Bayer-J&J Announce Positive Xarelto Data In Children With VTE

Bayer AG (DE:BAYGN) (OTC:BAYRY) and Johnson & Johnson’s (NYSE:JNJ) subsidiary, Janssen Pharmaceuticals Inc.,announced new results from the phase III EINSTEIN-Jr study in children with venous thromboembolism (VTE), with results similar to those seen in previous studies in adults.

In the study, pediatric patients (aged birth to 17 years) treated with blood thinner Xarelto (rivaroxaban) had a similar low risk of recurrent VTE or blood clots and similar rates of bleeding compared to current standard anticoagulation therapy.

EINSTEIN-Jr is the largest pediatric study conducted for the treatment of VTE, and the first to examine the use of a direct oral anticoagulant in this population.

The study showed that 4 out of 335 (1.2%) children treated with Xarelto and 5 out of 165 (3.0%) treated with standard of care had recurrent VTE. Clinically relevant bleeding occurred in 10 children (3%) treated with rivaroxaban and 3 (1.9%) with standard of care.

The absolute and relative safety and efficacy results seen in the EINSTEIN-Jr. study are consistent to those from previous rivaroxaban studies in adults. The composite of recurrent VTE and major bleeding occurred in 1.2% of the Xarelto group and 4.2% of the standard anticoagulation group.

Availability of rivaroxaban suspension for oral use will considerably reduce the number of injections needed for standard anticoagulation treatment and blood sampling.

Shares of Bayer have increased 11.4% year to date compared with the industry’s growth of 5.3%.

We remind investors that Xarelto is approved by the FDA to treat people with atrial fibrillation, a common heart rhythm disorder that increases the risk of stroke. The drug is used to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms. It is also used to reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease. The FDA is currently reviewing a supplemental new drug application (sNDA) for Xarelto for the prevention of VTE in medically ill patients.

Bayer will submit an application to the European Medicines Agency (EMA) for the extension of the Xarelto marketing authorization to make this new treatment option, including the granules for oral suspension, available for children with venous thromboembolism.

Zacks Rank and Other Stocks to Consider

Bayer currently carries a Zacks Rank #1 (Strong Buy).

Some better-ranked stocks in the large-cap pharmaceutical sector include Novartis AG (NYSE:NVS) and Merck and Co., Inc. (NYSE:MRK) . Both of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ earnings per share estimates increased from $4.98 to $5.01 for 2019 and from $5.48 to $5.56 for 2020 over the past 60 days. Share price of the company has increased 23% year to date.

Merck’s earnings per share estimates have moved up from $4.72 to $4.74 for 2019 and from $5.23 to $5.28 for 2020 in the past 60 days. Share price of the company has increased 11.4% year to date.

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