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Taxol commercial supply strategy
1Bristol-Myers Squibb Company, Princeton, NJ 08543-4000.
Abstract:
Evidence of Taxol's safety and efficacy for treatment of refractory ovarian cancer convinced the National Cancer Institute (NCI) to seek a pharmaceutical partner and approval. After an open competition, NCI entered a Cooperative Research and Development Agreement with Bristol-Myers Squibb Company (BMS) to obtain approval of a New Drug Application (NDA) so that Taxol could be marketed as well as to provide supplies for clinical trials and compassionate use. To assure a successful commercialization of Taxol, BMS developed a strategic plan for expanding drug supplies. The strategy included immediately increasing the amount of Taxol derived from yew bark and establishing a broad research program to evaluate alternative sourcing options and their commercial feasibility. The options included precursor isolation and semisynthesis, yew plantations for biomass production, plant cell culture, and total synthesis. A number of both academic and industrial investigators, already interested in various Taxol supply issues, were enlisted for collaborations with the company. Progress on this research during the first 18 months has enabled BMS to do the following: 1) double the yield of Taxol from bark extraction; 2) exceed NCI's request for drug supplies in 1991, permitting establishment of an ovarian cancer treatment referral center (TRC) with a national network of comprehensive cancer centers; 3) increase NCI supplies from 5000 to 50,000 vials/month in 1992, permitting establishment of TRC protocol for breast cancer; 4) identify several potentially viable alternative sources; 5) schedule production of large amounts of Taxol by precursor conversion during 1993; and 6) ensure that sufficient quantities of the product will be available for treatment and continued clinical research.(ABSTRACT TRUNCATED AT 250 WORDS)
Insights
Bristol-Myers Squibb partnered with the National Cancer Institute to commercialize Taxol, developing strategies to increase drug supply through bark extraction and alternative sourcing for cancer treatment.
Area of Science:
- Oncology
- Pharmacology
- Natural Product Chemistry
Background:
- Taxol demonstrated safety and efficacy for refractory ovarian cancer, prompting the National Cancer Institute (NCI) to seek commercialization.
- A Cooperative Research and Development Agreement was established between NCI and Bristol-Myers Squibb (BMS) for Taxol's New Drug Application (NDA) and supply.
- BMS developed a strategic plan to ensure a robust supply chain for Taxol, crucial for clinical trials and patient access.
Purpose of the Study:
- To outline BMS's strategic plan for expanding Taxol drug supplies.
- To detail the evaluation of alternative sourcing options for Taxol's commercial feasibility.
- To report on the progress made in securing sufficient Taxol quantities for treatment and research.
Main Methods:
- Increased Taxol yield from yew bark extraction.
- Initiated research into alternative sourcing: precursor isolation, semisynthesis, yew plantations, plant cell culture, and total synthesis.
- Collaborated with academic and industrial investigators to address Taxol supply challenges.
Main Results:
- Doubled Taxol yield from bark extraction within 18 months.
- Exceeded NCI's supply requests, enabling the establishment of a cancer treatment referral center (TRC).
- Increased NCI supplies significantly, facilitating TRC protocols for breast cancer and identifying viable alternative sources.
- Scheduled large-scale Taxol production via precursor conversion and ensured future availability for treatment and research.
Conclusions:
- BMS successfully implemented a multi-faceted strategy to secure and expand Taxol supply.
- Alternative sourcing research identified commercially feasible options, diversifying production methods.
- The strategic plan ensured adequate Taxol availability for ongoing clinical research and patient treatment needs.