FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive...

FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy
and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder

RISPERDAL(R) CONSTA(R) is theFirst and Only Long-Acting Antipsychotic Therapy
Available for Bipolar I Disorder

TITUSVILLE, N.J., May 18 /PRNewswire/ -- Janssen(R), Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the U.S. Food and
Drug Administration (FDA) has approved the Supplemental New Drug Applications
(sNDAs) for the use of RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting
Treatment as both monotherapy and adjunctive therapy to lithium or valproate
in the maintenance treatment of Bipolar I Disorder.

Bipolar Disorder is a brain disorder that causes unusual shifts in a person's
mood, energy and ability to function. It is often characterized by
debilitating mood swings from extreme highs (mania) to extreme lows
(depression). Type I Bipolar Disorder is characterized based on the occurrence
of at least one manic episode, with or without the occurrence of a major
depressive episode, and affects approximately 1 percent of the American adult
population in any given year.

"Long-acting therapies are moving to the forefront of treatment for mental
illness, and the approval of risperidone long-acting treatment for Bipolar
Disorder is exciting because it offers physicians assurance that the
medication is being taken as prescribed," said Caleb Adler, M.D., principal
investigator and associate professor of Clinical Psychiatry at the University
of Cincinnati. "Further the bi-weekly administration schedule encourages
regular contact between patients and their treatment team."

The approval is based on two prospective, randomized, double-blind,
placebo-controlled studies for the long-term treatment of Bipolar I Disorder.
The first demonstrated that RISPERDAL(R) CONSTA(R), when used as a
monotherapy, was significantly better than placebo at delaying the time to
relapse of any mood episode. The second study demonstrated that, for patients
already taking lithium or valproate, the addition of RISPERDAL(R) CONSTA(R)
significantly delayed the time to relapse compared to current treatments plus
placebo.

"We are very pleased with this FDA approval for RISPERDAL(R) CONSTA(R)," said
Husseini Manji, M.D., Global Therapeutic Area Head, Neuroscience, Johnson &
Johnson Pharmaceutical Research and Development. "We are committed to creating
new, long-acting therapies that offer safe and effective products for treating
patients with mental illnesses. This approval provides physicians and patients
with a new treatment option that offers a convenient and effective choice to
delay relapse."

RISPERDAL(R) CONSTA(R) was approved in 2003 as an atypical antipsychotic agent
indicated for the treatment of schizophrenia and is now the first and only
long-acting injectable antipsychotic therapy available for the treatment of
schizophrenia and Bipolar I Disorder.

Visit http://www.risperdalconsta.com for full prescribing information.

About RISPERDAL(R) CONSTA(R)
Risperidone long-acting treatment (RLAT) is a long-acting injectable form of
risperidone that was developed utilizing Alkermes' proprietary Medisorb(R)
drug-delivery technology. Using this technology, risperidone is encapsulated
in microspheres made of a biodegradable polymer, which are suspended in a
water-based solution and administered to patients by intramuscular injection
once every two weeks. RLAT is manufactured by Alkermes, Inc. and marketed by
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S.
and Janssen-Cilag outside of the U.S.

About J&JPRD
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a
member of the Johnson & Johnson family of companies, the world's most
broadly-based producer of health care products. J&JPRD is headquartered in
Raritan, N.J., and has facilities throughout Europe, the United States and
Asia. J&JPRD is leveraging drug discovery and drug development in a variety of
therapeutic areas, including CNS, Internal Medicine and Oncology, to address
unmet medical needs worldwide. More information can be found at
http://www.jnjpharmarnd.com.

About Janssen
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in
Titusville, N.J. and is the only large pharmaceutical company in the U.S.
dedicated solely to mental health. It currently markets prescription
medications for the treatment of schizophrenia, bipolar mania and the
treatment of symptoms associated with autistic disorder. Ortho-McNeil-Janssen
Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of
companies. For more information about Janssen(R), visit
http://www.janssen.com/.

IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)

Elderly Patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death compared to placebo. RISPERDAL(R)
CONSTA(R) (risperidone) is not approved for the treatment of patients with
dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side
effect reported with RISPERDAL(R) CONSTA(R) 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.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported
with RISPERDAL(R) CONSTA(R) 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.

High blood sugar and diabetes have been reported with RISPERDAL(R) CONSTA(R)
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(R) CONSTA(R). 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.

RISPERDAL(R) CONSTA(R) 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(R) CONSTA(R) 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.

RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability;
therefore, do not drive or operate machinery before talking to your healthcare
professional.

RISPERDAL(R) CONSTA(R) 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.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or
muscle disturbances, such as restlessness, tremors, and muscle stiffness. If
you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become
pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be
exercised when RISPERDAL(R) CONSTA(R) is administered to a nursing woman.

RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have
trouble cooling off, or be more likely to become dehydrated, so take care when
exercising or when doing things that make you warm.

Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your
healthcare professional of any medications or supplements that you are taking.
Avoid alcohol while on RISPERDAL(R) CONSTA(R).

RISPERDAL(R) CONSTA(R).
In a study of people taking RISPERDAL(R) CONSTA(R), the most common side
effects in the treatment of schizophrenia were headache, tremors, dizziness,
restlessness, tiredness, constipation, indigestion, sleepiness, weight gain,
pain in the limbs, and dry mouth.

If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk
with your doctor.

IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)

WARNING: Increased Mortality in Elderly Patients with Dementia-Related
Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of 17 placebo-controlled
trials (modal duration of 10 weeks), largely in patients taking atypical
antipsychotic drugs, revealed a risk of death in the drug-treated patients of
between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over
the course of a typical 10-week controlled trial, the rate of death in
drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the
placebo group. Although the causes of death were varied, most of the deaths
appeared to be either cardiovascular (e.g., heart failure, sudden death) or
infectious (e.g., pneumonia) in nature. Observational studies suggest that,
similar to atypical antipsychotic drugs, treatment with conventional
antipsychotic drugs may increase mortality. The extent to which the findings
of increased mortality in observational studies may be attributed to the
antipsychotic drug as opposed to some characteristic(s) of the patients is not
clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment
of patients with dementia-related psychosis.

Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been
reported in elderly patients with dementia-related psychosis taking oral
risperidone in clinical trials. The incidence of CAEs with risperidone was
significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved
for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom
complex, has been reported with the use of antipsychotic medications,
including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle
rigidity, fever, altered mental status and evidence of autonomic instability
(see full Prescribing Information). Management should include immediate
discontinuation of antipsychotic drugs and other drugs not essential to
concurrent therapy, intensive symptomatic treatment and medical monitoring,
and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible,
involuntary, dyskinetic movements that may develop in patients treated with
antipsychotic medications. The risk of developing TD and the likelihood that
dyskinetic movements will become irreversible are believed to increase with
duration of treatment and total cumulative dose. Elderly patients appeared to
be at increased risk for TD. Prescribing should be consistent with the need to
minimize the risk of TD. The syndrome may remit, partially or completely, if
antipsychotic treatment is withdrawn.

Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated
with ketoacidosis, hyperosmolar coma or death has been reported in patients
treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R).
Patients starting treatment with APS who have or are at risk for diabetes
should undergo fasting blood glucose testing at the beginning of and during
treatment. Patients who develop symptoms of hyperglycemia should also undergo
fasting blood glucose testing.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists
during chronic administration. Risperidone is associated with higher levels
of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic
hypotension associated with dizziness, tachycardia, and in some patients,
syncope, especially during the initial dose-titration period. Monitoring
should be considered in patients for whom this may be of concern.
RISPERDAL(R) CONSTA(R) should be used with caution in patients with known
cardiovascular disease, and conditions that would predispose patients to
hypotension.

Leukopenia, Neutropenia and Agranulocytosis have been reported with
antipsychotics, including risperidone. Patients with a pre-existing low white
blood cell count (WBC) or a history of leukopenia/neutropenia should have
frequent complete blood cell counts during the first few months of therapy.
At the first sign of a decline in WBC and in the absence of other causative
factors, discontinuation of Risperdal Consta should be considered.

Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the
potential to impair judgment, thinking, or motor skills. Patients should be
cautioned about operating hazardous machinery, including motor vehicles, until
they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them
adversely.

Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a
history of seizures or with conditions that potentially lower seizure
threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in
patients at risk for aspiration pneumonia.

Priapism has been reported. Severe priapism may require surgical intervention.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported.

Administration: Care should be taken to avoid inadvertent injection into a
blood vessel.

Suicide: The possibility of suicide attempt is inherent in psychotic
illnesses. Close supervision of high-risk patients should accompany drug
therapy.

Increased sensitivity in patients with Parkinson's disease or those with
dementia with Lewy bodies has been reported. Manifestations and features are
consistent with NMS.

Use Risperdal Consta with caution in patients with conditions and medical
conditions that could affect metabolism or hemodynamic responses. (e.g. Recent
Myocardial infarction or unstable cardiac disease)

Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse
events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and
placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%,
9%) and tremor (0%, 3%, 0%).

* Akathisia and restlessness
+ Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and
bradykinesia

Weight Gain: In a 12-week trial, the percentage of patients experiencing
weight gain (>7% of baseline body weight) was 6% placebo versus 9%
RISPERDAL(R) CONSTA(R).

Maintenance Treatment: Patients should be periodically reassessed to determine
the need for continued treatment.

Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most
common adverse reactions in clinical trials in patients with schizophrenia
(greater than or equal to 5%) were headache, Parkinsonism, dizziness,
akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain
in extremities, and dry mouth.

The most common adverse reactions in clinical trials in patients with bipolar
disorder trials were weight increased (5% in monotherapy trial) and tremor and
parkinsonism (greater than or equal to 10% in adjunctive therapy trial).

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are based
on current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from Janssen and/or Johnson & Johnson's expectations and
projections. Risks and uncertainties include general industry conditions and
competition; economic conditions, such as interest rate and currency exchange
rate fluctuations; technological advances and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and governmental laws and
regulations; and trends toward health care cost containment. A further list
and description of these risks, uncertainties and other factors can be found
in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent
filings, are available online at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertake to update
any forward-looking statements as a result of new information or future events
or developments.)

Contacts:

Media Investors
Srikant Ramaswami: Louise Mehrotra: (732) 524-6491
Office: (908) 927-7978 Johnson & Johnson
Cell: (609) 647-8195
Email: Sramaswa@its.jnj.com Lesley Fishman: (732) 524-3922
Johnson & Johnson

SOURCE Janssen Pharmaceuticals

Media, Srikant Ramaswami, +1-908-927-7978, cell, +1-609-647-8195,
Sramaswa@its.jnj.com, or investors, Louise Mehrotra, +1-732-524-6491, or
Lesley Fishman, +1-732-524-3922, all of Johnson & Johnson