Advancis Pharmaceutical Corporation Reaches Agreement with FDA for Resubmission of Amoxicillin PULSYS NDA
GERMANTOWN, Md., Feb. 28 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has conducted a meeting with the U.S. Food and Drug Administration (FDA), regarding the Company's New Drug Application (NDA) for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with pharyngitis/tonsillitis (commonly referred to as strep throat). In the meeting held on February 26, 2007, Advancis reached agreement with the FDA on the additional information that is required for its NDA filing to be accepted.
Advancis agreed to provide the additional information on its manufacturing processes requested by the FDA for the filing to be accepted, and the Company believes it will be in a position to resubmit its NDA via the 505(b)(2) regulatory pathway in March 2007.
"We are very grateful to the Agency for their clear direction and for quickly communicating what information they are requiring in our Amoxicillin PULSYS NDA," said Dr. Edward Rudnic, Advancis president and CEO. "With this additional clarity, we will be working diligently to gather the required information and resubmit our NDA as soon as possible. We expect this process will take approximately two weeks, allowing us to resubmit our NDA in March."
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. 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 about January 2008. If approved in January 2008, Advancis anticipates commercial launch of Amoxicillin PULSYS in late February 2008, approximately six weeks delayed from its prior launch expectations.
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. In its letter, the FDA indicated that Advancis' application was not sufficiently complete in that it did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls.
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.
In August 2006, Advancis announced that the Company's Phase III trial in 620 adults and adolescent patients with acute pharyngitis/tonsillitis due to Group A streptococcal infections successfully met its primary and secondary endpoints. The Company's Amoxicillin PULSYS dosage form for the treatment of pharyngitis was delivered in a once-daily 775 milligram tablet for 10 days, versus 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.
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 approximately $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.
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 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, (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 CorporationCONTACT: Robert Bannon, Vice President, Investor Relations & CorporateCommunications of Advancis Pharmaceutical Corp., +1-301-944-6710,rbannon@advancispharm.com
Web site: http://www.advancispharm.com/