Marking its own progress and in recognition of World Osteoporosis Day, USA-based Osteologix says it will continue the clinical development for its osteoporosis drug, NB S101 (strontium malonate), in the USA. An Investigational New Drug application for the drug ' which has reached Phase II trials, was accepted by the US Food and Drug Administration last year.
'We believe that NB S101 will bring a safe and effective new alternative therapy for the millions of patients with osteoporosis. Our product can be manufactured and commercialized in a way that should also appeal to the cost conscious patients, physicians and payers,' said Philip Young, chief executive of Osteologix. 'In addition, our recently expanded global patent estate will allow our shareholders a long window of opportunity to realize returns on their investments,' he added.
Different from other drug therapies available in the USA, NB S101 is a dual acting bone agent (DABA), designed to benefit patients by strengthening the bone in two ways. Unlike the aggressive actions of other therapies, which can sometimes lead to brittle bones after several years of therapy, strontium is a moderate anti resorptive drug that also works to enhance bone mineralization giving the patients stronger, more fracture-resistant bones. Another key advantage researchers note is that strontium therapy is an excellent choice for the significant number of women who cannot take or tolerate bisphosphonate treatment, (the largest class of drugs currently used to treat osteoporosis).
Benefits claimed over Servier's Protelos
Currently, there is one prescription strontium therapy widely used in Europe and other parts of the world, Protelos (strontium ranelate), which is marketed by the independent French pharmaceutical company Laboratoires Servier. Protelos has been prescribed for five years and has demonstrated excellent efficacy and safety in patients of all ages. It is unavailable in the USA.
Strontium therapy with NB S101 should be preferred over the French product, Osteologix claims. First, NB S101 is a tablet, not a powder that needs to be suspended in water, which the US firm believes will aid in compliance, as it is easier for patients to take. Second, studies conducted by the company have demonstrated that NB S101 has better bioavailability -- meaning the patients can take a lower dose of the active element, strontium, and obtain the same blood level. Osteologix believes that its drug will provide fracture reduction and safety on par with or better than the French product.
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