Bioenvision Obtains U.K. Marketing Rights to Modrenal.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--Aug. 20, 2003 Bioenvision, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BIOV) today announced that it has obtained the rights to market Modrenal(TM) (trilostane), its approved compound for the treatment of advanced post-menopausal breast cancer, in the United Kingdom. Stegram Pharmaceuticals, Ltd. transferred the marketing rights to Bioenvision pursuant to an amendment to the July 1998 co-development agreement between the companies. In accordance with the amendment, Bioenvision will also receive all revenue streams for sales of Modrenal as of January 1, 2003. "We received a highly encouraging response after releasing our positive data in May regarding Modrenal's unique dual mode of action," said Hugh Griffith, Commercial Director of Bioenvision. "We aim to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. this momentum in order to significantly increase the current level of sales of Modrenal in the U.K." "This is another critical development in Bioenvision's internal growth," said David P. Luci, Director of Finance and General Counsel of Bioenvision. "With the introduction of revenues from sales of Modrenal in the U.K, we expect to significantly reduce our burn rate at a pivotal time in the development of our lead drugs, clofarabine and Modrenal." In support of the marketing effort, Bioenvision is initiating further clinical trials of Modrenal in Europe, with the intention of increasing physician and patient awareness of the product and the unique characteristics of the drug. A trial of the use of Modrenal in pre-menopausal patients with breast cancer is planned for later this year. Mr. Griffith added, "We plan to extend the marketing of Modrenal into other European countries via the mutual recognition pathway. This will bring Modrenal to a much wider audience of physicians and patients and greatly increase the marketing opportunity." Modrenal has shown clinical benefit rates between 35% and 55% in post-menopausal patients with advanced breast cancer who have relapsed following prior therapies. Bioenvision previously reported that Modrenal has two unique mechanisms of action, affecting both the ER alpha and ER beta estrogen receptors estrogen receptor A protein of a superfamily of nuclear receptors for small hydrophilic ligands–eg, steroid hormones, thyroid hormone, vitamin D, retinoids; the presence of ERs in breast CA generally is associated with a better prognosis, as they respond to . ER beta is known now to play an important role in the development of hormone sensitive cancers, such as breast and prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , and this receptor has therefore become a prime target for new forms of treatment. Bioenvision believes that Modrenal can alter the effect of estrogen at the binding site ER beta, thereby reversing or slowing the progression of breast cancer. Research published last year in the International Journal of Cancer support Modrenal's activity as an ER beta modulator Modulator Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier. (Puddefoot JR et al "Non-Competitive Steroid Inhibition of Estrogen Receptor Functions". Int J Cancer: 101, 17-22, 2002). Bioenvision also plans to run clinical trials in the U.S. to determine Modrenal's effect on prostate cancer in patients refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. to hormone-based therapy. About Modrenal Modrenal has been approved for the treatment of advanced post-menopausal breast cancer by United Kingdom regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities . It has been extensively studied in controlled trials controlled trial Clinical research A clinical study in which one group of participants receives an experimental drug while the other receives either a placebo or an approved–'gold standard' therapy. See Blinding, Double-blinded. in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Europe and Australia. Over 700 patients with breast cancer have received Modrenal in clinical trials, and its anti-tumor activity has been well documented; it is effective in a significant proportion of breast cancer patients, particularly those with hormone-sensitive tumours. About Bioenvision Bioenvision's (OTCBB: BIOV.OB) primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine, Modrenal(R), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON technology, an advanced biomaterial biomaterial /bio·ma·te·ri·al/ (bi?o-mah-ter´e-al) a synthetic dressing with selective barrier properties, used in the treatment of burns; it consists of a liquid solvent (polyethylene glycol-400) and a powdered polymer. that has been incorporated into various FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved medical devices. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements. |
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