Biota Holdings Limited

Overview

Biota is a leading anti-infective drug development company, based in Melbourne, Australia and Oxford, UK.

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 antivirals, of which the lead product lnavir^®, is approved for marketing in Japan. Biota holds a contract from the US Office of Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of laninamivir in the USA.

Recent achievements:

Phase IIa clinical trials of its lead human rhinovirus (HRV) drug achieved clinical proof-of-concept. The drug is aimed at prevention and treatment of one of the major causes of the common cold which is also thought to be a major cause of exacerbations in patients with chronic obstructive pulmonary disease and asthma.
Inavir^® (laninamivir) is approved for sale in Japan and is marketed by Daiichi Sankyo.
Biota expanded its antibacterial interests following the asset acquisitions of Prolysis Limited and MaxThera Inc.
Biota awarded a contract up to US$231 million by the US Office of Biomedical Advanced Research & Development Authority (BARDA) for the advanced development of laninamivir in the USA.

The Company's research pipeline also extends beyond respiratory diseases, including early stage research targeting the hepatitis C virus (HCV) and respiratory synctial virus (RSV).

Biota is listed on the Australian Securities Exchange (ASX:BTA).

Main business focus/
Listing by sector:

Drug Discovery & Development
Infectious Diseases

Competitive Advantages

World-recognised expertise the development of small molecule antiviral drugs for the treatment and prevention of viral diseases.
Key management in place with outstanding industry experience and commercial partnering skills.
Integrated in-house expertise in drug discovery and clinical development.

Corporate Alliances/Partnerships

Biota has key partnerships with:

Daiichi-Sankyo: for the development of second generation influenza antivirals (called LANI or long-acting inhaled neuraminidase inhibitors).

Partnering Opportunities

In addition to those products already partnered or licensed, Biota has a number of projects approaching key milestones of commercial interest:

Biota, together with our Japanese based partner, Daiichi Sankyo, have developed a second generation of inhaled antiviral compounds for influenza, called long-acting inhaled neuraminidase inhibitors (LANI), which are currently available for licensing ex-Japan. The lead product, Inavir^® (laninamivir), has been approved for sale in Japan.

Biota's human rhinovirus (HRV) drug for the prevention and treatment of one of the major causes of the common cold, BTA798, has completed Phase I and Phase IIa clinical trials. Biota is prepared to accept early expressions of interest from partners interested in this program.

Biota's preclinical stage respiratory syncytial virus (RSV) drug for the prevention and treatment of one of the major causes of morbidity in children, the elderly and immunocomprised patients is available for licensing.

Gyrase

There is a clear unmet and growing need for antibacterial drugs that are active against drug-resistant disease in both the hospital and community settings. The Biota antibacterial portfolio seeks to address this need via the provision of a novel class of antibacterial drugs that are potent against drug-resistant bacteria, and which target both intravenous (IV) and oral (PO) delivery.

Biota is developing bacterial GyrB/ParE inhibitors that act by inhibiting bacterial proteins involved in controlling DNA supercoiling and chromosome decatenation. The Biota inhibitors are dual-targeting, inhibiting both the GyrB protein subunit of bacterial DNA gyrase and the ParE protein subunit of bacterial topoisomerase IV.

Biota’s dual-targeting inhibitors are active against fluoroquinolone and aminocoumarin resistant bacteria and offer the prospect for a new class of antibacterials that are effective against drug and multi-drug resistant bacteria. The profile of the Biota dual-targeting GyrB/ParE inhibitors is consistent with a market leading commercial position.

HCVNN

The Biota HCV non-nucleoside compounds target NS5b RNA-dependent RNA polymerase, the protein responsible for viral RNA synthesis and genome replication. Biota has identified a novel class of small molecule non-nucleoside inhibitors that target the non-nucleoside (NNI) site 4 (palm 2) of NS5b polymerase. Biota’s compounds are potent inhibitors of HCV with activity in the low nanomolar range in NS5b enzyme and replicon cell-based assays against multiple HCV genotypes.

Readers who would like to know more about these or other potential opportunities, should contact Biota's Vice President Business Development, Dr Leigh Farrell on +61 (3) 9915 3700 or l.farrell@biota.com.au.

Contact Details

Contact person	Dr Leigh Farrell
Job Title	Vice President, Business Development
Address	10/585 Blackburn Road
City/Suburb	Notting Hill
State	Victoria
Email	l.farrell@biota.com.au
Phone	+61 3 9915 3700
Fax	+61 3 9915 3702
Website	http://www.biota.com.au

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