NPS Pharmaceuticals, Inc. announced that the company and its partner for European commercialization of Preotact (full-length parathyroid hormone [PTH 1-84]) (US trade name PREOS ), Nycomed, have entered an agreement expanding and amending rights and responsibilities under the Preotact license originally entered into in 2004.
Under the new agreement, Nycomed will gain the right to commercialize Preotact in all ex-US territories, excluding Japan, for which NPS retains commercial rights, and Israel which is the subject of a pre-existing distribution agreement with Israel-based Neopharm, Ltd. Upon registration and approval in the United States, rights to Canada and Mexico will revert to NPS.
According to a NPS Pharma press release, the agreement provides for the transfer of manufacturing responsibility from NPS to Nycomed for drug supply in its territories. Additionally, the agreement grants NPS the right to monetize the royalty stream from Preotact sales. As part of the manufacturing transfer, Nycomed will pay NPS $11 million for a significant portion of the existing bulk drug supply. Additional financial details were not disclosed.
Tony Coles, M.D., president and CEO of NPS said, "This transaction does two important things. First, it provides for broader registration and commercialization of PREOS globally. Preotact has had a good launch in the European markets and appears to be well accepted by physicians and well tolerated by patients. Second, this transaction supports our strategy to consolidate operations. The transfer of non-US manufacturing responsibility allows us to focus our investment and efforts on advancing our late-stage compounds, PREOS and teduglutide."
Hakan Bjorklund, Nycomed CEO stated, "This expanded agreement allows Nycomed to fully leverage the commercial capabilities and infrastructure we gained through the acquisition of ALTANA Pharma. The early experience with Preotact in the European markets has been encouraging and we look forward to continuing to build our global presence with a product as therapeutically important as Preotact."
NPS developed Preotact and licensed European and CIS marketing rights to Nycomed in 2004. The drug was approved by the European Medicines Agency in 2006 for the treatment of osteoporosis in postmenopausal women at high risk of fractures and has been launched in most of the major European markets. Nycomed expects to complete the drug's launch throughout the European Union this year.
NPS discovers and develops small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development backed by a strong discovery research effort.