Through 2021, Major Constraints in the Hospital-Treated Infections Drug Market Will Include the Loss of Patent Protection for Key Branded Products-Notably Pfizer”s Zyvox-and Continued Generic Erosion of Premium-Priced Agents Such as Meropenem

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the hospital-treated infections (HTI) drug market, the loss of patent protection for key branded products-notably Pfizer’s Zyvox, the HTI sales leader in 2011-and the continued generic erosion of premium-priced agents such as meropenem (Cubist Pharmaceuticals/AstraZeneca’s Merrem/Meronem; Dainippon Sumitomo’s Meropen; generics) as well as increasingly stringent regulatory and reimbursement environments will be the major constraints of market growth through 2021.

The HTI market is currently dominated by parenteral agents, and drug developers recognize the need for more-convenient dosing, either in the form of oral formulations or drugs that require less frequent administration. This convenience would facilitate early patient discharge, thereby reducing hospital and patient costs. Five of the emerging therapies slated to launch by 2021-Rib-X’s delafloxacin, Furiex’s JNJ-Q2, Trius/Bayer’s tedizolid, Tetraphase’s eravacycline and Nabriva/Forest’s BC-3781-are being developed in both intravenous and oral formulations. Additionally, long-acting therapies such as Durata’s dalbavancin and The Medicines Company’s oritavancin have the potential for once-a-week dosing and would enable convenient outpatient parenteral antibiotic therapy.

The findings also reveal that, because of the increasing prevalence and severity of infections due to MDR gram-negative bacteria, infectious disease physicians have called for new therapies that are active against these pathogens. There is a growing need for antibiotics that target pathogens that express beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), Klebsiella pneumoniae carbapenemases (KPCs), and metallo-beta-lactamases. Two antipseudomonal cephalosporin/beta-lactamase inhibitor combinations will launch during the forecast period: Cubist’s CXA-201 and AstraZeneca/Forest’s CAZ-AVI.

“CXA-201 and CAZ-AVI provide broad-spectrum, gram-negative coverage and stability against ESBLs and CAZ-AVI has the added advantage of expanded coverage of some class C beta-lactamases and the class A carbapenemases KPC,” said Decision Resources Analyst Maria Ascano, Ph.D. “According to infectious disease experts we interviewed, when approved, both agents are likely to partly replace carbapenems for treatment of MDR-gram-negative pathogens, thereby stemming emergence of carbapenem resistance.”