CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 9, 2009--Alkermes, Inc. (NASDAQ: ALKS) today announced that its partner, Johnson
& Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has
initiated a phase 1 study of a four-week long-acting injectable
formulation of risperidone for the treatment of schizophrenia. The
single-dose, open-label study is designed to assess the
pharmacokinetics, safety and tolerability of a gluteal injection of this
risperidone formulation in approximately 26 patients diagnosed with
chronic, stable schizophrenia. A two-week long-acting injectable
formulation of risperidone, marketed as RISPERDAL(R) CONSTA(R)
((risperidone) Long-Acting Injection), is commercially available in more
than 60 countries.
"We are pleased to build upon our formulation expertise with RISPERDAL
CONSTA , an important therapy with demonstrated ability
to improve outcomes for many patients with schizophrenia," stated Dr.
Elliot Ehrich, chief medical officer of Alkermes. "Patients and
physicians need multiple, effective options to treat schizophrenia,
including different types of dosing regimens. A four-week long-acting
injectable formulation of risperidone would provide another valuable
approach for managing this serious, chronic disease."
RISPERDAL CONSTA is manufactured by Alkermes and marketed in the U.S. by
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Administered once every two weeks, RISPERDAL CONSTA is the first and
only long-acting atypical antipsychotic commercially available in the
U.S. The extended-release formulation is based on Alkermes' proprietary
Medisorb(R) technology, which enables the controlled,
extended-release of medication into the body over time and alleviates
the need for daily dosing.
Schizophrenia is a chronic, severe and disabling brain disorder. The
disease is marked by positive symptoms (hallucinations and delusions)
and negative symptoms (depression, blunted emotions, and social
withdrawal), as well as by disorganized thinking. An estimated 2.4
million Americans have schizophrenia, with men and women affected
equally. Worldwide, it is estimated that one person in every 100
develops schizophrenia, one of the most serious types of mental illness.
About RISPERDAL CONSTA
RISPERDAL CONSTA was approved for the treatment of schizophrenia in the
U.S. in 2003 and is commercially available in more than 60 countries.
The medication uses Alkermes' proprietary Medisorb technology to deliver
and maintain therapeutic medication levels in the body through just one
injection every two weeks. Available in 12.5 mg, 25 mg, 37.5 mg and 50
mg dose units, RISPERDAL CONSTA is approved for the treatment of
schizophrenia. RISPERDAL CONSTA is marketed by Janssen, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is
manufactured by Alkermes. For more information about RISPERDAL CONSTA,
IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA
Elderly Patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death compared
to placebo. RISPERDAL CONSTA (risperidone) is not approved for the
treatment of patients with dementia-related psychosis.
In a study of people taking RISPERDAL CONSTA, the most common side
effects in the treatment of schizophrenia were sleepiness, restlessness,
tremors and muscle stiffness, stomach upset, constipation, dry mouth,
feeling tired and weight increase.
High blood sugar and diabetes have been reported with RISPERDAL CONSTA
and similar medications. If the person being treated has diabetes or
risk factors such as being overweight or a family history of diabetes,
blood sugar testing should be performed at the beginning and throughout
treatment with RISPERDAL CONSTA. Complications of diabetes can be
serious and even life threatening. If signs of high blood sugar or
diabetes develop, such as being thirsty all the time, going to the
bathroom a lot, or feeling weak or hungry, contact your doctor.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect
reported with RISPERDAL CONSTA and similar medications. TD includes
uncontrollable movements of the face, tongue, and other parts of the
body. The risk of developing TD and the chance that it will become
permanent is thought to increase with the length of therapy and the
overall dose taken by the patient. This condition can develop after a
brief period of therapy at low doses, although this is much less common.
There is no known treatment for TD, but it may go away partially or
completely if therapy is stopped.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal
side effect reported with RISPERDAL CONSTA and similar medicines. Call
your doctor immediately if the person being treated develops symptoms
such as high fever; stiff muscles; shaking; confusion; sweating; changes
in pulse, heart rate, or blood pressure; or muscle pain and weakness.
Treatment should be stopped if the person being treated has NMS.
RISPERDAL CONSTA should be used cautiously in people with a seizure
disorder, who have had seizures in the past, or who have conditions that
increase their risk for seizures.
RISPERDAL CONSTA and similar medications can raise the blood levels of a
hormone known as prolactin, causing a condition known as
hyperprolactinemia. Blood levels of prolactin remain elevated with
continued use. Some side effects seen with these medications include the
absence of a menstrual period; breasts producing milk; the development
of breasts by males; and the inability to achieve an erection. The
connection between prolactin levels and side effects is unknown.
Some people taking RISPERDAL CONSTA may feel faint or lightheaded when
they stand up or sit up too quickly. By standing up or sitting up slowly
and following your healthcare professional's dosing instructions, this
side effect can be reduced or it may go away over time.
Inform your healthcare professional if you become pregnant or intend to
become pregnant during therapy with RISPERDAL CONSTA. Also, tell your
healthcare professional if you are planning to breast-feed.
RISPERDAL CONSTA may affect your alertness or driving ability;
therefore, do not drive or operate machinery before talking to your
Some medications interact with RISPERDAL CONSTA. Please inform your
healthcare professional of any medications or supplements that you are
taking. Avoid alcohol while on RISPERDAL CONSTA.
If you have any questions about RISPERDAL CONSTA or your therapy, talk
with your doctor.
Alkermes, Inc. is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients' lives. Alkermes
developed, manufactures and commercializes VIVITROL(R) for
alcohol dependence and manufactures RISPERDAL(R) CONSTA(R) for
schizophrenia. Alkermes' robust pipeline includes extended-release
injectable, pulmonary and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system disorders, addiction
and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has
research facilities in Massachusetts and a commercial manufacturing
facility in Ohio.
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the development
activities for a four-week long-acting injectable formulation of
risperidone and the therapeutic potential of this four-week formulation
in schizophrenia. Although the company believes that such statements are
based on reasonable assumptions within the bounds of its knowledge of
its business and operations, the forward-looking statements are neither
promises nor guarantees and the company's business is subject to
significant risk and uncertainties and there can be no assurance that
its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: whether the
clinical trial discussed in this release will be completed on time or at
all; potential changes in cost, scope and duration of the clinical
trial; and whether a four-week long-acting injectable formulation of
risperidone will be approved by regulatory authorities. For further
information with respect to factors that could cause the company's
actual results to differ materially from expectations, reference is made
to the reports the company filed with the Securities and Exchange
Commission under the Securities Exchange Act of 1934, as amended. The
forward-looking statements made in this release are made only as of the
date hereof and the company disclaims any intention or responsibility
for updating predictions or financial expectations contained in this
Medisorb(R) is a registered trademark of Alkermes, Inc.,
VIVITROL(R) is a registered trademark of Cephalon, Inc. and
RISPERDAL(R) CONSTA(R) is a registered trademark of
Janssen-Cilag group of companies.