Advancis Pharmaceutical On Track to File NDA for Amoxicillin PULSYS
13 Septiembre 2006 - 7:10AM
PR Newswire (US)
Company Completes Review of Planned NDA Filing with FDA; No
Additional Studies Required, NDA Filing Expected by January 2007
GERMANTOWN, Md., Sept. 13 /PRNewswire-FirstCall/ -- Advancis
Pharmaceutical Corporation (NASDAQ:AVNC), a pharmaceutical company
focused on developing and commercializing novel anti-infective
products, today announced it has received correspondence from the
U.S. Food and Drug Administration (FDA), confirming that the
Company's recent successful Phase III clinical trial, along with
other data, would be considered adequate for filing a New Drug
Application (NDA) via the 505(b)(2) regulatory pathway. Advancis
received feedback from the FDA's Division of Anti-Infectives Drug
Products, confirming that the regulatory strategy and proposed
format for Advancis' NDA filing for its once-daily Amoxicillin
PULSYS product for pharyngitis/tonsillitis (commonly referred to as
strep throat) was acceptable. The FDA indicated that Advancis'
recently concluded Phase III clinical trial in adults and
adolescents, along with the Company's Phase I pharmacokinetic
studies, results from the Company's prior adult and adolescent
Amoxicillin PULSYS Phase III trial, and existing academic
literature would be sufficient to support an NDA filing. The
Company anticipates filing the Amoxicillin PULSYS NDA in December
2006 or January 2007. "We are very pleased to have received
agreement from the FDA on our regulatory strategy for Amoxicillin
PULSYS and are very eager to file our NDA as soon as possible,"
said Dr. Edward Rudnic, Advancis president and CEO. "Based on the
feedback we received from the FDA yesterday, we have reached
agreement that data in-hand and the results of our just concluded
Phase III trial will be sufficient to support an NDA filing for
Amoxicillin PULSYS for adults and adolescents with strep throat
around year-end." On August 10, 2006, Advancis announced that the
Company's Phase III trial for the treatment of acute
pharyngitis/tonsillitis in adults and adolescents 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. Approximately 60
million prescriptions for amoxicillin were written in 2005 and the
antibiotic is indicated for a broad range of infections.
Amoxicillin 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). If
Advancis' Phase III trial is 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 Advancis Pharmaceutical
Corporation: 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 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, Sr. Director, Investor Relations of Advancis Pharmaceutical
Corp., +1-301-944-6710, Web site: http://www.advancispharm.com/
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