Advancis Pharmaceutical Announces FDA Decision That its Amoxicillin Pulsys NDA is Not CompleteFDA 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., February 13, 2007 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , 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 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.
CONTACT: Robert Bannon, Vice President, Investor Relations & CorporateCommunications of Advancis Pharmaceutical Corp., +1-301-944-6710, firstname.lastname@example.org
Web site: http://www.advancispharm.com/
Ticker Symbol: (NASDAQ-NMS:AVNC)
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Posted: February 2007
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