Bigmar Receives FDA Approval for Daunorubicin Hydrochloride for Injection, USP; Seventh ANDA Approval in 1999.

JOHNSTOWN, Ohio--(BUSINESS WIRE)--June 1, 1999--

BIGMAR, INC. (Nasdaq SmallCap Market: BGMR) today announced that it has received Abbreviated New Drug Application ("ANDA") approval from the Food and Drug Administration ("FDA") for Daunorubicin Hydrochloride for Injection, USP 20 mg, its seventh ANDA approval thus far in 1999. Daunorubicin Hydrochloride for Injection, USP 20 mg/vial, used in combination with other approved anticancer drugs, is a cost-effective therapy for remission induction in acute nonlymphocytic leukemia. The estimated 1998 domestic market for Daunorubicin Hydrochloride for Injection was approximately $35 million.

So far this year, Bigmar has received FDA approval for the following products:

-- Methotrexate for Injection USP, 1g/vial (lyophilized)

-- Methotrexate Injection USP, 25 mg/mL, (Preserved)

-- Methotrexate Injection USP, 25 mg/mL, (Preservative-free)

-- Leucovorin Calcium for Injection USP, 200 mg/vial (lyophilized)

-- Leucovorin Calcium for Injection USP, 500 mg/vial (lyophilized)

-- Fluorouracil Injection, USP 50 mg/mL

-- Daunorubicin Hydrochloride for Injection USP, 20 mg/vial

The estimated combined total 1998 domestic market for all seven recently approved products was approximately $170 million.

The Company also recently announced the signing of a licensing and supply agreement with Graminex to develop a new prostatitis therapy, BGM-24, and plans to file an Investigational New Drug Application with the FDA for this therapy.

John G. Tramontana, Chairman and Chief Executive Officer, commented, "The FDA's approval of Daunorubicin Hydrochloride for Injection represents another significant milestone for the Company. Competition in generic oncology drugs for the US market is limited to only one or two suppliers. This fact combined with strong demand for Daunorubicin Hydrochloride should enable Bigmar to establish a strong market presence for this product and result in an increase in overall company sales." Mr. Tramontana continued, "We believe that Bigmar's portfolio of seven generic oncology products positions the Company to be a leading supplier of the most widely prescribed generic oncology drugs."

Along with the Company's other approved products, Daunorubicin Hydrochloride for Injection will be produced and distributed from Bigmar's FDA-inspected Barbengo, Switzerland manufacturing facility. This facility utilizes barrier isolation technology to manufacture FDA-approved parenteral drug products. This technology, where personnel and the outer environment are separated from exposed sterile products and packaging components, can be superior to traditional aseptic clean room processing by reducing contamination rates during aseptic filling operations. Bigmar is currently the only company to apply this highly automated containment technology to the manufacture of generic drugs.

BIGMAR, Inc.'s strategy is to supply world markets with a full line of high-quality, affordably priced pharmaceutical products focusing on oncology. With distribution rights to more than 20 generic pharmaceutical products, the Company manufactures, in its state-of-the-art facilities in Switzerland, and markets, through pharmaceutical company partners in Europe and the United States, off-patent generic oncology drugs and additional drugs as their patents expire.

Forward-looking statements involve known and unknown risks, uncertainties and other factors as detailed in the Company's SEC reports and filings, which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied in such forward-looking statements.