MiddleBrook Pharmaceuticals Announces Orange Book Listing of Moxatag(TM) Patents
November 06 2008 - 4:30PM
PR Newswire (US)
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.
DATASOURCE: MiddleBrook Pharmaceuticals, Inc. CONTACT: Investor
Relations-Media Contact: Faith Pomeroy-Ward of MiddleBrook
Pharmaceuticals, Inc., +1-301-944-6585 Web site:
http://www.middlebrookpharma.com/
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