Ockham Overturns Vectura Group plc's Challenge to Secure European Patent Rights for Inhaled Heparin in the Treatment of COPD

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Swanwick, UK – 3 June 2013 – Ockham Biotech Ltd (‘Ockham’), a company specialising in the research, development and commercialisation of new therapies for respiratory disorders, is pleased to announce that its European patent covering the use of inhaled heparin for the treatment of patients with chronic obstructive pulmonary disease (COPD) and mucus hypersecretion has been restored, following its grant in 2008 and subsequent revocation in 2011.

In 2002, Ockham filed three patent applications based on the mucolytic properties of inhaled heparin that were discovered by Dr Janis Shute, Scientific Director for the Company. These properties provide a means to improve airway mucus clearance and a ‘ballistic effect’ to deliver other inhaled drugs to mucus-congested airways more effectively. In addition to its multiple pharmacological and well-described anti-inflammatory properties, the use of inhaled heparin suggests an effective way to treat mucus hypersecretory diseases with airway mucus congestion.

The first European patent on the use of inhaled heparin as a mono-therapy was granted to Ockham in 2008. The patent was subsequently opposed by Vectura plc and was revoked at first instance by the Opposition Division of the European Patent Office in 2011. In March 2013, the Technical Board of Appeal set aside the first instance decision of the Opposition Division and maintained Ockham’s European patent with claims directed to administration via inhalation, intranasally or instillation.

There is a high level of unmet need for drugs to reduce COPD exacerbation rates, slow or halt the progression of COPD, and improve lung function and the quality of life in COPD patients. The development of novel inhaled therapies, based on the multiple pharmacological properties of heparin, either alone or in combination with other drugs, is anticipated to provide new COPD treatment options, expanding the COPD market in the coming years.

Mario Cazzola, Professor of Medicine at the University of Rome Tor Vergata, said: “An effective mucolytic for the relief of symptoms in COPD patients with mucus hypersecretion is urgently needed. It will be a significant development in the therapeutic strategy for the millions of patients with COPD who suffer with symptoms of breathlessness, cough and difficulty expectorating mucus.”

Andy Short, CEO of Ockham Biotech, added, “The science behind Dr Shute’s discovery of the mucolytic effects of heparin is compelling. Her invention provides a way to treat airway mucus obstruction in COPD and Ockham’s commissioned and on-going trial of inhaled heparin in patients with COPD support the safety and efficacy of this approach. Securing this patent was an important step for our company and we look forward to exciting opportunities to work with potential partners”.

For more information, please contact:

Andy Short, CEO

Ockham Biotech

T: +44 1489 587 168 / +44 1489 565 115

E: as@ockhambiotech.com

For media enquiries, please contact:

Stefanie Bacher/ Gemma Howe

College Hill

T: +44 20 7866 7860

E: ockham@collegehill.com

About Ockham Biotech Ltd

Ockham Biotech Ltd. is a research and development company specialising in the development of inhaled heparin for the treatment of obstructive airway diseases, including chronic obstructive pulmonary disease (COPD). www.ockhambiotech.com

About COPD

COPD is predominantly caused by cigarette smoking and inhalation of environmental factors, including wood smoke from cooking over open fires, and is believed to affect up to 10% of the world population. In 2009, the COPD market was estimated to be worth $7.2 billion and is projected to grow at a compound annual growth rate (CAGR) of 7.4% to reach $11.9 billion in 2016 [GlobalData.com]. The COPD market is growing significantly in most countries and it is expected that COPD will be the fourth leading cause of death worldwide by 2030.



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