Melinta, bouncing back from bankruptcy, lands FDA approval for speedy skin infection fighter

Antibiotic biotechs often struggle to turn their products into commercial triumphs, and that's certainly been the case for New Haven, Connecticut-based Melinta Therapeutics, which ultimately filed for bankruptcy in late 2019. But Melinta hopes its newly minted drug can become an exception, thanks to a convenience edge over rivals. 

The FDA approved Melinta’s Kimyrsa, also known as oritavancin, to treat adults with acute bacterial skin and skin structure infections caused by designated Gram-positive microorganisms, such as methicillin-resistant Staphylococcus aureus. With its sights set on a summer launch, Melinta aims to provide a one-and-done alternative to the current multidose standard for treatment, the company said in a release.

The drug is a next-gen version of Melinta's Orbactiv antibiotic and has been tested both head-to-head against the commonly used antibiotic vancomycin and alongside its predecessor. A long-acting lipoglycopeptide antibiotic Kimyrsa is given as a one-hour, 1,200-mg infusion, potentially offering clinicians flexibility to treat patients outside the hospital, Melinta said.

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That consideration could be especially beneficial to patients struggling to meet infusion schedules amid COVID-19, which has shut down or changed operations at clinics nationwide. 

Bacterial skin infections hit some 14 million patients in the U.S. each year, Meltina says. The infections cause more than 3 million visits to the emergency room annually and are the 8th most common cause of ER admissions. Admitted patients typically remain hospitalized for around 4.1 days, costing U.S. facilities $4 billion each year, the company added—a burden it aims to reduce thanks to Kimyrsa's abbreviated infusion time and volume. 

Regulators cleared the drug based on results from an open-label pharmacokinetics study that compared an hour-long Kimyrsa infusion with a three-hour Orbactiv infusion.

Kimyrsa also passed muster in the phase 3 Solo study, which also assessed Orbactiv. In that trial, researchers pitted a single, 1,200mg intravenous dose of Kimyrsa against twice-daily vancomycin in 1,987 adults, including a subset of 405 patients with methicillin-resistant Staphylococcus aureus infection, which can be tricky to treat. A single Kimyrsa dose was as effective as 7-10 days of twice-daily vancomycin at 15mg/kg, Melinta said.

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The approval could give a much-needed boost to Melinta, which filed for bankruptcy in 2019 after months of mounting financial tensions, though turning an antibiotic into a cash boon is almost always a tricky prospect.

Last February, a U.S. bankruptcy court gave groups interested in buying the biotech until March 2 to make an offer, with Deerfield Management then in the pole position to snap up Melinta as payment for a $140 million loan it extended during the company's original filing. 

Melinta made another bid to right its financials in June when it revealed it had won a bidding war with AcelRx Pharmaceuticals to buy up Tetraphase Pharmaceuticals. Tetraphase won FDA approval for the antibiotic Xerava in patients with complicated intra-abdominal infections in 2018, but like other antibiotic biotechs, it has struggled to turn Xerava into a commercial success.

By June 24, however, the deal entered the rearview after Tetraphase received a "superior offer" from La Jolla Pharmaceutical for $43.0 million in cash, plus an additional $16.0 million potentially payable under contingent value rights.