Redefining anti-infective therapy
Advancis Pharmaceutical is now MiddleBrook™ Pharmaceuticals, Inc.
MiddleBrook™ Pharmaceutical, Inc. is a pharmaceutical company focused on developing and commercializing anti-infective drug products that fulfill unmet medical needs in anti-infective therapy. We are developing a portfolio of drugs based on our novel biological finding that bacteria exposed to antibiotics in front-loaded, sequential bursts, or pulses, are killed more efficiently and effectively than those exposed to standard antibiotic treatment regimens. Based on this finding, we have developed a proprietary, once-a-day pulsatile drug delivery technology called PULSYS™.
The History of MiddleBrook™
2008
The U.S. FDA approves MiddleBrook's MOXATAG™ (Amoxicillin PULSYS) – the first and only once–daily amoxicillin product approved in the U.S.
2007
MiddleBrook's New Drug Application (NDA) is submitted to the FDA and is accepted for filing.
2006
MiddleBrook's Amoxicillin PULSYS™ Phase III trial for adolescents and adults with strep throat meets its desired endpoints.
2006
MiddleBrook receives approval to market a new 750mg strength of its Keflex brand of cephalexin.
2005
MiddleBrook begins redesigned Phase III clinical trial of Amoxicillin PULSYS for adolescents and adults with strep throat.
2004
Amoxicillin PULSYS™ becomes MiddleBrook’ first product to enter Phase III of clinical trials
2004
MiddleBrook acquires Keflex®—the most recognized brand of cephalexin in the United States—from Eli Lilly
2003
MiddleBrook completes its Initial Public Offering (NASDAQ: AVNC)
2003
Core patents are issued covering the pulsatile approach to dosing anti-infective drugs
2002
The pulsatile delivery of antibiotics to a patient in a single, once-daily tablet is demonstrated
2001
In vivo studies demonstrate the enhanced effectiveness of pulsatile dosing
2000
In vitro studies demonstrate that pulsatile dosing of antibiotics enhances antibacterial effectiveness
2000
MiddleBrook is founded on a novel discovery—changing the daily dosing paradigm changes bacteria’s response to an antibiotic
