GERMANTOWN, Md., Nov. 3 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has concluded a Pre-Phase III meeting with the Food and Drug Administration (FDA), which focused on Advancis’ adult and adolescent product development program for Amoxicillin PULSYS. Based on the outcome of the meeting, the Company believes its planned Phase III clinical trial design and its regulatory strategy for Amoxicillin PULSYS for adults and adolescents with pharyngitis/tonsillitis were acceptable to the FDA. Advancis is now ready to begin the Phase III trial and expects to start enrolling patients later this month.
“We are very pleased to be moving forward with our Phase III trial program for Amoxicillin PULSYS and are eager to start enrolling patients shortly,” said Dr. Edward Rudnic, Advancis chairman and CEO. “Based on our FDA meeting yesterday, we believe the analysis of our already-completed studies, relevant literature data, and the results of our upcoming Phase III trial, if successful, will be sufficient to support an NDA filing for Amoxicillin PULSYS for adults and adolescents with strep throat in late 2006.”
On November 2, 2005, Advancis conducted a meeting with the FDA’s Division of Anti-Infectives Drug Products to discuss the Company’s Phase III trial and regulatory strategy to support product approval for Amoxicillin PULSYS for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections. The Company expects to begin enrolling patients in the Phase III trial designed as a two-arm, double-blind, double- dummy, non-inferiority trial for its pulsatile form of amoxicillin in November 2005. Advancis expects to enroll at least 600 patients and 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 FDA for its adult and adolescent Amoxicillin PULSYS product in late 2006.
The pulsatile amoxicillin formulation selected for Advancis’ pharyngitis/tonsillitis Phase III trial utilizes the same formulation as Advancis’ prior adult and adolescent pharyngitis product; however, it is dosed for 10 days rather than seven days. Additionally, the Company’s upcoming Phase III trial is designed to enhance Amoxicillin PULSYS performance by adding a food requirement with dosing and adding new patient requirements to reinforce compliance. The new trial is designed to enroll at least 600 patients, as compared to 500 patients for the prior trial with a seven day treatment period.
As a result of Advancis’ conclusion that it will not be required to conduct additional studies beyond its planned adult and adolescent Phase III trial, the Company believes it will save the costs for previously budgeted Phase II clinical trials in 2006. Advancis continues to expect to end 2005 with cash equivalents and marketable securities of between $35 million and $38 million.
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 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 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
Web site: http://www.advancispharm.com/
