Merck's Breakthrough Drug Winrevair Approved by FDA for Pulmonary Arterial Hypertension, Priced at $14,000 per Vial

Stock trading depends onGolden Qilin Analyst Report, authoritative, professional, timely, comprehensive, help you explore potential thematic opportunities!

Editor of NBD, Bi Luming

Major pharmaceutical company suddenly announces significant positive news.

On Tuesday, Eastern Time, the U.S. pharmaceutical giant Merck & Co., Inc. (MRK, stock price: $131.75; total market value: $333.7 billion) announced that its new drug for treating a potentially fatal lung disease has been approved by the U.S. Food and Drug Administration (FDA).

　　As of the U.S. market close, MSD's stock price surged by approximately 5%, hitting a record high, with its latest total market value rising to $333.7 billion (approximately RMB 2,400 billion).

The trade name of the drug is Winrevair, used for treating pulmonary arterial hypertension (PAH). Each bottle is priced as high as $14,000 (approximately RMB 100,000), with annual costs reaching up to $242,000 (approximately RMB 1.74 million). According to a report by the Securities Times, some Wall Street analysts optimistically estimate that the annual sales of Winrevair could reach up to $7.5 billion (approximately RMB 54 billion).

Pulmonary hypertension is caused by an imbalance between pro-proliferative and anti-proliferative signals, leading to thickening of the pulmonary artery walls, restricted blood flow, and increasing strain on the right side of the heart, eventually resulting in heart failure. Clinical manifestations include shortness of breath, chest tightness, dizziness, and fatigue.

It is estimated that there were approximately 40 million PAH patients globally in 2021, with a mortality rate of about 43% within five years.

Currently, 11 drugs for the treatment of PAH have been approved for marketing. These 11 marketed drugs can alleviate the condition of patients by promoting pulmonary vasodilation but cannot fundamentally solve the issue of pulmonary vascular remodeling.

Jannie Oosthuizen, Head of Human Health at MSD U.S., stated, "We look forward to Winrevair bringing significant change to patients with a five-year mortality rate of 43%." MSD believes that Winrevair has the potential to become a cornerstone therapy for the treatment of pulmonary arterial hypertension.

In 2021, Merck & Co., Inc. (MSD) spent $11.5 billion (approximately RMB 82.8 billion) to acquire Acceleron Pharma, the company that developed the drug, gaining access to the key investigational drug sotatercept (the chemical name for Winrevair). In March of last year, a Phase III clinical trial showed that adding the experimental therapy sotatercept to a stable background treatment significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH).

MSD estimates that Winrevair will be available in some specialty pharmacies in the U.S. by the end of April. The drug is administered via injection every three weeks and distributed in single-vial or double-vial kits.

Regarding the high cost, MSD stated that since the dosage is calculated based on body weight, the cost will vary from patient to patient. A Merck spokesperson said in a statement that the company has a program to assist eligible patients with out-of-pocket costs and co-payments.

MSD Chief Medical Officer Eliav Barr stated, "Pulmonary arterial hypertension remains a disease with high morbidity and mortality, and the approval of Winrevair is an important milestone. We are proud to bring this new treatment option to patients."

JPMorgan analyst Chris Schott wrote in a report: "We expect Winrevair sales to be strong and quickly become part of the standard of care for eligible patients with pulmonary arterial hypertension." Schott forecasts that Winrevair’s annual sales will reach $5 billion (approximately RMB 36 billion) by 2030.

With the deepening understanding of PAH pathology, new drugs are constantly emerging, according toChina MedicineThe Pharma ONE Intelligent Drug Big Data Analysis Platform of the Industrial Information Center shows that currently, there are over 250 pulmonary arterial hypertension drugs at various stages of development worldwide, among which 18 drugs have entered phase III clinical trials.

New therapies include: FoxO1 pathway, 5-HT receptor inhibitors, BMPR2 pathway, GF/TK signaling pathway, inflammation and immunotherapy (interleukin-1/6, tumor necrosis factor-α, nuclear factor κβ), GF/TK signaling pathway, mineralocorticoid receptor antagonists, RhoA/Rho kinase pathway, mitochondrial dysfunction, etc.

Every day economic news comprehensive MSD, Securities Times

Disclaimer: The content and data in this article are for reference only, do not constitute investment advice. Please verify before use. Any actions taken based on this information are at your own risk.