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The Readout Damian Garde & Meghana Keshavan

Microbiome drugs seem to work. Now it's time to make them

The field of microbiome drug development has seen huge advances in recent years, with companies now poised to introduce actual medicines targeting the billions of organisms that live inside us. But with progress comes new challenges. Namely: How do you make these things at scale?

STAT’s latest report, authored by Kate Sheridan, takes a detailed look at how far microbiome science has come and the hurdles that remain. Among them: Because using bacteria as a treatment is a fairly newfangled idea, the drug industry is still catching up when it comes to infrastructure. Developers of pills and antibodies can take their pick among an ocean of FDA-compliant suppliers and contractors, but microbiome firms have sometimes been left to fend for themselves.

Even for Bacthera, a joint venture formed in 2019 to manufacture microbiome drugs, the field’s wide array of approaches makes it difficult to standardize the process, said Gemma Henderson, the company’s head of project and portfolio management. “There’s no sort of standard path for the way forward,” Henderson said. “That’s also part of the excitement of working in this industry.”

Read more.

Bristol Myers’s psoriasis drug beats Amgen’s blockbuster

Bristol Myers Squibb said its investigational pill for psoriasis proved more effective at clearing the chronic skin disease than placebo and a top-selling competitor from Amgen. Perhaps most important, Bristol’s drug appeared less toxic than a class of related treatments, which could help it become a mainstay medicine.

As STAT’s Adam Feuerstein reports, Bristol’s deucravacitinib was superior to placebo and Amgen’s Otezla across two Phase 3 studies. Those data, which will support deucravacitinib’s FDA application, could help Bristol compete with Amgen’s drug, which brought in $2.2 billion last year.

But the key comparison involves treatments not used in the study. Deucravacitinib is a molecular relative of autoimmune treatments called JAK inhibitors, which carry the FDA’s most serious safety warning due to risks of serious infections, blood clots, and cancer. In its clinical trials, Bristol’s treatment appeared to be better tolerated than JAK-targeting drugs, meaning it might be able to avoid such a dire safety label after approval. But the final decision rests with the FDA. 

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What if drug companies spent their profits on science, not share buybacks?

Last quarter, Biogen spent nearly 80% of its operating cash flow on buying back its own stock. Pouring money into buybacks, common in the drug industry, is generally good for shareholders’ pocketbooks and by extension executives’ job security. But shouldn’t a drug company spend its money on stuff that might lead to new drugs?

That’s the argument from Travis Whitfill, a health policy researcher at Yale University and a partner at the VC firm Bios Partners. Writing in STAT, Whitfill points out that Biogen’s approach to the balance is exemplary of the industry: From 2009 to 2018, the top 18 pharmaceutical companies in the S&P 500 spent $335 billion repurchasing their own shares, which is 1.14 times their R&D expenditures during that period.

That presents “a profound mismatch of priorities,” Whitfill writes. Drug companies almost universally argue that they are uniquely equipped to discover, develop, and market new treatments society needs. And yet when they divert billions of dollars into buybacks, they prize short-term gains in stock price over the long-term work it takes to actually do that, valuing shareholders over the patients they purport to serve.

Read more.

Sanofi inks ‘fill and finish’ deal with Moderna

Sanofi announced this morning that it had signed a "fill and finish" agreement to help produce up to 200 million doses of Moderna's Covid-19 vaccine.

It marks the third deal Sanofi has signed to provide manufacturing support for Covid-19 vaccines, following an agreement with BioNTech in the European Union and Johnson & Johnson in France. 

Sanofi is still seeking to develop its own Covid-19 vaccine, in conjunction with partners. It's collaborating with GSK on a recombinant protein-based vaccine, while also pursuing an mRNA vaccine in partnership with Translate Bio.

More reads

  • AI caught a hidden problem in one patient's heart. Can it work for others? (STAT)
  • Vaccine makers say IP waiver could hand technology to China and Russia. (Financial Times)
  • Bharat Biotech to charge as much as double its peer for vaccines. (Bloomberg)
  • Covid-19 gave scientists an opening to better understand how brain disorders arise. (STAT)

Thanks for reading! Until tomorrow,

Monday, April 26, 2021

STAT

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