Bigmar Announces United Kingdom Approval of First Pre-Mix Bupivacaine Infusion Solutions.Business Editors and Medical/Health Writers JOHNSTOWN, Ohio--(BW HealthWire)--July 24, 2000 Company Receives Marketing Authorization for Two Dosage Strengths (0.1% and 0.125%) in the UK Bigmar Inc. (Nasdaq:BGMR BGMR Bigmar Inc. (stock symbol) ) today announced that it has received licenses from the UK Medicines Control Agency granting authorization to market two dosage strengths of Bupivacaine HCL bupivacaine HCl (local) (byōōpiv´  kān´),n brand names: Marcaine, Senorcaine; drug class: Infusion Solution in the United Kingdom. Bigmar also reported that it expects to file similar applications for Bupivacaine in Germany, Austria and Italy within the next six months. The company currently markets pre-mix Bupivacaine in Switzerland. Bioren, S.A., a division of Bigmar based in Couvet, Switzerland, developed the novel formulation of Bupivacaine and will market the product in Europe. Bioren also currently markets a pre-mix IV 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. . Bupivacaine HCL is a long-acting local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. used for caudal caudal /cau·dal/ (kaw´d'l) 1. pertaining to a cauda. 2. situated more toward the cauda, or tail, than some specified reference point; toward the inferior (in humans) or posterior (in animals) end of the body. , epidural epidural /epi·du·ral/ (-dur´il) situated upon or outside the dura mater. ep·i·du·ral adj. Located on or over the dura mater. n. or peripheral nerve block nerve block n. Interruption of the passage of impulses through a neuron by the injection of alcohol or an anesthetic. nerve block, n 1. . Although injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. Bupivacaine was 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. in 1972, Bioren's, easy-to-use, pre-mix solution delivered in the IV infusion bag is the first such formulation of the drug. The company expects first-year sales of Bupivacaine HCL Infusion Solution in the UK to be approximately $1.3 million. "The trend in drug-delivery mechanisms of this type is clearly moving away from injectables and toward pre-mix IV solutions," said John G. Tramontana, Bigmar's chairman and chief executive officer. "We believe that our Bioren division is at the forefront of manufacturing and marketing IV solutions and will contribute substantially to the consolidated top- and bottom lines." The Bioren Facility is a 57,000-square-foot facility in Couvet, Switzerland, that houses manufacturing operations, laboratory facilities for quality assurance and quality control activities, including batch testing and multiple-batch stability testing operations, labeling and packaging operations, warehousing and storage operations and administrative areas. 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 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 news 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 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 December 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 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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