Melinta grabs $67M in pursuit of a big PhIII antibiotics finish, NDA

Melinta CEO Mary Szela

A few months after raising $357 million to back their new biotech investment group, the ex-Elan team at Malin has helped place a $67 million bet on Melinta Therapeutics, a late-stage antibiotics developer now taking a second stab at a pivotal Phase III study of their lead program.

Malin led the round with help from Vatera Healthcare Partners, which helped reorganize Melinta and placed Mary Szela in charge of the company a couple of years ago. Malin was established by ex-Elan CEO Kelly Martin and some of his longtime colleagues: Bob Ingram, Kieran McGowan and John Given. In a statement, Malin revealed that it had invested $35 million in Melinta and committed to hand over another $10 million within a year.

New Haven, CT-based Melinta is setting the stage for a new drug application at the beginning of next year, says Szela, who's hoping to make a transition into commercialization work next year with delafloxacin, a new antibiotic being tested on patients with acute bacterial skin and skin structure infections (ABSSI). There's enough money in the fourth round for an NDA as well as work on new indications for delafloxacin, including hospital-treated community-acquired bacterial pneumonia. 

"Everybody here has commercialized drugs in the hospital space before," says Szela. Outside the U.S., Melinta is already lining up partners. Brazil's Eurofarma signed on recently, and Szela says she expects to ink a deal with a European group as well as a company in Japan, which would need to mount their own study for an approval there.

Melinta went back into another Phase III to follow up on a "signal" that it tracked in which obese patients--about half of all the patients who suffer from skin infections as well as the toughest patients to treat--had significantly better outcomes with delafloxacin over vancomycin. Obese patients are far more likely to need readmission to a hospital, notes Szela, and the FDA considers treating the obese as a major unmet need.

Late-stage development isn't cheap, and Melinta has been devouring cash for some time. This new fundraising comes a little more than a year after the biotech raised $70 million from Vatera. At the time, Melinta execs were prepping an NDA for their antibiotic in gonorrhea, but Melinta scrapped their Phase III last fall after deciding that it was likely going to flunk out. At that point, they shifted their primary focus to ABSSI.

"We pursued gonorrhea for one primary reason," says Szela. Company execs felt they had a good shot at getting a rapid approval for a single dose. But when it became apparent that the disease would require added doses and more trial work, Szela's team decided the market opportunity wasn't big enough to warrant the shift.

Melinta raised $30 million in debt financing with Hercules Technology Growth Capital last February.

Szela took over in 2013, changing the company's name from Rib-X (a 2011 Fierce 15 company) and recruiting a new executive team to run the company as they concentrated on setting up a late-stage program. Since then, Roche ($RHHBY) and Merck ($MRK) have both upped their investments in the field, even as AstraZeneca ($AZN) decided to spin out its anti-infectives research unit in Waltham into a new, much smaller independent unit.

- here's the release

Special Report: FierceBiotech's 2011 Fierce 15 - Rib-X Pharmaceuticals

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