GAINing ground against Superbugs
Nearly 100,000 Americans lose their lives every year to infections, according to the CDC.
Infectious diseases are spreading across country borders, and the antibiotics that doctors previously relied on are becoming less effective.
Infection-causing bacteria, or Superbugs, are fighting back.
They are constantly evolving and mutating in a bid to survive, which means our aged arsenal of antibiotic medicines is simply not enough.
The Generating Antibiotic Incentives Now (GAIN) Act of 2011 will be an important step forward in providing balanced incentives for antibiotic research and development, which has languished during the past 10-20 years.
Today, only a handful of companies, including AstraZeneca, are investing in infection research. AstraZeneca scientists in Boston are collaborating with colleagues across the globe for novel antibacterial and antiviral medicines. In fact, our $100 million expansion of new laboratories in Boston was driven by the strategic business decision to expand our discovery research in infection.
A combination of factors has led to the industry’s diminishing antibiotic pipeline, including a limited market for these short-term therapies (especially as compared to drugs that treat chronic diseases) and the need for clear guidance from FDA on viable clinical trial design.
Discovery of new antibiotics is painstaking because the Superbugs we battle are so smart. These bacteria have multiple mechanisms of resistance, and it is difficult to find drug candidates to fight them. When a new treatment is found, resistance can develop before the new drug even reaches the market.
The GAIN Act addresses these challenges by proposing an extended term of exclusivity for infectious disease products, combined with priority review and fast track provisions.
The additional extended exclusivity provided for companion diagnostic tests will further support innovation. Requiring FDA to provide much-needed guidance on the conduct of clinical trials for antibiotic drugs generally as well as, upon request, specific advice on nonclinical and clinical investigations for individual qualifying pathogens is critically important to the development and approval of new antibiotics.
Without effective antibiotics, modern medical care would not be possible. Even routine procedures – hip replacements or chemotherapy for cancer patients – can’t happen safely without effective guards against infection.
AstraZeneca is asking Congress to support the GAIN Act and help our industry stop the Superbugs.
-by Laura Woodin