British Biotech in collaboration with ImmunoGen to develop and commercialize huN901-DM1 for the treatment of small cell lung cancer.Business & Health Editors OXFORD, England--(BUSINESS WIRE)--May 5, 2000 British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] and ImmunoGen Inc. ("ImmunoGen"), a NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on listed biopharmaceutical company, have today announced that they have entered into a collaborative agreement to develop and commercialize ImmunoGen's huN901-DM1, targeted at the treatment of small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. (SCLC SCLC abbr. Southern Christian Leadership Conference ). British Biotech has been granted the exclusive rights to apply for regulatory approval and commercialize huN901-DM1 in the EU and Japan. ImmunoGen will retain the rights to apply for regulatory approval and commercialize huN901-DM1 in the USA and the Rest of the World as well as the right to manufacture the product worldwide. Upon signature of the agreement, British Biotech paid US $1.5 million for its rights to huN901-DM1. Under the agreement, British Biotech and ImmunoGen will share responsibility for the development of huN901-DM1, which is currently in late preclinical development. ImmunoGen is responsible for completing the preclinical development and the manufacturing and supply of materials for clinical trials and commercial sales. British Biotech is responsible for conducting the clinical trials necessary to achieve regulatory approval in the USA, EU and Japan and will reimburse ImmunoGen for the cost of clinical trial supplies. In the event that ImmunoGen obtains regulatory approval for marketing the product in the USA, British Biotech will receive a one-off milestone payment. ImmunoGen will receive royalties on sales made in the EU and Japan. SCLC accounts for 25% of all lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. cases and is a significant unmet medical need. At present, there are few treatment options for patients who have relapsed or are refractory to chemotherapy. Median survival for such patients is less than a year. ImmunoGen is a leader in the development of anti-cancer agents with high potency and reduced toxicity, through the use of its proprietary Tumor-Activated Prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. (TAP) technology. TAPs are chemically-linked combinations of monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). and potent, cell-killing chemicals. By virtue of the attachment of the cell-killing chemical to the monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , the former is inactive until it reaches the tumor cell to which it is targeted by the monoclonal antibody. huN901-DM1 is a TAP consisting of a humanized monoclonal antibody (huN901) targeting SCLC cells, coupled with a highly potent cytotoxic cy·to·tox·ic adj. Of, relating to, or producing a toxic effect on cells. cy  to·tox·ic agent (DM1), a maytansine derivative. In preclinical studies preclinical studies,n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , huN901-DM1 eradicated SCLC tumors. In the same studies, cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. and etoposide, drugs used in current SCLC treatment, produced only temporary interruption of tumor growth. huN901-DM1 is in late preclinical development; formal toxicology studies are under way and it is anticipated that a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I will start in quarter four this year. Dr Elliot Goldstein, Chief Executive of British Biotech, commented, "This collaboration broadens our approach to the treatment of cancer beyond the area of metalloenzyme inhibition. Innovative deal terms, combined with our clinical development and regulatory capabilities have enabled us to obtain the commercialisation rights to a novel anti-cancer agent in Europe and Japan. We are delighted to be working with ImmunoGen to undertake the worldwide development of huN901-DM1." "This innovative collaboration allows us to benefit from British Biotech's clinical development capabilities while retaining rights in the US," said Mitchel Sayare, PhD, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of ImmunoGen. "We look forward to collaborating with British Biotech, one of only a few companies who have experience in conducting clinical trials in SCLC. We believe their unique experience in this disease, coupled with their enthusiasm for this product, will enable us to aggressively advance the development of huN901-DM1 to the market place." This news release contains forward-looking statements, which reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process. Notes to Editors British Biotech is a development-stage pharmaceutical company which is building a portfolio of products for the treatment of cancer, infection and inflammation. These opportunities will be generated from in-house research and development and by acquisition from, and collaboration with, outside parties. British Biotech currently has four products in development. Its lead product, marimastat, a matrix metalloproteinase inhibitor, is in Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA development for the treatment of cancer and has been licensed worldwide to Schering Plough Corporation except for Japan and the Far East where it has been licensed to Tanabe Seiyaku Co., Ltd. Further information on British Biotech is available at www.britishbiotech.com. ImmunoGen, a publicly traded biopharmaceutical company (NASDAQ: IMGN) founded in 1981, develops innovative biopharmaceuticals, primarily for cancer treatment. ImmunoGen is a leader in developing anti-cancer agents with high potency and reduced toxicity with its proprietary TAP technology. By combining extremely potent drugs with monoclonal antibodies that recognize and bind to tumor cells, ImmunoGen's products deliver chemotherapy directly to cancer cells. These products have the potential to revolutionize the treatment of cancer because they are designed to permit the use of highly toxic highly toxic Occupational medicine adjective Referring to a chemical that 1. Has a median lethal dose–LD50 of ≤ 50 mg/kg when administered orally to 200-300 g albino rats 2. chemicals to eradicate tumors without seriously impacting the health of the patient. This new generation of chemotherapeutics also has the potential to treat advanced or previously unresponsive forms of the disease. The most advanced TAP, huC242-DM1/SB-408075, designed to treat colorectal and pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. , has been licensed to SmithKline Beecham and is in a Phase I/II human clinical study. In addition to its maytansinoid platform of TAPs, the Company is working on other proprietary TAP platforms comprising agents, such as taxanes, which exert cell-killing activity via different mechanisms of action. Further information on ImmunoGen is available at www.ImmunoGen.com. |
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