Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA
2007年5月22日 - 8:55PM
PRニュース・ワイアー (英語)
Company Receives FDA Action Date of January 23, 2008 GERMANTOWN,
Md., May 22 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical
Corporation (NASDAQ:AVNC), a pharmaceutical company focused on
developing and commercializing novel anti-infective products, today
announced that the Company's once-daily Amoxicillin PULSYS New Drug
Application (NDA) has been accepted for filing by the U.S. Food and
Drug Administration (FDA). As previously reported, Advancis
resubmitted its NDA on March 23, 2007, for its once-daily
Amoxicillin PULSYS product for the treatment of adolescents and
adults with acute pharyngitis/tonsillitis (commonly referred to as
strep throat) via the 505(b)(2) regulatory pathway. The FDA has
accepted the Company's NDA for filing and has set a Prescription
Drug User Fee Act (PDUFA) target action date for the Company's NDA
of January 23, 2008. Advancis' Amoxicillin PULSYS is a once-a-day
presentation of amoxicillin intended to offer physicians a more
convenient once-daily alternative to currently approved penicillin
and amoxicillin regimens for treatment of their adolescent and
adult patients with strep throat. Studies have demonstrated that
less frequent daily dosing can lead to increased patient
compliance, a significant contributor to successful antibiotic
therapy. Should Advancis' Amoxicillin PULSYS NDA be approved for
marketing by the FDA in January 2008, the Company anticipates being
in a position to commercially launch the product to healthcare
professionals by as early as the beginning of the 2008/2009 cough
and cold season. 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 currently
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 $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
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, potential commercial success, and any financial
forecasts included in this announcement. 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) raise
additional capital and continue as an ongoing concern, (2) increase
Keflex 750 sales, (3) obtain FDA approval for its Amoxicillin
PULSYS product candidate, (4) successfully reduce costs, (5)
maintain compliance with its outstanding credit facility with
Merrill Lynch Capital, (6) reach profitability, (7) prove that the
preliminary findings for its product candidates are valid, (8)
receive required regulatory approvals, (9) successfully conduct
clinical trials in a timely manner, (10) establish its competitive
position for its products, (11) develop and commercialize products
that are superior to existing or newly developed competitor
products, (12) develop products without any defects, (13) have
sufficient capital resources to fund its operations, (14) protect
its intellectual property rights and patents, (15) implement its
sales and marketing strategy, (16) successfully attract and retain
collaborative partners, (17) successfully commercialize and gain
market acceptance for its Keflex products, (18) successfully obtain
sufficient manufactured quantities of its drug products at
acceptable rates, and (19) 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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