Johnson & Johnson (JNJ) recently received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Simponi (golimumab).
Johnson & Johnson was looking to expand Simponi’s label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance of reduction of signs and symptoms and maintenance of improved physical function in the treatment of moderately to severely active rheumatoid arthritis (RA).
The company had filed the sBLA in Sep 2010. In order to determine the steps needed to gain approval for the expanded indication, Johnson & Johnson intends to meet with the FDA and discuss the CRL.
Simponi, a once-monthly anti-tumor necrosis factor (TNF)-alpha therapy, first gained approval in the US, Europe and Canada in 2009 for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis.
Earlier this year, Simponi gained EU approval for use in combination with methotrexate for the treatment of adults with severe, active and progressive RA not previously treated with methotrexate, and for the reduction in the rate of progression of joint damage as measured by X-ray in patients with RA.
This was followed by approval in Japan for the treatment of RA including the prevention of articular structural damage in patients who showed inadequate response to conventional therapies.
While Johnson & Johnson markets Simponi in the US, Canada, Central and South America, the Middle East, Africa and Asia Pacific, Mitsubishi Tanabe Pharma Corporation has distribution rights in Japan, Indonesia, and Taiwan. Johnson & Johnson has retained co-marketing rights in these countries. Meanwhile, Merck & Co, Inc. (MRK) has distribution rights in Europe, Russia and Turkey. Simponi sales came in at $67 million in the second quarter of 2011, up 13.6%.
Neutral on Johnson & Johnson
We currently have a Neutral recommendation on Johnson & Johnson. The stock carries a Zacks #3 Rank (Hold rating) in the short run. Even though Johnson & Johnson has been facing challenges in the form of OTC product recalls, pricing austerity in the EU and generic competition, we believe that the company’s diversified business model, lack of cyclicality and strong financial position will help it in tough situations.
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment