BIGMAR Commences Proprietary Drug Development Strategy Via Licensing and Supply Agreement With Graminex.JOHNSTOWN, Ohio--(BUSINESS WIRE)--May 4, 1999-- Bigmar Expects to File First Investigational New Drug Application With the Food & Drug Administration For BGM-24, Prostatitis prostatitis (prŏs'tətī`tĭs), inflammation of the prostate gland. Acute prostatitis is usually a result of infection in the urinary tract or infection carried by the blood; in many cases the infection spreads from the urethra and is Therapy BIGMAR, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq SmallCap Market:BGMR BGMR Bigmar Inc. (stock symbol) ) today announced that it has signed a licensing and supply agreement with Graminex to develop a new prostatitis therapy, BGM-24. Bigmar intends to file an Investigational New Drug Application ("IND") with the Food and Drug Administration ("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. ") for this therapy, which would mark the Company's entrance into proprietary drug development. Since March 1999, Bigmar has received approvals from the FDA for its first six Abbreviated New Drug Applications for generic oncology products. These products are being manufactured in Bigmar's FDA-inspected manufacturing facility in Barbengo, Switzerland. BGM-24 is a plant-extracted, proprietary drug candidate to treat symptoms of Benign Prostatic Hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ), a non-cancerous enlargement of the innermost part of the prostate, and may also be considered for the treatment of chronic non-bacterial Prostatitis and Prostatodynia. BPH frequently results in a gradual squeezing of the part of the urethra urethra (y rē`thrə), canal in most mammals that carries urine from the bladder to the outside of the body; in the male it also serves as a genital duct. that runs through the prostate and the inability to completely empty the bladder. This causes patients to experience a frequent urge to urinate urinate /uri·nate/ (u´ri-nat) to discharge urine. u·ri·nate v. To excrete urine. urinate to void urine. and a burning sensation or similar discomfort during urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. . Most males will eventually suffer from BPH. The incidence of BPH for men in their fifties is 50% and rises to 80% by the age of 80. Worldwide there are approximately 118 million men over the age of 50 and in the United States, an estimated 30 million aged 50 and over have enlarged prostates. Of this group, approximately one-half will visit a urologist for relief of their symptoms. The general aging of the population and increasing life expectancies are anticipated to contribute to the continued growth in the number of BPH sufferers. Currently, there are three drugs to treat the symptoms of BPH with combined sales of approximately more than $1.5 billion. John Tramontana, Bigmar's Chairman & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , commented, "Our new licensing and supply agreement allows Bigmar to fully undertake the development of this exciting product. Proprietary drug development is a major part of our overall growth strategy. We intend to leverage our existing resources, facilities and relationships to develop proprietary pharmaceutical products, which positions Bigmar to add new potential revenue streams and serve unmet medical needs." BIGMAR, Inc.'s strategy is to supply world markets with a full line of high quality, affordably priced proprietary and generic pharmaceutical products. With distribution rights to more than 20 generic pharmaceutical products and six products approved by the FDA, the Company manufactures, in its state-of-the-art facilities in Switzerland, and market, through pharmaceutical company partners in Europe and the United States, off-patent generic oncology drugs and additional drugs as their patents expire. Graminex L.L.C. is a Michigan based botanical company dedicated to applying its proprietary development and manufacturing process technologies to develop pharmaceutical-grade dietary supplements and pharmaceutical products from natural plants. 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. |
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