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What Wegovy means, Lilly's billions, & an RNA umbrella

August 9, 2023
National Biotech Reporter
Hello, all. Damian here with a look at the unanswered questions from Novo Nordisk's landmark obesity study, the ever-ballooning value of Eli Lilly, and the future of Mirati Therapeutics. 

The need-to-know this morning

  • Regeneron Pharmaceuticals is buying Decibel Therapeutics, a developer of gene therapies for congenital hearing loss, for an upfront cash payment of $109 million, plus another $213 million if certain milestones are achieved. The two companies were already working together under a partnership agreement signed in 2017.

Obesity

How does Wegovy work, exactly?

A landmark Novo Nordisk study concluded that the blockbuster obesity drug Wegovy can reduce the risks of heart disease, but the results leave unanswered the vexing question of whether weight loss alone prevents cardiovascular illness.

Wegovy, a medicine that leads to dramatic weight loss, met its goals by cutting the risk of major heart problems by 20% in a study enrolling patients who already had cardiovascular disease. But some researchers and doctors cautioned that the results don't prove obesity treatments improve heart health solely by helping people lose weight. 

Decoding the underlying science of Wegovy's benefits will be vitally important for drug developers, prescribers, and the ongoing societal debate over the relationship between body weight and health.

Read more.



Biotech

Not all CEO resignations are bad

In the two years that David Meek served as CEO of Mirati Therapeutics, the company secured FDA approval for a KRAS-targeted lung cancer drug called Krazati, launched it reasonably well, but has so far found European regulators less receptive. Mirati's stock price has also dropped 84% during Meek's time as CEO, including a 39% fall this year, alone.

Yesterday, Meek resigned as CEO and gave up his seat on the company's board. He will be replaced on an interim basis by Charles Baum, one of Mirati's founders and a former CEO. 

Minutes after announcing Meek's exit, and with its stock price reacting positively, Mirati executed a $250 million stock offering. By this morning, the deal had been upsized to $300 million.


Financials

Eli Lilly is worth two Novartises

Or five GSKs, three Amgens, two Coca-Cola Companies, or a quarter of an Apple. More directly, yesterday's obesity data from Novo Nordisk helped send Eli Lilly's stock price up 15%, giving the company a $500 billion valuation and setting some daunting expectations for what is now the most valuable drug company in the world.

Lilly's stock is up about 43% in 2023, driven by the Phase 3 success of its Alzheimer's disease treatment donanemab and the rapid uptake of Mounjaro, a metabolic therapy that competes with Novo Nordisk's blockbuster Ozempic. That means its stock price is worth about 60 times its actual earnings per share, by far the largest multiple in the industry.

All those big numbers give Lilly a lot to live up to. In order for that valuation to make sense, donanemab will have to become a blockbuster, prevailing over the already-approved Alzheimer's treatment from partners Eisai and Biogen. And Mounjaro will need to continue its ascent and endure likely competition from a growing list of companies at work on rival medicines. 

Both things are possible, but there's also a risk that the markets for Alzheimer's and obesity medicines eventually become crowded with essentially interchangeable medicines, a future that would still be lucrative for Lilly, but perhaps not to the tune of a $500 billion valuation.


Startups

What rare diseases have in common

Alltrna, a 5-year-old startup founded by Flagship Pioneering, just raised $109 million in a Series B round. Now it's setting the path to develop its first drug candidate, targeting a little-discussed indication called stop codon disease.

During the process of translating genetic code into proteins, errors can get introduced in the form of codons — genetic base pairs that can sometimes prematurely halt the the translational work of RNA. About 10% of all patients with genetic diseases have these premature termination codons, or stop codons. Alltrna believes it can use transfer RNAs, or tRNAs, to identify and fix these genetic errors.

The catch? Stop codons are well-documented, but the umbrella term "stop codon disease'' is not. Mentions are scarce outside of Alltrna and Flagship's websites, raising questions about the feasibility of using it as a clinical trial indication.

"We are encouraged that a 'many diseases at a time' path is increasing in prevalence in the last decade," a company spokesperson told STAT, "and we have observed outward communication from various regulators, including the FDA over the last year, that suggests the 'many diseases at a time' strategy is warranted to address the urgent, and growing, unmet medical need in the rare disease setting." 


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More reads

  • Failed clinical trials don't always spell doom for a new drug. Here's why, STAT
  • 'Underwhelming:' NIH trials fail to test meaningful long COVID treatments — after 2.5 years and $1 billion, STAT
  • Novavax to sell 7% stake to South Korea's SK Bioscience, Reuters

Thanks for reading! Until tomorrow,


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