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Note 20 - Subsequent Events
6 Months Ended
Jun. 30, 2012
Subsequent Events [Text Block]
NOTE T – SUBSEQUENT EVENTS

On July 20, 2012 the EMA issued a press release concerning the marketability of approved calcitonin products in Europe, concluding there was evidence of a small increased risk of cancer with long-term use of current calcitonin medications approved and commercially available in Europe since 1973, and calling for curtailment of calcitonin usage.  On August 1, 2012, Health Canada announced that it is reviewing whether to follow European medical authorities and restrict use of a nasal spray prescribed to prevent osteoporosis because of the increased risk of cancer.

The Company has licensed to USL its patented nasal formulation of calcitonin for commercialization in the United States and has licensed the development and worldwide commercialization rights (except China) for its Phase 3 oral calcitonin to Tarsa.  However, since neither the Company nor its licensees are Market Authorization Holders in Europe, they do not have the right to appeal the EMA's recommendation.  The potential regulatory and commercial impact of this announcement on calcitonin related products marketed or under development by the Company’s licensees and partners in Europe and other markets as well as the resulting financial impact on its future business operations is currently being evaluated.  There is a possibility that other regulatory authorities, including the FDA, could take actions as a result of the EMA recommendation, including withdrawing calcitonin products from the market or limiting their use.  This could materially adversely affect the Company’s finances and operations by reducing or eliminating sales and royalties on Fortical, limiting the value of current calcitonin development projects and limiting the potential value of its investment in Tarsa.  Additionally, this could impact the carrying value of assets, including fixed assets, inventories and patents, as well as the Company’s ability to obtain adequate financing.   See Note A for additional discussion on the impact of these events on the Company’s liquidity.