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J&J's (JNJ) Xarelto/Aspirin Regimen Positive in Phase III

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Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen, announced data from a pivotal phase III study, showing that its blood thinner Xarelto has significantly reduced major cardiovascular events in patients with stable coronary and peripheral artery disease (CAD/PAD).

The study is being currently conducted to expand Xarelto’s label (rivaroxaban, 2.5 mg twice-daily) in combination with aspirin (100 mg once daily) versus aspirin alone.

Xarelto is presently marketed as an anticoagulant to reduce the risk of stroke and blood clots in patients with atrial fibrillation (AF), not caused by a heart valve problem. It is also approved in the United States to treat deep vein thrombosis (VTE) and pulmonary embolism.

Shares of J&J have outperformed the industry year to date. The stock increased 14.4% as against the industry’s 10.9% gain during the period.

The randomized phase III COMPASS (n=27,395) study, a part of the ongoing EXPLORER clinical research program, met its primary endpoints. Data from the study demonstrated that the Xarelto/aspirin combination reduced the combined risk of cardiovascular death, stroke and heart attack by 24% in patients with stable CAD/PAD compared with the aspirin alone.

The findings also showed a massive 42% decrease in any stroke and 22% fall in CV death. The trial was conducted at 602 centers in 33 countries. Also, PAD patients treated with the combination therapy had significantly fewer major adverse limb events compared with those taking aspirin alone. However, the risk of major bleeding was found to be significantly higher in patients receiving treatment by Xarelto/aspirin regimen.

Currently, there are eight new indications seeking studies for Xarelto as part of the EXPLORER clinical development program.

notably, Xarelto has been developed by J&J in partnership with Bayer AG BAYRY. The drug is launched in more than 80 countries and is marketed by Bayer outside the United States.

Per the company’s press release, CAD is found to be developing among one-third to one-half of all middle-aged populace during their lifetime in developed countries. Per an estimate, approximately 20% of adults aged above 55 years have evidence of PAD. Therefore, approval of Xarelto for these additional indications will provide the company an access to a huge globally potential market.

We remind investors that in June, J&J announced that the FDA has granted priority review to a sNDA of Xarelto for label expansion to include a 10 mg dose to reduce the risk of recurrent VTE.

Xarelto is currently approved in a 20 mg dose formulation. Only last month, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a label update regarding the use of 15 mg once-daily dose of Xarelto in combination with a P2Y12 inhibitor for treatment of patients with non-valvular atrial fibrillation (AF), who require oral anticoagulation and undergo percutaneous coronary intervention (PCI) with stent placement. The final decision of the European Commission is expected by the end of 2017.

Zacks Rank & Stocks to Consider

J&J currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector are Aduro Biotech, Inc. ADRO and ACADIA Pharmaceuticals Inc. ACAD, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates reduced from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 over the last 30 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

ACADIA’s loss per share estimates narrowed from $2.82 to $2.59 for 2017 and from $2.07 to $1.92 for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 7.97%.

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