Navigation Links
MiddleBrook Pharmaceuticals Announces Orange Book Listing of Moxatag(TM) Patents
Date:11/6/2008

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 http://www.middlebrookpharma.com.

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 http://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," 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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. MiddleBrook Pharmaceuticals Retains National Account Firm VCG & Associates
2. MiddleBrook Pharmaceuticals Schedules Conference Call and Webcast for Third Quarter 2008 Financial Results
3. MiddleBrook to Webcast Management Presentation at the 10th Annual Rodman & Renshaw Healthcare Conference
4. MiddleBrook Pharmaceuticals Reports Second Quarter 2008 Results
5. MiddleBrook Pharmaceuticals Reports First Quarter 2008 Results
6. MiddleBrook Pharmaceuticals Engages Morgan Stanley in Its Strategic Process
7. MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity
8. MiddleBrook Pharmaceuticals Reports Third Quarter 2007 Results
9. MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management
10. Webcast Alert: Isis Pharmaceuticals Cardiovascular Program Review
11. Alseres Pharmaceuticals, Inc. to Present at Rodman & Renshaw 10th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... February 22, 2017 , ... Stem ... recent years. The technology is so cutting edge, in fact, the U.S. Food ... stem cell procedures. However, successful patient outcomes in certain clinical stem cell procedures ...
(Date:2/22/2017)... ... February 22, 2017 , ... Secure Exchange Solutions, the ... network of hospitals, health information exchanges, physicians and patients, announced today that SES ... 2015 Edition Health IT Module Certification via Drummond Group LLC, an Authorized Certification ...
(Date:2/22/2017)... IL (PRWEB) , ... February 22, 2017 , ... South ... is proud to once again feature Heroes On The Water (HOW), a non-profit organization ... season’s all new episode has series host ‘Mike D’ traveling to Lake Denmark, New ...
(Date:2/22/2017)... ... February 22, 2017 , ... ... analytics to accurately understand each Medicare Advantage member’s risk, identify any gaps-in-coding, ... This new solution helps transform the HCC Risk Adjustment process from a ...
(Date:2/22/2017)... ... February 22, 2017 , ... A cylindrical ... and sometimes harder to reach ones, according to the results of a clinical ... Conference in Houston by Ricardo A. Hanel, MD, PhD, neurovascular surgeon with Baptist ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... February 22, 2017 The ... market are Olympus Corporation, Nikon Corporation, and Leica ... 75% in the overall market in 2015. The ... innovation through result-oriented research and development activities and ... to focus on expanding their business to emerging ...
(Date:2/22/2017)... Oregon and PUNE, India , ... published by Allied Market Research, titled, "Automated Radio Synthesis Modules ... the world automated radiosynthesis modules market was worth $20 million ... growing at a CAGR of 6.6% from 2016 to 2022. ... share in terms of both market revenues and unit volumes, ...
(Date:2/22/2017)... Research and Markets has announced the addition of ... Small Molecule Drugs), By Route of Administration (Systemic, Topical), By ... report to their offering. ... The global psoriasis drugs market is anticipated ... report provides a detailed analysis of the current and future ...
Breaking Medicine Technology: