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Advancis Pharmaceutical Reaches Agreement with FDA for Resubmission
of Amoxicillin PULSYS NDA
Revised NDA Expected to be Submitted in March 2007
GERMANTOWN, Md.
February 28, 2007
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.
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