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Radiation drug maker to increase supply in Europe

2022-03-29T20:18:05.050Z


Partner Therapeutics, maker of the radiation sickness drug Leukine, will increase its inventory in Europe ahead of the war in Ukraine.


Concern after Peskov interview: could Russia use nuclear weapons?

1:26

New York (CNNBusiness) --

Russia's refusal to rule out nuclear war has brought the world to an unsettling reality: The unthinkable is suddenly a possibility, albeit an extremely remote one.

One drugmaker, Partner Therapeutics, isn't waiting to get in on the action.


The company announced that it is helping to increase Europe's supply of Leukine, a drug to treat acute radiation syndrome (ARS), or radiation sickness resulting from exposure to high doses of radiation during a nuclear emergency.

The drug Leukine is used more widely and routinely to reduce the incidence of serious and life-threatening infections in cancer patients undergoing chemotherapy as part of their treatment.

But the injectable drug can also be given as a life-saving measure to patients exposed to dangerous levels of radiation outside of medical treatment: It can increase the chances of survival if it's given in the critical 48 to 96 hours after initial exposure to a high dose of radiation from a nuclear explosion or radioactive fallout.

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Leukine is not the only drug to treat acute radiation exposure in the United States.

The US Food and Drug Administration (FDA) previously approved three other drugs for this purpose: Amgen's Neupogen, Neulasta and NPlate.

Amgen did not respond to requests for comment on whether the company will increase supplies of its drugs for the treatment of acute radiation exposure.

Partner Therapeutics, has closely followed the ongoing destruction and destabilization in Ukraine and the increased vulnerability of Ukrainian nuclear power plants to Russian attack.

The company has been in contact with the World Health Organization and other NGOs to inform them about the drug.

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"We knew that in this situation we cannot directly contact the government of Ukraine. So we contacted the WHO to offer the drug on a humanitarian basis in case it is needed," said John McManus, chief commercial officer of Partner Therapeutics.

"There is a small window to treat people after a nuclear event. So our outreach is to educate, prepare and raise awareness of this drug if it is needed."

But Leukine (generic name sargramostim) is not currently approved for use in Europe to treat acute radiation syndrome.

McManus said the European medicines regulator, the European Medicines Agency (EMA), often refers to the WHO and International Atomic Energy Agency (IAEA) guidelines on treatments for acute radiation syndrome in an emergency.

The IAEA referenced sargramostim as a treatment for radiation emergencies in adults in a 2020 publication titled "Medical Management of Radiation Injuries."

Who is behind Leukine?

Headquartered in Lexington, Massachusetts, Partner Therapeutics was founded in 2017 as a private biotech company with an oncology background specializing in the research and development of treatments for infectious diseases, including COVID-19.

It makes Leukine at a plant in Lynnwood, Washington that employs 145 people.

The company does not disclose its annual revenue.

On March 29, 2018, the FDA approved Leukine to treat acute irradiation syndrome in a radiological or nuclear emergency.

In 2018, it acquired the global rights from French pharmaceutical giant Sanofi to manufacture and sell Leukine.

On March 24, one of Partner Therapeutics' international distributors, Tanner Pharma Group, said in a press release that it has partnered with the drugmaker to significantly increase stocks of the drug in Europe in response to the war in Ukraine and the "potential escalation of incidents that could require rapid deployment of medical interventions to treat radiation or chemical exposures."

  • What are potassium iodide tablets and what are they for?

    Do they work against radiation?

increase supply

In the event of a nuclear attack, having immediate access to Leukine will be critical to saving lives.

"Being prepared is the key," McManus said.


McManus noted that Leukine has never been widely distributed.

Most US hospitals maintain some supply of radiation exposure treatment drugs such as Leukine, which is a prescription drug administered by medical professionals to patients, said Dr. Nelson Chao, professor of medicine and immunology and chief of the division of cell therapy and bone marrow transplantation at Duke University.

In an emergency situation, such as a nuclear attack, he said first responders would quickly administer the drug to as many people as possible who have suffered extreme radiation exposure.

Partner Therapeutics manufactures Leukine at its production facility in Lynnwood, Washington.

"Hopefully within 24 hours," said Chao, who is also a member of the Radiation Injury Treatment Network, a national network of medical centers with expertise in treating acute radiation syndrome after a fatal disaster. masses of radiological, nuclear or chemical agents.

