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Lilly's new diabetes approval, M&A surges, & finally regulating LDTs?

 

The Readout

Meghana here. Today we discuss the prospect of a wave of startup acquisitions, a likely new diabetes blockbuster, and how lawmakers want to finally rein in the wild west world of cosmetics, laboratory developed tests, and supplements. 

Startups will likely lean toward M&A, not IPO

A surge of biotech M&A activity is likely soon, experts say — and if history repeats itself, early-stage startups will be of particularly interest. Almost a quarter of the companies acquired in the last biotech M&A wave had yet to begin a Phase 2 trial, a new STAT analysis of more than 250 acquisitions between 2000 and 2021 reveals. In typical years, early-stage companies make up just 10% of acquisitions.

As in the mid-2010s, many larger companies now have vast stockpiles of cash — and are on the cusp of losing patent protections on key products. Meanwhile, the markets are pretty hostile, so startups are less interested in going public and will likely be more inclined toward agreeing to acquisition.

Read more.

Will Lilly’s newly approved diabetes drug be a blockbuster?

The FDA has approved Mounjaro, a new Eli Lilly injection meant for type 2 diabetes. The drug, also known as tirzepatide, both lowers blood sugar and helps patients lose weight — and is being viewed by investors as a probable key driver of profit for the pharma giant.

“We think that when we look back at the 2020s and 2030s, we’ll see this as a time where we started to understand that obesity can be reversed, that this can be treated like a disease,” Lilly’s CSO said last December. “This is going to be a major change in public health.”

The company’s list price hasn’t yet been released, but analysts project sales could hit $14 billion annually by 2030.

Read more.

Senators want to further regulate LDTs, cosmetics, and supplements

Members of the Senate plan to unveil draft legislation today that will reform how the FDA regulates dietary supplements, cosmetics, and some lab-based tests, STAT reports. These categories have long been under-regulated, but reforms have been stalled for years — so there is a great deal of interest around these as-yet-to-be-disclosed potential changes.

The legislation will include the VALID Act, which would give the FDA greater authority to regulate LDTs, like assays used to measure cholesterol in the blood. The level of oversight will be proportional to the risks associated with the individual test.

Read more.

Mining interferon data

One of the many clever ideas for a Covid drug: using versions of interferons, a group of proteins that signal to cells to mount a stronger antiviral response. In March, Eiger BioPharmaceuticals announced that its interferon, given as an infusion, reduced hospitalizations by half. But a month earlier, the U.K. biotech firm Synairgen was not as lucky. Its inhaled interferon did not help hospitalized patients who needed oxygen recover faster or leave the hospital sooner. The company's stock fell 85% and hasn't budged since.

Synairgen data are being presented at a meeting of the American Thoracic Society in San Francisco, and the firm sees a silver lining. In a press release, the company said that in patients whose respiratory function was compromised — about a third of those enrolled in the trial — the drug did reduce the rate at which patients developed severe disease. However, the company said, this analysis is post-hoc, and proving that conclusion will require another trial. 

More reads

  • Will the FDA change how it vets drugs following the Alzheimer's debacle? (Nature)
  • Checkmate details troubled future if Regeneron’s $250 million buy fails. (FierceBiotech)
  • Italy solves its biotech chicken-and-egg problem. (Biocentury)
  • Trial for controversial China-made Alzheimer’s drug aborted as capital raise hits snag, Covid hurts sales (FiercePharma)

Thanks for reading! Until tomorrow,

@megkesh
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Monday, May 16, 2022

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