Healthcare Industry News: otitis media
News Release - September 13, 2006
Advancis Pharmaceutical On Track to File NDA for Amoxicillin PULSYSCompany Completes Review of Planned NDA Filing with FDA; No Additional Studies Required, NDA Filing Expected by January 2007
GERMANTOWN, Md., Sept. 13 (HSMN NewsFeed) -- Advancis Pharmaceutical Corporation (Nasdaq: AVNC ), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has received correspondence from the U.S. Food and Drug Administration (FDA), confirming that the Company's recent successful Phase III clinical trial, along with other data, would be considered adequate for filing a New Drug Application (NDA) via the 505(b)(2) regulatory pathway.
Advancis received feedback 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 for pharyngitis/tonsillitis (commonly referred to as strep throat) 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. The Company anticipates filing the Amoxicillin PULSYS NDA in December 2006 or January 2007.
"We are very pleased to have received agreement from the FDA on our regulatory strategy for Amoxicillin PULSYS and are very eager to file our NDA as soon as possible," said Dr. Edward Rudnic, Advancis president and CEO. "Based on the feedback we received from the FDA yesterday, we have reached agreement that data in-hand and the results of our just concluded Phase III trial will be sufficient to support an NDA filing for Amoxicillin PULSYS for adults and adolescents with strep throat around year-end."
On August 10, 2006, Advancis announced that the Company's Phase III trial for the treatment of acute pharyngitis/tonsillitis in adults and adolescents 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.
Approximately 60 million prescriptions for amoxicillin were written in 2005 and the antibiotic is indicated for a broad range of infections. Amoxicillin 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). If Advancis' Phase III trial is 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 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, 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.
Source: Advancis Pharmaceutical
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