Bigmar Receives Approval From Brazilian Authorities to Market Fluorouracil; Product is Bigmar's First Oncological Entry in Brazil.Health/Medical Writers JOHNSTOWN, Ohio--(BW HealthWire)--May 26, 2000 Bigmar Inc. (Nasdaq:BGMR BGMR Bigmar Inc. (stock symbol) ) announced today that it has received approval from Brazil's Agencia Nacional de Vigilancia Sanitaria (ANVS ANVS Agência Nacional de Vigilância Sanitária (National Sanitary Surveillance Agency; Brazil) ANVS Algemene Nederlandse Vereniging van Schuldbemiddelaars (Dutch: Professional diligence in indebtments) ) to market 5-fluorouracil in Brazil, effective immediately. A potent anticancer anticancer, n a medicine or substance used to treat cancer. agent, 5-fluorouracil is used in combination with other drugs to treat ovarian ovarian /ovar·i·an/ (o-var´e-an) pertaining to an ovary or ovaries. ovarian pertaining to an ovary. ovarian agenesis and breast cancer. The ANVS action marks the first oncological product approval received by Bigmar in Brazil. "We intend to market 5-fluorouracil under the Bigmar label," said John G. Tramontana, chairman and chief executive officer. "We anticipate receiving ANVS approvals for additional oncology products during 2000. "The anticancer market in Brazil is growing at a substantial rate," Tramontana added. "We hope to capture a material share of the generic business in the near term." Bigmar is a manufacturer of generic pharmaceutical oncology products and intravenous infusion solutions, which it manufactures at its state-of-the-art facilities in Switzerland. The company markets its products through partnerships of pharmaceutical distributors in Europe and 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. and focuses on off-patent oncological pharmaceuticals. For more information, visit the company's Web site, www.bgmr.com. Statements in this news 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 operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and accumulated deficits, the company's reliance on collaborative relationships, and uncertainties related to clinical trials, the ability to obtain the appropriate regulatory approvals and market acceptance, as well as other risks detailed from time to time in publicly available filings with the Securities and Exchange Commission such as the company's Annual Report on Form 10-KSB and its most recent Registration Statement on Form S-3 filed on Dec. 8, 1999. 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 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. 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. Reform Act of 1995. |
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