The Federal Association of German Pharmacists (BVDA) today presented its “Innovation Award 2013” to FLEXISEQ®, an innovative new treatment for pain and stiffness associated with osteoarthritis (OA).
The BVDA president, and pharmacist Thomas Hieble, explained;“The jury awarded the prize to FLEXISEQ® in recognition of the application of its innovative Sequessome Technology® to deliver symptom relief to sufferers of OA. The technology incorporates highly flexible phospholipid vesicles which can penetrate the skin and into the affected joint below. Once inside the joint, they accumulate on the surface of the cartilage to lubricate it.
The result: pain relief and increased joint mobility – achieved conveniently and without the risk of the well recognised, systemic side effects associated with drugs typically used for the treatment of OA.”
In their latest editions, various renowned medical journals such as “Ärzte Zeitung” and the “Zeitschrift für Rheumatologie” reported on this medical advance.
FLEXISEQ has an innovative mode of action due to its use of Sequessome Technology and its convenient gel formulation enables patients to self administer FLEXISEQ topically to the affected joint. The Sequessome™ vesicles contained within are proven to enter the synovial joint after application and increase phospholipid levels in the synovial fluid where they are known to be depleted in joints affected by OA. This physical, mode of action reduces the pain, (in phase III clinical trials, as effectively as the frequently prescribed oral drug medicine – celecoxib) and also improves joint mobility, thereby giving easier movement to patients.
Hundreds of millions of people worldwide suffer from OA, a chronic joint disease which makes the lives of those affected permanently more difficult. According to the Robert Koch Institute, the likelihood of contracting OA increases dramatically with age.
Professor Herbert Kellner, Munich, one of the panellists at the BVDA awards said, “More than 50% of people over 65 have already developed OA and its prevalence is as high as 90% in people over 75. Thus OA is of enormous social and economic significance.”
Patients with OA suffer from chronic pain and joint stiffness. “NSAID’s and COX II’s are frequently used without critical evaluation”, said Professor Martin Wehling, of The University of Heidelberg, a specialist in elderly patients with cardiovascular conditions. “However, this class of drugs is associated with a high risk.” He estimated that every year more than 3,000 patients die from bleeding complications in Germany alone. Wehling said that he was acutely aware that many OA patients also have other health issues such as cardiovascular conditions and hence NSAIDs/COX II are contra indicated or must only be used with caution in patients. In addition, chronic NSAID use is associated with approximately 20 other severe side effects. FLEXISEQ now provides a more appropriate and safer solution for these patients. This enables sufferers to avoid drug to drug interactions with other medicines which they may need to take for other common diseases. FLEXISEQ does not contain any pharmacological ingredients but provides a physical rather than chemical based treatment for this painful and debilitating disease. This physical approach avoids many of the significant side effects of conventional chemical based treatments alluded to by Professor Wehling.
Dr Matthias Rother, Munich, who was instrumental to the development of Sequessome Technology, explained that “FLEXISEQ was evaluated in a comprehensive clinical trial programme: 1,675 patients were treated with FLEXISEQ in six studies. Even for a treatment period, within one of the trials of up to 52 weeks, FLEXISEQ was well tolerated.”
Michael Earl, Chief Operating Officer of Pro Bono Bio, who own FLEXISEQ, said “Leading Rheumatologists are concerned about the limited treatments available for OA sufferers and also about the side effects of some existing therapies. FLEXISEQ is an important part of the answer to these concerns. Its launch in its home market of Germany in 2012 drew a lot of attention from physicians and pharmacists. We are delighted to win the BVDA Innovation
Award 2013, and encourage German patients to visit their local pharmacist to find out more about this exciting development for the millions of sufferers of Osteoarthritis in Europe. We are also delighted we have already started to export FLEXISEQ to Asia where the product has received a very warm welcome.”
Separately from the BVDA award, German patients are already benefiting from the treatment. One patient who wishes to remain anonymous reported, “I started using FLEXISEQ on the 3rd January 2013. Before then, I was hardly able to walk properly, sometimes I used walking aids but did not get further than 60 m and I was in a lot of pain. I heard about FLEXISEQ on ‘Feierabend.de’ and I AM VERY HAPPY! Now I can already walk 1.5 km – without pain!! I have an appointment for a scan of my knee in a clinic on the 3rd of April, but I am unsure whether to attend the appointment.”
Ascension Healthcare plc is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for the treatment of haemophilia and osteoarthritis. The Company has three products in clinical development for the treatment of haemophilia A and also a range of internationally marketed products for osteoarthritis sufferers. For more information please visit: www.ascension.co.uk/
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