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Bacterial Infections
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my personal edition > bacterial infections > news
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DGNews
Advancis Pharmaceutical Receives FDA Approval Letter for New Strengths of Antibiotic Keflex(R)
Company's First Product Approval Accompanied by Further Progress on PULSYS Clinical Study
GERMANTOWN, M.D. -- May 15, 2006 -- Advancis Pharmaceutical Corporation today announced that the U.S. Food and Drug Administration (FDA) has issued an Approval Letter in response to Advancis' supplemental New Drug Application (NDA) for two new strengths of the Company's antibiotic Keflex(R) (cephalexin capsules, USP). Advancis received approval to market 333mg and 750mg capsules.
"Receiving our first supplemental NDA approval is a very significant milestone for Advancis and we believe our new Keflex products will make a meaningful financial contribution to the Company in 2006 and 2007," said Edward M. Rudnic, PhD, president, and CEO of Advancis. "We are pleased to have the opportunity to bring physicians greater flexibility in their prescribing of a drug that many consider a standard of care for skin infections."
The new Keflex (cephalexin) 750mg strength provides healthcare professionals a more convenient way to deliver a total daily dose of 1500 mg per day, through the ability to use just two daily doses of the 750mg capsules. Keflex is approved for adult dosages ranging from one to four grams per day in divided doses; however, the majority of prescriptions are written for cephalexin 500mg three times daily -- totaling 1500mg per day.
As previously announced, in April, the FDA initiated a pre-approval inspection of the Company's contract manufacturing facility operated by CEPH International Corporation, a wholly-owned subsidiary of Patheon Inc. Advancis has been informed by the FDA that the pre-approval inspection has been successfully completed.
Advancis expects to begin marketing the new Keflex strengths nationwide with a targeted sales force of approximately 75 sales representatives beginning in July of 2006. The Company has entered into an agreement-to- proceed with a contract sales organization that will employ the dedicated Keflex sales team.
"Over the coming months we will be working with payers, distributors, and retailers to build awareness, inventory and access to this important new addition to the Keflex line," said Darren Buchwald, vice president, commercial development, sales and marketing of Advancis. "The addition of a sales force to market Keflex directly to health care providers adds a critical element to the commercial capabilities already in place to support Keflex. We look forward to introducing the new Keflex strengths this summer."
Advancis acquired the rights to manufacture, market, and sell Keflex in the United States in July of 2004. Cephalexin is the third most prescribed outpatient antibiotic in the United States, with more than 25 million prescriptions written annually. Keflex is the number-one most prescribed oral cephalosporin antibiotic and is also the number-one recommended oral antibiotic therapy for uncomplicated skin and skin structure infections. Advancis' net Keflex sales in 2005 were $4.8 million.
Amoxicillin PULSYS Phase 3 Trial Enrollment Update
The Company also announced that it was on schedule to complete its ongoing pivotal Phase III trial of Amoxicillin PULSYS for adolescents and adults with pharyngitis/tonsillitis by the end of this cold/flu season. Advancis enrolled a total of 574 patients as of the close of business May 12, 2006, and expects to enroll a total of at least 600 patients into the trial by the end of May. The Company plans to announce top-line trial results in the third quarter of 2006.
About Keflex:
Keflex(R) (cephalexin capsules, 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 is currently available in 250 mg capsules, 500 mg capsules, and powder for oral suspension. Keflex is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex.
SOURCE: Advancis Pharmaceutical Corporation
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