Pharmaceutical giants suddenly transmit significant positive news.
On Tuesday Eastern Time, US pharmaceutical giant Merck (MRK, stock price: $131.75; total market value: $333.7 billion) announced that its new drug for treating a deadly lung disease has been approved by the US Food and Drug Administration (FDA).
Screenshot of MSD's official website
As of the close of the US stock market, Merck's stock price has surged by about 5% to a historic high, with its latest total market value rising to $333.7 billion (approximately RMB 2400 billion).
The drug is marketed as Winrevair and is used to treat pulmonary arterial hypertension (PAH). Each bottle is priced at up to $14000 (approximately RMB 100000), and the annual cost is as high as $242000 (approximately RMB 1.74 million). According to the Securities Times, Wall Street analysts are optimistic that Winrevair's annual sales may reach as high as $7.5 billion (approximately RMB 54 billion).
Pulmonary arterial hypertension is caused by an imbalance in promoting and inhibiting proliferative signals, leading to thickening of blood vessels in the pulmonary artery wall, limiting blood flow, and increasing burden on the right side of the heart, ultimately leading to heart failure. The clinical manifestations include shortness of breath, chest tightness, dizziness, and fatigue.
It is estimated that there will be approximately 40 million PAH patients worldwide in 2021, with a 5-year mortality rate of approximately 43%.
At present, 11 drugs for treating PAH have been approved for marketing. The 11 drugs that have been launched can alleviate the patient's condition by promoting pulmonary vasodilation, but cannot fundamentally solve the problem of pulmonary vascular remodeling.
"We look forward to Winrevair bringing significant changes to patients with a five-year mortality rate of 43%," said Jannie Oosthuizen, the head of human health at Merck. Merck believes that Winrevair has the potential to become a cornerstone therapy for treating pulmonary hypertension.
In 2021, MSD spent $11.5 billion (approximately RMB 82.8 billion) to acquire Acceleron Pharma, the company that developed the drug, and obtained the key investigational drug sortercept (the chemical name of Winrevair). In March last year, a phase III clinical trial showed that the addition of its experimental therapy, rotatercept, to a stable background treatment can significantly improve the exercise ability of patients with pulmonary arterial hypertension (PAH).
Merck estimates that Winrevair will be launched in some specialty pharmacies in the United States by the end of April. The drug is injected every three weeks and distributed in single or double bottle reagent kits.
For the high cost, Merck said that due to the dosage being calculated based on body weight, the cost will vary among patients. A Merck spokesperson stated in a statement that the company has a plan to provide out of pocket and co payment assistance to eligible patients.
Eliav Barr, chief medical officer of MSD, said: "Pulmonary hypertension is still a disease with high incidence rate and mortality, and the approval of Winrevair is an important milestone. We are proud to bring this new drug to patients."
Morgan Stanley analyst Chris Schott wrote in a report, "We expect Winrevair sales to perform strongly and quickly become part of the care standards for eligible pulmonary hypertension patients." Schott predicts that Winrevair's annual sales will reach $5 billion (approximately RMB 36 billion) by 2030.
With a deeper understanding of PAH pathology, new drugs are constantly emerging. According to the Pharma ONE intelligent drug big data analysis platform of the China Medical Industry Information Center, there are currently over 250 pulmonary arterial hypertension drugs in different research and development stages worldwide, of which a total of 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.
Daily Economic News Comprehensive Merck and Securities Times
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