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“These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients,” she says.
The FDA initially approved Risperdal fourteen years ago for the treatment of schizophrenia in the adult population.
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COPYRIGHT 2008 Gale, Cengage Learning

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The National Prescription Audit also showed that the prescription growth rate of Risperdal far exceeded that of its competitors. From July 1995 to July 1996, prescriptions for Risperdal increased by 80 percent, while prescriptions for all antipsychotics combined increased only six percent.
Since its introduction, Risperdal has become a standard of care in treating schizophrenia because of its combination of efficacy, safety and tolerability. It is the first serotonin dopamine antagonist (SDA) to receive marketing approval for first-line use in the treatment of schizophrenia.
“We’re proud that Risperdal has redefined the treatment of schizophrenia and other psychoses. In just two years, Risperdal has helped more than one million people regain control of their lives, and has continued to demonstrate a predictable safety and tolerability profile,” said Bruce Given, M.D., group vice president, Janssen Pharmaceutica. “Becoming the most prescribed antipsychotic is a vote of confidence from psychiatrists and patients who turn to Risperdal as a standard of care. Risperdal will continue to be a therapy of choice even when new agents become available.”
In June of this year, Janssen received clearance from the U.S. Food and Drug Administration to market an oral solution formulation of Risperdal. Due to its ease of administration, Risperdal Oral Solution will provide treatment benefits to a wider range of patients, particularly for the elderly, for whom liquid formulations are frequently prescribed, and for patients treated in an acute care setting.
Janssen is also conducting a clinical trial with Risperdal among elderly patients to support a safety claim in the product’s labeling, and is investigating the use of Risperdal in elderly patients suffering from psychotic symptoms. Because of safety concerns, not all antipsychotics are potential first-line therapies for the elderly. A number of factors need to be considered, including the metabolic profile of the drug, comorbidities, concomitant medications and the like.
“In addition to being well tolerated, Risperdal has not been associated with impaired cognitive function, such as cloudy thinking or impaired memory that can hamper a patient’s ability to reintegrate into society,” noted Dr. Given. “Reducing cognitive impairment is the next frontier of antipsychotic research, and Janssen is leading the way.”
Clinical studies have shown that the incidence of extrapyramidal symptoms (EPS) with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea and tachycardia. Risperdal may also cause orthostatic hypotension, a form of low blood pressure, especially during the initial dosing period.
Janssen continues to pursue advances for the treatment of illnesses associated with central nervous system (CNS) disorders. As part of Janssen’s commitment to CNS research, Janssen is currently investigating treatments in the area of Alzheimer’s disease, stroke, anxiety and depression. Janssen Pharmaceutica has companies in 32 countries. U.S. headquarters are in Titusville, N.J.
Please refer to complete prescribing information for Risperdal(R) (risperidone).
Editor’s Note: Interviews are available with physician experts and Janssen executives.
CONTACT: Ketchum Public Relations
Christopher Smith, 212/878-4655
or
Pallavi Damani, 212/878-4629
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[ILLUSTRATION OMITTED]
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“We are encouraged by the compelling preclinical profiles emerging
for this series of orally active, proprietary molecules, which
represent multiple opportunities to advance novel drug candidates into
our pipeline,” stated Daniel Deaver, Ph.D., vice president,
non-clinical development of Alkermes. “These findings support the
continued development of next-generation therapeutics to treat a broad
range of diseases, including central nervous system disorders and
brain reward disorders, such as addiction, obesity and other
impulse-control disorders.”

The study results presented today included efficacy data from an
ethanol drinking behavior model in rodents, a well-characterized model
for evaluating the effects of potential therapeutics targeting opioid
receptors. Results showed that single, oral doses of Alkermes’ novel
molecules significantly reduced the ethanol drinking behavior in
rodents, with an average reduction from baseline ranging from 35
percent to 50 percent for the proprietary molecules compared to 10
percent for the active control (P less than 0.05). Details from an
evaluation of the in vivo pharmacology, pharmacokinetics and in vitro
metabolism were also presented. Data showed that the molecules have
improved metabolic stability compared to the active control when
cultured with human hepatocytes (liver cells), suggesting that they
are not readily metabolized by the liver. Pharmacokinetic results
showed that the oral bioavailability of ALKS 33 was significantly
greater than that of the active control.

“Alkermes is focused on developing pipeline candidates with a high
likelihood of success compared to traditional new chemical entities.
These proprietary molecules reflect the broadening of our strategy to
utilize chemistry to improve known molecules to enhance outcomes,”
said Elliot Ehrich, M.D., chief medical officer of Alkermes.

