European regulators have given clearance to Johnson & Johnson/Schering-Plough’s Simponi for the treatment of three rheumatic conditions: rheumatoid arthritis; psoriatic arthritis; and ankylosing spondilitis.

Following an approval in the US in April this year, the human monoclonal antibody Simponi (golimumab) has now also been given the green light in Europe as a once-monthly injection to treat moderate-to-severe, active RA in adult patients who have failed to respond to therapy with disease modifying anti-rheumatic drugs.

In addition, doctors are allowed to prescribe the drug alone or in combination with
methotrexate to treat active, progressive psoriatic arthritis in adult unresponsive to previous DMARD therapy, as well as for patients with severe, active AS who have responded inadequately to conventional treatments.

According to the firms, Simponi is the first and only once-monthly subcutaneous anti-tumor necrosis factor (TNF)-alpha cleared for all three conditions, and is available through SmartJect autoinjector or as a prefilled syringe. Its once-monthly dosing regimen offers an advantage over other anti-TNFs on the market such as Amgen/Wyeth’s Enbrel (etanercept), which needs to be injected every week, and Abbott’s every-other-week jab Humira (adalimumab).

Approval came on the back of a package of Phase III clinical trial data based on over 2,000 patients which showed the drug to be both safe and effective, although like others in the class Simponi must carry a boxed warning regarding the risk of contracting tuberculosis and serious fungal infections.

The drug, which analysts believe could rake in sales of $3 billion in the coming three years, was discovered and developed by J&J unit Centocor Ortho Biotech but S-P now owns rights in various markets including Europe.

Fight for rights
However, J&J is currently doing its best to terminate the groups’ marketing agreement for Simponi and the blockbuster Remicade (infliximab), as it argues that S-P’s merger with Merck & Co constitutes a “change of control” that would permit the termination of its arrangements. Merck and S-P, however, are arguing that they are undertaking a reverse merger, which basically enables the latter to continue operating as a separate entity.

In the meantime, “Schering-Plough can now bring Simponi, one of the five stars in our development pipeline, to market in Europe,” commented Thomas Koestler, executive vice president and president of Schering-Plough Research Institute. “Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients”, he added.