| | | |   | Good morning! Damian here, reminding you that STAT Madness, our annual bracket-style competition to choose the prior year’s most exciting biomedical discovery, begins tomorrow. | | | Can Novavax actually deliver? There’s no doubt that Novavax’s Covid-19 vaccine can prevent severe disease and keep people out of the hospital; the company has signed enough supply deals to make billions of dollars in the months to come. But with multiple delays on its résumé and competition on its heels, can the company really come through?
We’ll find out more this afternoon, when Novavax presents its 2021 financial results. The company’s vaccine has won authorizations in countries around the world, and management has promised to manufacture some 2 billion doses this year. What remains to be seen is whether Novavax can execute on its many supply agreements and capitalize on the demand. And whether it can do so before Sanofi's similar vaccine can enter the market.
Investors seem skeptical. Novavax has lost more than 40% of its value in 2022, and the company’s current stock price erases the majority of future Covid-19 vaccine sales and the potential of the its flu shot, according to Cowen analyst Georgi Yordanov. | Moderna’s Covid billions rely on pilfered patents, lawsuit alleges A years-long patent dispute related to Moderna’s Covid-19 vaccine could be headed to court thanks to a lawsuit claiming the company used someone else’s technology to make its mRNA vaccine actually work.
Genevant and Arbutus Biopharma, inventors of a key delivery technology, filed suit in federal court this morning, alleging that Moderna willfully infringed six of their patents related to lipid nanoparticles, which are used to get mRNA to its target cells. The companies don’t want to block the sale or manufacture of Moderna’s vaccine but rather seek monetary damages.
The dispute dates back to at least 2016, when Moderna and Arbutus got into a fight over the same technology. Moderna had access to Arbutus’ nanoparticles by taking out a sublicense with a third firm, which Arbutus later revoked. Shortly afterward, Moderna unsuccessfully challenged the nanoparticle patents in question, and a federal court rejected the company’s appeals in December.
According to the lawsuit, Genevant and Arbutus have repeatedly tried to negotiate a license agreement with Moderna, but the company has declined. Now they’re suing, making a detailed case that Moderna could not have produced its Covid-19 vaccine so swiftly without using their intellectual property. Moderna has maintained that its work employs proprietary technology. | Learning from innovation in rare disease science to create a more equitable health future Only 5% of rare diseases have an approved treatment option. Rare Disease Day is an annual reminder of the progress that has been made for the treatment of rare diseases, but also of the continued unmet needs that many people with these devastating diseases face. It is imperative that we collaborate to accelerate improvements in diagnostics, research and development, and access to care. Learn more about one company’s commitment to leading the way. | How to survive a biotech crash Sure, the biotech market looks bad in 2022. But that was true in 2002, and then again in 2008, and once more in 2016. And each time, good science won out in the end.
That’s according to biotech executive Edward Kaye, who lived through each of those downturns. Market crashes might put pressure on companies, Kaye writes for STAT, but they can also realign priorities and sharpen focus.
“There’s a reason why the fearsome biotech market downturn of 2016 — which at one point saw biotech stocks drop 50% — did little to stop the progress of the world’s first artificial pancreas or the enormous strides made against type 1 diabetes, cancer, Duchenne muscular dystrophy, and non-small cell lung cancer,” according to Kaye.
Read more. | Intercept Pharma’s long-delayed NASH ambitions It has been nearly two years since the FDA rejected Intercept Pharmaceuticals’ effort to sell its drug obeticholic acid, or OCA, for the treatment of people with NASH. And key clinical data, once promised for last year, are now expected this quarter, which means any day now.
Intercept’s next earnings call, scheduled for Wednesday, will bring the first update on the program since December. The ongoing trial, called REVERSE, is a study of OCA in patients with compensated cirrhosis due to NASH. The company is also reanalyzing results from an earlier study, one that enrolled patients with liver fibrosis due to NASH, to prepare for an FDA resubmission.
Intercept, which has lost 80% of its value since OCA’s FDA rejection, has said it expects to meet with the agency about a resubmission before the middle of the year. The company’s long road back to relevance starts with succeeding in REVERSE and meeting that target. | More reads - AI gone astray: How subtle shifts in patient data send popular algorithms reeling, undermining patient safety. STAT+
- Short on South Korea biotech company turns into $1 billion trader nightmare. Financial Times
- FTC’s top economist resigned amid dispute over pharma study. Politico
- NIH official accused of ‘bias’ against using a controversial law to address high drug prices. STAT+
| Thanks for reading! Until tomorrow,  | | | |
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