IRVINE, Calif., March 31, 2004 (PRIMEZONE) -- BioGentech Corp. (OTCBB:BGTH), a pharmaceutical company specializing in over-the-counter anti-allergy medications, announced today the finalization of two outsourcing contracts for the Phase III clinical research work on its new seasonal allergy product, Prehistin(tm). Patheon Pharmaceuticals (TSE:PTI), and Quest Diagnostics (NYSE:DGX), will play critical roles in the execution and analysis of these trials. A successful outcome to the Phase III trials will open the door for Prehistin to become the first-ever over-the-counter anti-allergy drug that helps to prevent the symptoms of seasonal allergies.
Patheon Pharmaceuticals, Inc. headquartered in Toronto, Canada, a leading global provider of drug development and manufacturing services, will manufacture and provide the study drug, including placebo, for these clinical trials. BioGentech is utilizing Patheon's expertise to formulate the optimal, patient-friendly sub-lingual lozenge.
Quest Diagnostics Clinical Trials, of Van Nuys, CA, the nation's leading provider of diagnostic testing, information and services, will function as the central laboratory for all blood and urine analyses. BioGentech selected Quest based on their expedient laboratory reporting, robust data management and extensive investigator support.
Ernest T. Armstrong, BioGentech's Vice President of Business Development, will be the project director for these Phase III trials. "Each company's management team has a track record of success in their areas of expertise. Strategically, outsourcing to these highly-respected organizations enables us to conduct adequate and well controlled studies required by the FDA to complete a New Drug Application for Prehistin. In addition, using these partners is an efficient use of our financial and human resources," commented Armstrong.
Chaslav Radovich, President and CEO of BioGentech commented, "We are very pleased to be working with these firms as they bring a tremendous amount of experience as well as global operations that will enable us to ensure the highest quality work for these studies. The fact that each of the allergists and immunologists we have secured to participate in these trials are Board Certified, only reinforces the importance of our decision to partner with the most professional organizations to execute the Phase III trials for Prehistin."
About BioGentech Corp. -- Prehistin(tm)
Headquartered in Irvine, California, BioGentech Corp. is an over-the-counter pharmaceutical company. Its flagship product, Prehistin, designed to prevent the primary cause of airborne allergies, is scheduled for Phase III clinical trials in the summer of 2004 and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. Prehistin, "the world's first pre-histamine," has shown in previous clinical studies to modulate the body's level of the protein IgE, reducing the overproduction of histamines, the primary cause of airborne allergy symptoms. Prior studies have shown that the active ingredient in Prehistin appears to have essentially no risks of adverse effects to the general population, including sedation and drowsiness found in many of the allergy products currently available.
For further information please visit the website at www.biogentec.com.
Safe Harbor
This news release includes statements that are not historical facts and are considered "forward-looking" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect BioGentech Corp's current views about future events. They are identified by their use of terms and phrases such as "believe," "expect," "plan," "anticipate", "possibility" and similar expressions identifying their forward-looking character. Investors should not rely on these forward-looking statements as assurances of future events, because such statements are inherently subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from the Company's expectations. The factors that may affect the outcome of such expectations include, but are not limited to factors detailed from time to time in the Company's filings with the Securities and Exchange Commission.