Vectura and Chiesi to develop inhaled HFA systems for systemic drug delivery

23 May 2000

Vectura and Chiesi to develop inhaled HFA systems for systemic drug delivery

Bath, UK … Vectura and Chiesi announce a major new collaboration to develop a novel system for delivery to the lung of systemically active pharmaceuticals based on HFA pMDI technology. The joint R&D programme will focus on selected products to treat Parkinson's disease, Pain and Osteoporosis. This follows on from a successful and on-going collaboration concerning the transition of Chiesi's CFC based suspension pMDI portfolio of asthma products to HFA solution based formulations.

The initial CFC/HFA transition programme between Vectura and Chiesi has resulted in the establishment of Chiesi's proprietary Modulite® HFA technology which has aroused considerable scientific and commercial interest. The first product Beclojet® (beclomethasone dipropionate - Modulite® pMDI), was recently launched in France, taking less than 4 years from project initiation to market. Registration and launch in other European countries is expected within 2001. Further Modulite® formulations involving b 2-adrenoceptor stimulants, other steroids and anti-muscarinics are at advanced stages of development.

In addition to enabling seamless CFC to HFA transition, the initial development programme together with Vectura's proprietary knowledge and expertise in pulmonary delivery has created HFA/pMDI systems for high efficiency drug delivery with fine particle doses better than 80% nominal. An ultimate goal of equivalence between delivered and fine particle dose is feasible and the systems have the potential for targeting to specific areas of the lung, including deep penetration to alveolar regions.

Professor David Ganderton, a Director of Vectura and Senior Consultant in pulmonary drug delivery states that:
"The vigorous re-evaluation of drug delivery via the lungs springs partly from the necessity for the administration of large labile molecules and partly from a new precision in aerosol generation. The latter is exemplified in the precise matching of CFC, and HFA products by Chiesi Farmaceutici/Vectura. This very successful collaboration is now being extended to apply the design of very fine, slow moving clouds to produce systems suitable for systemic absorption."

The initial focus of this new Vectura/Chiesi collaboration will be on potential treatments for osteoporosis (HRT), pain and parkinsonism, with Vectura having responsibility for development pharmaceutics, formulation and technical aspects of pMDI device development (valves, cans, actuators) including active dose discharge systems. Chiesi will fund this activity at Vectura and a 2.5 million dollars/euros budget has been ear-marked for the initial formulation/device development studies. Chiesi will be responsible for manufacturing scale-up, toxicity, clinical studies, registration and commercialisation. This new Vectura/Chiesi collaboration embodies royalty sharing arrangements between the companies.

Notes for editors

Vectura Ltd is a specialty pharmaceutical business which combines the proven capabilities of the UK's pre-eminent academic centre for drug formulation and delivery with a series of proprietary therapeutic development programmes, focused in four key areas (pulmonary delivery, tissue targeting, oral powders, dermal dosage forms)
The Company, founded in 1997, is based in Bath, England and employs ~50 people in its two operating divisions:* Vectura Core R&D: Research and Development of proprietary drug delivery technologies, delivery devices, carriers , pro-drugs and the development of therapeutics based on these approaches.

Vectura Development Services: A sophisticated drug formulation and delivery service business building on the success of the University of Bath's Centre for Drug Formulation Studies and Co-ordinated Drug Development Ltd. which were acquired by Vectura in 1999 Contact at Vectura Ltd

Peter Virley
Phone +44 1249 667700
Email: enquiries@vectura.com

Chiesi Farmaceutici is a privately owned research based pharmaceutical company located in Parma (Italy). Chiesi's core business areas are: asthma, cardiovascular and muscle skeletal. Chiesi Group turnover in 1999 was about 350 mill euros. The company, which ranks 15 in the Italian market, is also directly present in: France, UK, Spain, Greece, Brazil and Pakistan. Company's business strategy is to consolidate and expand its direct presence in the European Community, and maximise its sales through distributors in other countries. Contact in Chiesi Farmaceutici SpA

Gaetano Brambilla
Phone: +39 - 0521 - 279 680
E-mail: g.brambilla@chiesigroup.com

HFAs are HydroFluoroAlkanes a group of volatile chemicals used as propellants, which are replacements for CFCs and are ozone-sparing, this makes them an environmentally attractive solution for delivering pharmaceutical aerosols. pMDIs are pressurised Metered Dose Inhalers, another term for aerosols containing drugs dissolved or dispered in propellants, such as HFAs, pressurised in cans and sprayed through a valve which releases measured doses of aerosol in each shot. For further information please contact:

For further information please contact:

Vectura Limited
Peter Virley
Tel: +44 (0)1249 667700
Fax: +44 (0)1249 667701
Email: enquiries@vectura.com

Financial Dynamics
David Yates / Lucy Briggs
Tel: + 44 (0) 207 269 7242