New Haven drugmaker begins to market drug to fight bacterial skin infections
NEW HAVEN — Officials with Melinta Therapeutics announced Monday the company is launching an intravenous and oral formulation of its bacterial skin infection fighting drug Baxdela in the United States.
The launch of the drug comes seven months after the federal Food and Drug Administration approved Baxdela for use. Dan Wechsler, president and chief executive officer of Melinta Therapeutics, said in a statement that the launch of Baxdela “is a major milestone ... one that comes on the heels of a very successful year, cementing our leadership position in the antibiotics space.”
Roughly 14 million patients are treated annually for serious skin infections, many of which are caused by methicillin-resistant staphylococcus aureus or MRSA, according to company officials. MRSA is a bacteria that causes infections in different parts of the body and is more difficult to treat than most strains of staph infections because of its resistance to commonly used antibiotics.
Mike McGuire, Melinta’s senior vice president in charge of commercialization, wouldn’t say what market share Melinta officials expect Baxdela to achieve. McGuire said Baxdela gives physicians a new tool in terms of treating the infections of patients whose conditions require treatment alternatives.
“These patients often present treatment challenges because of underlying medical conditions (such as obesity and diabetes), which can make optimal antibiotic selection difficult,” McGuire said. “There are no dosage adjustments required due to weight, hepatic or mild-moderate renal impairment, so physicians can give more of a standard dose.”
Melinta already has a portfolio of infectious disease products it is marketing, including Vabomere, Orbactiv and Minocin for injection.
Between the time the drug was given FDA approval and today, Melinta completed a pair of deals that, according to McGuire, put the company in a stronger postion to market Baxdela.
The company completed an agreement in November to merge with the subsidiary of a North Carolina drug maker. The deal with Cempra Inc. gave Melinta access to the drugs that Cempra makes, which are designed to prevent infections in acute care facilities.
Then, earlier this month, Melinta completed a deal that was first announced in late November in which the New Haven company acquired the infectious disease business from The Medicines Co., a New Jersey-based drugmaker. The deal was valued at $215 million in cash, shares of Melinta common stock and other considerations.
“Acquiring The Medicines Company increased the size of our sales force available to market Baxdela,” McGuire said.