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  4. > A Product and Pipeline Analysis of the Antibacterial Drugs Market : Regulatory Approaches to Combat Microbial Resistance and Stimulate Antibiotics R&D

Key Findings

•2014 has turned out to be a flagship year in the history of antibacterial drugs development.
oThree new systemic antibacterial drugs gained Food and Drugs Administration (FDA) approval for acute bacterial skin and skin structure infection in 2014, including Dalvance (Durata Therapeutics), Orbactive (The Medicines Company), and Sivextro (Cubist Pharmaceuticals).
oNew Drug Applications (NDA) were submitted for two combination bacterial therapies for complicated Urinary Tract Infection (UTI) and complicated intra-abdominal infection indications in 2014.
oOnly two new systemic antibacterial agents were approved for use in humans by the US FDA from 2008–2012, while sixteen of them were approved from 1983–1987, including Ceftolozane/Tazobactam (Cubist Pharmaceuticals) and Ceftazidime/Avibactam (AstraZeneca/Forest Laboratories).
oIt is alarming to note that no new classes of antibacterial drugs have been approved for the treatment of Gram-negative Bacilli (GNB) in the last 40 years, leaving fluoroquinolones as the last new class of antibacterial drugs to treat GNB.
oDrug-resistant bacteria, or superbugs, pose a serious threat to human health.
oAccording to the Centre for Disease Control and Prevention (CDC), x million Americans acquire serious infections caused by antibiotic-resistant bacteria every year, of which x die.
oDeveloping new antibacterial drugs requires a great deal of time, effort, expenditure, and scientific research, making it a less attractive segment for investment by pharmaceutical companies.
oSeveral new initiatives and measures have been adopted by agencies such as the FDA and the Infectious Diseases Society of America (IDSA) to spur the development of novel antibacterial drugs and help lure companies back into antibacterial research and development (R&D).

•Currently, there are x new antibacterial drugs in the development stage that could potentially address many, but not all, resistant bacteria, as per the findings of the PEW Charitable Trusts.
oOf the x drugs in the pipeline, x are in phase x clinical trials, x in phase 2, x in phase 3, and x have submitted NDAs.
oThree of the seven antibacterial drugs in phase 3, as well as the two drugs submitted for FDA review, are known to have the potential to address the single most pressing unmet need—infections caused by GNB.
oAt least of the antibacterial drugs in the pipeline are designated as “qualified infectious disease products (QIDP)” which means they are being studied for serious or life-threatening infections and are entitled to receive benefits provided under the Generating Antibiotic Incentives Now (GAIN) Act of 2012.
oAt least two antibacterial drugs in the early stages of development represent an entirely new class of drugs by sidestepping the resistance of some bacteria to available antibacterial drugs, while the others target the same existing components using new chemical compounds; these include FabI inhibitors and Defensin-mimetics.

•Given the high probability of product failure and R&D costs, big pharma companies have exited the antibacterial drugs market in the past. For example, Pfizer that was once a leader in the antibiotics R&D space closed its antibacterial research facility in Connecticut in 2011.
oOf the x or so companies developing antibacterial drugs, only x are big pharma companies, including GlaxoSmithKline, AstraZeneca, and Merck & Co.
oRoche recently made a big come-back into the antibiotics field after having exited this market in 1999. The company has entered into strategic license agreement partnerships with three small biotech companies—Pylor, Discuva Ltd., and Spero Therapeutics.
oSanofi-aventis, Eli Lilly, and Bristol-Myers Squibb (BMS) are among the notable big pharma companies that have exited antibiotics R&D since the 1990s.
oNearly x % of the products currently in the pipeline are being developed by smaller pharma or biotech companies, of which half of them are pre-revenue companies, which means they do not have any commercialized products in the market.

•Research hospitals and universities are also known to make huge contributions toward the development of novel antibiotics for the treatment of drug-resistant superbugs.
oResearchers from the University of British Columbia have recently discovered a peptide to combat infections caused by Gram-positive bacteria by breaking up biofilms or clusters of bacteria impossible to be treated with antibiotics.

Table Of Contents

A Product and Pipeline Analysis of the Antibacterial Drugs Market : Regulatory Approaches to Combat Microbial Resistance and Stimulate Antibiotics RandD
Executive Summary 3
Introduction 14
Classification of Antibacterial Drugs by Mechanism of Action 18
Antibacterial Drugs Market—Pipeline Analysis 47
Antibacterial Drugs Market—Major Clinical Milestones 61
Antibacterial Drugs Market—Product Dashboard of Recently Approved and Late-stage
Pipeline Drug Candidates 65
Antibiotic Resistance—A Critical Unmet Need that Poses Challenges to Antibiotic RandD 78
Antibacterial Drugs Market—Timeline of Key Events 87
Regulatory Approaches to Stimulate Antibiotics RandD 93
Antibacterial Drugs Market—Key Companies to Watch 107
Conclusions 110
Appendix 113
The Frost and Sullivan Story 115

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