GERMANTOWN, Md., March 23 /PRNewswire/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has resubmitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with pharyngitis/tonsillitis (commonly referred to as strep throat) via the 505(b)(2) regulatory pathway.
"We are very pleased to be resubmitting our Amoxicillin PULSYS NDA so quickly after conducting our clarifying meeting with the FDA last month," said Dr. Edward Rudnic, Advancis president and CEO. "We are grateful to the Agency for their clear guidance on what additional information they are requiring in our application, and we believe that we have responded to their requests fully and directly. We now are looking forward to working with the Agency as we move through the regulatory approval process and to our anticipated NDA target action date in January 2008."
In accordance with FDA guidelines, the Agency is expected to preliminarily review the NDA submission and assess whether the application is acceptable for filing and substantive review within 60 days from its submission today. Should the FDA accept the application for filing, the Company expects to receive a Prescription Drug User Fee Act (PDUFA) action date of 10 months from the date of submission, or in January 2008.
On February 12, 2007, Advancis received a "refusal to file" letter from the FDA for its once-daily Amoxicillin PULSYS NDA, requesting additional information on the Company's planned commercial manufacturing processes. Advancis conducted a meeting with the FDA February 26, 2007, reaching an understanding on the additional information that would be required for its NDA filing to be accepted.
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 current 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 $600 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.
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 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, (11) successfully attract and retain collaborative partners, (12) successfully commercialize and gain market acceptance for its 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.
Advancis Pharmaceutical Corp.