GERMANTOWN, Md., Jan. 5 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that its proposed sale of the U.S. rights to the Keflex(R) brand of cephalexin was not completed by December 31, 2005, as earlier expected. Advancis entered into an agreement-in-principle in August 2005 which contemplated the sale of those rights to a private company.
Under the terms of the agreement-in-principle, the private company was to have paid Advancis $11 million for the exclusive rights to manufacture, market and sell Keflex (cephalexin capsules, USP) in the United States. As part of the agreement-in-principle, Advancis received an initial non-refundable deposit of $1 million in exchange for assurances that Advancis would not seek or negotiate with additional partners or potential buyers through December 31, 2005. Under certain limited circumstances, the private company may still purchase the rights to Keflex on or prior to February 28, 2006.
The Company’s intention is to pursue development of new Keflex products, including a Keflex PULSYS product, and to seek partners to assist in the marketing and sale of its Keflex products. Advancis will continue to record Keflex product sales.
“While we would have welcomed the additional corporate funds a sale of Keflex would have generated in 2005, we believe the Keflex franchise should generate meaningful revenue in 2006 as well as over the years to come,” said Edward M. Rudnic, Ph.D., chairman, president, and CEO of Advancis.
Advancis’ net Keflex sales in 2005 were approximately $4.5 million. The Company ended the year of 2005 with approximately $27 million of cash, cash equivalents and marketable securities. Advancis believes its current cash position and anticipated Keflex revenues will provide sufficient funding to support the Company’s ongoing pivotal Phase III trial of Amoxicillin PULSYS and other planned operations through 2006 and into early 2007.
Amoxicillin PULSYS Phase III Trial Enrollment Update
The Company also announced that as of the close of business January 4, 2006, it was slightly ahead of schedule and had enrolled a total of 115 patients into its ongoing pivotal Phase III trial of Amoxicillin PULSYS for adolescents and adults with pharyngitis/tonsillitis. Advancis expects to enroll at least 600 patients into the trial and to announce 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. More information on Keflex and prescribing information are available at http://www.advancispharm.com/products/keflex .
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 portfolio of anti-infective drugs based on its novel biological finding that bacteria exposed to antibiotics in frontloaded 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 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 financial results. 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, (12) successfully develop, receive regulatory approval, and commercialize any new 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 Corporation
CONTACT: Robert Bannon, Senior Director, Investor Relations of AdvancisPharmaceutical Corporation, ir@advancispharm.com, +1-301-944-6710
Web site: http://www.advancispharm.com//