Healthcare Industry News: sinusitis
News Release - June 1, 2006
Advancis Pharmaceutical Completes Enrollment in Amoxicillin PULSYS Phase III TrialTop-Line Trial Results Expected in August
GERMANTOWN, Md., June 1 (HSMN NewsFeed) -- Advancis Pharmaceutical Corporation (Nasdaq: AVNC ), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has completed enrollment in the Company's Amoxicillin PULSYS Phase III clinical trial for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis concluded enrollment with a total of 620 adult/adolescent patients as of close-of-business May 31, 2006.
Advancis' adult and adolescent pivotal program is designed as a 600- patient, double-blind, double-dummy, non-inferiority Phase III trial and began on November 9, 2005. Over the coming weeks, patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization will collect and analyze the clinical data. The Company expects to publicly report top-line results around mid-August 2006. If the trial is successful, Advancis expects to file a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration for the product early in the first quarter of 2007.
"We are very pleased to have completed enrollment in our adult and adolescent Phase III trial on schedule," said Edward M. Rudnic, Ph.D., Advancis president and CEO. "We are hopeful that, if successful, Amoxicillin PULSYS will provide physicians a tool to deliver the established safety and efficacy of amoxicillin in the first and only once-daily presentation in the U.S."
Advancis is comparing its Amoxicillin PULSYS dosage form for the treatment of pharyngitis/tonsillitis in adults delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days. The primary endpoint for the study is bacterial eradication, as measured by throat cultures obtained both before and after treatment.
More than 59 million prescriptions for amoxicillin were written in 2005 with total retail sales of approximately $640 million. Amoxicillin is indicated for a broad range of infections, and 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). According to data from IMS Health, a pharmaceutical research company, approximately one-quarter of amoxicillin prescriptions are written for pharyngitis, strep throat, and tonsillitis in adults and children.
ABOUT ADVANCIS PHARMACEUTICAL:
Advancis Pharmaceutical Corporation (Nasdaq: AVNC ) 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 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
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