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Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) Receives Not Approvable Letter From FDA For Tipifarnib Based On Phase II Data


10/19/2005 5:09:24 PM

RARITAN, N.J., June 30, 2005 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) for the tipifarnib new drug application (NDA), which was based on data from a single Phase II study. Tipifarnib is an oral medication studied to treat acute myeloid leukemia (AML) in elderly patients who are not candidates for standard chemotherapy. The not approvable letter explains why the NDA cannot be approved based on currently submitted data.

The company remains committed to the development of tipifarnib. Recognizing the unmet medical need in this area, the company is reviewing the FDA's letter and will determine appropriate next steps.

J&JPRD completed the submission of the tipifarnib NDA to the FDA under the Continuous Marketing Application Pilot-1 Program in December 2004, and the application was discussed at a May 5, 2005 Oncology Drugs Advisory Committee meeting. As a drug intended to treat a life-threatening disease for which there is an unmet medical need, tipifarnib was granted "Fast Track" status by the FDA in June 2004. Tipifarnib also was granted Orphan Drug status, a designation given to medications used to treat a rare disease or condition.

AML is a rare but often fatal cancer that will impact nearly 12,000 Americans in 2005.

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of the Johnson & Johnson Family of Companies, the world's most broadly-based producer of healthcare products. J&JPRD, with its headquarters in Raritan, N.J., has eleven sites throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. Combining innovation and experience, the company's major therapeutic areas of focus include hematology, oncology, infectious disease, neurology and psychiatry, pain and women's health.

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 Company'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(b) of the Company's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at http://www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

CONTACT: Media Contact - Doug Stokke, Office: +1-908-927-3783, Mobile:+1-908-208-6353, or Analyst Contacts - Helen Short, +1-732-524-6491, orStan Panasewicz, +1-732-524-2524, all for Johnson & Johnson PharmaceuticalResearch & Development, L.L.C.



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