28 October 1998
Melbourne, Australia - Biota Holdings Limited announced today that its development partner, Glaxo Wellcome plc, has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market RelenzaTM (zanamivir) for the treatment of influenza.
"The filing of RelenzaTM with the U.S. FDA is Biota's most significant milestone for this year," said Biota's Chief Executive Officer, Dr. Hugh Niall. "The U.S. represents the single largest potential market for RelenzaTM."
"Influenza is a serious respiratory illness that each year affects millions of people worldwide," said Glaxo Wellcome's Vice President of Therapeutic Development and Product Strategy for Infectious Diseases & Hepatitis, Dr. Marc Rubin. "RelenzaTM represents a major development in managing the disease in that it blocks replication of the virus and thereby reduces both the severity and duration of illness."
RelenzaTM is the first orally inhaled drug for treating influenza and the first in a new generation of specific treatments for the influenza virus known as neuraminidase inhibitors, which work by interfering with the life cycle of the influenza virus. RelenzaTM blocks the neuraminidase enzyme on the surface of the virus, preventing spread to neighbouring cells within the respiratory tract.
Administering RelenzaTM via an oral inhaler ensures that the drug is rapidly delivered directly to the surface of the respiratory tract - the only site of influenza virus infection in humans. This means that high levels of the drug reach the site of virus replication, whilst minimising potential side effects by avoiding general distribution throughout the body.
Market Applications Have Been Filed with Worldwide Regulatory Bodies
The U.S. FDA filing marks the fourth market clearance application to market RelenzaTM in a series of worldwide regulatory body filings during 1998. Earlier this year, the Company announced that an application to market RelenzaTM for the treatment of influenza had been filed with Australia's Therapeutic Goods Administration (TGA). Last month, the Company also announced regulatory application filings in Europe and Canada to market RelenzaTM for both the treatment and prevention of influenza.
Clinical Trials Confirm Safety and Efficacy
RelenzaTM, which has been studied in over 4,000 patients in clinical trials, consistently shortens the duration of influenza by up to 2½ days. Clinical trial data presented in September at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) confirmed the efficacy of RelenzaTM against influenza in large numbers of patients, including those considered at "high risk" of complications. The primary endpoint of the study was median time to alleviate clinically significant influenza symptoms. RelenzaTM showed clinically and statistically significant benefit in terms of this endpoint.
Patients were treated within 36 hours of the onset of symptoms with 10mg twice daily of RelenzaTM or a placebo for 5 days. Results showed that patients at risk of developing complications as a result of influenza infection experienced a 71% reduction in complications when given RelenzaTM (p=0.004) and 65% reduction in associated antibiotic use (p=0.025) compared to placebo. The results showed that "high risk" patients experienced fewer complications (14% RelenzaTM vs 46% placebo) leading to a reduction in the associated use of antibiotics.
Glaxo Wellcome is a research-based pharmaceutical company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to the healthcare providers who serve them.
Biota is an Australian listed company (BTA) based in Melbourne and engaged in the funding and management of a research and development program focusing principally on the discovery of new human pharmaceuticals for the treatment of cancer and viral respiratory disease. The company's ADRs (BTAHY) trade in the US on the pink sheets at a ratio of three shares to each ADR. |
