Synairgen Regulatory News (SNG)

PRESS RELEASE

5 August 2015

SYNAIRGEN PLC

("Synairgen" or "the Company")

Synairgen and Pharmaxis announce research collaboration to develop LOXL2 inhibitor for pulmonary fibrosis

Southampton, UK, 5 August 2015: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, and Australian pharmaceutical company Pharmaxis Ltd (ASX: PXS) today announced they have entered into a research collaboration to develop a selective inhibitor to the lysyl oxidase type 2 enzyme (LOXL2) to treat the fatal lung disease idiopathic pulmonary fibrosis (IPF).

IPF affects in the region of 100,000 people in the US. Current products are expected to produce global revenues in excess of $1.1 billion by 2017. The LOXL2 enzyme is being targeted because it is known to promote scar tissue which hardens and irreparably damages the lungs of IPF patients. It is hoped that the inhibition of LOXL2 will slow the build-up of scar tissue and improve survival rates that are worse than for many cancers.

The LOXL2 inhibitor program comes from the same Pharmaxis chemistry platform as the SSAO inhibitor that was recently acquired by Boehringer Ingelheim. Under the terms of the agreement Synairgen will fund further activity of the program at Pharmaxis, use its BioBank and in vitro lung model platform, and collaborate with the IPF research team at the University of Southampton to complete pre-clinical and early clinical development. The IPF program will be managed by a joint steering committee through to the end of phase 1 or phase 2a clinical trials, at which time the collaboration will seek a license partner. Pharmaxis and Synairgen will share any licensing revenues in accordance with the ratio of total investment by the two companies at that time. The share of licensing revenues is expected to be approximately equal for a compound licensed for IPF after early clinical development. Pharmaxis will continue to develop compounds outside the collaboration for other indications where LOXL2 inhibitors have shown potential such as liver and kidney fibrosis, and metastatic cancer. The agreement does however allow for scenarios where the collaboration licenses its program for multiple indications.

Synairgen's CEO, Mr. Richard Marsden, said: "We are delighted to be collaborating with Pharmaxis in idiopathic pulmonary fibrosis, a severe and fatal lung disease. Pharmaxis has a proven competence in the discovery and development of novel molecules, making it an ideal partner. LOXL2 is a target which is of interest not only to our IPF clinical experts in Southampton but also to large pharmaceutical companies; in 2011 Gilead Sciences acquired Arresto Biosciences for $225 million for its Phase I LOXL2 targeting antibody simtuzumab and is currently conducting a large efficacy trial in IPF. 

"Using existing financial resources from our fundraising in 2014, we will apply our BioBank platform of advanced human tissue models and understanding of respiratory biology to develop the LOXL2 inhibitor. We look forward to working closely with Pharmaxis and the world class academics at the University of Southampton to progress this opportunity into the clinic in patients with IPF."

Pharmaxis' CEO, Mr. Gary Phillips, said: "We have continued to make good progress in our preclinical LOX inhibitor program and in particular on LOXL2 small molecule inhibitors to treat various diseases where fibrosis is a major problem. The significant interest among leading clinicians and pharmaceutical companies in the role of LOXL2 in a number of different diseases has highlighted the need for us to collaborate for selected indications in order to fully exploit the potential value of our intellectual property. Synairgen has a demonstrated excellence in respiratory drug development, having successfully licensed its inhaled IFN-beta Phase 2 program to AstraZeneca. We believe our collaboration with Synairgen will accelerate the development of a highly competitive once a day oral treatment for patients with IPF and enable Pharmaxis to develop LOXL2 inhibitors for other potential indications such as liver and kidney fibrosis, and cancer."

ENDS

For further information, please contact:

Synairgen plc 

Richard Marsden, Chief Executive Officer

John Ward, Finance Director

Tel: + 44 (0) 23 8051 2800

finnCap

Geoff Nash, James Thompson (Corporate Finance)

Stephen Norcross, Simon Johnson (Corporate Broking)

Tel: + 44 (0) 20 7220 0500

Pharmaxis Ltd

Felicity Moffatt, Pharmaxis Public Affairs

felicity.moffatt@pharmaxis.com.au

Tel: +61 418 677 701

Consilium Strategic Communications (Financial Media and Investor Relations)

Mary-Jane Elliott / Jessica Hodgson / Laura Thornton

synairgen@consilium-comms.com

Tel: +44 (0) 20 3709 5701

Notes for Editors

About Synairgen 

Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on asthma and COPD, uses its differentiating human biology Biobank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. Leveraging its scientific and clinical facilities at Southampton General Hospital, the Company uses in vitro and ex vivo models to progress opportunities into clinical development. The Biobank of human samples is used in these models to increase confidence in the likelihood of successful drug development. Core to Synairgen's business strategy is the realisation of value via licensing transactions - validated in June 2014 by the SNG001 (now AZD9412) agreement formed with AstraZeneca. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen and the interferon beta programme, please see www.synairgen.com.

About Pharmaxis

Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company with a portfolio of products at various stages of development and approval. Its product Bronchitol® for cystic fibrosis is marketed in Europe and Australia and a phase 3 trial to enable completion of an NDA for the US market is underway. Its product Aridol® for the assessment of asthma is sold in Europe, Australia and Asia. The company's development pipeline is centred on its expertise in amine oxidase chemistry and includes Semicarbazide-Sensitive Amine Oxidase Inhibitors (SSAO) for Non-alcoholic Steatohepatitis (NASH) and inflammatory diseases including Chronic Obstructive Pulmonary Disease (COPD), and Lysyl Oxidase Inhibitors (LOX) targeting fibrotic diseases including pulmonary fibrosis and some cancers. In May 2015, Boehringer Ingelheim acquired the Pharmaxis investigational drug PXS4728A, to develop it for the treatment of the liver-related condition NASH. Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company's head office, manufacturing and research facilities are located in Sydney, Australia.