Biota Obtains US$2.9m NIH Grant for the Development of Novel Antibacterial

Biota Holdings Limited (ASX:BTA) advises that its wholly owned subsidiary, Biota Scientific Management Pty Ltd, has been awarded a grant to fund the preclinical development of a lead candidate for the treatment of Clostridium difficile (C. difficile).

The first years payment is US$830,287 of a 5 year grant totalling US$2.9m. Future payments to Biota are subject to satisfactory project progress and the availability of funding.

The award (Number ROI A1094456) is from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS).

The C. difficile program was part of the assets acquired from Prolysis in November 2009.

About Clostridium difficile

C. difficile infection (CDI) usually occurs in hospitalised patients who have been treated with antibiotics. Antibiotics disrupt the balance of naturally occurring bacteria in the gut, allowing C. difficile to multiply and cause a spectrum of symptoms ranging from diarrhoea to life-threatening inflammation of the colon. C. difficile forms persistent infective spores that can act as a reservoir for transmission of the infection in hospitals.

In recent years, the emergence of a new, more virulent strain of C. difficile has resulted in an increase in CDI incidence, severity and consequent deaths. Hospital costs associated with CDI have been estimated to be in excess of $3.2 billion per annum in the US. Current CDI treatment usually involves the use of metronidazole or vancomycin; however, a significant number of patients treated with these drugs continue to suffer from reoccurrence of CDI and novel treatment options are urgently required.

About Biota

Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza™. Biota research breakthroughs include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems.

In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which the lead product, lnavir®, is approved for marketing in Japan.

Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.

Inavir® is registered to Daiichi Sankyo.