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

Antibioticbiotechs often struggle to turn their products into commercial triumphs, and that's certainly beenthe case for New Haven, Connecticut-based Melinta Therapeutics, which ultimately filed for bankruptcy in late 2019. ButMelinta hopesits newly minteddrug can become an exception, thanks toa convenience edge over rivals.

The FDA approved Melintas Kimyrsa, also known asoritavancin, 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-actinglipoglycopeptide antibioticKimyrsa isgiven as a one-hour, 1,200-mg infusion, potentially offeringclinicians flexibility to treat patients outside the hospital, Melinta said.

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

Bacterial skin infectionshitsome 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, costingU.S. facilities$4 billion each year, the company addeda 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 thephase 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 singleKimyrsa 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, thoughturning an antibiotic into a cash boon is almost always a tricky prospect.

Last February, a U.S. bankruptcy court gavegroups interested in buying the biotechuntil March 2 to make an offer, withDeerfield Management thenin the pole position to snap upMelinta as payment for a $140 million loan it extended during the company's originalfiling.

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

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

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