Bigmar's Two Anti-Cancer Drug Dosage Presentations of Methotrexate Approved By FDA.Business Editors JOHNSTOWN, Ohio--(BUSINESS WIRE)--Nov. 27, 2001 Bigmar Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BGMR BGMR Bigmar Inc. (stock symbol) ) announced today that it has received 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. approval for the marketing of two additional dosages of Methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. , a generic anti-cancer drug. The presentations that have been approved are 500 mg and 1000 mg preservative-free solutions of this drug. "Methotrexate is a drug that can be used alone or in combination with other anticancer agents in the treatment of breast cancer, in acute lymphocyte lymphocyte: see blood; immunity. lymphocyte Type of leukocyte fundamental to the immune system, regulating and participating in acquired immunity. Each has receptor molecules on its surface that bind to a specific antigen. leukemia, cancers of the head and neck, 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. and other types of cancer," stated John Tramontana, President 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 Bigmar. "These two additional dosages are ones that best serve the needs of the hospital pharmacists," he noted, adding "we believe that with these approvals Bigmar now has the most comprehensive presentations available on this important highly-prescribed anti-cancer drug." These two additional FDA approvals now bring the total of ANDAs Bigmar holds in the United States to eight. The Company also holds four ANDAs from the Swiss FDA, four ANDAs from the Italian FDA and six ANDAs from the Brazilian FDA for its generic oncology products. The Company's strategy has been to broaden its product portfolio as it strives to become one of the preeminent manufacturers of generic cancer pharmaceutical products. Generic pharmaceuticals are an attractive market because the safety and efficacy of these products are well known, providing the company with rapid market entry and near term revenues. The worldwide pharmaceutical market for cancer and cancer-related drugs products is estimated at over $13 billion. About Bigmar Inc. Bigmar Inc, founded in 1995, consists of three wholly owned subsidiaries Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. : Bioren SA, Bigmar Pharmaceuticals SA and Bigmar Therapeutics. Through these subsidiaries the company manufactures generic pharmaceutical oncology products and intravenous infusion solutions, marketing these products in Europe, the United States and other countries primarily through pharmaceutical distributors. The company believes it is the only manufacturer of pre-mixed solutions such as nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate. packaged in infusion bags. The company commands approximately 60 percent of the market in Switzerland for its intravenous infusion solutions. Bigmar has manufacturing facilities in Switzerland and Johnstown, Ohio, and executive offices in Saginaw, Michigan. More information on Bigmar can be obtained at www.bgmr.com. Statements in this press release that are not strictly historical may be "forward looking" statements, which involve risks and uncertainties. No assurance can be given that the Company will successfully develop or commercialize its products, complete clinical trials, obtain regulatory approvals (or that any such approvals will be obtained on a timely basis) or be able to manufacture or successfully commercialize such products. Actual results may differ from those described in this press release due to risks and uncertainties that exist in the Company's operations including, without limitation, the ability to obtain additional financing to continue operations when needed, a history of operating losses and accumulated deficits, the Company's reliance on collaborative relationships, and approvals and market acceptance, as well as other risks detailed from time to time in the company's filings with the U.S. Securities & Exchange Commission such as the Company's Annual Report on Form 10-KSB and its most recent Registration Statement on Form S-3. Actual results may differ materially from those currently anticipated as a result of such risks, and results for interim periods are not necessarily indicative of results to be expected for the full year. The Company undertakes no obligation to release publicly the results of any revision to these forward-looking statements to reflect events or circumstances arising after the date hereof. These statements are made pursuant to the Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. Act of 1995. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion