Nycomed expands Preotact® deal


Nycomed and its partner NPS Pharmaceuticals announced today that they have entered an agreement expanding and amending rights and responsibilities under the Preotact® (full-length parathyroid hormone [PTH 1-84]) 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 Neopharm.

Håkan Björklund, Nycomed CEO said, “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.”

Tony Coles, M.D., president and CEO of NPS said, “This transaction does two important things. First, it provides for broader registration and distribution of PREOS globally. Preotact has had a good start in the European markets that have launched and appears to be well accepted by physicians and well tolerated by patients. Second, it supports our strategy to consolidate our operational efforts and improve operating efficiency. This transfer of manufacturing responsibility allows us to focus our investment and efforts on advancing our late-stage compounds.

Upon registration and approval in the United States, rights to Canada and Mexico will revert to NPS. The agreement also provides for the transfer of manufacturing responsibility from NPS to Nycomed for drug supply in its territories. The agreement grants NPS the right to monetize the royalty stream and all future royalty income, as a result of Preotact sales. Additional financial details were not disclosed.

NPS developed Preotact (U.S. trade name PREOS®) and licensed European and CIS marketing rights to Nycomed in 2004. The drug was approved by the European Commission 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.

About Preotact

Preotact (US trade name Preos®) is a full-length parathyroid hormone (PTH 1-84). NPS has studied Preotact in a number of clinical settings to document its safety and its effect on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-centre, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH (1-84) to reduce the risk of vertebral fractures in post-menopausal women.

In the TOP study Preotact demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without osteoporosis-related fractures prior to entering the study. Results from the TOP study have been the foundation of both the EU and the US marketing authorisation applications.

About Nycomed

Nycomed provides products for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group had non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).

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