Pro Bono Bio Launches Flexiseq™: A Novel Approach to the Treatment of Osteoarthritis
Product News Sep 12, 2011
Pro Bono Bio™, has announced the launch of Flexiseq™, an unique approach to the treatment of osteoarthritis in the UK. Pro Bono Bio plans to launch Flexiseq™ in Germany in October and other European markets will be phased in over the next two years.
Extensive clinical trials have shown that Flexiseq™ is clinically effective in treating OA pain, and a European Phase III trial completed in 2009 involving 698 patients in the three arms (Flexiseq™, celecoxib and the placebo) showed that Flexiseq™ is as effective as the leading prescribed COX-2 product for patients suffering pain caused by osteoarthritis.
This study and others have also shown that Flexiseq™ is generally safe and well tolerated. It is estimated that there are over 80 million osteoarthritis sufferers in Western Europe and CIS, around half of whom are diagnosed and who may be looking for improved options to treat their osteoarthritis.
Pro Bono Bio believes that Flexiseq’s characteristics will make it an important new entrant into the prescription osteoarthritis market given the limited number of treatment options that have been introduced over the last five years.
Clinical trials in over 1,000 patients have shown that Flexiseq™ is both efficacious and well tolerated. The only side effects attributed to the product have been transient, localized skin irritations experienced by a small proportion of the patients.
Flexiseq™ has also been used alongside oral NSAIDS without adding to their side effects. These promising results have been demonstrated for treatment periods of up to a year.
Flexiseq™ is available as a gel that contains absorbing microstructures, called Sequessomes, which are able to cross the skin and reach the site of pain.
Sequessomes physically absorb (sequester) and remove chemicals that are a key component in the pain and inflammation cascade. Flexiseq™ provides a localized, soothing effect on joint pain.
Flexiseq’s novel mode of action allows it to be used either alone or in conjunction with the patient’s existing osteoarthritis treatment regime.
Flexiseq™ has no known interactions with other medicines, so patients who are taking other therapies can achieve pain relief with Flexiseq™ without stopping their other treatments, including NSAIDS.
Osteoarthritis is a condition where patients and physicians are still looking for improved therapies. The World Health Organization has measured the prevalence of the disease around the world and has shown that the average disability adjusted life years lost (per capita) due to osteoarthritis is much higher in the CIS than in most of the rest of the world. This medicine will therefore particularly benefit the Russian public.
Pro Bono Bio has a humanitarian pricing policy and as part of this it will be periodically shipping free supplies of Flexiseq™ to The East African Community. Overtime these shipments will equal the number of Flexiseq™ tubes sold at normal prices in West European markets.
Flexiseq™ is expected to launch in Russia in the second quarter of 2012 once Russian regulatory approval has been received and is expected to be priced there at a discount to West European markets.
Flexiseq™ is the first of several products that use Sequessome Technology™ and which are the subject of several global patents.
Michael Earl, Chief Operating Officer of Pro Bono Bio, 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 has been kept secret to coincide with the launch of Pro Bono Bio – now the secret is out we are expecting Flexiseq™ to draw a lot of attention from physicians and patient groups.”