Advancis Pharmaceutical Reaches Agreement with FDA for Resubmission of Amoxicillin PULSYS NDA
28 Febrero 2007 - 5:45AM
PR Newswire (US)
Revised NDA Expected to be Submitted in March 2007 GERMANTOWN, Md.,
Feb. 28 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical
Corporation (NASDAQ:AVNC), a pharmaceutical company focused on
developing and commercializing novel anti-infective products, today
announced that it has conducted a meeting with the U.S. Food and
Drug Administration (FDA), regarding the Company's New Drug
Application (NDA) for its once-daily Amoxicillin PULSYS product for
the treatment of adolescents and adults with
pharyngitis/tonsillitis (commonly referred to as strep throat). In
the meeting held on February 26, 2007, Advancis reached agreement
with the FDA on the additional information that is required for its
NDA filing to be accepted. Advancis agreed to provide the
additional information on its manufacturing processes requested by
the FDA for the filing to be accepted, and the Company believes it
will be in a position to resubmit its NDA via the 505(b)(2)
regulatory pathway in March 2007. "We are very grateful to the
Agency for their clear direction and for quickly communicating what
information they are requiring in our Amoxicillin PULSYS NDA," said
Dr. Edward Rudnic, Advancis president and CEO. "With this
additional clarity, we will be working diligently to gather the
required information and resubmit our NDA as soon as possible. We
expect this process will take approximately two weeks, allowing us
to resubmit our NDA in March." 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. 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 about January 2008. If
approved in January 2008, Advancis anticipates commercial launch of
Amoxicillin PULSYS in late February 2008, approximately six weeks
delayed from its prior launch expectations. 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. In its letter, the FDA indicated that Advancis'
application was not sufficiently complete in that it did not
include a proposed commercial batch record or a detailed commercial
process description with process parameters and in-process
controls. 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. In August 2006,
Advancis announced that the Company's Phase III trial in 620 adults
and adolescent patients with acute pharyngitis/tonsillitis due to
Group A streptococcal infections successfully met its primary and
secondary endpoints. The Company's Amoxicillin PULSYS dosage form
for the treatment of pharyngitis was delivered in a once-daily 775
milligram tablet for 10 days, versus the standard comparator
therapy of 250 milligrams of penicillin VK dosed four times daily,
for a total of one gram per day, for 10 days. 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 approximately $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
PULSYS(TM). 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 Corporation 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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