|Mary Szela--FierceBiotech file photo|
In the 10 months since Mary Szela took charge of Melinta Therapeutics--the antibiotics developer once known as Rib-X--the CEO has built up an experienced team of R&D executives. Now she also has the money needed to wrap an ambitious late-stage program for their lead product while preparing to usher a new set of assets into the clinic.
Monday morning Melinta will announce that it has rounded up a whopping $70 million venture round with a significant portion of the cash coming from its major backer, Vatera Healthcare Partners. Much of the money will be used to fund an ongoing Phase III study of oral delafloxacin for uncomplicated gonorrhea, which launched about a month ago. And there are Phase III studies of delafloxacin underway for acute bacterial skin and skin structure infections.
Melinta should be ready to submit an NDA for gonorrhea by the end of this year, says Szela, who declined to say how many patients were being recruited for the Phase III program.
Vatera played a big role in reorganizing Melinta last year. The company was put on a short track to late-stage development, advancing plans to complete its first new drug application by several years, says Szela. The biotech is one of a handful of independent antibiotics developers, a field that has seen a widespread retreat by Big Pharma companies turned off by slim margins.
But Szela sees opportunity after pharma players discounted the field. Health officials around the world have been raising an alarm about drug-resistant bacteria for several years now.
"From the regulatory standpoint, there's been a very big shift in terms of support for new antibiotics," Szela tells FierceBiotech. "There's a very robust market opportunity for an antibiotic that really beings value."
The company plans to keep growing its staff of 45 this year in the lead-up to a potential market launch, which Szela says could be handled by a relatively small marketing group. Melinta might bring in a partner for the ex-U.S. market, she adds, acknowledging that an IPO is one of the financing options that's currently on the table for review.
Back in November Szela recruited Sue Cammarata as chief medical officer, bringing in an experienced R&D hand with a track record that includes Cubicin and Zyvox. More recently Baxter vet Paul Estrem was named chief financial officer.
In addition to Vatera, which led the round, new investors including Falcon Flight LLC, an investment vehicle for the Santo Domingo Group, participated in the financing. The biotech raised $67.5 million in its last venture round.