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Advancis Pharmaceutical To Begin Inaugural
PULSYS Phase III Trial

Company Conducts Meeting with FDA to Review Study Design for First Phase III Trial for Amoxicillin PULSYS for Pharyngitis;
Trial Results Expected Within Nine Months;
Product Launch Could Be as Soon as 2006

GERMANTOWN, MD
September 23, 2004

Advancis Pharmaceutical Corporation (NASDAQ: AVNC), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it completed its Pre-Phase III meeting with the Food and Drug Administration (FDA), which focused on Advancis' product development program for Amoxicillin PULSYS. The Company believes its Phase I development program, Phase III clinical trial design, and its regulatory strategy for Amoxicillin PULSYS were acceptable to the FDA. Advancis expects to begin the Phase III trial in October 2004.

The pulsatile amoxicillin formulation selected for this Phase III trial utilizes Advancis' proprietary PULSYS release profile while also achieving a prolonged exposure of the antibiotic, effectively maintaining concentrations of the drug necessary for bacterial eradication. Advancis believes its lower-dose, shorter course of therapy amoxicillin will deliver similar effective bacterial eradication as the comparator drug, and will serve as the basis for its expected comparable efficacy. Advancis expects to continue optimizing its pulsatile amoxicillin formulation to increase efficiency and effectiveness at even lower dosages and shorter courses of therapy in additional clinical trials.

"We are very optimistic about the success of the formulation we selected for our pharyngitis Phase III trial, as we expect it to deliver favorable clinical outcomes while providing increased patient convenience," said Dr. Barry Hafkin, Advancis senior vice president and chief scientific officer. "Further, we are continuing to work on improving the formulation for harder-to-treat infections such as acute otitis media, taking advantage of improved bacterial killing effects from pulsatile dosing that we have seen demonstrated in our preclinical studies."

Based on Advancis' meeting with the FDA's Division of Anti-Infectives Drug Products on September 22, the Company will proceed with its Phase III clinical program designed to support product approval for Amoxicillin PULSYS for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections. Advancis is scheduled to begin a two-arm, 500-patient, double-blind, non-inferiority Phase III trial in October for a 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 a period of seven days to the FDA standard comparator therapy of 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days. This protocol design, utilizing penicillin as the comparator, is consistent with the guidance the FDA has in place for the development of new products for this indication.

The primary endpoint for the study will be bacterial eradication, as measured by throat swabs both before and after treatment. The trial will be conducted primarily in individual or group physicians' offices specializing in family practice, pediatrics, or internal medicine. Through a contract research organization, Advancis has accepted 60 sites in 22 states across the U.S. to enroll and treat patients in the trial program. The Company is holding an Investigators Meeting on October 1 and expects to begin dosing patients later that month. The trial is expected to last from six to nine months and the Company expects to file a 505(b)(2) New Drug Application with the FDA for this product in the second half of 2005.

Advancis' Amoxicillin PULSYS dosing of 775 milligrams for seven days - or just over 5 grams in total for this new therapy - compares to the most common amoxicillin therapy for pharyngitis that is dosed 500 milligrams three-times daily for a period of 10 days - or a total of 15 grams of amoxicillin over the full course of therapy. If successful, physicians prescribing Amoxicillin PULSYS would be able to dose approximately one-third the amount of amoxicillin in adult and adolescent patients with pharyngitis/tonsillitis, while at the same time providing the convenience of once-daily dosing and the likely impact of reduced drug-related side effects and increased patient compliance.

More than 62 million prescriptions for amoxicillin were written in 2003 and the antibiotic has had more than one billion total patient exposures. 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). According to data from IMS Health, a pharmaceutical research company, annual U.S. amoxicillin sales are currently about $500 million with approximately one-quarter of total amoxicillin prescriptions written for pharyngitis, strep throat, and tonsillitis for both adults and pediatrics.

"We are extremely pleased to be conducting our first Phase III trial for a PULSYS product," said Edward M. Rudnic, Ph.D., chairman, president and CEO of Advancis. "Along with our partner on this product, Par Pharmaceutical, we believe a once-daily, lower-dose amoxicillin therapy achieved through our pulsatile dosing approach offers patients and physicians an effective alternative to currently available treatments and could represent a meaningful commercial product opportunity to our companies by as early as 2006."

As previously announced, Advancis is partnering with Par on Amoxicillin PULSYS and has received a $5 million upfront fee and a commitment from Par to fund all further anticipated development costs. Advancis will be responsible for the manufacture of the product and for the patent and trademark enforcement. The companies expect to jointly market and sell the product, and to split operating profits equally.

About Advancis Pharmaceutical:
Advancis Pharmaceutical Corporation (NASDAQ: AVNC) 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 a broad portfolio of 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 and effectively than those under standard treatment regimens. Based on this finding, Advancis has developed a proprietary, once-a-day pulsatile delivery technology called PULSYS. 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 and 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.

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, (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, 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.