Strontium Succinate

Dublin, 3 March 2014
http://www.osteologix.com/wb0005.php?oid=0

Les Laboratoires Servier has terminated its licensing agreement with Osteologix for developing and commercializing NB S101 (strontium malonate) to treat post-menopausal osteoporosis, other bone and joint disorders and dental indications. As a result, Osteologix regains all rights to continue the development and commercialization of its improved formulation once day tablet of Strontium Succinate either independently or in collaboration with third parties. The company is currently assessing the most favorable way to move forward and will evaluate all options.

Development Plan for Strontium Malonate in U.S.

On August 16, 2010, Osteologix, Inc., filed its quarterly Q-10, a required financial statement. Part of the report is quoted here: "We believe that our available existing resources will provide liquidity to fund our planned operations, excluding any clinical trials, into the second quarter of 2011. Because the business of developing pharmaceutical products is time-consuming and expensive, and NB S101 (strontium malonate), our most advanced investigational drug, still must complete pivotal human clinical trials before it can be marketed, we will require additional financial resources to carry out our business strategy. The development plan for NB S101 will require a larger phase 2 and/or phase 3 clinical trial that we estimate will take at least two years to complete. After or possibly concurrent with our next clinical trial, either one or two similar or potentially larger phase 3 trials will be required. We are seeking a third party development partner with substantially more resources than us for further clinical development in the United States, and we do not expect to proceed with further U.S. clinical development until we enter into a development agreement with such a partner Off-Balance Sheet Arrangements."

Strontium Malonate Licensing Agreement

On August 2, 2010, Osteologix and Servier announced an ex-U.S. licensing agreement for NB S101 (strontium malonate). Osteologix has granted Servier an exclusive royalty-bearing license to develop and commercialize NB S101 to treat postmenopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the United States. Under the terms of the agreement, Osteologix will receive up to €12 million in upfront and milestone payments. Additionally, Osteologix is eligible to receive up to €30 million in minimum royalty payments creditable against mid to low single digit royalties on sales. Osteologix will also be eligible to receive milestone payments and royalties on product development and sales in Japan. Servier will be responsible for all costs outside of the U.S. associated with development, regulatory approval and commercialization of NB S101. Osteologix will continue to own intellectual property rights for development in the U.S. This information is from a press release issued by Osteologix at http://www.osteologix.com/wb0005.php?oid=12.

Comparison of Strontium Malonate to Strontium Ranelate

Currently, Osteologix’s primary goal is to obtain approval for NB S101 (strontium malonate) for the treatment and prevention of osteoporosis. Their phase I study of the pharmacokinetic, or PK, properties of NB S101 revealed that a one gram tablet dose of NB S101 resulted in approximately the same level of strontium in human serum as a European company's approved product containing two grams of strontium ranelate in sachet formulation, which must be mixed with water before ingestion. Thus, at a significantly lower dose, their tablet formulation of strontium has shown bioequivalent levels of strontium to a marketed sachet product that has been proven safe and effective in osteoporotic patients in Europe.

More importantly, the recent results of their phase II study demonstrated that NB S101 decreased an established biomarker of bone resorption, CTX-1, in a dose-dependent manner by an amount statistically equivalent to or superior to the product approved in Europe. The phase II results also showed that NB S101 significantly increased bone mineral density at the lumbar spine and hip with only 12 weeks of treatment, and no significant side effects were noted in the trial.

Update On Strontium Malonate For Osteoporosis

Osteologix, Inc. has received a key U.S. Patent Allowance for its osteoporosis drug, NB S101 (strontium malonate). This brings the company closer to its goal of manufacturing and marketing a prescription strontium drug in the U.S.

The Notice of Allowance from the U.S. Patent and Trademark Office is for U.S. Patent Application Number 11/269,289 titled "Water-Soluble Strontium Salts for Use in Treatment of Cartilage and/or Bone Conditions." It allows claims covering the treatment of osteoporosis and related bone conditions using NB S101 (strontium malonate). The patent will most likely issue in the second half of 2009 and expire in 2024.

The company has a number of other pending patent applications covering various aspects of the NB S101 drug program, including composition, manufacturing and method of use patent applications. "Based on the Notice of Allowance and the claims allowed by the USPTO, we believe the intellectual property protections established by this US patent allowance, coupled with our recently upheld European equivalent, will significantly enhance our ability to finalize strong development collaborations with potential partners to complete the Phase III development of NB S101 in osteoporosis," stated Philip J. Young, President and Chief Executive Officer of Osteologix. This is from the company's website at http://www.osteologix.com/.