The latest news about Xtandi, Triesence and AskBio

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Hello! Today we get some optimism from the new director of the National Cancer Institute, despite an industry brain drain and stagnant funding figures. Advocates are also urging the federal government to encourage production of the prostate cancer drug Xtandi.

Supporters are urging the government to exercise the right of march for Xtandi

Advocates are urging the Biden administration to license patents for Xtandi, a prostate cancer treatment, to other manufacturers so that cheaper versions become available. In a letter to CMS, they said two different federal laws — including march-in rights — would allow the U.S. government to allow “qualified companies” to make and sell generic versions of the blockbuster drug.

Xtandi, which is sold in the US by Astellas and Pfizer, is currently priced three to six times more than in other high-income countries. In 2022, the average Medicare price was $130.66 per capsule; Last year that rose to $136.50. According to the CMS letter, government payers spent more than $5 billion on this U.S. government-funded cancer drug.

The Biden administration rejected this petition a year ago, but has since issued a framework to enforce the right to march on lower drug costs created in part by taxpayer money.

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NCI director optimistic about research despite logistical hurdles

The director of the National Cancer Institute channeled Taylor Swift when he spoke this week at the American Association for Cancer Research — with optimism about the past, present and future “eras” of cancer research. Kimryn Rathmell noted that scientists are generally moving from more isolated research units to broader interdisciplinary teams, and that this is a trend that should continue.

“I’m very optimistic,” she said. “The kinds of questions we can ask today are unprecedented. I think the way people are willing to work together, across borders, has never been so strong and committed.”

That said, she acknowledged that state funding for research scientists is stagnant or shrinking, and said the agency is considering reducing costs for contractors and the overall workforce. This exacerbates the ongoing exodus of life scientists from academia.

“It’s very concerning,” Rathmell said. “We absolutely need basic discovery science… we need people who are passionate about that, to get into those fields and feel like that field is a career path for them.”

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The reason for a 486% increase in drug prices

An injectable eye drug called Triesence has been largely sold out for years, despite being used to treat several diseases. Early last year, a small company called Harrow bought the treatment and has plans to innovate and upgrade production of the drug – and increase the price by 486%. The drug was underpriced and is “extremely challenging” and “difficult” to produce, CEO Mark Baum told STAT. It took “tens of millions of dollars” in manufacturing and regulatory costs to create a steady new supply of the drug.

“It is a very important product in ophthalmology and currently you do not have access to it as a retinal surgeon or general ophthalmologist. The drug has not been available for five years,” Baum said. “So whether it’s $160 or $944, it doesn’t matter. There is no stock at any distributor…. Some significant investments need to be made. It was a Model T vehicle in a Tesla Model S world.”

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Biotech financing at two-year high

After a three-year slump, biotech startups just had an excellent fundraising quarter, raising $6.8 million in venture capital. That is the highest number since the beginning of 2022, data from HSBC shows. This isn’t precise enough to say the biotech sector has fully recovered, an HSBC executive told STAT.

“It’s really hard to talk about this without saying it’s like the tale of two cities, where you see a lot of really interesting momentum that’s very positive, but on the other hand you still have the frothyness of 2020 and 2021, in the form of higher valuations and perhaps of companies that would not have gotten the financing they did get in a recession and then having to work their way through that [investment] around,” he said. “That’s still happening, and it will happen this year and early next year.”

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AskBio CSO is stepping down and has a new project in stealth mode

Jude Samulski, the early pioneer of gene therapy, resigned yesterday as chief scientist of AskBio, the company he founded in 2001 to commercialize his work at a time when pharma and investors were fleeing the field. He will be replaced by Mansuo Shannon, chief scientist of Eli Lilly’s subsidiary Prevail Therapeutics.

It’s a notable departure, four years after Bayer bought AskBio and its pipeline of experimental therapies for up to $4 billion. At the time, Samulski said the company chose Bayer from a series of suitors because the German pharma promised to keep its new subsidiary at arm’s length, leaving Samulski and then-CEO and co-founder Sheila Mikhail in charge. Now Mikhail and Sumalski are gone (Mikhail has left after a cancer diagnosis). Prominent gene therapy researcher Kathy High also left last year, after joining in 2021.

Samulski, who will remain on AskBio’s board, said he’s not done yet. “Retirement, I don’t think so. Starting something new in stealth mode,” he said in a text message, adding: “You can publish that.”

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