GERMANTOWN, Md., April 21 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation (Nasdaq: AVNC - News), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that its review of the supplemental New Drug Application for additional Keflex® (cephalexin capsules, USP) products is still ongoing.
“We were notified yesterday that the Agency has not yet completed their review of our application,” said Edward M. Rudnic, Ph.D., president and CEO of Advancis. “However, we were informed that the FDA will be working to complete their review and we look forward to receiving the FDA’s final action in the near future. We draw no negative inference from the notification and we continue to prepare for a launch of the products this July, assuming FDA approval.”
Advancis acquired the rights to manufacture, market, and sell the Keflex brand of cephalexin in the United States in July of 2004. Cephalexin is the third most prescribed outpatient antibiotic in the United States, with more than 25 million prescriptions written annually. Cephalexin is the number-one most prescribed oral cephalosporin antibiotic and is also the number-one recommended oral antibiotic therapy for uncomplicated skin and skin structure infections. Advancis’ net Keflex sales in 2005 were $4.8 million.
Advancis initiated Phase I studies for the development of a once-a-day Keflex product utilizing the Company’s proprietary PULSYS(TM) technology in late 2005 and hopes to advance the product candidate into Phase II clinical development in the first half of 2007. 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.
Amoxicillin PULSYS Phase III Trial Enrollment Update
The Company also announced that it was on schedule to complete its ongoing pivotal Phase III trial of Amoxicillin PULSYS for adolescents and adults with pharyngitis/tonsillitis by the end of this cold/flu season. Advancis enrolled a total of 525 patients as of the close of business April 20, 2006, and expects to enroll a total of at least 600 patients into the trial. The Company plans to announce top-line trial results in the third quarter of 2006.
About Keflex:
Keflex® (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: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. Keflex is currently available in 250mg capsules, 500mg capsules, and powder for oral suspension. Keflex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex.
ABOUT ADVANCIS PHARMACEUTICAL:
Advancis Pharmaceutical Corporation (Nasdaq: AVNC - News) 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 a portfolio of anti-infective drugs based on its novel biological finding that bacteria exposed to antibiotics in frontloaded 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. 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,” “plan,” “hope,” 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 financial results. 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, (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 develop, receive regulatory approval, and commercialize any new 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 Corporation
