Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS
23 März 2007 - 4:44PM
PR Newswire (US)
GERMANTOWN, Md., March 23 /PRNewswire/ -- Advancis Pharmaceutical
Corporation (NASDAQ:AVNC), a pharmaceutical company focused on
developing and commercializing novel anti-infective products, today
announced it has resubmitted a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA), for its once-daily
Amoxicillin PULSYS product for the treatment of adolescents and
adults with pharyngitis/tonsillitis (commonly referred to as strep
throat) via the 505(b)(2) regulatory pathway. "We are very pleased
to be resubmitting our Amoxicillin PULSYS NDA so quickly after
conducting our clarifying meeting with the FDA last month," said
Dr. Edward Rudnic, Advancis president and CEO. "We are grateful to
the Agency for their clear guidance on what additional information
they are requiring in our application, and we believe that we have
responded to their requests fully and directly. We now are looking
forward to working with the Agency as we move through the
regulatory approval process and to our anticipated NDA target
action date in January 2008." In accordance with FDA guidelines,
the Agency is expected to preliminarily review the NDA submission
and assess whether the application is acceptable for filing and
substantive review within 60 days from its submission today. Should
the FDA accept the application for filing, the Company expects to
receive a Prescription Drug User Fee Act (PDUFA) action date of 10
months from the date of submission, or in January 2008. On February
12, 2007, Advancis received a "refusal to file" letter from the FDA
for its once-daily Amoxicillin PULSYS NDA, requesting additional
information on the Company's planned commercial manufacturing
processes. Advancis conducted a meeting with the FDA February 26,
2007, reaching an understanding on the additional information that
would be required for its NDA filing to be accepted. About
Amoxicillin PULSYS: Advancis' Amoxicillin PULSYS is a once-a-day
pulsatile-release formulation of amoxicillin for oral
administration. Amoxicillin PULSYS is intended to provide a lower
treatment dose, once-daily alternative to current approved
penicillin and amoxicillin regimens for the treatment of adults and
adolescents with tonsillitis and/or pharyngitis. Amoxicillin is
indicated for a broad range of infections, and is commonly
prescribed as a first-line therapy for common infections such as
otitis media (middle ear infection), pharyngitis (sore throat), and
sinusitis (sinus infection). Group A streptococcus, the primary
bacteria causing pharyngitis, have been uniformly susceptible to
amoxicillin and have not developed resistance to the penicillins,
despite the long-term use of amoxicillin for pharyngitis. According
to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written
for pharyngitis, strep throat, and tonsillitis in adults and
children. Approximately 59 million prescriptions for amoxicillin
were written in 2006 with total retail sales of more than $600
million. The most commonly prescribed treatment for the management
of Group A streptococcal pharyngitis is 500 milligrams of
amoxicillin dosed three-times daily for a period of 10 days.
Amoxicillin is currently not approved for once- daily dosing to
treat pharyngitis. If approved for marketing, physicians
prescribing Amoxicillin PULSYS would have available the first
once-daily product in the aminopenicillin class for the treatment
of pharyngitis while utilizing approximately one-half the amount of
amoxicillin currently used. About pharyngitis/tonsillitis:
Pharyngitis is a painful inflammation of the throat caused by a
variety of microorganisms, both viral and bacterial. About 15
million patients annually seek relief of sore throat symptoms in
the United States. The most common bacterial cause of acute
pharyngitis is Streptococcus pyogenes, or Group A streptococcus,
which is referred to as "strep throat." Symptoms of strep throat
include fever, painful swallowing, swelling of the throat, and
headache. Strep throat can lead to complications, such as rheumatic
fever, and should be treated with antibiotic therapy. About
Advancis Pharmaceutical Corporation: Advancis Pharmaceutical
Corporation (NASDAQ:AVNC) is a pharmaceutical company focused on
the development and commercialization of anti-infective drug
products that fulfill substantial unmet medical needs in the
treatment of infectious disease. The Company is developing
anti-infective drugs based on its novel biological finding that
bacteria exposed to antibiotics in front- loaded staccato bursts,
or "pulses," are killed more efficiently than those under standard
treatment regimens. Based on this finding, Advancis has developed a
proprietary, once-a-day pulsatile delivery technology called
PULSYSTM. 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," 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 potential commercial success. 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 with favorable results, (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 commercialize and gain
market acceptance for 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 Corp. CONTACT: Robert Bannon,
Vice President, Investor Relations & Corporate Communications,
of Advancis Pharmaceutical Corp., +1-301-944-6710, Web site:
http://www.advancispharm.com/
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