"In case of acute radiation exposure, the disease is determined by the degree of exposure to radiation dose and time," Chao said.

But Leukine is not a universal solution.

For people whose exposure is in the most severe range of the radiation risk scale, as determined by the Centers for Disease Control and Prevention (CDC), Chao said treatment with Leukine or any other medicine or treatment will not save lives.

"These treatments work to increase the chance of survival, but only for a certain level of radiation exposure where the level of toxicity and trauma is not extreme after a nuclear event," he said, adding that Leukine and its competing drugs They also won't treat other side effects of radiation exposure that may occur.

While Chao said he is not aware of US hospitals stocking up on more Leukine, Neopogen or the other drugs, he said he is directly aware of his counterparts in Ukraine who want to get these drugs as soon as possible.

"There is a lot of demand [in Ukraine] right now," he said.

How does it work

Leukine was developed to help white blood cells recover after chemotherapy or radiotherapy.

Acute exposure to high doses of radiation can damage a person's bone marrow and cause mild, moderate, or severe loss in blood cell production.

White blood cells are essential for the proper functioning of the body's immune system and for fighting infections.

Acute exposure to high doses of radiation has also occurred outside of a medical setting.

Leukine was also used to treat victims of the Chernobyl accident in Ukraine in 1986 and the Tokaimura nuclear accident in Japan in 1999, McManus said.

On March 29, 2018, the FDA approved Leukine to treat acute irradiation syndrome in the event of a radiological or nuclear emergency.

The agency said Leukine was found to increase survival when given within the first 48 hours after total body irradiation at doses expected to be life-threatening within the first few weeks after exposure.

The government's approval of Leukine was based on animal studies.

Partner Therapeutics manufacturing facility in Lynnwood, Washington.

"Leukine has been shown to mitigate radiation sickness and improve chances of survival when administered within the first 96 hours after exposure," said Dr. Isabel Lauren Jackson, radiation oncology researcher and associate professor in radiation oncology at the University of Maryland School of Medicine.

Jackson advises Partner Therapeutics and US government agencies on radiation countermeasures.

"The type of weapon that has been mentioned in the news is a tactical nuclear warhead or a low-yield nuclear weapon. In a nuclear attack, people are at risk of being exposed to radiation from the explosion itself or from radioactive fallout." Jackson explains.

People within 1.6 kilometers of the explosion would be at greatest risk of exposure to radiation doses that could cause acute radiation sickness from the explosion itself, and anyone within 16 kilometers, in wind direction, it would be in the wider radiation hazard zone, he said.

  • Why Potassium Iodide Pills Are Suddenly in High Demand

Potassium iodide vs.

Leukin

Demand for another radiation protection measure, potassium iodide pills, has skyrocketed in recent weeks as anxiety has grown over the imminent threat of nuclear weapons use in Ukraine, which would risk the release of radioactive iodine. (or radioiodine).

It can be breathed in and can contaminate the water, soil, plants and animals closest to ground zero.

If ingested or inhaled, radioactive iodine can damage the thyroid, a butterfly-shaped gland in the front of the neck that produces many of the body's regulating hormones, and increase the risk of thyroid cancer, according to the CDC .

When used as directed, potassium iodide in liquid or pill form can quickly overwhelm the thyroid gland and prevent it from absorbing radioactive iodine.

Jackson said that potassium iodide, which consumers can buy directly, does not treat acute radiation sickness.

The US government has had a stockpile of Leukine since 2013 for possible use in a radiation emergency and purchased an additional supply in 2016 and 2019, McManus said.

He declined to say whether the government has increased its supply in recent weeks, coinciding with the Russian invasion of Ukraine, but said the company is focused on helping build up inventory of Leukine in Europe in case it is needed immediately for use. within 24 hours.

Partner Therapeutics continues to investigate the potential of Leukine to treat other diseases.

During the pandemic, it initiated studies involving hundreds of patients, supported by the United States Department of Defense, to assess the role of Leukine in reducing disease progression and the need for hospitalization in patients of covid-19.

The drugmaker is preparing to present those results to the FDA.

EuropeDrugRadiation

Source: cnnespanol

All news articles on 2022-03-29

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