Bayer hits the R&D accelerator on late-stage contenders in cancer, cardio

Kemal Malik, head of pharmaceutical development and chief medical officer at Bayer HealthCare

Over the past two years Bayer has snagged an impressive string of key approvals for cancer and cardiovascular drugs--a much better record than many of its larger Big Pharma rivals. And today the pharma player is rolling out i­­­­­ts slate of the next top drug prospects being groomed for late-stage pipeline work.

All 5 are top priorities at Bayer R&D, with investigators charged with hustling them into Phase III trials by 2015.

Their top prospect for advancement in oncology is Copanlisib (BAY 80-6946), a PI3k inhibitor that's been tapped for accelerated development. Bayer says the drug demonstrated some promising anti-tumor effects in a Phase I study of follicular lymphoma. A Phase II study in patients with non-Hodgkin's lymphoma is currently underway, with a blueprint for Phase III ready to go.

Bayer has good reason to hurry. PI3k is a big target in cancer R&D, with Gilead ($GILD)--among others--targeting a subset of the proteins known to accelerate the development of cancer.

Bayer highlighted two key drugs in cardiology. First up is finerenone (BAY94-8862), a non-steroidal mineralocorticoid receptor antagonist designed to block the effects of aldosterone and replace steroidal MR agonists linked to some serious side effects. Second is an oral guanylate cyclase stimulator (BAY 1021189). A Phase IIb trial among patients with worsening chronic heart failure is expected later this year.

Molidustat (BAY 85-3934) is under investigation for renal indications. It's being studied for anemia associated with chronic kidney disease and end-stage renal disease. Molidustat inhibits hypoxia-inducible factor prolyl hydroxylase, which stimulates erythropoietin (EPO) production and the formation of red blood cells. Bayer says the early-stage data have shown that inhibiting HIF-PH by Molidustat spurs a spike in the endogenous production of EPO.

In the field of women's health there's sPRM (BAY 1002670), an oral progesterone receptor modulator that Bayer believes can effectively treat patients with symptomatic uterine fibroids. Based on its early clinical data Bayer plans to start Phase III in mid-2014.

Bayer has attracted some positive attention for its confident and effective approach in guiding Xarelto (partnered with Johnson & Johnson ($JNJ) and approved in the U.S. in 2011), Stivarga, Xofigo, Eylea (with Regeneron) and riociguat to the market. Now Bayer wants to add some additional approvals for their use as well while proving it can follow up with more new product approvals, putting it in league with some companies with much larger R&D budgets.

Bayer Group spends about $2.5 billion a year on drug R&D, putting it well below the top 10 pharma companies' total research budget. But the company has a lot to show for it.

"Our drug development pipeline holds a number of promising candidates which we want to bring to patients who need them urgently", said Kemal Malik, the head of pharmaceutical development at Bayer HealthCare. "Furthermore we are continuing to expand the range of indications for all our recently launched products Xarelto, Stivarga, Xofigo, Riociguat as well as Eylea and further refine the profile of these drugs in specific patient populations." 

- here's the release

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