Osteologix IND For NB S101 For Osteoporosis Accepted By FDA

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 May 2008 - 2:00 PDT

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Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead development candidate NB S101 (strontium malonate), for the treatment and prevention of osteoporosis. NB S101, a dual acting bone agent, has a demonstrated ability to decrease resorption of bone while maintaining formation of new bone. The drug has been formulated as a convenient once-daily tablet.

In September 2007, the company presented data from a Phase 1 study at the American Society for Bone and Mineral Research, demonstrating that NB S101 has superior bioavailability as compared to Protelos® (strontium ranelate), a strontium-based compound approved for sale in Europe and other territories outside the United States.

In November 2007, Osteologix announced significant results from its Phase 2 STRONG Study, demonstrating that NB S101 met its primary endpoint. At all doses tested, NB S101 demonstrated statistically significant decreases in CTX-1, a well-validated biomarker that measures bone resorption activity. When directly compared to the EU-approved strontium drug Protelos®, a 2 gram dose of NB S101 achieved significantly greater reductions of CTX-1 (p<0.001) than the 2 gram dose of Protelos. In addition, all dose groups demonstrated significant increases in bone mineral density at 12 weeks.

The Company will present data from the Phase 2 STRONG Study at the European Calcified Tissue Society May 22, in Barcelona Spain.

Regarding the IND acceptance, Osteologix President and Chief Executive Officer Philip Young said, "This is an important step in the process of developing this exciting compound and we look forward to working with the agency as we prepare for the next clinical trials."

About Osteoporosis

Osteoporosis is the most common bone disease and, according to the National Osteoporosis Foundation (NOF), 10 million Americans are estimated to have the disease and almost 34 million more are estimated to have osteopenia, or low bone mass, placing them at increased risk for osteoporosis. The most severe consequence of osteoporosis is skeletal fracture. Osteoporosis is responsible for more than 1.5 million fractures annually and direct expenditures for hip fractures are estimated to cost society more than $18 billion annually. According to NOF, one in two women and one in four men over age 50 can be expected to have an osteoporosis-related fracture at some time.

About Osteologix

Osteologix is a specialty biopharmaceutical company committed to improving the health of those afflicted with musculoskeletal diseases, such as osteoporosis, by developing innovative therapies. Its lead investigational product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. For more information please visit http://www.osteologix.com.

Forward Looking Statements

Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding clinical trial results of NB S101, Osteologix's plans for Phase 3 clinical trials, the estimated size of the market and the potential therapeutic benefits and side-effects of NB S101. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Osteologix's ability to commence, enroll or complete future clinical trials of NB S101, risks that the FDA or other regulatory bodies may require additional data or additional pre-clinical or clinical trials of NB S101, the results of future clinical trials or non-clinical studies of NB S101 (including product safety issues and efficacy results), Osteologix's ability to secure and obtain adequate supplies of NB S101 and risks related to Osteologix's ability to obtain intellectual property rights for NB S101. Further information regarding these and other risks is included under the heading "Risk Factors" in Osteologix's Report on Form 10-K, which was filed with the Securities Exchange Commission on March 25, 2008 and is available from the SEC's website (http://www.sec.gov) and on our website (http://www.osteologix.com) under the heading "Investors." Osteologix undertakes no duty to update any forward-looking statement made in this news release.

Osteologix