Advancis Pharmaceutical Corporation Reports on Meeting with FDA Reviewing Keflex PULSYS Phase III Trial Design
Published: Jun 27, 2007
GERMANTOWN, Md., June 26 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has concluded a Pre-Phase III meeting with the U.S. Food and Drug Administration (FDA), which focused on Advancis' product development program for its once-daily Keflex PULSYS product candidate. Based on the outcome of the meeting, the Company believes its planned non-inferiority Phase III clinical trial design and its regulatory strategy for Keflex PULSYS for adults and adolescents with uncomplicated skin infections were acceptable to the FDA.
On June 25, 2007, Advancis completed a meeting with the FDA's Division of Anti-Infective and Ophthalmology Products to discuss the Company's Phase III trial and regulatory strategy to support product approval for Keflex PULSYS for the treatment of uncomplicated skin and skin structure infections (uSSSIs) in adults and adolescents due to susceptible Staphylococcus aureus and/or Streptococcus pyogenes. Advancis' planned Phase III trial is designed as a two-arm, double-blind, non-inferiority trial with a minimum enrollment of 600 patients. The Company expects to compare its 1200 milligram Keflex PULSYS product administered once-daily for 10 days to 250 milligrams of Keflex dosed four-times daily, for a total daily dose of 1000 milligrams, for 10 days.
"We are gratified to have received FDA clarity regarding our Keflex clinical program and regulatory strategy," said Dr. Edward Rudnic, Advancis president and CEO. "We feel this positive outcome to our FDA meeting not only validates the clinical approach to our Keflex PULSYS product candidate, but also reinforces our belief that non-inferiority trials are considered adequate to support regulatory approval for certain antibiotic indications. We are very pleased to now have our once-daily Keflex product ready from a regulatory perspective to proceed into the Phase III stage of clinical development."
Advancis' once-daily Keflex PULSYS product candidate is designed to increase the convenience of cephalexin therapy, which is currently dosed two to four times daily for a period of seven to 14 days. There is currently no once-daily cephalexin product approved for marketing in the United States.
Approximately 25 million prescriptions for cephalexin were written in 2006 and the antibiotic is indicated for a broad range of infections. Cephalexin is commonly prescribed as a first-line therapy for common uncomplicated skin infections such as impetigo (skin lesions), simple skin abscesses, and cellulitis (acute inflammation of connective tissue of the skin).
As previously announced, Advancis' future development efforts for its PULSYS product candidates, including Keflex PULSYS, will be dependent upon its ability to secure additional capital or to find a partner to help fund their continued development. However, having received clarity from the FDA on the Keflex PULSYS clinical program and regulatory strategy, Advancis is now prepared to begin its Phase III trial upon successfully securing such capital or a partner.
Advancis can give no assurance that its planned Phase III trial will be successful or that the agreed upon regulatory strategy will be adequate to support ultimate approval of Keflex PULSYS.
Keflex(R) (cephalexin capsules, USP) is a first-generation cephalosporin antibiotic shown to be active against strains of both gram-positive and gram- negative aerobes in vitro and in clinical infections. Keflex is indicated for treatment of the following infections: skin and skin structure infections, respiratory tract infections, otitis media, bone infections, and genitourinary tract infections. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex .
About Advancis Pharmaceutical Corporation:
Advancis Pharmaceutical Corporation 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 a portfolio of 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 and effectively 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, 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 a going 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.Advancis Pharmaceutical Corporation
CONTACT: Robert Bannon, Vice President, Investor Relations & CorporateCommunications of Advancis Pharmaceutical Corp., +1-301-944-6710,email@example.com