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MiddleBrook Pharmaceuticals to Launch Moxatag(TM) March 2009

January 7, 2009

The first and only FDA-approved once-daily amoxicillin will be promoted to health care professionals nationwide

WESTLAKE, Texas, Jan. 7 /PRNewswire-FirstCall/ — MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), today announced that the professional launch of Moxatag (amoxicillin extended-release) Tablets, 775mg, will begin on March 16, 2009. The Company has hired over half of its 270-person field force which will promote Moxatag, the first and only FDA-approved once-daily amoxicillin, to health care professionals nationwide. Moxatag is approved for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. MiddleBrook also announced that it completed its manufacturing validation of Moxatag, and in preparation for the Moxatag trade launch, Moxatag shipments to the Company’s third-party logistics provider began in January 2009.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090107/PH56153 )

MiddleBrook President and CEO John Thievon said, “All 30 of our district sales managers are now on board, and with over half of our sales force hired, we can say that MiddleBrook is well on its way to becoming a sales-driven organization.”

“We’re in the process of securing national retail distribution for Moxatag across the food, drug and mass channels, which includes independent and chain retailers,” Thievon continued. “The entire MiddleBrook team is working diligently to ensure the successful launch of Moxatag, and as a result of our efforts to date, I’m extremely pleased to announce that Moxatag’s professional launch will begin on March 16, 2009.”

MiddleBrook plans to hire sales representatives to fill the remaining open positions for its field force over the next several weeks. Interested job applicants can find more information about MiddleBrook’s open positions and apply online at the Careers section of MiddleBrook’s web site, www.middlebrookpharma.com.

MiddleBrook Pharmaceuticals Reports Inducement Grants Under NASDAQ Marketplace Rule 4350

MiddleBrook Pharmaceuticals also announced today that on Dec. 31, 2008, it granted options to purchase 328,100 shares of MiddleBrook’s common stock to sixteen (16) 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 business 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 Dec. 31, 2008.

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. The Company 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 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. For more information about Moxatag, please visit www.middlebrookpharma.com.

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 Quarterly Report on Form 10-Q for the quarter ended Sept. 30, 2008, 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, M1 (stylized), Moxatag 1 (stylized) 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.


Source: newswire



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