Bayer Announces Positive Phase I Data - Analyst Blog

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The HealthCare segment of Bayer (BAYRY) recently announced positive results from a phase I study on prothrombin complex concentrates (PCCs). The study evaluated three- and four-factor PCCs in 34 healthy adults.

Results from the phase I study revealed that three- and four-factor PCCs can be used to reverse the anticoagulant effect measured by coagulation assays in patients treated with blood thinner Xarelto (20mg twice daily). The study further revealed that the three-factor PCC was more effective than the four-factor PCC on reversing Xarelto-induced changes in thrombin generation.

Bayer stated in its press release that currently there are no approved reversal agents for Xarelto. In Feb 2013, Bayer along with partner Johnson & Johnson (JNJ) collaborated with Portola Pharmaceuticals Inc. (PTLA) to evaluate the potential ability of PRT4445 in reversing the anticoagulant activity of Xarelto in emergency situations.

We note that Xarelto is marketed by Johnson & Johnson in the US and by Bayer outside the US.

Meanwhile, Bayer and Johnson & Johnson received a huge setback from the US Food and Drug Administration (FDA) last month, when the US regulatory body issued a complete response letter (CRL) to the supplemental New Drug Application (sNDA) of Xarelto for the reduction of risk of stent thrombosis in patients suffering from acute coronary syndrome (ACS).

Bayer/Johnson & Johnson are no strangers to setbacks regarding the ACS indication in the US. In Mar 2013, the companies received a second CRL from the FDA for Xarelto's (2.5 mg twice daily) sNDA submission for the reduction of the risk of secondary cardiovascular events in patients suffering from ACS. The initial CRL for this indication was issued in Jun 2012, after which Bayer and Johnson & Johnson had resubmitted the sNDA for blood-thinner Xarelto in Sep 2012.

Xarelto is, however, approved for sever! al indications in the US including stroke prevention in nonvalvular atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE) and reduction of the risk of recurrent DVT and PE.

Bayer, a large-cap pharma company, presently carries a Zacks Rank #4 (Sell). Meanwhile, other large-cap stocks such as Novo Nordisk (NVO) currently look more attractive with a Zacks Rank #2 (Buy).