Synairgen Regulatory News (SNG)

28 Sep 2007 07:04

Synairgen plc28 September 2007 SYNAIRGEN PLC ('Synairgen' or the 'Company') Synairgen Announces Exclusive Licence And Supply Agreement For A Novel Formulation Of Interferon-Beta Southampton, UK - 28 September 2007: Synairgen plc (LSE:SNG), the drug discoverycompany focused on asthma and COPD, today announces it has signed an exclusiveagreement with the Rentschler Group ('Rentschler') for the licence and supply byRentschler of a patent-protected novel formulation of Interferon-beta('IFN-beta') for the treatment of respiratory diseases by inhalation. In addition to supplying IFN-beta, Rentschler, a specialist internationaldeveloper and manufacturer of biopharmaceuticals, will work in collaborationwith Synairgen on the next stages of its proprietary development programme. Inreturn, Rentschler will be paid milestone payments dependent upon Synairgentaking on a commercial partner for the product. Further financial details havenot been disclosed. This agreement with Rentschler supports Synairgen's lead programme to develop aninhaled formulation of the drug to help asthmatics and COPD sufferers fight offthe debilitating effect of common cold viral infections, which trigger asignificant proportion of hospitalisations related to these respiratorydiseases. Building on a successful Phase I safety study, which was completedthis year, Synairgen anticipates commencing a safety study of inhaled IFN-betain asthma early in 2008. Richard Marsden, Managing Director of Synairgen, said: "We are delighted to have Rentschler on board as a collaborative partner withenormous expertise in the manufacture and development of biological products.Following on from our successful first Phase I study, this agreement addssignificant value to our lead programme. The exclusive licence of a proprietaryformulation of IFN-beta, which offers advantages over other currently availableformulations, complements our own intellectual property relating to its use inasthma and COPD. With Synairgen and Rentschler working together on thisprogramme, we are well placed to attract a commercialisation partner." Ends For further information, please contact: Synairgen Tel: + 44 (0) 2380 512 800Richard Marsden, Managing DirectorJohn Ward, Finance DirectorRentschler Tel: + 49 (0) 7392 7010Dr Wieland Wolf, Director Strategic CooperationThe Hogarth Partnership (Synairgen Media Enquiries) Tel: + 44 (0) 20 7357 9477Melanie Toyne-Sewell Notes for Editors About Synairgen Synairgen is a drug discovery company founded by Professors Stephen Holgate,Donna Davies and Ratko Djukanovic, focused on identifying and out-licensing newpharmaceutical products which address the underlying causes of asthma andchronic obstructive pulmonary disease. Synairgen is listed on AIM (LSE: SNG). For more information about Synairgen please see www.synairgen.com. About Rentschler The Rentschler Group is based in Laupheim, Germany. Its biotechnology division,Rentschler Biotechnologie GmbH, is an international full-service contractmanufacturer with in excess of 300 employees, and has more than 30 years ofexperience in the development, production and approval of biopharmaceuticals incompliance with international GxP standards. Regulatory advice and fill & finishare part of the company's service range. As a pioneer in the development andproduction of biopharmaceuticals, Rentschler was the first company in the worldto gain market authorisation for an interferon-containing drug. In 2006,Rentschler announced an investment program of €50 million for the expansionof its production systems. Its first new 500 litre system went into operation inmid-2007. For more information, please see www.rentschler-biotechnologie.de andwww.rentschler.de. Interferon Beta ('IFN-beta') in rhinovirus-induced asthma and COPD exacerbationsSynairgen is investigating a novel application of inhaled IFN-beta to reducecold virus-induced exacerbations in both asthma and COPD. This virus is a majortrigger for the worsening of both asthma symptoms (with up to eight out of tenasthma related emergency department visits being associated with these viralinfections) and COPD exacerbations (up to 60% of all COPD exacerbations arepreceded by the common cold). Currently there are limited satisfactorytreatments available to address either of these significant unmet needs. Asthma statistics • There are approximately 22 million asthmatics in the USA(1) • The economic cost to the USA is $19.7 billion per year(2) • Asthma accounts for 1,770,000 emergency department visits per year in the USA(1) • The cost of emergency department visits and in-patient care in relation to asthma in the USA is $4.7 billion(2) • Up to 80% of asthma exacerbations which result in emergency department visits are associated with RV infections(3) • 50% of the total cost of the asthma is apportioned to 10% of the asthmatic population with the severest disease(4) COPD statistics • COPD is the 4th leading cause of death in the USA: 118,171 (2004)(5) • The economic cost to the USA of COPD is $42.6 billion(2) • Direct health expenditure on COPD in the USA is $26.7 billion (asthma $14.7billion)(2) • Research by the SUPPORT investigators estimated the average cost of a hospitalisation for a severe COPD patient to be $7,100(6) • The global market for COPD drugs is forecast to increase from $4 billion to $7 billion by 2010(7) Information about common colds and rhinovirus ('RV') • Adults get an average of two to four colds per year, mostly between September and May(8) • Young children suffer from an average of six to eight colds per year(8) • Asthmatics have similar upper respiratory tract (nose and throat) symptoms as non-asthmatics(9) • Asthmatics frequently suffer lower respiratory tract (the airways in the lung) infections(9) References 1. American Lung Association. Trends in Asthma Morbidity and Morality. 2007 www.lungusa.org 2. Morbidity & Mortality: 2007 Chart Book on cardiovascular, lung and blood diseases produced by National Heart, Lung, and Blood Institute 3. S. King et al, Persistence of Rhinovirus RNA after asthma exacerbations in children. Clin Exp Allergy 2005 May 35 (5) 672-8 4. P.J. Barnes, B. Johnson, J.B. Klim. The Costs of Asthma. Eur Respir J 1996 9, 636-642 5. National Center for Health Statistics. Deaths: Final Data for 2004 (August 2007) 6. Connors AF Jr et al. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators. Am J Respir Crit Care Med 1996; 154:959-967 7. Espicom Business Intelligence: New Drug Futures: Respiratory Chapter 2006 8. Cold and Flu Guidelines: The Common Cold www.lungusa.org 9. J.M. Corne et al Frequency, severity and duration of rhinovirus infections in asthmatic and non-asthmatic individuals: a longitudinal cohort study. Lancet 2002 Mat 9; 359 (9309):831-4 This information is provided by RNS The company news service from the London Stock Exchange