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A focus on KRAS, who benefits from the Medicare 10, & Catalent's activist negotiation

August 30, 2023
Biotech Correspondent

Hey there! Today, we unravel the implications of the government's Medicare negotiation plans for a variety of interested parties. We'll talk about the deep history of the KRAS oncogene, and take a peek at Catalent's ongoing issues with an activist investor. 

drug prices

The victors (and losers) of the Medicare 10

The government has finally unveiled which 10 medicines will be subject to Medicare price negotiation in 2026 — and there are some clear winners and losers. Without a doubt, the release of the list is a victory for President Biden and his administration. But, as STAT's Matthew Herper and Damian Garde write, it's also a win for some drugmakers whose treatments were expected to be on the list but were absent. 

The list has varying implications for pharmaceutical companies: Six of Novo Nordisk's long-acting insulins are on the list, for example, but companies like Eli Lilly and Sanofi are thus far unscathed. 

Read more.


oncology

The history of the 'undruggable' KRAS oncogene

The KRAS mutation has been a tantalizing but bedeviling target for cancer drugmakers: Until recently, it was considered "undruggable." But that perspective changed a decade back when a UCSF biologist discovered a chemical vulnerability in the oncogene that led to the first KRAS drugs being approved.

STATs Angus Chen and Bree Iskandar explore the complex race to unravel KRAS, which began back in 1978 when scientists began studying whether cancer-causing genes were present in certain animals. It's part of a trio of genes called RAS genes that are involved in cellular growth and proliferation. The proteins from the RAS genes have a sort of switch that turns on and off to regulate growth and proliferation — a tool that's invaluable to cancer growth, but could also be manipulated to destroy tumors.

Two drugs, made by Amgen and Mirati, take advantage of these cellular toggles for division and apoptosis — but their efficacy has been only modest. While there still seems to be a lot of potential for KRAS as a target, the issue with existing KRAS inhibitors is that patients quickly develop resistance. But more drugs are in the pipeline to find new ways to target the oncogene: As one researcher put it, "the race is on."

Read more.



covid

Catalent plans to settle with activist investor

Catalent may soon settle with the activist investor that's been attempting a takeover, Reuters writes. The contract drugmaker, which manufactures most of Novo Nordisk's best-selling weight loss drug Wegovy, will add new directors to its board and explore the possibility of a sale. Catalent was highly productive during the pandemic, filling vials of Covid-19 vaccine for companies like AstraZeneca, Johnson & Johnson, and Moderna. Its market value comes in at about $8 billion.

But it's faced several "productivity issues" and quality control lapses in recent months, its stock price has plummeted, and it has seen turnover in its C-suite. The hedge fund Elliott Investment Management has historically threatened the sale of portions of companies in exchange for seats at the board — so it's possible that this is the strategy they used at Catalent as well.

There's some worry that the uncertainty at Catalent might endanger its relationship with Novo Nordisk, but the latter's CEO told Reuters it was "confident" Catalent would resolve its Wegovy production problems.


anemia

Expanded approval for Reblozyl

Bristol Myers Squibb just had a win: Reblozyl, a drug that helps red blood cells mature, was just approved by the FDA as a first-line treatment for anemia in patients with low- or intermediate-risk myelodysplastic syndromes. This could expand the market for Reblozyl to $4 billion in peak sales, analysts say. The drug was first approved in 2019 to treat the anemia experienced by patients with beta thalassemia.

It's been a difficult run for Bristol Myers Squibb, which is in the midst of layoffs and recently lost patent exclusivity for its blockbuster cancer drug Revlimid. Reblozyl is being positioned as one of seven drugs that the company hopes to generate a cumulative $25 billion in sales by 2030, FiercePharma writes.


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Thanks for reading! Until tomorrow,


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