FDA Grants QIDP Designation to Two Cubist Phase 3 Antibiotic Candidates

December 11, 2012

Cubist Pharmaceuticals, Inc., a Foley Hoag LLP client, announced yesterday that it secured designations of two antibiotics under development from the Food and Drug Administration (FDA) as "qualified infectious disease products" (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act enacted this summer.  The two drugs, CXA-201 (ceftolozane/tazobactam) and CB-315, are being investigated by Cubist in phase 3 trials against infections caused by Gram-negative bacteria and as a treatment against Clostridium difficile-associated diarrhea, respectively.

The Foley Hoag Government Strategies practice, led by partners Nick Littlefield, Paul Kim and senior policy advisor Kevin Brennan, worked closely with Cubist over several years in developing and advocating for congressional enactment of the GAIN Act.  Congressman Ed Markey led the Massachusetts House delegation, including Congressman Ed Keating and Congresswoman Niki Tsongas, in supporting the bipartisan GAIN Act, which was introduced by Senator David Blumenthal of Connecticut in the United States Senate.

As a result of the GAIN Act, urgently needed antibiotics designated as QIDPs may qualify upon FDA approval for extended exclusivity, helping to reverse the decline in the development of new treatments against novel, resistant, serious and life-threatening infections.  Assuring priority review and fast track consideration of QIDPs by the FDA will also help spur investment and stimulate innovation in this critical area of public health.

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