Spinifex Closes AU$18.25M(~US$19M) Expanded Series B Round

MELBOURNE, Australia, August 23, 2011 -

Additional Funds to Broaden Phase  2 Program for New Pain Drug

• AU$6.25M (~US$6.5M) investment by GBS Venture Partners, Brandon Capital, Uniseed and UniQuest completes round
• Two additional Phase 2 studies will run in parallel with planned clinical trial in postherpetic neuralgia patients

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

This expanded Series B funding builds on a previously announced AU$12 million investment from the same syndicate and will be used in part to expand the Phase 2 clinical trial program for EMA401 to a further two indications, specifically;

• The treatment of pain and hypersensitivity in peripheral nerve injury patients.
• The treatment of pain and hypersensitivity in cancer chemotherapy patients.

These new clinical trials are a translation into clinical research of the results from Spinifex’s ongoing collaboration with Prof. Praveen Anand (Professor of Clinical Neurology at Imperial College London’s Hammersmith Hospital) and his research laboratory.

The studies will run alongside a soon to be initiated Phase 2 clinical trial of EMA401 in postherpetic neuralgia, a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

EMA401 is an angiotensin II type 2 (AT₂) receptor antagonist. The discovery that this class of molecules offers an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at the University of Queensland. Having licensed the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase 1 studies.

Spinifex Pharmaceuticals CEO Tom McCarthy said: “We appreciate the ongoing support of our investors. Their further investment allows us to expand the EMA401 Phase 2 clinical program and also gives us additional flexibility as we plan the further development of this asset. Building on Prof. Smith’s original discovery, Prof. Anand’s studies on the AT₂ receptor in tissue samples collected from patients with different neurological conditions, have demonstrated a clear rationale for the use of AT₂ receptor antagonists in a number of painful conditions and we have used this data to select these important additional clinical indications.”

Prof. Anand commented: “Based on our human tissue laboratory data, the AT₂ receptor is a very promising novel target in pain research and EMA401 has demonstrated excellent results in our studies. We are excited to expand our collaboration with Spinifex into clinical research. Our innovative study designs incorporate new functional pain biomarkers and correlative histological assessments. In addition, the selection of the clinical indications was informed by a broad assessment of AT₂ receptor localisation in somatic and visceral pain pathways, and functional studies in isolated human neurones to better define clinical doses.”

Prof. Chas Bountra, Chair of Spinifex’s Scientific Advisory Board said: “The discovery and the development of new pain medicines desperately needs innovative approaches in order to address the significant unmet medical need. Prof. Anand’s approach of conducting fundamental pharmacology studies in human tissue samples and then translating the results into clinical proof of concept studies represents a paradigm shift in how new pain medicines are discovered. Using this approach, Prof. Anand moved the development of a number of assets forward during my time as Vice President and Head of Biology at GSK’s Neurology and Gastrointestinal Diseases CEDD, including most recently their novel p38 mitogen-activated protein kinase (MAPK) inhibitor dilmapimod, and we will use the same approach in our studies with EMA401.”

Spinifex’s clinical program for EMA401 is initially focused on neuropathic pain, an area of high unmet medical need. The market for neuropathic pain treatments is expected to continue to increase and is projected to reach US$6.2 billion by 2017. Despite this growth, current therapy needs to be improved as a significant proportion of neuropathic pain patients don’t respond to current therapy and these treatments have dose-limiting side effects. As a result, EMA401 is being developed as a potential first-in-class oral treatment for neuropathic pain and related symptoms without central nervous system side effects.

Spinifex Pharmaceuticals

Spinifex Pharmaceuticals is an Australian biotechnology company developing new drug candidates for the treatment and management of pain.

Established in 2005 and based in Melbourne, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for neuropathic pain and related symptoms without CNS side effects. Spinifex is conducting Phase 2 clinical trials with EMA401 in a number of neuropathic pain conditions.

www.spinifexpharma.com.au

Brandon Capital Partners

Brandon Capital Partners makes seed and venture capital investments into emerging businesses in the high-growth life science industry. Brandon Capital Partners’ team has a track record of successful life science investment as well as a history of working in research, operations and business development in the healthcare industry.

www.brandoncapital.com.au

GBS Venture Partners

GBS Venture Partners is Australia’s leading life science venture capital group with in excess of $400 million under management. GBS invests from seed through early expansion stage and has invested in more than 30 life science companies.

www.gbsventures.com.au

Uniseed

Uniseed is a $60 million commercialisation fund operating at the Universities of Melbourne, New South Wales and Queensland. Apart from these three universities, AustralianSuper, one of Australia’s largest and best performing industry superannuation funds, is also a member. Uniseed has made over 30 investments in technologies arising from its three partner universities including Vintela (AVCAL Best Early-Stage Deal 2005) and QRxPharma Ltd (largest biotech IPO in ASX history).

www.uniseed.com

Uniquest

Established by The University of Queensland in 1984, UniQuest is widely recognised as one of Australia’s largest and most successful university commercialisation groups, benchmarking in the top tier of technology transfer worldwide. From an intellectual property portfolio of 1,500+ patents it has created over 60 companies, and since 2000 UniQuest and its start-ups have raised more than $400 million to take university technologies to market. Annual sales of products using UQ technology and licensed by UniQuest are running at $3 billion. UniQuest now commercialises innovations developed at The University of Queensland and its commercialisation partner institutions: the University of Wollongong, University of Technology Sydney, James Cook University, University of Tasmania, Mater Medical Research Institute, and Queensland Health. www.uniquest.com.au

For more information please contact:

Company
Dr Tom McCarthy
CEO Spinifex Pharmaceuticals
Tel: +61(0)3-9938-1205
Email: tom.mccarthy@spinifexpharma.com.au

Media
Chris Gardner/Nina Enegren
Citigate Dewe Rogerson
Tel: +44(0)20-7638-9571
Email: nina.enegren@citigatedr.co.uk

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