Melinta Therapeutics has raised $318m in venture cash over the last 14 years and may soon, finally, have something to show for it. A phase III trial of its antibiotic Baxdela has succeeded in hard-to-treat patients, and regulatory filings are likely later this year.
With doctors clamoring for new antibiotics big pharma is increasingly keen to get into this space – witness Merck's (NYSE:MRK) purchase of Cubist for $9.5bn in 2014 – and dealmakers are sure to come knocking, either to licence Baxdela or take out Melinta. Whether they will pay enough for the group's backers to get a decent return is another matter.
Gaze into the ABSSSI
The pivotal phase III study, snappily titled RX-3341-303, pitted Baxdela against a combination of vancomycin and aztreonam in 850 patients with acute bacterial skin and skin structure infections (ABSSSI). The drug was administered intravenously at first – 300mg every 12 hours for 6 doses – and then orally as a 450mg pill twice a day for a total of between five and 14 days, as necessary.
In the intent-to-treat population, Baxdela met the FDA-mandated primary endpoint of statistical non-inferiority, with 84% of patients responding 48-72 hours after initiation of therapy compared with 81% of the control group. It also met the EMA’s required endpoint: non-inferiority on complete cure, as determined by resolution of all baseline signs and symptoms at 14 days, with 58% of Baxdela-treated patients meeting this goal compared with 60% of those on vancomycin/aztreonam.
The rates of adverse events were similar in the two treatment arms, Melinta said, though 1.2% of Baxdela-treated patients stopped taking the drug owing to side-effects.
Importantly, half the patients in the trial were obese and had a higher prevalence of comorbidities such as diabetes and cardiovascular disease. Success in this growing population bodes well for Baxdela, as these people are harder to treat.
An FDA submission will be made in the second half of this year and the company is preparing for launch. But the VC companies that have ploughed hundreds of millions of dollars into the company over more than a decade will be impatient for a payday that revenues from Baxdela alone cannot supply. They will want a deal.
It should not be too hard to find a partner for Melinta. Approval looks fairly likely and the IV-to-oral dosing regimen is more appealing than the IV-only antibiotics it will be competing with – not least to payers, as it will enable patients to leave hospital earlier. Then there is the suite of add-on indications Melinta says it will pursue, including community-acquired bacterial pneumonia and complicated urinary tract infections.
But could a licensing deal bring in the sort of money that would grant Melinta's investors a return? They would surely prefer a trade sale.
Hopefully the Merck-Cubist deal, marred by the unfortunate and horribly timed loss of patent protection for Cubicin, has not put off potential acquirers of antibiotic developers (Cubist patent loss means buyer’s remorse for Merck, December 9, 2014).