Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.
Earlier in the week, the HealthCare segment at Bayer (BAYRY) announced the initiation of the phase III EINSTEIN CHOICE study (n=2,850) on Xarelto. The study will evaluate two doses (10 mg or 20 mg) of Xarelto versus acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (:VTE), including deep vein thrombosis (:DVT) and pulmonary embolism (:PE).
The EINSTEIN CHOICE study will evaluate whether once-daily Xarelto is superior to ASA in the prevention of fatal or non-fatal symptomatic recurrent VTE, in patients who have finished anticoagulant treatment for 6 to 12 months for their index DVT or PE event.
We note that Xarelto is jointly developed by Bayer and Johnson & Johnson (JNJ). The drug is marketed by Johnson & Johnson in the U.S. and by Bayer outside the U.S. Xarelto is approved for several indications including stroke prevention in nonvalvular atrial fibrillation, DVT, PE and reduction of the risk of recurrent DVT and PE. Bayer recorded Xarelto sales of €259 million for the third quarter of 2013.
Although Bayer and Johnson & Johnson has progressed well with Xarelto in several indications, they have really struggled with Xarelto in the acute coronary syndrome (:ACS) indication in the U.S. Last week, the U.S. Food and Drug Administration (:FDA) issued complete response letters (CRLs) to Xarelto’s supplemental New Drug Applications (sNDA) in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events and stent thrombosis in patients suffering from ACS. The news came as a huge dissapoinment for both the companies. Bayer and Johnson & Johnson have earlier been subject to a series of setbacks regarding the ACS indication of Xarelto in the U.S.
Bayer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Actelion Ltd. (ALIOF). While Alexion holds a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).