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Advancis Pharmaceutical Corporation (AVNC) Announces FDA Acceptance of Amoxicillin PULSYS NDA


5/22/2007 10:52:32 AM

GERMANTOWN, Md., May 22 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that the Company's once-daily Amoxicillin PULSYS New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA).

As previously reported, Advancis resubmitted its NDA on March 23, 2007, for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with acute pharyngitis/tonsillitis (commonly referred to as strep throat) via the 505(b)(2) regulatory pathway. The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee Act (PDUFA) target action date for the Company's NDA of January 23, 2008.

Advancis' Amoxicillin PULSYS is a once-a-day presentation of amoxicillin intended to offer physicians a more convenient once-daily alternative to currently approved penicillin and amoxicillin regimens for treatment of their adolescent and adult patients with strep throat. Studies have demonstrated that less frequent daily dosing can lead to increased patient compliance, a significant contributor to successful antibiotic therapy.

Should Advancis' Amoxicillin PULSYS NDA be approved for marketing by the FDA in January 2008, the Company anticipates being in a position to commercially launch the product to healthcare professionals by as early as the beginning of the 2008/2009 cough and cold season.

About Amoxicillin PULSYS:

Advancis' Amoxicillin PULSYS is a once-a-day pulsatile-release formulation of amoxicillin for oral administration. Amoxicillin PULSYS is intended to provide a lower treatment dose, once-daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and adolescents with tonsillitis and/or pharyngitis.

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). Group A streptococcus, the primary bacteria causing pharyngitis, have been uniformly susceptible to amoxicillin and have not developed resistance to the penicillins, despite the long-term use of amoxicillin for pharyngitis.

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. Approximately 59 million prescriptions for amoxicillin were written in 2006 with total retail sales of more than $640 million.

The most commonly prescribed treatment for the management of Group A streptococcal pharyngitis is 500 milligrams of amoxicillin dosed three-times daily for a period of 10 days. Amoxicillin is currently not approved for once- daily dosing to treat pharyngitis. If 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 pharyngitis/tonsillitis:

Pharyngitis is a painful inflammation of the throat caused by a variety of microorganisms, both viral and bacterial. About 15 million patients annually seek relief of sore throat symptoms in the United States. The most common bacterial cause of acute pharyngitis is Streptococcus pyogenes, or Group A streptococcus, which is referred to as "strep throat." Symptoms of strep throat include fever, painful swallowing, swelling of the throat, and headache. Strep throat can lead to complications, such as rheumatic fever, and should be treated with antibiotic therapy.

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 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 PULSYSTM. 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 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 an ongoing 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,ir@advancispharm.com


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