Life Science Leader Magazine

MAR 2015

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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM MARCH 2015 30 additional classes, and that is always challenging, but with drug-resistant pathogens and mechanisms changing all the time, there's always a need to stay one step ahead of the bacteria. There are also certain pathogens, such as Acinetobacter, that many drugs don't cover yet. And there are certain other holes in the armamentarium that scien- tists will be working on over time." Antibiotics also continue to carry busi- ness challenges, and Gilman sees the need for additional incentives beyond the GAIN Act. " We need to question old pricing models because they are based on the incorrect assumption that antibiotics should be cheap and easily available. Most of the inexpensive anti- biotics don't actually work against the most problematic pathogens nowadays." Postmerger plans are short-term for Gilman at the time of our interview just before year's end, with the rest of the Cubist top-management team now mostly replaced. He is still discussing his future with Merck but wants to make sure he does everything possible to help in the transition, including the launch of Zerbaxa in the United States and its regulatory approval in Europe. His parting words likely capture the sentiments of the entire Cubist community as their company changes hands. "We are proud to have built a signifi- cant company with multiple products, particularly now with Zerbaxa approved — a very exciting event, of course. We are proud to have built a company that's helped so many people, and we are looking forward to continuing that mission in the new arrangement with Merck." We ended our conversation with hopeful wishes for the new year, knowing events will continue to unfold in unpredictable ways by the time this article is pub- lished. But those developments will play out in the context of this unique venture that stepped in to fill a gap in Big Pharma R&D; and thereby opened new territory now drawing the industry back to a pressing medical need. L ZERBAXA — A LAUNCH IN THE LIMELIGHT Just as Merck's acquisition of Cubist hit the veritable newsstands last December, the to-be-acquired company accomplished another FDA approval, for its new Gram-negative antibiotic Zerbaxa (ceftolozane/tazobactam). Cubist's long-time chief scientist at the time of the product's approval is Dr. Steven C. Gilman. He says Zerbaxa rounds out the company's fight against drug-resistant bacteria with the first antibiotic approved by the FDA in the U.S. under the GAIN (Generating Antibiotic Incentives Now) Act to address certain serious and resistant Gram-negative strains: "Cubist has taken the charge and has worked quite diligently to come up with new therapeutic agents for certain Gram-positive and Gram-negative bacterial infections. With products, such as Sivextro (tedizolid phosphate), approved earlier in 2014, and Cubicin (daptomycin), on the market for more than 10 years, we have very significant agents against Gram-positives, but the emergence of resistant Gram-negative pathogens has been quite significant. Zerbaxa is the first new approval for drugs effective against drug-resistant Gram-negative pathogens under the GAIN Act of 2012. Zerbaxa is also the first of the Infectious Diseases Society of America's (IDSA) 10 x '20 Initiative, which in 2010 called for the development of 10 new antibiotics by 2020, to address certain serious and resistant Gram-negative bacteria. Zerbaxa is now approved in the United States for two indications, complicated urinary tract infections and complicated interabdominal infections, which are generally administered by IV in the hospital often to patients infected with drug-resistant pathogens; so we believe Zerbaxa will be a significant new addition to the physicians' armamentarium. We are now watching the drug's performance as we deliver it to the U.S. population with serious infections by multi-drug-resistant pathogens. "We believe Zerbaxa therapy will help patients get out of the hospital more quickly, and, of course when you do that, you can save healthcare costs. Generally speaking, when you're infected with a drug-resistant pathogen but inappropriately treated, the duration of your hospital stay can double. The hospital costs can be double, and the risk of death is sometimes double, depending on the indication and whether the patient is infected with a drug-susceptible pathogen." CUBIST: THE CURTAIN CLOSES By W. Koberstein

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