Advancis Pharmaceutical Files New Drug Application For Once-Daily Amoxicillin PULSYS
2006年12月15日 - 9:00PM
PRニュース・ワイアー (英語)
GERMANTOWN, Md., Dec. 15 /PRNewswire-FirstCall/ -- Advancis
Pharmaceutical Corporation (NASDAQ:AVNC), a pharmaceutical company
focused on developing and commercializing novel anti-infective
products, today announced it has filed 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 with the timely achievement of this
significant milestone for Advancis," said Dr. Edward Rudnic,
Advancis president and CEO. "We are proud to have completed our
first NDA for a proprietary PULSYS product, and if approved, we
believe Amoxicillin PULSYS would offer physicians and patients a
major advance in the most commonly prescribed antibiotic in the
United States. I am very proud of our R&D team for this
tremendous accomplishment." The FDA is expected to determine within
60 days whether the submission is acceptable for filing. 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 filing. On August 10, 2006, Advancis
announced that the Company's Phase III trial for the treatment of
acute pharyngitis/tonsillitis in 620 adults and adolescent patients
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. In
September 2006, Advancis received correspondence 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 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.
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 2005 with total retail sales of more than $640
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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