Riociguat

Bayer's shares fell up to 14% on Tuesday as the company slashed its profit guidance for the year and warned of more pain to come in 2025, including further loss of exclusivity on the oral anticoagulant Xarelto. "We expect a muted outlook on top and bottom line next year with likely declining earnings," said chief financial officer Wolfgang Nickl.To mitigate, Bayer may look to further reduce its workforce, having cut 5500 positions this year, including 3200 full-time, mostly managerial jobs in the first half. "We plan to accelerate our cost and efficiency measures to partly compensate," Nickl added.Xarelto is already facing generic competition in some markets — notably Europe and Canada — with sales in the third quarter crumbling 23.8% to €802 million ($851 million). Bright spots for Bayer included Eylea (+5.7%, €848 million), Nubeqa (+79.7%, €417 million), Kerendia (+90.9%, €126 million) and Adempas (+7.1%, €182 million). Overall sales in Bayer's pharmaceutical segment slipped 0.6% to €4.5 billion, as the company's total revenue fell 3.6% to €9.7 billion. Meanwhile, a loss of €4.2 billion was posted in the three-month period, narrowed slightly from a loss of €4.6 billion in the prior year. Despite the relatively flat prescription drug sales, CEO Bill Anderson said Bayer is confident that the division will be able to deliver at the upper end of the 2024 guidance of up to 3% growth. "We're happy with what we see from our launch products." Accelerating Xarelto declineFor next year, Bayer expects to see continued growth momentum for cancer drug Nubeqa and Kerendia, its treatment for patients with chronic kidney disease associated with type 2 diabetes. Anderson hopes that this will offset lower Xarelto sales, which are "expected to accelerate in the other direction."JPMorgan analyst Richard Vosser noted that while the pharmaceutical segment was the bright spot in Bayer's results, the erosion of Xarelto was "more rapid" than anticipated. Meanwhile, Barclays analyst Emily Field said "the key takeaway is that 2025 may be looking a bit worse across business segments than the street has been modelling."($1 = €0.94213593)

A drug approved to treat pulmonary arterial hypertension may be effective at managing hypertension and end-organ damage in patients with sickle cell disease, according to a new study. An early phase randomized clinical trial involving 130 patients with sickle cell disease found that the drug, called riociguat, was found to be safe to use and well tolerated in these patients and significantly improved their blood pressure. Preliminary efficacy data suggested the medication might improve heart function. A drug approved to treat pulmonary arterial hypertension may be effective at managing hypertension and end-organ damage in patients with sickle cell disease, according to a new study published in Lancet Haematology. An early phase randomized clinical trial involving 130 patients with sickle cell disease found that the drug, called riociguat, was found to be safe to use and well tolerated in these patients and significantly improved their blood pressure. Preliminary efficacy data suggested the medication might improve heart function. An estimated 100,000 Americans have sickle cell disease, and the disease occurs in about 1 out of every 365 Black or African-American births, according to the Centers for Disease Control and Prevention. People with sickle cell disease are at high risk for vascular complications that can lead to pulmonary hypertension, stroke, and kidney failure as well as severe pain when red blood cells block blood flow through tiny blood vessels in the chest, abdomen, and joints. These complications can be worsened by hypertension. Unfortunately, previous research found that sildenafil, an effective treatment for pulmonary hypertension, caused unacceptable side effects in patients with sickle cell disease. It found that those who took this drug experienced high levels of pain that caused increased admissions to the hospital compared to those who took a placebo treatment. This new study was designed to test the safety of riociguat and how well it works in preventing or reducing the clinical complications for patients with sickle cell disease. In the study, patients with sickle cell disease and mild hypertension or protein in their urine (an early sign of kidney disease) were randomly assigned to receive either riociguat or a placebo in a double-blind clinical trial. Both groups received the study drug at a starting dose of 1 milligram, which was gradually increased up to 2.5 milligram, taken three times a day for 12 weeks. The researchers found that among the participants who took riociguat, 22.7 percent experienced at least one serious adverse event related to the treatment. In comparison, in the group that received the placebo, 31.3 percent of participants had at least one serious adverse event during the study. The differences were not statistically significant. There were no differences between the two groups in the rates of pain severity, pain interference in their daily lives, and in vascular events related to their sickle cell disease. When it comes to the effectiveness of the drug treatment, participants who took riociguat had their blood pressure drop by 8.20 mmHg, while those who took a placebo only saw a decrease of about 1.24 mmHg. The result was highly statistically significant, meaning riociguat was much more effective at lowering blood pressure compared to the placebo, with a difference of approximately 6.96 mmHg. In summary, riociguat was found to be safe and led to a significant improvement of blood pressure over the duration of the study. "Our results are encouraging and open the door to larger clinical trials involving this class of drugs in patients with sickle cell disease who have pulmonary hypertension or kidney disease. Having a drug that's easy to tolerate can help them better manage their blood pressure and help prevent serious complications down the road," said study leader Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of UMSOM, and Vice President for Medical Affairs at University of Maryland, Baltimore. Bayer Pharmaceuticals, manufacturer of riociguat, provided funding (as well as the drug and placebo) for the study. The study was led by the clinical and data coordinating centers at the University of Pittsburgh. Study co-authors included faculty from the University of Illinois at Chicago, Albert Einstein College of Medicine, University of Pittsburgh, Emory University, Duke University, Johns Hopkins School of Medicine, and other institutions.