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Pfizer's Xeljanz Tops Phase III Ulcerative Colitis Studies

Pfizer Inc.PFE announced top-line data from two phase III induction studies on its rheumatoid arthritis (RA) drug, Xeljanz (tofacitinib; 10 mg twice daily), from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) global development program.

Both studies - OCTAVE Induction 1 and OCTAVE Induction 2 - were conducted for the treatment of adults suffering from moderate-to-severe ulcerative colitis (UC) and achieved their primary endpoints. On the safety front, no new safety issues were reported. Pfizer intends to present detailed analyses including additional efficacy and safety data at a future scientific meeting.

We note that Pfizer is conducting two other studies under the OCTAVE program - OCTAVE Sustain (phase III maintenance study with data expected by the end of 2016) and OCTAVE Open (long-term extension study). Based on results from these four studies, Pfizer intends to file regulatory applications for the UC indication.

We are encouraged by Pfizer's efforts to expand Xeljanz's label further. Xeljanz registered worldwide sales of $224 million in the first half of 2015, reflecting a year-over-year increase of 86%. Label expansion of the drug should boost sales further.

Currently, Xeljanz (5 mg and 10 mg) is under review in the U.S. for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. A final decision is expected next month. In addition, a once-daily modified release formulation of Xeljanz (11 mg) for moderate-to-severe RA is under FDA review with a response expected by Feb 2016.

Meanwhile, Pfizer is evaluating Xeljanz for several additional indications like psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis.

Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD , Regeneron Pharmaceuticals, Inc. REGN and Medivation, Inc. MDVN . All three carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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