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PROSPECTUS SUMMARY (From 3/11/04 S-1) ... Overview We are a biopharmaceutical company focused on licensing, developing and commercializing therapeutic products for the treatment of cardiopulmonary and infectious diseases. Ventavis, our lead product candidate, is an inhaled prostacyclin analogue for the treatment of pulmonary arterial hypertension, or PAH, that we believe offers advantages over existing therapies. Ventavis is currently marketed in various European countries by Schering AG and we licensed the exclusive U.S. rights to Ventavis from Schering AG in October 2003. We plan to file a New Drug Application, or NDA, for Ventavis with the U.S. Food and Drug Administration, or FDA, in 2004 based primarily on the results of the clinical trials conducted by Schering AG. In addition, we plan to investigate the use of Ventavis in combination therapy with a currently approved treatment for PAH in order to expand the commercial potential of Ventavis. We are also developing CTX-100 for the treatment of emphysema. We believe that our in-depth understanding of the biology of cardiopulmonary and infectious diseases, combined with our management’s development and commercialization experience, will enable us to continue to identify and license or acquire product candidates in our target disease markets. Ventavis Ventavis, or iloprost, is delivered using a nebulizer for the treatment of PAH, a highly debilitating disease characterized by severe constriction of the blood vessels in the lungs. This condition leads to very high pulmonary arterial pressure and makes it difficult for the heart to pump blood through the lungs to be oxygenated. We estimate that PAH afflicts approximately 50,000 people in the U.S., of which 15,000 people are currently diagnosed and under various treatments, including prostacyclins and endothelin receptor antagonists. We expect to compete primarily with other prostacyclin therapies. Current prices of existing prostacyclin therapies are approximately $100,000 per patient annually. Currently marketed prostacyclins for PAH are difficult to administer because they require continuous delivery through subcutaneous or intravenous routes. Ventavis targets the pulmonary vessels directly through inhalation, eliminating many of the inconveniences and potentially reducing many of the side effects associated with subcutaneous or intravenous delivery. We believe Ventavis is more conveniently administered than existing prostacyclin therapies and will become the preferred prostacyclin treatment for most PAH patients. In addition, we believe Ventavis offers therapeutic characteristics that support development for combination therapy, PAH associated with idiopathic pulmonary fibrosis and other possible indications, including PAH associated with sickle cell anemia. Ventavis was approved in September 2003 by the European Agency for the Evaluation of Medicinal Products, or EMEA, for the treatment of primary pulmonary hypertension. In Schering AG’s Phase III trial, the primary composite endpoint was met by 17% of patients taking Ventavis and 5% of patients taking the placebo, a result that was statistically significant and clinically meaningful. The results of the six-minute walk test and New York Heart Association class improvement, two commonly used measurements of PAH severity and secondary endpoints of this trial, were also statistically significant and clinically meaningful. Flushing and jaw pain, both typical side effects of prostacyclin therapies, were more common in the Ventavis group. CTX-100 CTX-100 is a proprietary hyaluronic acid solution inhaled using a nebulizer that we are developing for two indications, emphysema due to smoking and genetic emphysema. We believe that CTX-100 may slow the rate of lung function decline and protect lung tissue from the harmful effects of chronic inflammation associated with smoking or genetic emphysema. In separate Phase I trials, delivery of CTX-100 to the lungs of normal human volunteers and patients with genetic emphysema was shown to be well tolerated. We intend to commence a fourteen-day, multiple-dose Phase I/II trial in 48 patients with emphysema and a history of smoking in the second half of 2004. Business Strategy We intend to build a biopharmaceutical company focused on the commercialization of therapeutic products for cardiopulmonary and infectious diseases. The key elements of our strategy are to: obtain U.S. regulatory approval for Ventavis; build our own specialty U.S. sales and marketing organization and leverage its capabilities to attract and commercialize other products; maximize the commercial potential of Ventavis by investigating its use in combination therapies and in treating PAH associated with idiopathic pulmonary fibrosis and other potential indications; license or acquire complementary products in the areas of cardiopulmonary and infectious diseases; and establish strategic collaborations to enhance our ability to move products efficiently through development to commercialization and penetrate new market opportunities. Our Management Team We have assembled a management team with significant experience in the development, registration, manufacture and commercialization of products and medical devices. Our team has obtained regulatory approval for and commercially launched several biopharmaceutical products. To date, we have licensed two promising product candidates in our target therapeutic areas and we intend to leverage our experience and relationships to continue licensing or acquiring additional product candidates. Risks Our business is subject to a number of risks, which you should be aware of before making an investment decision. These risks are discussed more fully in “Risk Factors.” All of our current product candidates, including Ventavis and CTX-100, are in clinical stages of development. Accordingly, we have not received regulatory approval for, or received commercial revenues from, any of our product candidates. It is possible that we may never successfully commercialize any of our product candidates. As of December 31, 2003, we had incurred $20.4 million in losses from operations since inception. We expect to continue to incur increasing losses over the next several years, and we may never become profitable. Corporate Information We were incorporated in Delaware in February 2000 as Exhale Therapeutics, Inc. and changed our name to CoTherix, Inc. in October 2003. Our principal executive offices are located at 1301 Shoreway Drive, Suite 320, Belmont, CA 94002 and our telephone number is (650) 486-2100. Our website address is www.cotherix.com. Information contained in our website is not a part of this prospectus. References in this prospectus to “we,” “us” and “our” refer to CoTherix, Inc. Proposed Nasdaq National Market symbol CTRX .... | ||||||||||||||
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