2001
An innovative new breath-actuated inhaler providing better asthma management completes first development phase
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05 July 2001
SkyePharma plc and Meridica Ltd, the new drug delivery company formed by PA Consulting Group, today announced the successful completion of the design and formulation stage for Xcelovent™ - an innovative breath-actuated metered-dose inhaler for use with ozone-friendly formulations of Budesonide and Formoterol which they are developing jointly. The two companies also announced the start of clinical lung deposition studies using the device, which SkyePharma and Meridica aim to bring to market in record time. Xcelovent™ will provide better treatment for asthma sufferers in a market currently worth an estimated $5.8 billion and growing.
The health benefit
Xcelovent™ removes the need for patients to co-ordinate triggering of the device with inhalation, so ensuring the best possible and most accurate delivery of the drug into the lungs. Inadequate co-ordination often results in less than the prescribed dose being delivered to the lungs. It is particularly important to eliminate the possibility of variable dosing for the modern preventative treatment of asthma and chronic obstructive pulmonary disease (COPD).
Speed of development
The initial phase of the Xcelovent™ development, including finalisation of design and the formulation of two initial compounds to be delivered by the device, has now been completed according to plan. Since its inception, Meridica and Skyepharma, working with PA's device development group, have taken the development of Xcelovent™ from the drawing board to fully functional moulded devices in less than 15 months, an industry record by far. In parallel, the patented CFC-free formulations of Budesonide and Formoterol have successfully passed long term stability tests, and SkyePharma and Meridica are now seeking licensees for both compounds under development.
Clinical lung deposition studies - an important milestone
Xcelovent™ will commence clinical lung deposition studies in asthmatic patients in July 2001. The aim of this study is to demonstrate equivalence with a standard 'press and breathe' metered dose inhaler (MDI) under circumstances that remove the inherent user induced variability of dosing. It is recognised that over 50% of patients, particularly children and the elderly, receive sub-optimal medication using press and breathe MDIs . These studies are intended to confirm that the device delivers the required quantity of drug to the right place within the lung without the need for careful co-ordination.
Michael Ashton, CEO of SkyePharma plc said:
"I am very pleased with the progress of this project. SkyePharma's leadership position in dry powder inhalation and its formulation expertise in non-CFC metered dose inhalers is widely recognised in the drug delivery industry. PA's novel breath actuated inhaler device will significantly strengthen our franchise in inhalation delivery technologies."
Jon Moynihan, Chairman of Meridica and PA's Executive Chairman, said:
"PA's world-renowned product development and project management skills, combined with Meridica's and SkyePharma's industry expertise, has enabled this product to reach this stage of development in record time. We are delighted to be involved with this pioneering project which will benefit thousands of asthma sufferers''.
Dr Ian Smith, President at Meridica comments:
"In the 21st century it is unacceptable for important drugs for the treatment of life-threatening respiratory diseases like asthma and COPD to be delivered other than by a breath-actuated device. Xcelovent™ will fill an important market need, giving both physicians and patients the highest level of assurance that the correct dose has been delivered. Patients deserve better than some current treatments on offer."
New 'better asthma management' Web site
To underpin this important step in drug delivery, a new Web site, www.betterasthmanagement.com gives full details of the project and the licensing opportunity.
ends
For more information, please contact:
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| David Edwards |
| PA Consulting Group |
| Cambridge Technology Centre Melbourn |
| Royston |
| SG8 6DP |
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Tel: +44 1763 261 222 |
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E-mail:
david.edwards@meridica.com |
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Notes to editors
1. SkyePharma PLC, one of the world's leading drug delivery companies, develops and manufactures advanced drug-delivery solutions. Its five platform technologies (oral controlled release, inhalation, injectables, topical delivery and solubilization technology) give SkyePharma a presence in over 95% of the fast growing drug delivery market. SkyePharma has the facilities and expertise to develop products from feasibility stage to commercial launch.
Through its wide range of innovative technologies and services, SkyePharma offers its clients a one-stop shop. Additionally, SkyePharma uses its delivery technology to build a pipeline of internally developed pharmaceutical products. SkyePharma is headquartered in London with major R&D and production centres in San Diego, US, Muttenz, Switzerland and Lyon, France.
2. Meridica's vision is to become the leading source of creative drug delivery systems and drug products for the pharmaceutical sector, based on the excellence and quality of its products. It will enable the full exploitation of the 'biotechnological' advances made in the last decade, and build a position as the leading industry provider of cutting-edge solutions to delivery systems.
Although Meridica Limited is a wholly-owned PAGroup company, it operates as a separate and independent entity with its own board, senior management team, finances and development organisation.
3. PA Consulting Group is a leading management, systems and technology consulting firm, with a unique combination of these capabilities. Established almost 60 years ago, and operating world-wide from over 40 offices in more than 20 countries, PA draws on the knowledge and experience of around 4,000 people, whose skills span the initial generation of ideas and insights all the way through to detailed implementation.
PA builds strategies for the creation and capture of shareholder and customer value, and helps clients accelerate business growth through innovation and the application of technology. PA works with clients to improve performance, mobilise human resources and deliver change effectively, including managing major projects, and designing and implementing enterprise-wide systems and full e-business solutions.
PA focuses on creating benefits for clients rather than merely proposing them, and this focus is supported by an outstanding implementation track record in every major industry and for governments around the world. PA also develops leading-edge technology both for its clients and within its own portfolio of venture companies in areas ranging from software to wireless technology to life sciences.
PA distinguishes itself from its competitors through the range and quality of its people, the depth of its industry insight, its development and use of technology, and also its independence and culture of respect, collaboration and flexibility in working with clients.
We are proud that our clients say "PA makes it happen".
4. PA Consulting Group has a unique combination of pharmaceutical industry expertise and engineering capability, delivering solutions from concept right through to launch. PA Consulting Group offers its clients (including Meridica) a world-class service in the design and development of inhalation devices and other drug delivery products.
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