Bigmar Receives Approval From Swiss Regulatory Authority to Market Pre-Mix Bupivacaine Infusion Solutions.

Business & Health/Medical Editors

JOHNSTOWN, Ohio--(BW HealthWire)--Aug. 7, 2001

Company Receives Marketing Authorization for

Two Dosage Strengths In Switzerland

Bigmar, Inc. (OTCBB:BGMR) announced today that it has received licenses from The IKS (the Swiss FDA) to market two dosage strengths of Bupivacaine HCL Infusion solution in Switzerland.

This approval follows a similar one received last year from the UK Medicines Control Agency. Bigmar also announced that the company expects to file similar applications in all of the remaining European countries and in Central and South America during the next several months.

Bioren, SA, a division of Bigmar based in Couvet, Switzerland, developed the novel formulation of Bupivacaine and will market the product in Europe. The approval covers two dosage strengths of 0.1% and 0.125%. Bioren currently markets a pre-mix I.V. formulation of nitroglycerin, believed to be the only infusion solution delivery of its kind.

Bupivacaine HCL is a long-acting local anesthetic prescribed for caudal, epidural or peripheral nerve block, such as those used in (let's list some well-known procedures like obstetric delivery, etc.) Although injectable Bupivacaine was approved by the U.S. FDA in 1972, Bioren's easy-to-use, pre-mix solution delivered in the I.V. infusion bag is the first such formulation of the drug.

The total market for Bupivacaine worldwide is approximately $80 million. The company expects that it should be able to capture a relevant market share once it has received all appropriate marketing authorizations.

"We are confident that with this approval, Bioren can accelerate the introduction of other interesting pre-mix products that we have in the pipeline," said John G. Tramontana, Bigmar's chairman and chief executive officer.

About Bigmar

Bigmar, Inc., founded in 1995, consists of three wholly owned subsidiaries: 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 packaged in infusion bags. Bigmar recently signed a distribution agreement with Baxter SA granting Baxter the exclusive rights to market the company's standard intravenous solutions products throughout Switzerland and Liechtenstein for a minimum period of five years. The company commands approximately 60 percent of the market in Switzerland for its intravenous infusion solutions. Bigmar has manufacturing facilities in Switzerland and in Johnstown, Ohio, and executive offices in Saginaw, Michigan. More information on Bigmar can be obtained at www.bgmr.com or at www.watchlistlive.com.

Statements in this press release that are not strictly historical may be "forward looking" statements, which involve risks and uncertainities. 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 uncertainties related to clinical trials, the ability to obtain the appropriate regulatory approvals and market accept5ance, as well as other risks detailed from time to time in public 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. 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 provisions of the Securities Litigation Act of 1995.