re: Tamoxifen
The following is from the 10-K.
" IMPROVED TAMOXIFEN SYNTHETIC PROCESS PROJECT -- One women's health project that is being overseen by Duramed Europe is an exclusive option, which Duramed purchased in December 1998, to an improved Tamoxifen synthetic process from Generic Biologicals Limited, ("GBL") a United Kingdom-based product development company. Under the terms of the option, milestone payments are being made by Duramed to GBL based on successful completion of the drug substance scale-up process. With this process, Duramed may pursue commercialization of the drug substance as well as a branded finished drug product. Duramed will have exclusive rights to this technology in the United States, Canada and Mexico. GBL will receive royalties on Duramed's North American sales.
Tamoxifen, which has been used for the past 25 years for the treatment of patients with advanced breast cancer, was recently approved by the FDA for prophylactic use for patients with a high genetic risk of developing breast cancer. This was the first instance when a medicine won formal FDA approval as a way of reducing the risk of breast cancer. GBL's novel patent-pending synthetic process yields a purer form of the Z-Tamoxifen drug substance. The currently
available preparations of Tamoxifen contain a low level of the E-isomer impurity of Tamoxifen, which may be associated with an increased risk of endometrial cancer. Tamoxifen is one of only a few approved drug substances in the U.S. Pharmacopeia ("USP") for which there is a limit on the amount of a single isomer (E-Tamoxifen) that can be present. GBL's purer form of Z-Tamoxifen, with greatly
reduced levels of the E-isomer, may have the potential for reducing the risk associated with endometrial cancer, particularly when the drug is prescribed for long-term prophylactic use. In addition to producing purer Z-Tamoxifen, GBL's patent-pending process is less complex, which should lower production costs...."
What do you know about this market and the process for getting this approved and marketed in the US? I will try to read up on this, I believe there are a number of medical sites which discuss this drug.
Thure |
