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The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease. The condition refers to when the small blood vessels in the lungs narrow. He noted that the drug will be a "paradigm shift" for patients living with PAH. That includes reducing the risk of death or worsening of the condition by 84% compared to an existing drug alone. Those trials include late-stage studies on patients with more advanced PAH disease, and those who are within the first year after diagnosis.
Persons: Chris Schott, Eliav Barr, PAH, Barr, Merck Organizations: Merck, Drug Administration, JPMorgan, CNBC, Acceleron Pharma Locations: Rahway , New Jersey, U.S, Winrevair
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.
If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. "The clock for that patent would start ticking from the time we would get that patent approved." Drug patents have a guaranteed term of exclusivity for 20 years after receiving a patent under U.S. law, but sometimes the companies are able to add additional patents that extend their exclusivity. Merck's patents on the subcutaneous version of Keytruda could protect that formulation until at least 2040, according to Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Access & Knowledge (I-MAK). Northwell's Mulloy said moving patients to subcutaneous versions of drugs also opens up spots in infusion centers for additional patients.
Moderna spiked as much as 17% on Wednesday after the company teamed up with Merck to develop personalized cancer vaccines. Data from an ongoing phase 2 trial of Moderna's vaccine used in combination with Merck's Keytruda is expected in the fourth quarter. Under an existing licensing agreement that was initially inked in 2016, Merck had the option to exercise an option to jointly develop and sell the personalized cancer vaccines. Merck will pay Moderna $250 million to exercise its option, and will collaborate on the development and commercialization of the vaccines. Merck's cancer drug Keytruda is currently being evaluated in combination with Moderna's mRNA-4156/V940 vaccine as a treatment for patients with high-risk melanoma.
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