TUE AM News: SHINE submits drug master file to FDA; Free telehealth COVID-19 treatment program ending

April 9, 2024

— SHINE Technologies has submitted its drug master file to the FDA for a material used in precision cancer treatment.

The Janesville-based company yesterday announced the submission for non-carrier added lutetium-177 chloride, or Lu-177. This radiopharmaceutical is used alongside a cancer-seeking molecule to attack cancer cells, and is “especially useful” against prostate cancer, according to the release.

The filing covers detailed information about SHINE Technologies’ facilities and procedures involved with manufacturing, processing and storing the drug. The company made its first commercial sale of Lu-177 in 2020, according to an earlier release.

It will be produced exclusively at the company’s Cassiopeia facility in Janesville, the largest of its kind in North America with initial capacity to produce 100,000 doses per year. SHINE says that could rise to 200,000 doses annually in time. The company last summer announced the opening of the production facility.

“Our rapid progress in delivering Cassiopeia, a first-of-its-kind facility, equipped with the most innovative and efficient technology in the industry demonstrates the value our team can bring as demand for new radioisotope-based cancer therapies scale,” founder and CEO Greg Piefer said yesterday in a statement.

He emphasized the importance of developing domestic production of Lu-177, noting the U.S. is the largest market for cancer therapy in the world.

“The [drug master file] means we’re on the fast track to deliver for our customers, reducing U.S. dependency on foreign sources while also enhancing global supply chains for critical medical radioisotopes,” he said.

Lu-177, a radioactive form of the rare earth metal lutetium, is fairly short-lived with a half life shorter than a week, according to the company’s website. It’s not naturally occurring, and must be synthesized using nuclear technology.

The material’s radiation can destroy cancer cells when deployed correctly, but it can’t be stockpiled because its rate of decay is so rapid. The company notes this radiation is useful for treating cancer because it can hit the tumors while causing “minimal damage” to nearby healthy tissues. Lutetium treatment costs $10,000 per course on average, according to SHINE.

See more in the release, and listen to a recent podcast with Piefer.

— The state’s free COVID-19 treatment telehealth program will end tomorrow amid low levels of viral activity in Wisconsin.

The program was originally planned to end in 2023 but was extended with federal funding, according to Department of Health Services Deputy Secretary Deb Standridge. Since launching in November 2022, the program completed 8,819 consults, a DHS release shows.

It has offered health guidance and access to COVID-19 antiviral treatments to residents across the state, the agency says. At the end of 2023, about half of all visits were higher-risk patients aged 60 years and older.

“We’re extremely proud of the success of this program … As the program ends, we urge Wisconsinites, to remember COVID-19 has not gone away. We now have better tools to protect, prevent, and ensure access to COVID-19 vaccination, testing, and treatment through your health care provider, community clinic, or pharmacy,” Standridge said in a statement.

DHS notes state residents will be able to access antiviral medications through health care providers, community clinics or pharmacies, though related costs will depend on health insurance coverage.

People without health insurance or with policies that don’t cover COVID-19 care may be eligible for the state’s ForwardHealth free or inexpensive health clinics, the release shows. And patients with Medicare or Medicaid and the uninsured can still get free treatment through the federal Patient Assistant Program through the end of the year.

The announcement comes as COVID-19 “is currently circulating at low levels and transmission is decreasing” in Wisconsin, according to the latest DHS respiratory virus surveillance figures.

See the release.

Top headlines from the Health Care Report…

— Houston-based Nutex Health has announced the opening of Green Bay ER & Hospital in Bellevue, its first hospital in Wisconsin.

For more of the most relevant health care news, reports on groundbreaking research in Wisconsin, links to top stories and more, sign up today for the free daily Health Care Report from WisPolitics and WisBusiness.com.

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— Dairyland Power Cooperative and ITC Midwest are appealing a court order that stopped a land exchange related to the controversial Cardinal-Hickory Creek Transmission Line Project, the utilities announced.

They’re seeking to lift the preliminary injunction order from the U.S. District Court for the Western District of Wisconsin that delayed the last 1.1 miles of the transmission project being finished, according to yesterday’s release. The 102-mile project is nearly finished, the release shows, as the eastern half of the line went into service late last year.

Under the preliminary injunction, the whole project wouldn’t be able to meet the target in-service date of June 28, the utilities say. The litigation relates to a land exchange with the U.S. Fish and Wildlife Service, the release shows.

The National Wildlife Refuge Association, Driftless Area Land Conservancy and Wisconsin Wildlife Federation — which sued to stop construction on the project — didn’t immediately respond to a request for comment.

ITC Midwest President Dusky Terry argues the legal fight surrounding the transmission line will “only serve to further increase costs” for customers.

“We strongly assert that the federal agencies that granted the land exchange and issued permits for the project acted within their legal authority under federal law and their environmental review complied with the National Environmental Policy Act,” Terry said in a statement. “Just as in prior litigation, we are confident that we will ultimately prevail in this case and move forward with project completion.”

See the release.

— Gov. Tony Evers has vetoed legislation that would’ve eliminated the requirement for 14- and 15-year-olds to obtain work permits, telling a conference of machinists that it wasn’t a serious proposal by GOP lawmakers to address the state’s workforce challenges.

Evers said his veto of SB 436 was due to a combination of his concerns that 14- and 15-year-olds would be put in inappropriate work situations and that eliminating work permits for those teens infringed on parents’ rights to have a say in where their children work.

“It sends a message that 14- and 15-year-olds can do anything,” including working in unsafe conditions, Evers said yesterday before vetoing the bill.

The veto was the 189th bill the guv has vetoed during his five years in office, 22 more than any other guv in Wisconsin history.

GOP state Sen. Cory Tomczyk, one of the bill’s co-authors, knocked Evers for liking to “talk a big game” on helping address the state’s workforce shortage, but refusing to “get the government out of the way.”

“This bill would not have solved that problem as a whole but would have been a step in the right direction,” the Mosinee Republican said. “Big government liberals like Tony Evers don’t actually want to solve this issue and that was proven today. He may stand in the way but I’ll keep working to help kids enter the workforce.”

See more at WisPolitics.

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