Pfizer Inc. (PFE) recently announced that the new drug application (NDA) for its rheumatoid arthritis candidate, tofacitinib, has been accepted by the US Food and Drug Administration (FDA) for review. Pfizer is looking to get the candidate approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
With the FDA accepting Pfizer’s application for tofacitinib, a response should be out in August 2012. Pfizer is also seeking approval for tofacitinib in the EU and Japan.
Tofacitinib is one of the most promising candidates in Pfizer’s pipeline. Earlier this year, the company had presented encouraging data on tofacitinib from a phase III study. Tofacitinib met its primary endpoint in the ORAL Sync phase III study (A3921046), which was conducted with patients suffering from moderate-to-severe rheumatoid arthritis. Results showed that compared to placebo, tofacitinib achieved a statistically significant reduction in signs and symptoms of rheumatoid arthritis.
The safety profile of the candidate was found to be consistent with previous results with no new safety signals being detected.
Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor. Being an oral treatment, tofacitinib could have an edge over existing therapies which need to be injected or administered through infusion. The rheumatoid arthritis market currently has players like products like Abbott’s (ABT) Humira and Johnson & Johnson’s (JNJ) Remicade and Simponi among others.
In addition to evaluating tofacitinib for the treatment of rheumatoid arthritis, Pfizer is studying the candidate for other indications including Crohn’s disease and ulcerative colitis. While Pfizer expects to initiate a phase III study for the ulcerative colitis indication in 2012, a phase II study for the Crohn’s indication is also expected to commence in 2012.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer. We are pleased to see the company’s progress on the pipeline front. While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will depend on the success of drug development.
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