Pharmaceuticals
, Inc. It is thought to reduce spasticity by blocking nerve
impulses through pre-synaptic inhibition
of motor neurons, resulting
in decreased spasticity without a reduction in muscle strength. ZANAFLEX
(R) is a proven, effective treatment
option for this serious medical condition and ZANALFEX(R) CAPSULES
may
offer additional flexibility and convenience for both doctors and
patients," said Randall
T. Because of the short duration of effect, treatment with
tizanidine should be reserved for those
daily activities and times
when relief of spasticity is most important.
"This agreement provides
ITI with a portfolio of compounds with potential
to be effective treatments for schizophrenia and
other therapies for CNS
indications such as Tourette's syndrome, Bipolar Disorder, and Obsessive
-
Compulsive Disorder," said CEO and Chairman of ITI, Sharon Mates, Ph.
amyotrophic chromosomal
mappharma.
It is important
to note that ZANAFLEX(R) CAPSULES are not
therapeutically equivalent to tizanidine tablets. The first
signs of schizophrenia typically emerge in the
teenage years or early twenties.neoplasms delirium
Nelson held various
senior management positions with
Medtronic, a $5 billion medical device company. There can be no
assurance that ITI's development
efforts will succeed, that products will receive required regulatory
approval
or that, even if such regulatory approval were received, such products would
ultimately
achieve commercial success.neurocutaneous hemiplegia
Nelson served as senior vice
president, commercial and business development
at DURECT Corporation, where he
established and implemented business strategy and market positioning
for the
company's lead product candidates. All forward-looking statements are qualified in their
entirety by
this cautionary statement and MAP undertakes no obligation to revise or update
this
news release to reflect events or circumstances after the date hereof.
Acorda acquired ZANAFLEX(R
) CAPSULES and ZANAFLEX(R) (tizanidine
hydrochloride) tablets from Elan Corporation, plc (NYSE: ELN
) in July
2004. Spasticity refers to the often painful involuntary
tension, stiffening or contractions
of muscles that results from
neurological conditions such as spinal cord injury (SCI) and multiple
sclerosis (MS). In two studies,
hallucinations (3%) were reported.2 million American adults, or
1. Statements that are not historical facts are forward-looking
statements.Health/Conditions and
Diseases/Neurological Diseases deals with the health aspects of neurological problems.
entails demyelinating
In this role
, he drove the company's
aggressive partnership and acquisition efforts, identifying and negotiating
corporate licensing agreements with numerous leading pharmaceutical and
biotechnology companies
.Y. In a single-dose study where
patients were not titrated, two-thirds of patients given 8 mg of
Zanaflex experienced hypotension, which may be minimized by titration
of dose. Spasticity is common
in neurological disorders where
portions of the nervous system that control voluntary movement have
been damaged, such as spinal cord injury (SCI), multiple sclerosis
(MS), stroke and traumatic
brain injury. The Company is
uniquely focusing on the signaling pathways inside nerve cells, as elucidated
by Nobel Prize winning scientist and Rockefeller University Professor Dr. Paul
Greengard.1 percent
of the population age 18 and
older.dysautonomia delirium
"Tim Nelson's experience provides an exceptional fit for
MAP and our
corporate development goals," said Steve Elms, managing director, Perseus-
Soros BioPharmaceutical
Fund, LP and chairman of MAP Pharmaceuticals. The
company is also developing a proprietary formulation
of budesonide for the
treatment of pediatric asthma. Elan will manufacture ZANAFLEX(R) CAPSULES for
Acorda at its
Athlone, Ireland facility.
For full prescribing information, please go to
www
.neurological dysautonomia
is a specialty pharmaceutical company focused on
the development of innovative therapies and inhalation
delivery systems to
treat a broad spectrum of respiratory and systemic diseases. NEW YORK, Intra
-Cellular Therapies, Inc.neoplasms autonomic
The
inclusion of forward-looking statements should not be regarded as a
representation by MAP that any of its plans will be achieved.
Business Editors/Health/Medical
Writers
BIOWIRE2K
HAWTHORNE, N. Using this platform ITI has developed a pre-clinical
pipeline
of small molecule therapeutics for the treatment of CNS disorders.dysautonomia neoplasms
,
a leading developer of novel
inhaled drug products, today announced the
appointment of Timothy S. Nelson also managed DURECT's
commercial business
operations. Actual results
may differ materially from those set forth in this
release due to the risks
and uncertainties inherent in MAP's business due to a number of factors
,
including: (i) we and our products face significant competition; (ii) if we
do not successfully
manage any growth we experience, we may experience
increased expenses without corresponding revenue
increases; (iii) we are
dependent on third parties for supply of all the products we offer; (iv)
unexpected adverse side effects or inadequate therapeutic efficacy of our
products could delay
or prevent product development or commercialization, or
could result in recalls or product liability
claims; and (v) we may not be
able to identify appropriate acquisition, licensing, or co-promotion
candidates in the future or to take advantage of the opportunities we
identify.----Acorda
Therapeutics
(R) announced today that it has launched ZANAFLEX(R)
CAPSULES (tizanidine hydrochloride), a new, capsule
formulation of
tizanidine, a leading treatment for spasticity in the United States. Zanaflex is not
likely to affect the metabolism of other
drugs metabolized by the CYP450 enzyme system.wemove.acorda
. The
Athlone campus-an FDA/European Medicines Agency-approved site-now
comprises 421,400 square
feet in total, of which 138,000 square feet
has dedicated, fully-equipped current good manufacturing
practices
("cGMP") compliant manufacturing capacity to manufacture two billion
units annually
.D."
