A 'left-field' FDA clearance in Covid-19

InflaRx, a thinly traded German biotech company, saw its share price nearly double yesterday after the FDA granted an emergency authorization to the firm's antibody treatment for critically ill Covid-19 patients.

The "left-field" approval "comes as a major surprise," SVB Securities analyst Joseph Schwartz wrote in a note to clients, as investors had largely written off the potential of InflaRx's treatment, called vilobelimab. The FDA has cleared the therapy for severely ill patients who are within 48 hours of starting mechanical ventilation, based on a randomized trial in which InflaRx's treatment reduced mortality by about 24%.

The question now is how InflaRx, which ended last year with less than $100 million in cash, will divide its limited resources between commercializing vilobelimab for Covid-19 and developing the drug for the rare skin disorder pyoderma gangrenosum. The company is hosting a conference call later this morning to explain.

Financials

Illumina still knows how to sell a sequencer

Regulators are cracking down and shareholders might soon revolt, but Illumina, the global hegemon in genome sequencing, still knows how to move machines.

The company's latest product, called NovaSeq X, racked up more than 200 orders in the first quarter, Illumina said yesterday, marking a corporate record. Perhaps just as important, about 15% of those orders come from first-time customers, suggesting Illumina isn't simply cannibalizing sales from its older machines. NovaSeq X is twice as fast as its predecessor and can get sequencing down to $200 per genome, according to Illumina.

Meanwhile, Illumina is preparing to face its less-than-adoring public on April 25, when the company will present its quarterly earnings and field questions about the disastrous effort to acquire Grail and the looming proxy challenge from activist investor Carl Icahn, who wants to shake up the board and replace top management.

Patents

There's a lot of money in microscopic fat

Moderna and partners Pfizer and BioNTech have made more than $100 billion selling vaccines for Covid-19. Two lesser-known companies say their intellectual property got infringed, and they'd like a cut of those revenues.

Yesterday, Arbutus Biopharma and Genevant Sciences filed a lawsuit against Pfizer and BioNTech, claiming the companies violated their patents on lipid nanoparticles, the tiny fat envelopes used to get mRNA vaccines to their target cells. Arbutus and Genevant want "a reasonable royalty on all infringing sales" of the vaccine.

The lawsuit is nearly identical to one Arbutus and Genevant filed against Moderna last year, which has plodded through the courts ever since. Notably, Moderna has argued that all of the vaccine doses sold to the federal government would be ineligible for litigation. If that contention holds up in court and extends to Pfizer and BioNTech, Arbutus and Genevant could be left fighting for royalties on the much smaller commercial revenues from each vaccine.

Supply Chain

Mark Cuban's pharmacy is branching out from generics

Mark Cuban's Cost Plus Drug Company, a pharmacy founded to sell cheap generic medicines, is now selling two on-patent diabetes medicines from Johnson & Johnson at reduced prices, the latest evolution in the billionaire's stated goal of disrupting the pharmaceutical supply chain.

As STAT's Ed Silverman reports, Cuban's company is selling Invokana and Invokamet at a monthly cost of $243.90, which is a significant cut from the $582.89 lowest price on GoodRx's website and the average retail price of $676.14.

The deal with J&J is the latest bid by Cuban to streamline the process of purchasing medicines, which is typically complicated by opaque costs and unaccountable middlemen. Cuban's online pharmacy, which he started last year, boasts that it negotiates directly with manufacturers and breaks out related costs — including shipping fees and its own 15% mark-up — on its website. It does not accept insurance.