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SWISS IKS APPROVES FORMULATION OF METRONIDAZOLE IN IV BAGS.


Bigmar, Inc. (Nasdaq SmallCap: BGMR BGMR Bigmar Inc. (stock symbol) ) has received approval from the Intercantonal Office for the Control of Medicine (IKS IKS Tiksi (Russia)
IKS Interkantonale Kontrollstelle für Heilmittel
IKS Imperial Klingon Ship (Star Trek)
IKS International Kolping Society (Cologne, Germany)
IKS Independent Karate School
) in Switzerland to utilize IV bags as a drug delivery system for Metronidazole metronidazole /met·ro·ni·da·zole/ (-ni´dah-zol) an antiprotozoal and antibacterial effective against obligate anaerobes; used as the base or the hydrochloride salt. It is also used as a topical treatment for rosacea. , an antibiotic used in the treatment of serious infections caused by anaerobic bacteria. This approval allows Bigmar to manufacture and market IV bags formulated with Metronidazole within Switzerland.

The company also filed for approval from the IKS for the formulation of 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.  IV bags to be used in treating patients with heart disease. If approved by the IKS, management believes Bigmar will be the first company to manufacture and market Nitroglycerin in IV bags. Additionally, the company plans to file for approval with the IKS to formulate Bupivacaine in infusion bags to be used in conjunction with patient-controlled pumps. Bupivacaine is a local anesthetic used in pain management.

These products will be produced by the company's Bioren SA subsidiary in Switzerland for use in clinical settings. The company expects to file Abbreviated New Drug Applications ("ANDA ANDA
abbr.
abbreviated new drug application
") with the Food and Drug Administration in the United States and also seek approvals from European regulatory authorities for these products.

Shipments of the Nitroglycerin IV bags to Brazil have already commenced.

"The formulation of Metronidazole, Nitroglycerin and Bupivacaine in IV bags are the first steps towards what we believe is a much broader opportunity for Bigmar. By leveraging Bigmar Pharmaceuticals' expertise in utilizing Isolator Technology along with Bioren's infusion production capabilities, we seek to become the first company offering generic oncology (cancer) drugs in IV bags, which have been traditionally delivered in vials," stated John Tramontana, chairman and chief executive officer of Bigmar.

The procedure for formulating various dosages of drugs in IV bags is highly sophisticated. This is particularly true in the case of oncology drugs, which are very toxic and dangerous to handle. Approximately 30% of Bigmar's total R&D spending for the nine months ended September 30, 1999 was devoted to determining the stability of various drugs in IV bags, including the company's generic oncology products.

Tramontana continued, "This is a unique innovation which we believe will be welcomed by healthcare workers in hospital and clinical settings, who will now be able to administer oncology drugs in an efficient, cost effective and ready to use package, completely avoiding the manipulation of toxic substances. In addition, they will no longer need to perform any dosage calculation, since Bigmar will formulate these drugs in varying but frequently prescribed dosages."

Tramontana concluded, "We believe that our Bigmar Pharmaceuticals SA and Bioren SA subsidiaries have the only facilities currently capable of formulating and mass producing various generic oncology drugs in IV bags."

Bigmar intends to formulate and market a number of generic oncology drugs in IV bags, including, Fluorouracil fluorouracil: see metabolite. , Doxorubicin, 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. , Dacarbazine, Carboplatin, Aclarubicin, Ganciclovir, Azathioprine azathioprine: see metabolite. , Cyclophosphamide cyclophosphamide /cy·clo·phos·pha·mide/ (-fos´fah-mid) a cytotoxic alkylating agent of the nitrogen mustard group; used as an antineoplastic, as an immunosuppressant to prevent transplant rejection, and to treat some diseases , Ifosfamide, Melphalan, Vincristinsulphate, Cisplatin, Amsakrine, Etoposide, Vinblastin and Dactinomycin dactinomycin /dac·ti·no·my·cin/ (dak?ti-no-mi´sin) actinomycin D, an antibiotic derived from several species of Streptomyces; used as an antineoplastic.

dac·ti·no·my·cin
n.
. In this regard, Bigmar plans to apply for ANDA approvals in the United States as well as various approvals from European regulatory authorities for the above-mentioned generic oncology drugs in IV bags during the first half of 2000. The company has already received ANDA approvals in the United States for seven generic oncology drugs, including Fluorouracil and Methotrexate, but only in vials for injection.

Bigmar, Inc.'s strategy is to supply world markets with a line of high quality, affordably priced pharmaceutical products with a focus on oncology. The company has distribution rights to more than 20 generic oncological products and seven products approved by the 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.
, which are manufactured in the company's state-of-the-art facilities in Switzerland.

The company markets its products through partnerships with pharmaceutical distributors in Europe and the United States and focuses on off-patent oncological drugs.

For more information, call 740/966-5800.
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Comment:SWISS IKS APPROVES FORMULATION OF METRONIDAZOLE IN IV BAGS.
Publication:Worldwide Biotech
Article Type:Brief Article
Geographic Code:4EXSI
Date:Feb 1, 2000
Words:618
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