Specialty Sales Gets No Resistance - Pharmaceutical Executive


Specialty Sales Gets No Resistance

Pharmaceutical Executive

Given the issue of antibiotic resistance, how do you balance promotion for the drug with the message of responsible use?

I'm actually very proud of the failed Phase III study that occurred in 2002. The data from that study showed that this was not a good drug for pneumonia. We probably spent as much time in the first year of launching this drug making sure physicians understood that [issue] as we did talking about Cubicin for its approved indication for complicated skin infections.

We have a relentless commitment to ensuring that the drug is appropriately used—and we talk a lot about appropriate use starting from the orientation sessions for new employees. We try to stay focused on the question, "What information would you like your physician to have if you developed a serious infection?" And that really guides how we promote the drug. It's not about any kind of slick, Madison Avenue marketing messaging. It's about being true to what the drug can and cannot do.

What's your reaction to the changing standards for antibiotic drug development at FDA?

We can deal with most standards. What we're looking for is clarity. The uncertainty has grown in the past few years about what standards are going to be applied by FDA to register a new antibiotic in certain indications, such as pneumonia. In fact, that uncertainty has had a chilling effect on the amount of money that capital markets or individual companies are willing to invest in new antibiotics. But if they could land on some specific guidance, then we could let our own bright people figure out how we get the data to meet that guidance.

Even draft guidance would help provide some framework. If we start seeing decisions that are consistent with the draft guidance, then it provides the kind of clarity and transparency that I think any company really needs from its governing regulatory body.

Bacteria evolve so quickly. How can drug development keep up?

Our most recent addition to the pipeline is Ecallantide, which is a Phase II compound. We see that cardiothoracic surgery is likely to continue, particularly with the aging population, and that there is an enormous unmet medical need here for clean surgical fields, reduced bleeds, fewer transfusions, as well as better outcomes.

But aside from that, a core part of our business is understanding microbes and how they develop resistance and what the most current thinking is in terms of how to deal with those mechanisms of resistance. Some of our new antibiotics are responsive to early indicators of new trends. There was a new strain of C.difficile identified in Quebec, back about four or five years ago. These new strains produce toxins at 10 to 20 times the volume compared with previous strains, and we anticipate that this will become a big problem. There aren't a lot of treatment options for these patients.

In many academic institutions, we're seeing Klebsiella and Acinetobacters and e-colis that are resistant to all antibiotics today, so we've been hard at work for a couple of years now, trying to identify new molecules that can deal with some of these pan-resistant gram negative infections. It takes a long time to develop a new drug, and by the time this makes it to the market, our expectation is that these pan-resistant gram negatives are going to be a big problem, not unlike MRSA today. They're the next generation of super bugs.

Industry Insider Michael Bonney has served as president and CEO of Cubist Pharmaceuticals since June 2003. Before that, he served as chief operating officer. From 1995 to 2001, he held various positions at Biogen—including vice president of sales and marketing from 1999 to 2001—where he built the commercial infrastructure for the launch of Avonex.


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