Advancis Pharmaceutical Announces FDA Decision That its Amoxicillin PULSYS NDA is Not Complete
2007年2月14日 - 10:15AM
PRニュース・ワイアー (英語)
FDA Requires Additional Data Regarding Proposed Commercial Drug
Manufacture; Company Intends to Re-submit NDA after Clarifying
Issues with FDA; No Clinical Deficiencies Cited by FDA GERMANTOWN,
Md., Feb. 13 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical
Corporation (NASDAQ:AVNC), a pharmaceutical company focused on
developing and commercializing novel anti-infective products, today
announced that it has received a "refusal to file" letter from the
U.S. Food and Drug Administration (FDA) for the Company's
once-daily Amoxicillin PULSYS New Drug Application (NDA),
requesting additional information on the Company's planned
commercial manufacturing processes. As previously reported,
Advancis submitted an NDA on December 14, 2006, 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. In accordance
with FDA guidelines, the FDA has 60 days to preliminarily review
the NDA filing and assess whether the application is acceptable for
filing and substantive review. In its letter dated February 12,
2007, 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.
Advancis intends to meet with the FDA as soon as practicable to
discuss the issues raised and to reach agreement on what additional
information is required for the filing to be accepted. The Agency
did not raise any clinical or other issues in its communication.
"We are very surprised to learn of the FDA's decision not to accept
our application, and we regret the delay this will cause in our
Amoxicillin PULSYS regulatory review," said Dr. Edward Rudnic,
Advancis president and CEO. "However, as the concerns communicated
by the Agency relate to manufacturing issues, and not clinical
data, we believe we will be able to address the concerns relatively
quickly and limit the delay in re-submitting our NDA. We are fully
committed to working with the FDA to resolve the issues raised as
soon as possible." Advancis anticipates meeting with the FDA within
the next few weeks to discuss what steps are required to resolve
the deficiencies cited by the Agency. After the conclusion of this
meeting with the FDA, the Company will update its plans for a
re-submission of the NDA, and the anticipated delay in the
commercialization of Amoxicillin PULSYS. 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, regulatory submissions, 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) 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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