MiddleBrook Pharmaceuticals Launches MOXATAG™, The First And Only FDA-Approved Once-Daily Amoxicillin

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses
Article Date: 18 Mar 2009 - 0:00 PDT

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MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) launched MOXATAG (extended-release amoxicillin) Tablets, 775 mg, the first and only FDA-approved once-daily amoxicillin. MOXATAG is approved for the treatment of pharyngitis/tonsillitis secondary to Streptococcus pyogenes in patients twelve years and older. MOXATAG is dosed once-daily at 775 mg, versus the current most commonly prescribed generic amoxicillin treatment regimen for pharyngitis/tonsillitis which is 500 mg three times per day according to the 2008 IMS Health National Drug Therapeutic Index. There is no AB-rated generic for MOXATAG.

MOXATAG is the first product formulated with MiddleBrook's proprietary PULSYS® technology. PULSYS enables the pulsatile delivery, or delivery in rapid bursts, of amoxicillin from MOXATAG. MiddleBrook's PULSYS technology prolongs the release and absorption of amoxicillin from MOXATAG.

"MOXATAG's once-daily dosing advances traditional treatment with amoxicillin, a drug that has been trusted and relied upon for the treatment of pharyngitis and tonsillitis for decades," said MiddleBrook President & CEO John Thievon. "MOXATAG is effective, and MOXATAG uses a lower overall dose than conventional amoxicillin or penicillin treatments for pharyngitis and tonsillitis."

"Studies show that enhanced patient convenience improves compliance," Thievon continued, "and we believe that compliance is a critical success factor in antibiotic therapy. In fact, studies show that failure to take antibiotics properly is the number one reason patients fail antibiotic therapy. Accordingly, MOXATAG has the potential to help improve clinical outcomes. Our 271-person field force today began educating healthcare professionals across the nation about the benefits of MOXATAG. We are excited about MOXATAG's commercial potential."

About MiddleBrook Pharmaceuticals

MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) is a pharmaceutical company focused on developing and commercializing anti-infective products that fulfill unmet medical needs. We have developed a proprietary delivery technology called PULSYS, which enables the pulsatile delivery, or delivery in rapid bursts, of certain drugs. We are currently developing a portfolio of anti-infective PULSYS products. Our near-term corporate strategy is to improve dosing regimens and/or reduce frequency of dosing which we believe will result in improved patient dosing convenience and compliance for antibiotics that have been used and trusted by physicians and patients for decades. MiddleBrook currently markets KEFLEX, the immediate-release brand of cephalexin, and MOXATAG - the first and only FDA-approved once-daily amoxicillin. For more information about MiddleBrook, please visit http://www.middlebrookpharma.com.

About MOXATAG

MOXATAG (amoxicillin extended-release) Tablets, 775mg, is a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release component and two delayed-release components. The three components of MOXATAG are combined in a specific ratio to prolong the release of amoxicillin compared to immediate-release amoxicillin. MOXATAG is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.

Forward-Looking Statements

This announcement contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933, that involve risks and uncertainties. In some cases, forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "potential," "estimate," "will," "may," "predict," "should," "could," "would" and similar expressions. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this announcement. All of these forward-looking statements are based on information available to us at this time. Actual results could differ from those projected in these forward-looking statements as a result of many factors, including those identified in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," and elsewhere in our Annual Report on Form 10-K for the year ended Dec. 31, 2008, and in similar disclosures made by us from time to time in our other filings with the Securities and Exchange Commission. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our filings with the Securities and Exchange Commission. KEFLEX, MiddleBrook, MiddleBrook Pharmaceuticals (stylized), MiddleBrook Pharmaceuticals, Inc., M1 (stylized), MOX-10, MOXAKIT, MOXATAG1 (stylized), MOXATAG, MOXATEN, MOX-PAK and PULSYS are our trademarks and have been registered in the U.S. Patent and trademark office or are the subject of pending U.S. trademarks applications. Each of the other trademarks, tradenames, or service marks appearing in this document belongs to the respective holder. As used herein, except as otherwise indicated by the context, references to "we," "us," "our," "MiddleBrook," or the "Company," refer to MiddleBrook Pharmaceuticals, Inc., and its subsidiaries.

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MiddleBrook Pharmaceuticals, Inc.