Schering-Plough/J&J's Simponi gets EU approval for rheumatoid arthritis

The European Commission has approved Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).

The drug was discovered and developed by Centocor Ortho Biotech, a unit of Johnson & Johnson, which retains marketing rights for the USA, where the compound was approved in April. Schering-Plough holds marketing rights outside the USA, excluding China, Japan, Indonesia and Taiwan.

However, it remains unclear whether Schering-Plough will be able to retain its forerunner RA drug Remicade (infliximab) ' which generates revenues of some $2 billion a year- and Simponi rights following completion of its $41 billion acquisition by Merck & Co, which has been structured as a reverse deal. Merck has said it will inherit overseas rights to the drugs, but J&J is planning to challenge that assumption.

The companies are in arbitration over the revenue from Remicade and Simponi, with J&J claiming it is entitled to all of these because S-P is being bought by Merck & Co.

In the latest European Union decision, Simponi is approved as a 50mg subcutaneous injection once a month and is indicated:

' In combination with methotrexate, for the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. Simponi has also been shown to improve physical function in this patient population;

' Alone or in combination with methotrexate, for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. The drug has also been shown to improve physical function in this patient population; and

' For the treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.

In Japan, Indonesia and Taiwan Simponi will be co-marketed by Mitsubishi Tanabe Pharma and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where the drug will be exclusively marketed by Janssen-Cilag (also a J&J unit); and China, where this will be the responsibility of Xian-Janssen.

"With this approval, Schering-Plough can now bring Simponi, one of the five stars in our development pipeline, to market in Europe," said Thomas Koestler, executive vice president and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands upon our leading immunology franchise in meeting the needs of the rheumatology community."