Bayer AGBAYRY and partner J&J JNJ announced data from two late-stage studies, which showed that its blood thinner drug, Xarelto failed to show statistical benefits. These studies were being evaluated to expand the drug's eligible patient population.
Data from the two phase III studies - MARINER and COMMANDER HF - showed no significant difference between Xarelto and placebo for the primary efficacy endpoints.
The data was presented at the European Society of Cardiology (ESC) Congress 2018 and simultaneously published in The New England Journal of Medicine.
Shares of Bayer have decreased 22.4% compared with the industry 's growth of 5.3% year to date.
We remind investors that Xarelto is 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 (PE).
Coming back to the release, the COMMANDER HF heart failure study showed that there was no statistically significant difference between Xarelto 2.5 mg given twice daily and placebo, in reducing the risk of death, heart attack and stroke in patients. However, the patients receiving Xarelto showed numerically fewer events for both heart attack and stroke. Also, the patients receiving Xarelto had similar and in general low rates of severe bleeding compared to those receiving placebo.
The MARINER study showed that Xarelto 10 mg once daily did not significantly reduce the composite endpoint of symptomatic venous thromboembolism (VTE) or blood clots and VTE-related death post hospital discharge in acutely medically ill patients when compared with placebo. Though the major bleeding rate with Xarelto was generally low, it was not significantly different compared to placebo.
The MARINER and COMMANDER HF studies are part of Xarelto's large clinical development program EXPLORER, which evaluates the potential role of Xarelto in treating a wide range of critical medical needs.
Xarelto is a significant contributor to Bayer's revenues. In the second quarter of 2018, Xarelto's sales were $679 million, up 5.8% year over year. Xarelto is marketed outside the United States by Bayer and in the United States by Janssen Pharmaceuticals, Inc.
In a separate release, Bayer announced that it has submitted the marketing authorization application (MAA) for larotrectinib to the European Medicines Agency (EMA). Larotrectinib, an investigational tropomyosin receptor kinase (TRK) inhibitor, is being developed to treat adult and pediatric patients with locally advanced or metastatic solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Bayer and Loxo Oncology, a biopharmaceutical company, are jointly developing larotrectinib.
Bayer Aktiengesellschaft Price
Zacks Rank & Stocks to Consider
Bayer has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. GILD and Ligand Pharmaceuticals Inc. LGND , both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.
Gilead's earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 4.4% so far this year.
Ligand's earnings per share estimates moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.5%. Share price of the company has increased 87.6% year to date.
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