With RA indication, J&J's Simponi an up-and-comer

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Johnson & Johnson's biotech arm, Janssen Biotech, received an expanded indication for its anti-TNF (tumor necrosis factor) infusion therapy, Simponi Aria (golimumab), for patients with moderate-to-severe active rheumatoid arthritis. As last Friday's approval highlights, despite competition from injectables and orals, infusion therapies continue to maintain a presence.

In a Phase III trial, 59% of patients saw a 20% improvement (as defined by American College of Rheumatology criteria) after 14 weeks of treatment with Simponi Aria and methotrexate. Janssen says Simponi Aria is the first anti-TNF infusion therapy approved in more than a decade for patients with moderate-to-severe RA. The injectable form of the drug, originally sanctioned in 2009, was approved by FDA for ulcerative colitis this past May and has also been approved for psoriatic arthritis, RA and ankylosing spondylitis.

Simponi Aria now joins J&J's RA portfolio, which also includes the stalwart Remicade, an autoimmune therapy. Remicade, which J&J markets with Merck, brought in US sales of $3.6 billion last year, up by 9.4%. Remicade recently saw its patent expiration pushed back in the EU when it received a new pediatric indication. Its new indication will preserve its exclusivity there well into 2015. (Its US patent expiry is scheduled for 2018.)

Analysts told Bloomberg potential Simponi global sales could reach $1.2 billion by 2016. It pulled in $607 million globally in 2012. Credit Suisse contends that the worldwide market for RA is $23 billion worldwide.

Sales show that infusable anti-TNFs, like Remicade and now Simponi Aria, remain a go-to tool in the rheumatologists' pharmacopeia, despite injectable drugs like AbbVie's Humira and the recent launch of oral alternatives like Pfizer's Xeljanz. Doctors may be waiting for more data on Xeljanz's safety profile, and the launch has been so-so (FDA has required a REMS program due to potential risks).

The EU seems to be following suit. This past April, the CHMP (Committee for Human Medicinal Products) gave Xeljanz a thumbs-down in an advisory committee due to “safety concerns [which] included an increased risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood. It was not clear that these risks could be managed successfully in medical practice,” it said in a statement accompanying the decision.

While anti-TNFs still hold significant equity with docs, one analyst contends that it could only be a matter of time before orals begin to trickle onto the prescription pad. Bernstein analyst Tim Anderson said in an investor note this past March that “oral RA therapies like Xeljanz might eventually cause a paradigm shift away from injectable products.”

Pfizer got some help last week when Xeljanz was granted approval in Russia, Argentina, Kuwait, the United Arab Emirates and Switzerland—the first European country to allow sales. The drugmaker, as reported by the Associated Press, also said it “is asking advisers to European Union medical regulators to reconsider their recommendation in April not to approve the drug.”

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