TITUSVILLE, N.J., July 24 Ortho-McNeil Neurologics, adivision of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today thatthe U.S. Food and Drug Administration (FDA) has granted pediatric exclusivityfor TOPAMAX(R) (topiramate), based on studies submitted in response to aWritten Request by the FDA to investigate the use of TOPAMAX in pediatricpatients aged 1 to 24 months with partial onset seizures.
In addition to granting pediatric exclusivity, the FDA is continuing itsreview of the application to determine the safety and efficacy of TOPAMAX inthis patient population. Based on the data submitted, no indication is soughtfor this age group.
A recent court decision confirmed the validity of the TOPAMAX patent,which is set to expire in September 2008. However, this grant will extend theperiod of exclusivity through March 2009. TOPAMAX is not approved for use inpediatric patients aged 1 to 24 months.
TOPAMAX(R) is indicated as initial monotherapy in patients 10 years of ageand older with partial onset seizures or generalized tonic-clonic seizures.It also is indicated as adjunctive therapy for adults and children (aged twoand above) with partial onset seizures or generalized tonic-clonic seizures,and in adults and children as adjunctive therapy for the treatment of seizuresassociated with Lennox-Gastaut syndrome. TOPAMAX(R) is indicated in adultsfor the prophylaxis of migraine headache.
Important Safety Information: Serious risks associated with TOPAMAXinclude lowered bicarbonate levels in the blood resulting in an increase inthe acidity of the blood (metabolic acidosis). Symptoms could includehyperventilation (rapid, deep breathing), tiredness, loss of appetite,irregular heartbeat or changes in the level of alertness. Call your doctorimmediately if you get these symptoms. Your doctor may want to do simpleblood tests. Chronic, untreated metabolic acidosis may increase the risk forkidney stones or bone disease.
Other serious risks include decreased sweating, increased bodytemperature, kidney stones, sleepiness, dizziness, confusion, difficultyconcentrating, and increased eye pressure (glaucoma). Call your doctorimmediately if you have any decrease in vision or eye pain. These problemscan lead to blindness if not treated right away.
More common side effects are tingling in arms and legs, loss of appetite,tiredness, nausea, diarrhea, taste change and weight loss.
Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division ofOrtho-McNeil-Janssen Pharmaceuticals, Inc., focuses exclusively on providingsolutions that improve neurological health. The company currently marketsproducts for Alzheimer's disease, epilepsy and acute and preventive migrainetreatment. In conjunction with internal and external research partners,Ortho-McNeil Neurologics continues to explore new opportunities to developsolutions for unmet health care needs in neurology.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)is a wholly-owned subsidiary of Johnson & Johnson, the world's mostbroadly-based producer of health care products. J&JPRD is headquartered inRaritan, N.J., and has facilities throughout Europe, the United States andAsia. J&JPRD is leveraging drug discovery and drug development in a varietyof therapeutic areas, including CNS, Internal Medicine and Oncology, toaddress unmet medical needs worldwide. More information can be found athttp://www.jnjpharmarnd.com.
(This press release contains "forward-looking statements" as defined inthe Private Securities Litigation Reform Act of 1995. These statements arebased on current expectations of future events. If underlying assumptionsprove inaccurate or unknown risks or uncertainties materialize, actual resultscould vary materially from the Company's expectations and projections. Risksand uncertainties include general industry