Profile: MiddleBrook Pharmaceuticals, Inc. (MBRK.O)

MiddleBrook Pharmaceuticals, Inc., formerly Advancis Pharmaceutical Corporation, incorporated December 1999, is a pharmaceutical company focused on developing and commercializing anti-infective drug products that fulfill unmet medical needs. The Company developed a delivery technology called PULSYS, which enables the pulsatile delivery, or delivery in rapid bursts, of certain drugs. It is approved for the treatment of pharyngitis/tonsillitis secondary to Streptococcus pyogenes, commonly known as strep throat, for adults and pediatric patients age 12 and older. The Company operates in one business segment: prescription pharmaceuticals. The Company markets KEFLEX (Cephalexin, USP) capsules, to wholesalers in capsule formulations.

The Company developed a delivery technology called PULSYS, which enables the pulsatile delivery, or delivery in rapid bursts, of drugs. PULSYS technology offers the prolonged release and absorption of a drug. It can be utilized in a solid oral dosage form which may contain multiple units with varying release profiles. These units are combined in a proportion to produce targeted systemic drug levels. It can also be utilized in other dosage forms, including topicals, transdermals and insertables.

MOXATAG (amoxicillin extended-release) Tablets, 775 mg

MOXATAG (amoxicillin extended-release) Tablets, 775 mg is a once-daily treatment for pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes, more commonly known as strep throat, in adults and pediatric patients 12 years and older. On January 23, 2008, the Company received the United States Food and Drug Administration (FDA) approval for its amoxicillin PULSYS product, under the trade name MOXATAG (amoxicillin extended-release) Tablets, 775 mg. MOXATAG’s once daily extended-release tablet consists of three components: one immediate-release and two delayed-release components. The three components are combined in a specific ratio to prolong the release of amoxicillin from MOXATAG compared to immediate-release amoxicillin. MOXATAG is intended to provide a lower treatment dose, once-daily alternative to approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. Streptococcus pyogenes remains uniformly sensitive to penicillin and amoxicillin with no resistant strains reported. It concluded a Phase III clinical trial for the treatment of pharyngitis/tonsillitis for adults and pediatric patients 12 years and older using a 10-day treatment period.

KEFLEX (Cephalexin, USP) Capsules 250 mg, 500 mg, and 750 mg

KEFLEX (Cephalexin, USP) Capsules 250 mg, 500 mg, and 750 mg is a cephalosporin product approved for treatment of several types of bacterial infections. It is most commonly used in the treatment of skin and skin structure infections and, to a lesser extent, upper respiratory tract infections. The Company markets KEFLEX in the United States to healthcare practitioners, pharmacists, pharmaceutical wholesalers and retail pharmacy chains. United States Food and Drug Administration approved two new strengths of immediate-release KEFLEX capsules for marketing, 333 mg and 750 mg. The Company is in the in the early stages of preparing for a Phase III clinical trial for 750 mg product candidate for the treatment of skin and skin structure infections.

The Company has two PULSYS product candidates in clinical development, namely KEFLEX (Cephalexin) -Adolescent & Adult and Pediatric Amoxicillin PULSYS - Sprinkle. It is in the Phase III clinical trial for its KEFLEX (Cephalexin) PULSYS product candidate. KEFLEX (Cephalexin) is in the Phase III clinical trial for skin and skin structure infections the dosing regimen is 500 mg three times per day for a period of ten days. Amoxicillin Pediatric PULSYS Sprinkle is in the development stage intended for pediatric patients age two and older. It is dosed in multiparticulate granules, which can be sprinkled over food.

The Company competes with Pfizer, GlaxoSmithKline, Wyeth, Bristol-Myers Squibb, Merck, Johnson & Johnson, Roche, Schering-Plough, Novartis, sanofi-aventis, Abbott Laboratories, AstraZeneca, Bayer, Trimeris, Vertex, Gilead Sciences, Cubist, Basilea, InterMune, Oscient, King, Advanced Life Sciences, Biovail, DepoMed, Flamel Technologies, SkyePharma, Teva, Ranbaxy, Sandoz and Stada.