Johnson and Johnson (JNJ) recently presented long-term data from two phase III clinical trials of Simponi (golimumab), carried out on rheumatoid arthritis (RA) patients. It was observed that patients taking Simponi every four weeks achieved sustained improvements through one year. The data were presented at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting held last month.

Data from the first trial – GOlimumab After Former anti-TNF (tumor necrosis factor) Therapy Evaluated in RA (GO-AFTER) revealed that patients previously treated with TNF inhibitors (adalimumab, etanercept or infliximab) responded as well as showed continued response to the drug for an entire year. At week 52, data measured by American College of Rheumatology (ACR 20) response found a 20% improvement in arthritis symptoms in 63% of patients receiving the drug while 41% of the patients achieved a 50% improvement in arthritis symptoms measured by ACR 50 response.

Results from the second trial – GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) study proved the effectiveness of Simponi in patients with active RA despite prior treatment with methotrexate. Like the earlier trial, this trial also presented positive results for Simponi. At week 52, 64% of patients taking the drug and methotrexate achieved ACR 20 response while 25% achieved a 70% improvement in arthritis symptoms as measured by ACR 70 response. Both these studies were carried out with Simponi in 50 mg dosage as a once-monthly subcutaneous injection.

Earlier in April 2009, Simponi received approval from the US Food and Drug Administration and Health Canada approved Simponi for the treatment of moderate to severe active RA, active psoriatic arthritis (PsA) and active ankylosing spondylitis. Thereafter, in October 2009, the drug received approval from the European Commission as well.

As a reminder, on May 27, 2009 Johnson & Johnson announced an arbitration demand against Schering-Plough (now a part of Merck, MRK) requesting a ruling regarding the ex-US rights of Remicade and Simponi. J&J developed both compounds and licensed marketing rights outside the US to Schering-Plough. However, J&J contends that the merger between Schering-Plough and Merck has triggered a change of control provision in the licensing agreement, resulting in its termination, thereby returning full rights to the compounds to J&J.

Remicade is approved for 15 indications in the US alone including RA. Remicade generated almost $5.9 billion in worldwide revenues in 2008 Incorporatedluding $2.1 billion in sales outside the US, which Schering-Plough booked as revenues. The pending case is of great importance to both companies given the sales contribution from the product. We are Neutral on J&J.

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