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MiddleBrook Pharmaceuticals Announces Orange Book Listing of Moxatag(TM) Patents

GERMANTOWN, Md., Nov. 6 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that three patents protecting Moxatag (amoxicillin extended-release) Tablets, 775mg, were listed in the FDA Orange Book on Oct. 24, 2008, pursuant to Section 4 of Public Law No. 110-379, which was enacted on Oct. 8, 2008.

MiddleBrook President & CEO John Thievon said, "Public Law No. 110-379 provides important incentives for drug developers to innovate in the antibiotic arena. MiddleBrook has already made progress in this therapeutic class with Moxatag, the first and only FDA-approved once-daily amoxicillin. We believe that Moxatag addresses significant unmet needs in the antibiotic therapeutic area through patient convenience and a lower overall dose."
MiddleBrook Pharmaceuticals Reports Inducement Grants

Under NASDAQ Marketplace Rule 4350 MiddleBrook Pharmaceuticals also announced today that on Oct. 31, 2008, it granted options to purchase 584,000 shares of MiddleBrook's common stock to four (4) new employees as a material inducement for them to join MiddleBrook. The options were granted pursuant to NASDAQ Marketplace Rule 4350(i)(1)(A)(iv) and under MiddleBrook's New Hire Stock Incentive Plan, which was approved by MiddleBrook's Board of Directors on Sept. 26, 2008. The options have a per share exercise price equal to the closing price of MiddleBrook's common stock on the NASDAQ Global Market on the day immediately preceding the grant date, a ten-year term and vesting over four years, with 25 percent of the options vesting one year from the grant date and 1/48th of the options vesting monthly thereafter. The options have a grant date of Oct. 31, 2008.

About Moxatag:

Moxatag (extended-release amoxicillin) 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 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 currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. For more information about Moxatag, please visit

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 are currently developing a portfolio of anti-infective products utilizing our proprietary, once-a-day pulsatile delivery technology called Pulsys. Our near-term corporate strategy is to improve dosing regimens and/or 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 the Keflex brand of cephalexin and has received regulatory approval for Moxatag -- the first and only once-daily amoxicillin product approved for marketing in the U.S. For more information about MiddleBrook, please visit

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," in our Registration Statement on Form S-3 as filed with the Securities and Exchange Commission on October 17, 2008, and in our "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, 2007 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. MiddleBrook, MiddleBrook Pharmaceuticals (stylized), MiddleBrook Pharmaceuticals, Inc., Pulsys, Moxatag and Keflex are our trademarks and have been registered in the U.S. Patent and Trademark Office or are the subject of pending U.S. trademark applications. Each of the other trademarks, tradenames or services marks appearing in this document belongs to its respective holder.

SOURCE MiddleBrook Pharmaceuticals, Inc.
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