Pfizer Inc. (PFE - Free Report) announced detailed data from the two phase III OPAL (Oral Psoriatic Arthritis TriaL) studies – Broaden and Beyond – on Xeljanz. The data will be presented at the ACR/ARHP annual meeting.
OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of Xeljanz in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and tumor necrosis factor inhibitors, respectively.
Both the studies achieved the primary efficacy endpoint of a statistically significant improvement with twice-daily Xeljanz 5 mg and 10 mg, compared with placebo, at three months, as measured by American College of Rheumatology 20 response, and the change from baseline in the Health Assessment Questionnaire Disability Index score.
Overall safety results from these studies were found to be consistent with those observed in the broader rheumatology development program for Xeljanz.
The latest study results are encouraging. According to the press release issued by Pfizer, an estimated three million people in the U.S. and Europe suffer from active PsA. An approval would thus provide an alternative to patients who currently have limited treatment options.
We note that Xeljanz is already approved as a second-line treatment for adult patients with moderate-to-severe active rheumatoid arthritis who have had inadequate response or intolerance to methotrexate. Xeljanz can also be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. A once-daily formulation of Xeljanz was approved by the FDA in Feb 2016.
In the first nine months of 2016, Xeljanz generated revenues of $649 million, reflecting a year-over-year increase of 85%.
Meanwhile, Xeljanz is under review in the EU for the treatment of rheumatoid arthritis. In addition, Xeljanz is being studied for the treatment of ulcerative colitis. Label and geographical expansion would boost the drug’s commercial potential significantly.
PFIZER INC Price
Zacks Rank & Stocks to Consider
Pfizer is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While Anika and Vanda sport a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 15% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016 while earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 84% year to date.
Exelixis’ loss estimates narrowed from 65 cents to 51 cents for 2016 and from a loss of 7 cents to earnings of 4 cents for 2017 over the last 60 days. The company posted a positive surprise twice in the trailing four quarters with an average beat of 38.52%. Its share price has skyrocketed above 150% year to date.
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