ZarnestraTreatment for Acute Myeloid Leukemia
Johnson & Johnson Completes Submission of Tipifarnib NDA to FDA
RARITAN, N.J., January 24, 2005 -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has completed the submission of a New Drug Application (NDA) for tipifarnib, an investigational cancer drug, to the U.S. Food and Drug Administration (FDA) Continuous Marketing Application (CMA) Pilot-1 Program. Tipifarnib, administered orally, is being investigated in patients 65 years of age and older with newly diagnosed acute myeloid leukemia (AML).
As a drug intended to treat a life-threatening disease for which there is an unmet medical need, tipifarnib (R115777) was granted "Fast Track" status by the FDA in June 2004. The Company has submitted the tipifarnib NDA based on Phase II clinical data, which use measurements of activity or responsiveness of a disease to the treatment rather than survival endpoints. In October 2004, J&JPRD initiated a Phase III study to fully demonstrate the clinical benefit of tipifarnib in this condition.
Under the CMA Pilot-1 Program, J&JPRD submitted reviewable units of the tipifarnib NDA as they were completed, receiving ongoing feedback from the FDA. The standard FDA review time for the CMA Pilot-1 Program is six months following submission of the final reviewable unit. Tipifarnib also was granted Orphan Drug status, a designation given to medications used to treat a rare disease or condition.
"The Fast Track status of tipifarnib reflects a significant unmet medical need, and this is particularly rewarding for our company because tipifarnib was discovered within the Johnson & Johnson research organization," said Garry Neil, M.D., president, Johnson & Johnson Pharmaceutical Research & Development.
In addition to funding global clinical studies for tipifarnib, J&JPRD collaborated with the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP), which sponsors clinical studies in many diseases, including those with unmet medical needs to accelerate access to new compounds. CTEP, under a Clinical Trials Agreement between J&JPRD and NCI, conducted the pivotal Phase II study that supports the tipifarnib NDA. In October 2004, J&JPRD initiated the Phase III international study. J&JPRD continues to investigate other potential uses of tipifarnib in solid and hematologic malignancies, including various stages of myeloid leukemia.
If approved, tipifarnib will be marketed in the United States by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. J&JPRD will seek approval from regulatory authorities around the world for tipifarnib.
About Acute Myeloid Leukemia
AML is a rapidly progressing form of leukemia, which, especially in elderly patients, often results in death within a few months of diagnosis. Nearly 12,000 new cases of AML were expected to be diagnosed in the United States in 2004, with more than two-thirds of the cases in patients over 65 years of age.
About Johnson & Johnson Pharmaceutical Research & Development and Tibotec Therapeutics
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Tibotec Therapeutics and Ortho Biotech are all part of the Johnson & Johnson Family of Companies, the world's most broad-based producer of healthcare products.
J&JPRD, with its headquarters in Raritan, N.J., has nine sites throughout Europe and the United States. J&JPRD employs approximately 3,500 professionals in drug discovery, drug evaluation and drug development in a variety of therapeutic areas. The company's major therapeutic areas of focus include hematology, oncology, infectious disease, obesity and metabolic disorders, neurology and psychiatry, pain and women's health.
Tibotec Therapeutics was established in March 2003 as a division of Ortho Biotech Products, L.P. Headquartered in Bridgewater, N.J., the organization is dedicated to delivering innovative oncology, virology and other specialty therapeutics that improve patients' survival and quality of life, and address serious unmet needs in the healthcare community.
For more information about the companies, visit the Tibotec Therapeutics Web site at http://www.tibotectherapeutics.com/ or the Johnson & Johnson Pharmaceutical Research & Development Web site at http://www.jnjpharmarnd.com/.
Posted: January 2005
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data - June 30, 2005