RARITAN, N.J., Oct. 24 Johnson & Johnson PharmaceuticalResearch & Development, L.L.C. (J&JPRD) announced today that it has submitteda New Drug Application to the U.S. Food and Drug Administration (FDA) forcarisbamate, a new investigational compound for the adjunctive treatment ofpartial onset seizures in patients 16 years of age and older.
The filing is supported by data from three placebo-controlled clinicaltrials in patients with epilepsy. Results from the first study were presentedat the Ninth EILAT Conference on Antiepileptic Drugs in June and results fromtwo additional studies will be presented at the annual meeting of the AmericanEpilepsy Society later this year.
In 1999, J&JPRD and SK Holdings Co., Ltd. (SK) entered into a licenseagreement to develop and commercialize carisbamate. J&JPRD received globalmarketing rights for the compound. If approved by the FDA, carisbamate willbe marketed by Ortho-McNeil Neurologics, a division of Ortho-McNeil-JanssenPharmaceuticals, Inc. Carisbamate has received provisional approval by theFDA 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 "primarygeneralized" or "partial onset" depending on the specific location of theabnormal electrical activity in the brain that typically characterizes thedisorder. Partial-onset seizures are the most common type, and are generallymore difficult to treat. Virtually any movement, sensory, or emotional symptomcan occur as part of a partial seizure, including complex visual or auditoryhallucinations. There are two categories of partial onset seizures: simplepartial seizures (in which consciousness is retained), and complex partialseizures (in which consciousness is impaired or lost). Partial seizures cangeneralize and lead to tonic clonic seizures, during which the patient losesconsciousness and is at risk for falling or injury.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)is a subsidiary of Johnson & Johnson, the world's most broadly-based producerof health care products. J&JPRD is headquartered in Raritan, N.J., and hasfacilities throughout Europe, the United States and Asia. J&JPRD isleveraging drug discovery and drug development in a variety of therapeuticareas, including CNS, Internal Medicine and Oncology, to address unmet medicalneeds worldwide. More information can be found athttp://www.jnjpharmarnd.com.
About Ortho-McNeil Neurologics
Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division ofOrtho-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 andacute and preventive migraine treatment. In conjunction with internal andexternal research partners, Ortho-McNeil Neurologics continues to explore newopportunities 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 thePrivate Securities Litigation Reform Act of 1995. These statements are basedon current expectations of future events. If underlying assumptions proveinaccurate or unknown risks or uncertainties materialize, actual results couldvary materially from the J&JPRD's expectations and projections. Risks anduncertainties include general industry conditions and competition; economicconditions, such as interest rate and currency exchange rate fluctuations;technological advances and patents attained by competitors; challengesinherent in new product development, including obtaining regulatory approvals;domestic and foreign health care reforms and governmental laws andregulations; and trends toward health care cost containment. A further listand description of these risks, uncertainties and other factors can be foundin Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscalyear ended December 30, 2007. Copies of this Form 10-K, as well as subsequentfilings, are available online at http://www.sec.gov, http://www.jnj.com or onrequest from Johnson & Johnson. J&JPRD does not undertake to update anyforward-looking statements as a result of new information or future events ordevelopments.Contacts: Media Investors Kara Russell: (609) 730-3592 Louise Mehrotra: (732) 524-6491 [email protected]
Johnson & Johnson Lesley Fishman: (732) 524-3922 Johnson & Johnson
SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.