Orion and Abbott think over phase III study for Simdax

Orion has announced it is considering a further phase III study for Simdax, its calcium sensitiser designed to improve cardiac efficiency by increasing the force of heartbeats and avoiding the build-up of calcium in the heart.

Simdax (levosimendan) is currently marketed by Abbott Laboratories in Germany, France and the UK, although it is a proprietary drug owned by Orion, which markets it in Finland, Norway, Sweden and Denmark. It is in use in over 40 countries.

Orion says it is in negotiations with Abbott regarding the design and scope of any further trial and it adds that one proposal is for Orion to provide the necessary funding.

The drug last year completed two clinical development trials, as reported by Abbott, which agreed renewed licensing arrangements with Orion in 2004. Jeffrey M Leider, who stepped down as chairman and chief executive officer of Abbott’s medical and pharmaceuticals operations, commented at the time: “We believe that levosimendan represents a significant advance in the treatment of congestive heart failure and for patients in many parts of the world, it has already proven beneficial.”

Yesterday a study in the Journal of the American Medical association highlighted a small increased risk of major infections and malignant tumours for users of it Abbott’s anti-TNF drug, Humira (licensed from Cambridge Antibody Technologies). It is used for treating inflammatory autoimmune disorders such as rheumatoid arthritis.

Abbott said the conclusions offered by the journal provided no new information about the drug and the company questioned the researchers’ methods, deeming the study “not consistent” with previous studies on anti-TNF agents.

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