If, God forbid, there’s ever a nuclear war, a Lexington biotechnology startup will be able to sell a drug that’s been proven effective against radiation sickness.
It’s definitely a “good news/bad news’’ situation, but it’s better than nothing.
The Food and Drug Administration has lifted the final regulatory hurdle for Partner Therapeutics Inc., or PTx, to market Leukine as a treatment for radiation poisoning in adults and children, the company said on Wednesday.
Partner Therapeutics, which was officially launched in January to find untapped uses for existing drugs, recently bought the global rights to Leukine, a decades-old cancer medicine, from Cambridge-based Sanofi Genzyme.
The company is betting that demand will soar globally because of escalating fears of a nuclear attack. The Bulletin of the Atomic Scientists in January moved the minute hand forward on the symbolic Doomsday Clock to two minutes to midnight — closer to the apocalypse than it has been since World War II, in large part because of saber-rattling by President Trump and North Korean leader Kim Jong Un.
Leukine has been approved since 1991 in the United States to bolster immune systems weakened by chemotherapy in patients with acute myeloid leukemia. But recent laboratory tests found that rhesus monkeys were far more likely to survive high doses of radiation if injected with Leukine 48 hours after exposure.
“Leukine not only showed improved survival despite initiating therapy two days after the radiation exposure but also demonstrated these beneficial effects on survival at both standard and higher doses of radiation’’ said Dr. Debasish Roychowdhury, PTx’s chief medical officer.
The FDA approved two other drugs in 2015 to treat radiation sickness, Neupogen and Neulasta, made by Amgen Inc. The federal government paid Amgen $37.7 million to stockpile Neulasta, according to the Health and Human Services agency. But those drugs must be injected almost immediately after exposure to radiation to work, according to Roychowdhury.
The FDA approved Leukine as a treatment for acute radiation syndrome on March 29, but the agency didn’t issue a biologic license to PTx to market it until this week, said company officials.
PTx leaders said they also acquired Leukine to treat other conditions besides radiation sickness. The drug has shown promise in melanoma patients being treated with cutting-edge therapies to bolster their immune system. And company officials say Leukine may have potential as a medicine for common neurological conditions, including Alzheimer’s disease.
Sanofi Genzyme’s parent company, the giant French drug maker Sanofi, said in January that it sold Leukine to focus on developing other products. At the time, the list price of the medicine was $1,237 for a package of five vials. It’s unclear how much the drug will cost as a radiation treatment.
Jonathan Saltzman can be reached at jsaltzman@globe.com
