Navigation Links
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate
Date:10/24/2008

Seeks Approval for Use in Epilepsy as Adjunctive Treatment in Partial Onset

Seizures

RARITAN, N.J., Oct. 24 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for carisbamate, a new investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.

The filing is supported by data from three placebo-controlled clinical trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.

In 1999, J&JPRD and SK Holdings Co., Ltd. (SK) entered into a license agreement to develop and commercialize carisbamate. J&JPRD received global marketing rights for the compound. If approved by the FDA, carisbamate will be marketed by Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of COMFYDE(TM).

About Partial Onset Seizures and Epilepsy

Epilepsy is one of the most common disorders of the nervous system, defined by recurrent unprovoked seizures. It is categorized as "primary generalized" or "partial onset" depending on the specific location of the abnormal electrical activity in the brain that typically characterizes the disorder. Partial-onset seizures are the most common type, and are generally more difficult to treat. Virtually any movement, sensory, or emotional symptom can occur as part of a partial seizure, including complex visual or auditory hallucinations. There are two categories of partial onset seizures: simple partial seizures (in which consciousness is retained), and complex partial seizures (in which consciousness is impaired or lost). Partial seizures can generalize and lead to tonic clonic seizures, during which the patient loses consciousness and is at risk for falling or injury.

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, 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 Ortho-McNeil Neurologics

Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy and acute and preventive migraine treatment. In conjunction with internal and external research partners, Ortho-McNeil Neurologics continues to explore new opportunities to develop solutions for unmet health care needs in neurology.

Note Regarding Forward-Looking Statements

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 the J&JPRD'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 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. J&JPRD does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Contacts:

Media Investors

Kara Russell: (609) 730-3592 Louise Mehrotra: (732) 524-6491

Krussel3@prdus.jnj.com Johnson & Johnson

Lesley Fishman: (732) 524-3922

Johnson & Johnson


'/>"/>
SOURCE Johnson & Johnson Pharmaceutical Research & Development,L.L.C.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Legendary Earvin Magic Johnson Joins AFL/Signalife Cardiovascular Protection Team
2. Angiotech reaches agreement with Johnson & Johnson to settle outstanding patent litigation
3. Morria Biopharmaceuticals Plc Appoints Dr. Johnson Lau and Dr. David Sidransky to Board of Directors
4. Entry of Biogenerics and Decreasing Use of Amgens Epogen and Johnson & Johnsons Procrit Will Cause a $2.8 Billion Decline in the Drug Market for Chemotherapy-Induced Anemia by 2016
5. Johnson & Johnson Announces Changes to Accelerate Growth
6. Drugs from Johnson & Johnson/Basilea and Forest Are the Most Promising Antibiotics in the Community-Acquired Pneumonia Pipeline
7. Two-time Defending NASCAR Sprint Cup Series Champion Jimmie Johnson Joins the Team at CORD:USE Cord Blood Bank to Help Win the Race for Life
8. MultiVu Video Feed: Johnson & Johnson Diabetes Institute, LLC Launches New Training Center to Improve Community-Based Diabetes Care
9. Ortho Biotech Oncology Research & Development Unites Johnson & Johnson Biopharmaceutical Oncology R&D Assets
10. Craig Johnson Joins Ardea Biosciences Board of Directors
11. Migenix averts proxy contest; reaches agreement with DJohnson holdings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... , Febr. 10, 2016 /PRNewswire/ - BioAmber Inc. (NYSE: ... pleased to announce that Mitsui & Co. Ltd., its ... succinic acid plant, is investing an additional CDN$25 million ... increasing its stake from 30% to 40%.  Mitsui will ... bio-succinic acid produced in Sarnia , ...
(Date:2/10/2016)... , Feb. 10, 2016 NX Prenatal ... its proprietary NeXosome® technology for early warning of ... its most recent study by Dr. Thomas ... the Society for Maternal Fetal Medicine,s (SMFM) annual meeting ... 1-6 th , 2016.  The presentation reported initial ...
(Date:2/10/2016)... (NYSE MKT: ISR), a medical technology company and innovator ... treatment of prostate, brain, lung, head and neck and ... second quarter and six months of fiscal 2016, which ... --> Revenue was $1.19 million for ... 31, 2015, a 12% increase compared to $1.07 million ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... announced today the promotion of two long-standing principal investigators (PI) to the roles ... Clinical Research and Development. , Dr. Laurence Chu, a Benchmark Research PI in ...
Breaking Biology Technology:
(Date:2/9/2016)... Feb. 9, 2016 Aware, Inc. (NASDAQ: AWRE ), ... results for its fourth quarter and year ended December 31, 2015.  ... the fourth quarter of 2015 was $6.9 million, an increase of ... Operating income in the fourth quarter of 2015 was $2.6 million ... --> --> Higher revenue and ...
(Date:2/8/2016)... 2016 Worldcore is ... innovation for clients, comfort and unbeatable security, with ... --> Worldcore is the first EU-regulated ... comfort and unbeatable security, with a Voice Biometrics ... Worldcore is the first EU-regulated global payment ...
(Date:2/4/2016)... 4, 2016 The field of Human ... the most popular hubs of the biotechnology industry. ... huge studies of human microbiota, have garnered a ... the microbiome space has literally exploded in terms ... This report focuses on biomedical aspects of research, ...
Breaking Biology News(10 mins):