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.
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.
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.