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Genta and Emisphere Technologies Enter into Exclusive Worldwide Licensing Agreement for Development of an Oral Gallium Compound.

Article Excerpt
Novel Product May Address Important Diseases Associated with Accelerated Bone Loss

BERKELEY HEIGHTS, N.J. and TARRYTOWN, N.Y., March 23 /PRNewswire-FirstCall/ -- Genta Incorporated and Emisphere Technologies, Inc. today announced that they have entered into an exclusive worldwide licensing agreement to develop an oral formulation of a gallium-containing compound. Gallium compounds are bone-targeting agents that are potent inhibitors of bone breakdown and may be broadly useful for diseases associated with accelerated bone loss. Ganite(R) (gallium nitrate injection), Genta's first commercialized product, is derived from this class of compounds and is approved in the U.S. for patients with cancer-related hypercalcemia. The license is a result of a research collaboration between the two companies that has demonstrated the ability of Emisphere's eligen(R) technology to deliver an oral gallium-containing compound in preclinical in vivo models.

Under the agreement, Emisphere will utilize its proprietary oral delivery technology, eligen(R), to supply a finished oral dosage form to Genta. Genta will be responsible for toxicology, clinical development, regulatory submissions, and worldwide commercialization. In addition to royalties on net sales of the product, Genta has agreed to fund Emisphere's development activities and to pay performance milestones related to filing and approval of regulatory applications. Patent applications have already been filed worldwide that may provide up to 20 years of protection on oral products.

"Compounds such as bisphosphonates have been established leaders in this space for some time. However, emerging safety consideration such as GI intolerance and osteonecrosis combined with substantial efficacy of IV Ganite,...