Opioid modulators can act as agonists, antagonists or partial
agonists at opioid receptors in the brain. In addition to the
treatment of opioid and alcohol dependence, opioid dependence and
other addictions, opioid modulators are thought to have a number of
clinical applications, including the treatment of central nervous
system disorders and impulse-control disorders.

About Alkermes

Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients’ lives, manufactures
RISPERDAL(R) CONSTA(R) for schizophrenia and developed and
manufactures VIVITROL(R) for alcohol dependence. 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 and
manufacturing facilities in Massachusetts and Ohio. For more
information about Alkermes, visit http://www.alkermes.com.

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 potential
therapeutic value of Alkermes’ proprietary molecules targeting opioid
receptors and Alkermes’ plans to continue development of such
proprietary molecules. 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. 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 release.

VIVITROL(R) is a registered trademark of Cephalon, Inc.;
RISPERDAL(R) CONSTA(R) is a registered trademark of Janssen-Cilag
group of companies.

Alkermes is evaluating the impact of the termination of the AIR
Insulin program on its business and will provide further details
following a comprehensive business analysis.

About Alkermes

Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients’ lives, manufactures
RISPERDAL(R) CONSTA(R) for schizophrenia and developed and
manufactures VIVITROL(R) for alcohol dependence. 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 and
manufacturing facilities in Massachusetts and 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, statements regarding
the termination of the AIR Insulin clinical program. Although Alkermes
believes that such statements are based on reasonable assumptions
within the bounds of its knowledge, the forward-looking statements are
neither promises nor guarantees, and Alkermes’ business is subject to
significant risk and uncertainties. As such, there can be no assurance
that Alkermes’ actual results will not differ materially from its
expectations. These risks and uncertainties include, among others, the
impact of the termination of the AIR Insulin program on Alkermes’
business. 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 company disclaims any intention or
responsibility for updating forward-looking statements made in this
release.

AIR(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 Johnson & Johnson Corporation.

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Johnson & Johnson, through more than 250 operating companies, manufactures and sells a broad range of products in the healthcare field for the pharmaceutical, consumer, and medical devices and diagnostic markets to most countries of the world. The company is organised on the principles of decentralised management, which gives the company a focus and a sense of ownership in local markets.
J&J’s major pharmaceutical growth drivers are Risperdal/Risperdal Consta, Topamax, Concerta and Remicade. However, within our forecast period all of these products bar Remicade are predicted to experience significant sales declines related to patent expiries and generic competition. Other top selling products such as Duragesic, Procrit, Floxin, Levaquin and Aciphex are expected to report reduced sales by 2011.
These threats to sales and growth have placed considerable pressure on J&J’s pharmaceutical R&D efforts, although the company has had some recent developmental successes. In 2006, Prezista was launched, becoming J&J’s first in-house developed anti-HIV compound. The company is placing increasing importance on virology and Prezista will be J&J’s flagship product as it moves into this relatively new area of interest. In addition, 2006 saw the launch of Dacogen for the treatment of myelodysplastic syndromes. This product, alongside Velcade and Doxil, should help expand J&J’s profile in the increasingly lucrative field of oncology. The most recent success in R&D was the launch of Invega in January 2007, for the treatment of schizophrenia. J&J’s current top-selling product is the Risperdal/Risperdal Consta franchise, also used in the treatment of schizophrenia. Patent protection for Risperdal expires in June 2008, and consequently, the company will hope Invega can become a long-term replacement as Risperdal becomes increasingly less profitable.
Historically, the Consumer segment has been the smallest of J&J’s three core businesses. However, in December 2006, the company completed the acquisition of Pfizer’s Consumer Healthcare Business for US$17 billion. This purchase should see the Consumer segment compete more effectively with Medical Devices and Diagnostics and Pharmaceuticals. Within Pharmaceuticals, J&J can expect a difficult transition period as older, non-patented products, are replaced with new compounds. The bolstering of the Consumer segment should help overshadow these difficulties in the short-term, and J&J has both in its pipeline, and in its most recent product launches, the assets to achieve growth and strong sales in the medium- to long-term.
This new strategic analysis report Johnson & Johnson: Performance, Products, Pipeline and Potential, provides a complete and critical review of the company and includes unique and independent assessments and forecasts of key products. The report is updated on a quarterly basis. Buyers of the web edition receive quarterly reports for a year. Buyers of the print/pdf editions receive the latest version. All formats are the same price.
For more information, visit http://www.researchandmarkets.com/reports/c64668
Source: Espicom
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