Advancis Pharmaceutical Corporation Begins Pivotal Amoxicillin PULSYS Phase III Trial

GERMANTOWN, Md., Nov. 11 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has begun enrollment in its Phase III clinical trial for Amoxicillin PULSYS for adults and adolescents with pharyngitis/tonsillitis. The Company believes the study will be the largest pharyngitis/tonsillitis trial evaluating the safety and efficacy of an aminopenicillin class antibiotic ever conducted.

Advancis enrolled its first patient on November 9, 2005, and expects to enroll a total of at least 600 patients throughout the 2005/2006 respiratory infection season. The Company anticipates completing enrollment by June 2006 and announcing the trial results in the third quarter of 2006.

"We are excited to have started enrollment in our Phase III trial program for Amoxicillin PULSYS and are now focused on managing the trial in a professional and efficient manner," said Dr. Edward Rudnic, Advancis chairman and CEO. "We believe this pivotal trial will provide a definitive assessment of the efficacy of Amoxicillin PULSYS as well as the value of our pulsatile dosing technology."

The Company's Phase III trial to support product approval for Amoxicillin PULSYS for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections is designed as a two-arm, double-blind, double-dummy, non-inferiority trial for its pulsatile form of amoxicillin. Advancis will compare its Amoxicillin PULSYS dosage form for the treatment of pharyngitis delivered in a once-daily 775 milligram tablet for 10 days to 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.

The primary endpoint for the study will be to demonstrate statistical non- inferiority of bacterial eradication rates between the two treatment arms, as measured by throat cultures both before and after therapy. The trial is designed to utilize approximately 50 sites across the U.S. and Canada and is anticipated to last from six to nine months. If the trial is successful, Advancis expects to file a 505(b)(2) New Drug Application (NDA) with the Food and Drug Administration (FDA) for its adult and adolescent Amoxicillin PULSYS product in late 2006.

Approximately 55 million prescriptions for amoxicillin were written in 2004 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 successful and the product 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 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 and reach its sales goals, (11) successfully attract and retain collaborative partners and have its partners fulfill their obligations, and (12) 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, Sr. Director, Investor Relations of AdvancisPharmaceutical Corp., +1-301-944-6710, rbannon@advancispharm.com

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