TMC's McGuire preps CRE antibiotic for market

Since early 2011, The Medicines Company SVP and infectious disease care commercial lead Mike McGuire has helped commercialize a broad range of anti-infectives and related products favored in the hospital environment. Photo credit: Matt Greenslade

Were there ever to be a therapeutic area characterized by marketers as “sexy,” the infectious diseases space wouldn't be it. As opposed to drugs that target metabolic conditions or cancers, antibiotics are often short-term propositions: You get treated and, ideally, you get better. Most people don't think about anti-infectives until they're desperately needed.

Mike McGuire, SVP and in­fectious disease care commercial lead at The Medicines Company, isn't most people. First at Hoffmann-La Roche (where he worked on Tamiflu and oversaw essential brands like Rocephin, Versed, and Toradol) and since early 2011 at The Medicines Company, McGuire has helped commercialize a broad range of anti-infectives and related products favored in the hospital environment. Indeed, he likens work in the infectious-diseases marketplace to running a marathon (McGuire should know: He has run six, plus a half marathon less than six months after under­go­ing quadruple bypass surgery).

See also: Therapeutic Focus: Infectious Diseases

“You've got the training part: market prep and product development while you're involved with R&D partners. Then there's the race, when you go commercial and start working to get products on formulary at hospitals,” he explains. At the same time, McGuire notes other challenges that are largely absent within other therapeutic categories. “We've got to guess the bacteria, so to speak. We also have to figure out the why and where.”

By “why and where,” McGuire refers to treatment para­digms and pathways—which, especially within hospital environments, are often quite resistant to change. “We're not just selling a product. We're attempting to help [hospitals] find the best way to utilize these innovations to help patients. Some pathways have been in place for many, many years.” Translation: Selling an institution on a single-dose treatment for acute bacterial skin infections, like TMC's ­Orbactiv, ain't as linear a process as one might expect.

Thus, when McGuire and his anti-infective colleagues sit down with their customers, they need to evince a thorough understanding of the hyperlocal epidemiology. Are there issues with regard to bacterial resistance in the ICU? in the burn unit?

“There ­aren't many other areas where you need to understand how every­thing's going down on an account-by-­account, patient-by-­patient basis,” McGuire says. “We provide interventions to help them. We're right there with the microbiology departments at these institutions.”

TMC's breakthrough antidote for carbapenem-resistant enterobacteriaceae is expected to be filed for FDA new drug approval this year. CRE produces a distinctive clover-leaf shaped growth pattern. Photo credit: Melissa Dankel/CDC

The Medicines Company's infectious disease unit also strives to make a strong pricing/value case for its products— which hasn't traditionally been the highest of priorities for entities within the space.

“To capture the real-world economic benefits of our products, we look at the various scenarios in which they're used,” McGuire explains. “So with Orbactiv, if a patient is treated in the ER and sent home—rather than having to stay in an observation setting—there might be a savings of $6,000. It's critical now to conduct that analysis of how a product impacts the cost of patient care.” Indeed, The Medicines Company has assigned a team of investigators to that particular assignment.

At this time next year, the company will likely find itself making that case on behalf of Carbavance, viewed as a breakthrough antidote for carbapenem-resistant enterobacteriaceae. Expected to be filed for new drug approval at some point this year, Carbavance could significantly reduce a mortality rate that currently hovers around 50%. McGuire can't share many details, given where Carbavance is in its development, but he notes that “a year from now, things could look drastically different in how we're positioned in this arena.”

See also: White House "superbug" plan has five-year goal

It's worth noting here that McGuire is not someone prone to overstatement: He only shares information when pressed (one of the cooler personal details: He's a distant relative of the person for whom New Jersey's McGuire Air Force Base is named). So his “drastically different” shouldn't be read as wishful thinking.

“We see ourselves as a world-class organization,” he says. “But the bacteria we see—these single-celled things have turned out to be far smarter than we are. It's not a business for anyone who isn't thinking long term.”