Advancis Pharmaceutical Announces Launch of Keflex 750mg Capsules
25 Juli 2006 - 2:00PM
PR Newswire (US)
750mg Capsules Now Shipping to Pharmacies Across the U.S.
GERMANTOWN, Md., July 25 /PRNewswire-FirstCall/ -- Advancis
Pharmaceutical Corporation (NASDAQ:AVNC), a pharmaceutical company
focused on developing and commercializing novel anti-infective
products, today announced the commercial launch of Keflex 750mg
capsules. The new strength of Keflex allows health care
professionals the flexibility to deliver higher doses of Keflex
with fewer capsules per day. Keflex 750mg capsules have been
manufactured, packaged, and are currently being distributed to
pharmacies nationwide in bottles of 50. "With the availability of
Keflex 750mg capsules, physicians and other health care
professionals will be able to deliver a total daily dose of Keflex
with fewer capsules per day," said Edward M. Rudnic, Ph.D.,
president and CEO of Advancis. "With pharmacy distribution
underway, our sales force will begin promoting Keflex 750mg
capsules to high volume prescribers across the United States."
Advancis has deployed 83 field-based sales personnel, including 75
sales representatives and eight district sales managers, fully
dedicated to the promotion of Keflex 750mg. Sales representatives
from Advancis have been presenting Keflex 750mg to pharmacists and
pharmaceutical distributors since July 17, 2006. Advancis' sales
representatives are expected to begin directly promoting Keflex
750mg to targeted physicians as well as providing patient starter
samples later this week. The Company expects to see measurable
Keflex 750mg prescription volume beginning the week of July 31,
2006. Advancis' sales force territories cover zip codes from which
more than 80% of all cephalexin market prescriptions are generated.
Advancis will augment its sales force efforts with advertising,
direct mail, and telemarketing. Advancis acquired the rights to
manufacture, market, and sell Keflex in the United States in July
of 2004. Cephalexin is the third most prescribed outpatient
antibiotic in the United States, with more than 25 million
prescriptions written annually. Keflex is the number-one most
prescribed oral cephalosporin antibiotic and is also the number-one
recommended oral antibiotic therapy for uncomplicated skin and skin
structure infections. Advancis received approval for introduction
of the Keflex 750mg capsules in May, 2006. About Keflex: Keflex(R)
Capsules (Cephalexin, USP) is a first-generation cephalosporin
antibiotic shown to be active against strains of both gram-positive
and gram- negative aerobes in vitro and in clinical infections.
Keflex is indicated for treatment of the following infections:
respiratory tract infections, otitis media, skin and skin structure
infections, bone infections, and genitourinary tract infections.
Keflex is currently available in 250mg capsules, 500mg capsules,
and powder for oral suspension. Keflex is contraindicated in
patients with known allergy to the cephalosporin group of
antibiotics. Before therapy with cephalexin is instituted, careful
inquiry should be made to determine whether the patient has had
previous hypersensitivity reactions to cephalexin, cephalosporins,
penicillins, or other drugs. Keflex should be administered with
caution in the presence of markedly impaired renal function or a
history of gastrointestinal disease, particularly colitis. More
information on Keflex and prescribing information are available at
http://www.keflex.com/ ABOUT ADVANCIS PHARMACEUTICAL: Advancis
Pharmaceutical Corporation (NASDAQ:AVNC) is a pharmaceutical
company focused on the development and commercialization of
pulsatile drug products that fulfill substantial unmet medical
needs in the treatment of infectious disease. The Company is
developing a portfolio of anti-infective drugs based on its novel
biological finding that bacteria exposed to antibiotics in
frontloaded staccato bursts, or "pulses," are killed more
efficiently and effectively than those under standard treatment
regimens. Based on this finding, Advancis has developed a
proprietary, once-a-day pulsatile delivery technology called
PULSYS. By examining the resistance patterns of bacteria and
applying its delivery technologies, Advancis has the potential to
redefine infectious disease therapy and significantly improve drug
efficacy, shorten length of therapy, and reduce drug resistance
versus currently available antibacterial products. For more on
Advancis, please visit http://www.advancispharm.com/. This
announcement contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
These statements are based on Advancis' current expectations and
assumptions. These statements are not guarantees of future
performance and are subject to a number of risks and uncertainties
that would cause actual results to differ materially from those
anticipated. The words, "believe," "expect," "intend,"
"anticipate," "plan," "hope," and variations of such words, and
similar expressions identify forward-looking statements, but their
absence does not mean that the statement is not forward-looking.
Statements in this announcement that are forward- looking include,
but are not limited to, statements about the Company's future
development plans, clinical trials, and financial results. The
actual results realized by Advancis could differ materially from
these forward-looking statements, depending in particular upon the
risks and uncertainties described in the Company's filings with the
Securities and Exchange Commission. These include, without
limitation, risks and uncertainties relating to the Company's
financial results and the ability of the Company to (1) reach
profitability, (2) prove that the preliminary findings for its
product candidates are valid, (3) receive required regulatory
approvals, (4) successfully conduct clinical trials in a timely
manner, (5) establish its competitive position for its products,
(6) develop and commercialize products that are superior to
existing or newly developed competitor products, (7) develop
products without any defects, (8) have sufficient capital resources
to fund its operations, (9) protect its intellectual property
rights and patents, (10) implement its sales and marketing
strategy, (11) successfully attract and retain collaborative
partners, (12) successfully develop, commercialize, and receive
market acceptance of its Keflex products, and (13) retain its
senior management and other personnel. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of today's date.
Advancis undertakes no obligation to update or revise the
information in this announcement, whether as a result of new
information, future events or circumstances or otherwise.
DATASOURCE: Advancis Pharmaceutical Corporation CONTACT: Robert
Bannon, Senior Director, Investor Relations, of Advancis
Pharmaceutical Corporation, +1-301-944-6710, Web site:
http://www.advancispharm.com/ http://www.keflex.com/
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