German pharmaceutical giant Bayer AG (BAYZF.PK,BAYRY.PK,BYR.L) Tuesday said it plans to accelerate the development of five promising drug candidates that are currently undergoing phase I and II clinical studies. The goal is to progress these experimental drugs - in the areas of oncology, cardiology and women's health - into phase III clinical studies by 2015.
According to the Chief Executive Officer Dr. Marijn Dekkers , the five chosen drug candidates have the potential to impact the way diseases are treated for the benefit of patients. They have been chosen for accelerated development based on positive "proof-of-concept" data from early clinical studies.
The decision to speed up development of these candidates comes after the recent commercial introduction of five new drugs - anticoagulant Xarelto, cancer drugs Stivarga and Xofigo, eye treatment Eylea and hypertension drug Riociguat.
Three of these are development compounds in the area of cardiology or the cardio-renal syndrome. One of them is Finerenone or BAY 94-8862, currently in clinical Phase IIb development for the treatment of worsening chronic heart failure, as well as diabetic nephropathy.
The second drug candidate is an oral soluble guanylate cyclase stimulator (BAY 1021189). A Phase IIb study in patients with worsening chronic heart failure is expected to begin later this year.
For the cardio-renal syndrome, a Phase IIb program with the investigational new drug Molidustat (BAY 85-3934) is under initiation in patients with anemia associated with chronic kidney disease and/or end-stage renal disease.
In oncology, Copanlisib (BAY 80-6946) was selected for accelerated development. It demonstrated a broad anti-tumor spectrum in preclinical tumor models and promising early clinical signals in a Phase I study in patients with follicular lymphoma. A Phase II study in patients with Non-Hodgkin's lymphoma is currently in progress.
According to Bayer, it has also made good progress in the development of new treatment options for patients with gynecological diseases. sPRM (BAY 1002670), a novel oral progesterone receptor modulator, holds the promises of long-term treatment of patients with symptomatic uterine fibroids. Based on promising early clinical data, the initiation of a Phase III study is planned for the middle of 2014.
The stock is up 0.3 percent in early morning trading at 85.09 euros.
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by RTT Staff Writer
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