References in periodicals archive ?
com), a chemistry-driven biopharmaceutical company, presented the latest data on the company's Cyclosporine program at the Third Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2003) in Paris, France, on Sunday, May 18, 2003.
Jens Eckstein, Enanta's Director, Lead Discovery, presented new research on a novel class of cyclosporine analogs that were discovered at Enanta with improved toxicity profiles, and have potential for the improved treatment of diseases such as transplantation, psoriasis, and asthma.
Important factors common to the regulatory review and approval process could cause actual results to differ materially with regard to the approvability and possible market acceptance of SangStat's finished CYCLOSPORINE drug product and THYMOGLOBULIN.
Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the current or future manufacturing of commercial quantities of CYCLOSPORINE and THYMOGLOBULIN on commercially favorable terms, adequate and continuous supply of bulk CYCLOSPORINE drug substance, market acceptance, profitability, competition and potential litigation.
Under the terms of the agreement, Amgen will have exclusive rights to market CYCLOSPORINE, under SangStat's branded trademark, in Australia, New Zealand, China and Taiwan.
We are delighted to establish our first CYCLOSPORINE licensing agreement with Amgen, the world's largest biotechnology company, and an experienced marketer of high tech biopharmaceuticals in the renal disease and cancer markets," said Philippe Pouletty, M.
Eli Lilly manufactured the exhibit batch used in SangStat's pivotal CYCLOSPORINE bioequivalence trials.
SangStat recently completed pivotal bioequivalence trials demonstrating that SangStat's CYCLOSPORINE formulation is bioequivalent to Neoral.
A Program to Develop a Cyclosporine Formulation that is Bioequivalent to Neoral; Timothy Schroeder, et al.
Both Sang-35, a Novel Cyclosporine Formulation, and Neoral Result in Low Pharmacokinetic Variability in Healthy Volunteers; Philippe Pouletty, et al.
Under current FDA regulations and policy, a cyclosporine formulation that is shown to be bioequivalent to Neoral may be approved without the need to duplicate safety and efficacy trials.
Neoral, an improved formulation of cyclosporine with increased bioavailability, was launched first in Europe in 1994 and then in the United States in September 1995.