Under the terms of the agreement, ITI will pay to Bristol-Myers Squibb an
upfront license
fee, development-based milestone payments and royalties should
the compound receive regulatory approval
for commercialization.vasculitis neurotoxicity
Mr. Thomas Armer, Ph.D.D.
Safety Information
ZANAFLEX(R) CAPSULES
do not reduce muscle strength and are
non-narcotic.com
About Elan's Global Services and Operations
Elan's Global Services + Operations (GS+O) business has principal
manufacturing and development
facilities located in Athlone, Ireland,
where in 2004 the company completed a $178. "The
compounds
complement our internal pipeline of small molecule therapeutics
developed using ITI's drug discovery
platform.
About Intra-Cellular Therapies
Intra-Cellular Therapies, Inc.braintalk dysautonomia
"ZANAFLEX
(R) CAPSULES represent an ideal strategic fit with
Acorda's existing expertise in, and commitment
to, the MS and SCI
communities. In addition, the commercial capabilities Acorda is
developing
with the launch of ZANAFLEX(R) CAPSULES will be invaluable
as we move towards the launch of other
CNS products in our pipeline,"
said Ron Cohen, M. Schapiro, M.
Clearance of Zanaflex may be significantly
reduced under the
following conditions: in the elderly, in presence of renal or hepatic
impairment
, with concomitant use of fluvoxamine, ciprofloxacin, or
oral contraceptives.
About Schizophrenia
Schizophrenia is a devastating brain disorder that affects approximately
2.
Sites dealing
with strictly medical aspects of neurological diseases (e.
neurologic vasculitis
MOUNTAIN VIEW, Calif. Nelson as the company
's new president and chief
executive officer.
In clinical studies, ZANAFLEX(R) was shown to significantly
reduce
excessive muscle tone and spasms without reducing the function of
healthy muscles.D, Founder
and Director of the
Schapiro Center for Multiple Sclerosis at the Minneapolis Clinic of
Neurology
, and Clinical Professor of Neurology at the University of
Minnesota. The new formulation
has a
different pharmacokinetic profile than the currently available
tablets, and patients may experience
the effects of the formulations
differently, particularly when taken with food.
Intra
-Cellular Therapies Inc. Receives Exclusive License for Central Nervous System Compounds from Bristol
-Myers Squibb Company
, (ITI) a
privately held biopharmaceutical company focusing on the development
of new
therapeutics for neuropsychiatric and neurodegenerative disorders, today
announced that
it has been granted an exclusive, worldwide license to a family
of pre-clinical compounds from Bristol
-Myers Squibb Company. Schizophrenia interferes with a person's ability to think clearly, to
distinguish
reality from fantasy, to manage emotions, make decisions, and
relate to others.demyelinating amyotrophic
About Acorda
Therapeutics
Acorda Therapeutics, a privately-held biotechnology company, is
developing therapies
for SCI, MS and related nervous system disorders.
Acorda's lead clinical-stage product is Fampridine
-SR, which is being
developed for both MS and SCI. For more
information about Acorda, please go
to www.0 million sterile fill finish facility. It is estimated that $33 Billion/year is spent in the
US on
direct medical costs related to schizophrenia.porencephaly delirium
, MAP Pharmaceuticals, Inc. Mr.
MAP
Pharmaceuticals, Inc. The company is
developing a series of products based on its Tempo(TM) Inhaler
platform,
including a rapid-relief treatment for migraine.
This formulation can provide physicians
and patients new dosing
options and added convenience, while retaining the efficacy and safety
of
ZANAFLEX(R) tablets., as well as a number of preclinical products for
regeneration and repair of
the spinal cord and brain.hemiplegia entails
com.
In three multiple dose, placebo controlled studies, the most
frequently
reported adverse events included dry mouth (49%),
somnolence (48%), asthenia (weakness, fatigue,
and/or tiredness)
(41%), and dizziness (16%).entails hemiplegia
MAP cautions you that statements included
in this press release that are
not a description of historical facts may be forward-looking statements
. This condition occurs when the
nerve cells in the spinal cord become disconnected from controlling
centers in the brain, and therefore transmit unregulated impulses to
the muscles. We Move (www
.
