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LIFESCIENCELEADER.COM APRIL 2014 47 that target pricing and reimbursement would likely work." PUBLIC POLICY EFFORTS CREATE INCENTIVES Cubist engages policy leaders at all levels in the U.S. and Europe about the global anti- biotic pipeline. Along with the Infectious Diseases Society of America (IDSA) and other groups, the company has called for regulatory reform to create the incentives that will persuade companies to continue their development of antibiotics against multidrug-resistant bacterial infections and, if they are not invested in antibiotics, to add it to their list of target therapeutic areas. The public policy efforts of Cubist, IDSA, and other groups have resulted in bipar- tisan legislation to make antibiotic devel- opment more attractive. The legislation, the Generating Antibiotic Incentives Now (GAIN) Act, which was signed into law by President Obama in 2012, may be one reason that two pharmaceutical giants, Roche Holding AG and GlaxoSmithKline, recently initiated R&D; programs focused on antibiotics. The GAIN Act provides incentives such as priority review of NDAs, and for certain new antibiotics that are approved by the FDA, the act extends the period of mar- ket exclusivity by five years. Under the GAIN Act, specific proposed indications for tedizolid qualify for the incentives. Additional legislation to encourage investment in antibiotic R&D; also may be enacted. In December 2013, a bipartisan group of representatives introduced a bill that would build on GAIN by creating an accelerated approval pathway for anti- biotics designed to treat specific patient populations. If approved by Congress and signed into law by President Obama, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act would require the FDA to approve antibiotics and drugs against fungal infections for these popula- tions based on, for example, clinical trials with fewer patients than required in con- ventional clinical studies. Will Cubist's success combined with leg- islative initiatives such as GAIN inspire more companies to add antibiotics against multidrug-resistant infections to their core therapeutic disease areas? As Gilman pointed out, industrywide investment in antibiotic R&D; is required to stay ahead of emerging superbugs and prevent what many public health authorities fear could be a return to an era when infectious dis- eases will overwhelm cardiovascular dis- eases as our number-one killer. L STEVEN GILMAN Ph.D. Executive VP of R&D; and CSO of Cubist The Perfect Balance Between Timing, Quality and Value Accelerate your program from DNA to Commercialization CMC Biologics will accelerate the development of your biopharmaceutical SURJUDPIURP'1$WKURXJKFRPPHUFLDOL]DWLRQZLWKRXWVDFUL¿FLQJTXDOLW\RU increasing your project costs. Strike the perfect balance for your project by choosing CMC Biologics as your development and manufacturing partner. United States +1 425 485 1900 Europe +45 7020 9470 www.cmcbiologics.com 0 4 1 4 _ R D _ C u b i s t . i n d d 2 0414_RD_Cubist.indd 2 3 / 2 4 / 2 0 1 4 4 : 0 0 : 1 4 P M 3/24/2014 4:00:14 PM