GERMANTOWN, Md., June 8 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, announced today that it has launched Keflex(R) Powder for Oral Suspension (cephalexin, USP). The launch marks the return of great-tasting Keflex to pharmacy shelves. Keflex Powder for Oral Suspension is available in two strengths and two bottle sizes.
"We are pleased to offer Keflex to customers once again. Pediatricians and parents understand how challenging it can be to administer antibiotic therapy to pediatric patients. We are hopeful that the appealing flavor of Keflex will improve patient cooperation and compliance," stated Darren Buchwald, Advancis vice president, marketing.
The usual dosage of Keflex Powder for Oral Suspension is 25 to 50 milligrams per kilogram of patient weight per day in divided doses. Keflex is approved for treatment of respiratory tract infections caused by S. pneumoniae and S. pyogenes; otitis media due to S. pneumoniae, H. influenzae, and M. catarrhalis; and skin and soft tissue infections due to staphylococci and/or streptococci as well as several other bacterial infections. Keflex has 30 years of safety experience and is generally well tolerated. The most frequent adverse events reported in cephalexin clinical trials were diarrhea (1.3%), nausea (1.0%), and vomiting (0.6%).
Keflex Powder for Oral Suspension is available in 125 mg/5 mL and 250 mg/5 mL strengths in two bottle sizes:
125 mg/5 ml strength in 100 ml bottle
125 mg/5 ml strength in 200 ml bottle
250 mg/5 ml strength in 100 ml bottle
250 mg/5 ml strength in 200 ml bottle
Keflex is available from pharmaceutical distributors and wholesalers. Customers can contact Advancis at 877-363-8080 to identify a distributor or to order Keflex Powder for Oral Suspension.
About Advancis Pharmaceutical:
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 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 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 http://www.advancispharm.com.
ABOUT KEFLEX:
Keflex(R) (cephalexin, USP) is a first-generation cephalosporin antibiotic shown to be active against strains of both gram-positive and gram-negative aerobes in vitro and in clinical infections. Keflex is indicated for treatment of the following infections: respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. Keflex(R) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Keflex(R) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex in the subsequent prevention of rheumatic fever are not available at present. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex.
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. Statements in this announcement that are forward-looking include, but are not limited to, statements about the Company's product development and commercialization schedule and its expected milestone payments; expectations regarding development and commercialization of the Company's products, Mr. Buchwald's comments and expectations concerning the Company; the Company's initiatives to develop improved antibiotics; the Company's existing and anticipated collaborative agreements; the completion of the Company's proposed private placement; and all of the financial forecasts and projections for the full year of 2004 included under the Financial Guidance section of 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) 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