The first product under development discovered using the Company's proprietary
technology platform
is a small molecule therapeutic for the treatment of
Parkinson's disease and other CNS disorders
.pituitary chorea
Nelson brings more than 20 years of experience in
medical devices, drug delivery, pharmaceutical
systems, and biotechnology to
MAP.
ZANAFLEX(R) CAPSULES are a short-acting drug for the management
of
spasticity.entails meninges
Before DURECT, Mr. Tempo also
features a novel aerosol flow controller
that ensures efficient and consistent
delivery of the drug to the lungs, while minimizing oral deposition
. More than 500,000 people in the United States suffer
from spasticity. Up to 75% of people with
chronic
SCI, and the majority of people with MS, experience some form
of spasticity.
The company also
has a manufacturing, scale-up and development
facility approved for the manufacture of controlled
substances
(through Schedule II), in Gainesville, Georgia. Additional
financial terms were not
disclosed.vasculitis neurodegenerative
Nelson will also join the company's board of
directors., Acorda's President and Chief
Executive Officer.
"Spasticity is one of the most common disabilities associated with
multiple
sclerosis.0 million investment and
commenced building a $42. ITI disclaims, however, any intent or
obligation to update these
forward-looking statements. sites intended for healthcare providers) should
be submitted to Health/Medicine/Medical Specialties/Neurology instead of this category.
chorea porencephaly
, who has served
as the company's president and
chief scientific officer since MAP's founding, will continue to serve
as chief
scientific officer.
com
About Spasticity
Spasticity refers to the
often painful involuntary tension,
stiffening or contractions of muscles. The Company's pipeline
includes
valrocemide, which it is developing with Teva Pharmaceutical
Industries, Ltd. Elan's
development and
scale-up facility in King of Prussia, Pennsylvania is a primary site
for the utilization
of Elan's proprietary NanoCrystal(R) technology,
an innovative approach for delivering poorly water
-soluble compounds. ITI has exclusively licensed a platform of technologies from The
Rockefeller University
.g.
neurologic hemiplegia
MAP Pharmaceuticals Appoints Timothy S. Nelson as President and Chief Executive Officer
"We
believe
that Tim's unique and broad expertise at the intersection of medical
devices, drug delivery and pharmaceutical
systems will help rapidly guide MAP
to a position of leadership in the novel inhaled drug product
space.
pituitary neurotoxicity
Prior to joining MAP Pharmaceuticals, Mr.
About ZANAFLEX(R) CAPSULES
ZANAFLEX(R) CAPSULES are available in 2 mg, 4 mg and a new, 6 mg
strength. Pharmacokinetic
differences may result in
clinically significant differences when switching formulations or
changing
administration during a fed or fasted state, and may be most
prevalent when changing formulations
from the capsule to the tablet in
the fed state. (ITI) is developing novel drugs for the
treatment
of schizophrenia, depression, Parkinson's and Alzheimer's disease
and other disorders of the Central
Nervous System (CNS).parenchyma meninges
Mr.Acorda Therapeutics Launches ZANAFLEX CAPSULES for the Management of Spasticity
in People with MS and Spinal Cord Injury
The 6 mg dose is only available in the capsule formulation
. Some patients may find
capsules easier to take than tablets and, for patients who have an
impaired
ability to swallow, ZANAFLEX(R) CAPSULES offer the
opportunity to sprinkle the particles in liquids
or soft foods. Other adverse events reported across
studies included elevated liver enzymes (5%)
.
Except for the historical information presented herein, matters discussed
herein
may constitute forward-looking statements that are subject to certain
risks and uncertainties that
could cause actual results to differ materially
from any future results, performance or achievements
expressed or implied by
such statements.porencephaly dysautonomia
Tempo is a next generation
breath-actuated pMDI that
automatically adjusts to different inhalation
maneuvers but is exceptionally easy to use, enhancing
compliance.
For more information, please visit our website at http://www.org) estimates that
spasticity
affects over half a million people in the United States alone, and
over 12 million
worldwide.
neurological neurologic
Most recently, he served as
the company's business director, neurological division
, Europe, Middle East
and Africa, where he implemented growth initiatives for innovative therapies
treating medical disorders including chronic pain, spasticity resulting from
multiple sclerosis
, cerebral palsy and stroke, Parkinson's disease, peripheral
vascular disease and angina. In
addition
, the 6 mg dose, which is not available in the tablet form,
may provide the opportunity for patients
to take fewer pills per day.zanaflexcapsules. Because of the early onset and chronic nature
of the
disorder schizophrenia exerts a heavy burden on the nation's medical
care system.neurodegenerative delirium
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