New antibiotic developments are on the horizon

Fact:
As antibacterial drugs lose their effectiveness, new antibiotic and anti-infective products must be developed to prevent, rapidly diagnose, and treat infections.

—Centers For Disease Control and Prevention, Task Force on Microbial Resistance, 2002

Our business is focused on the development of antibiotics that can be utilized to successfully treat community-acquired bacterial infections. Our lead candidate, Amoxicillin PULSYS, is based on a drug that continues to play a critical role in the treatment of several upper respiratory tract infections and is the number-one prescribed type of antibiotic in the United States. Our Keflex brand of cephalexin is the flagship brand of that antibiotic, the third most prescribed antibiotic in the United States, and the number-one prescribed antibiotic for treatment of uncomplicated skin infections. We believe our efforts to develop PULSYS versions of these off-patent compounds could result in their utility as front-line antibiotics continuing for another generation as our patented technology addresses a fundamental weakness both drugs share: inconvenience. Inconvenience can lead to missed doses, which may result in treatment failures and the development of antibiotic resistance. We believe addressing inconvenience could markedly improve these drugs? utility going forward by leading to better compliance and more successful treatment outcomes.

New antibiotic product candidates—featuring PULSYS:

• Amoxicillin PULSYS
  Amoxicillin is commonly used to treat a variety of conditions, including upper and lower respiratory, urinary tract, and skin infections. Using PULSYS, our new antibiotic formulation promises to cut daily dosing by approximately one-half and provide the convenience of once-daily dosing. We intend to develop pulsatile amoxicillin alone and possibly in new antibiotic combinations.
• Cephalexin PULSYS
  Cephalexin is a commonly prescribed antibiotic for skin infections and post-operative infection. MiddleBrook Pharmaceuticals, Inc. is poised to begin clinical development of another new antibiotic—PULSYS-enhanced cephalexin. Our new antibiotic development will be designed to reduce current cephalexin dosages from two to four times to daily to just once a day. Learn more about cephalexin use.

Other possible PULSYS products
We have also identified additional product candidates which we believe could be developed for delivery in a pulsatile manner. The timing of further development work on these candidates depends on our resources as well as our evaluation of the commercial potential of the products. We believe we may be able to utilize our PULSEYS technology in the creation of antibiotic product condidates that target some of the most common use of antibiotics. These uses include: sinusitus, chronic bronchitis, acute otitis media, urinary tract infections, and community—acquired methicillin resistant staphylococcus aureus (MRSA).

MiddleBrook also intends to explore the use of our pulsatile dosing approach beyond antibiotics to other therapeutic categories, such as antivirals and antifungals.

The benefits of MiddleBrook’s new antibiotic products
Bolstered by our proprietary pulsatile dosing approach, each new antibiotic product in the MiddleBrook pipeline promises to offer at least one significant advantage over similar drugs currently on the market.

• Once-a-day formulation
• Lower dosages
• Shorter duration of therapy
• Reduced side effects profile
• Reduced incidence of resistance
• Combination products with superior efficacy over either product alone
• Improved pediatric dosage form
• Improved geriatric dosage form