Biota and BioStar Begin North American Clinical Trials of Influenza Diagnostic
Biota Holdings Limited (Australian Stock Exchange: BTA) today announced that with its development partner, BioStar, Inc., it has commenced North American clinical trials of its influenza diagnostic, being conducted at several locations in the United States (U.S.). The North American trial is designed to assess the performance of Biota's new 15-minute diagnostic for both influenza A and influenza B using several patient specimen types. Biota expects its new revolutionary diagnostic to be submitted for regulatory clearance in the U.S. in the second quarter of 1998.
Utilising BioStar's proprietary Optical Immunoassay (OIAr) technology, the test will allow the practitioner to collect a patient specimen and detect both types of influenza within 15 minutes. The test also has the potential to provide rapid diagnosis of unusual flu variants, such as the recent avian virus found in Hong Kong. Currently available influenza diagnostics detect only influenza A or require hours or days to provide results.
Biota maintains worldwide marketing rights of the product, with the exception of the U.S., and is currently reviewing additional marketing alliances for sale of the product in those areas. BioStar will utilise its 90 person direct marketing force for sale of the product in the United States.
Biota and BioStar estimate that there are more than 350 million cases of influenza around the world each year. The lack of accurate and timely diagnosis of influenza is estimated to be the leading cause of influenza complications, such as pneumonia, especially in the elderly. People with immunocompromised systems (such as cancer patients) are also at high risk of developing complications from influenza. In the U.S. influenza and its complications represent the sixth leading cause of death.
"We are pleased with the timely and progressive joint development of this simple and rapid influenza diagnostic and the planned dedication of BioStar's sales force," said Dr. Hugh Niall, Chief Executive Officer of Biota. "It moves us one step closer to our goal which is that our new diagnostic will be used in conjunction with a broadly effective anti-influenza drug when this becomes available." Biota's new influenza therapeutic zanamivir (RelenzaTM) is in advanced development in collaboration with partner Glaxo Wellcome.
"The influenza diagnostic will allow physicians to be effective in the appropriate management of influenza, and to distinguish it from influenza like illness," stated Teresa Ayers, President and CEO of BioStar, Inc. "The rapid joint development programme between BioStar and Biota has allowed us to conduct clinical trials of the diagnostic this winter in the Northern Hemisphere."
RelenzaTM, the first effective treatment for all strains of influenza, is currently in Phase III clinical trials in the Northern Hemisphere, after having completed Phase III clinical trials in the Southern Hemisphere during their flu season. RelenzaTM is being developed by Biota in partnership with Glaxo Wellcome and filing for regulatory clearance worldwide is expected in the second half of 1998. |
