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Executive Summary

The National Cancer Institute is negotiating with potential corporate sponsors on at least three active cancer product projects: 9-amino-camptothecin, BUDR/IUDR and Suramin (with Warner-Lambert). Responses to a CRADA (cooperative research and development agreement) for CAI, a signal transduction inhibitor, are currently being evaluated by NCI. The cancer institute is also looking to negotiate CRADAs for the development of novel heparinbinding peptides and for a project on the biomedical use of stabilized nitric oxide complexes. With 25 active CRADAs, NCI has the largest number of such R&D collaborations in the Public Health Service, followed by the Centers for Disease Control and Prevention with 23, and the National Institute of Allergy and Infectious Diseases, which has 21. According to Michael Friedman, associate director of NCI's Cancer Therapy Evaluation Program, the number of CRADA collaborations involving clinical trials is rapidly accelerating. NCI's ability to close the current CRADA negotiations will be watched closely to determine the effect of the scrutiny that Bristol-Myers Squibb is receiving on the Taxol development program. The recent inclusion of "reasonable pricing" clauses in NIH/NCI CRADA contracts is reportedly making a number of firms skittish about the agreements. Bristol, with two CRADAs, is doing the spadework on the pricing clauses. The company came through a first experience with Videx (ddI) without much trouble; the publicity fallout from Taxol, however, may be more telling (see related story, below). Bristol-Myers Squibb Pharmaceutical Group Senior VP Bruce Ross noted in Dec. 2 comments to NIH that NIH officials previously have testified on Capitol Hill that commercial sponsors have backed out of CRADAs because of the pricing provisions. "Other companies can be expected to withdraw from the process as well, if the NIH adopts a policy that favors the use of pricing clauses to set prices, or to impose burdensome requirements on collaborators with respect to the submission of confidential financial information in support of the prices they have established," Ross said. At least one company, Merck, is understood to have informed NIH that it will not participate in CRADAs which include "reasonable pricing" clauses. An NIH researcher recently reported an anecdotal account of a modification in progress to a CRADA with Pfizer to delete a pricing clause as a precondition for getting the company's participation. Pharmaceutical Manufacturers Association President Gerald Mossinghoff told an NIH Director's advisory committee meeting on Dec. 2 that more layers of pricing review by NIH would cause the number of firms declining to participate to increase. Among other institutes, ongoing clinical trial CRADAs sponsored by NIAID include a collaboration with Chiron and SmithKline Beecham for evaluation of acellular pertussis vaccines; a collaboration with Wyeth-Ayerst to develop a live attenuated respiratory syncytial virus vaccine; and a CRADA with Warner- Lambert for evaluation of the quinolone sparfloxacin to treat AIDS patients with Mycobacterium aviumintracellular complex. The National Institute on Neurological Disorders and Stroke has industrial partners for cerebral imaging studies (Upjohn), anticholinesterase therapy for Alzheimer's-type dementia (Warner- Lambert); studies of felbamate, an anti-epileptic compound (Carter-Wallace) and cholinomimetic treatment of senile dementia (Hoechst-Roussel Pharmaceuticals).

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