Osteologix Inc. Announces Plans To File For European Marketing Authorization For Proprietary Osteoporosis Drug
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Osteologix Inc. (OLGX.OB) announced that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis.
Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos® (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities. As a result of these discussions, Osteologix has determined that the company will be positioned to pursue a European Marketing Application for NB S101 as a treatment for post-menopausal osteoporosis. The company expects that it can complete the additional development work in 2010 and will be prepared to file a marketing application during the first half of 2011. This pathway is in keeping with the Company's overall strategy of developing its once-daily strontium tablet for the osteoporosis market. Osteologix has initiated discussion with potential regional and global partners and believes that the selected partner(s) will be able to begin marketing the novel product by 2012, providing them with at least 12 years of patent protection in the European Union.
"Following the regulatory meetings, we now believe we are well positioned to leverage our existing data package combined with new clinical data that we expect to generate in the next year to obtain European approval for our lead product. Our strategy to obtain approval for NB S101 is in keeping with current regulatory directives," said Philip J. Young, President and CEO of Osteologix. Young continued: "We are well on our way to achieving a significant milestone for Osteologix and our stakeholders. We believe that our product will be a significant addition to the osteoporosis market, and we anticipate that our product will benefit the millions of women with osteoporosis who are in search of a safe and tolerable therapy."
As previously reported during the 35th European Symposium on Calcified Tissue, the Phase 2 study comparing NB S101 to Protelos demonstrated that NB S101 was safe and well tolerated in the target patient population with the frequency and types of adverse events comparable to those with the active comparator, Protelos (strontium ranelate). NB S101 induced a significant dose-dependent reduction in bone resorption relative to placebo. In addition, all three doses of NB S101 significantly increased bone mineral density (BMD) as measured at the total hip and lumbar spine.
Strontium ranelate, marketed in Europe since 2004 by Servier as Protelos or Osseor®, is the only prescription strontium-based therapy for the treatment of osteoporosis. This year the product is projected to reach sales of more than $300 million, with approximately 80% of this revenue being generated in Europe. Unlike Protelos (strontium ranelate), which is formulated as a powder and packaged in a sachet, NB S101 (strontium malonate) is manufactured as a tablet. Young further states, "We believe our tablet will be preferred over a powder formulation, and should rapidly garner significant market share. We expect the overall strontium market to grow as NB S101 establishes itself as a viable alternative for the treatment of osteoporosis."
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