Cardiovascular disease is the leading cause of death in the United States. In 1998, the American Heart Association reported that an estimated 58 million patients in the United States had cardiovascular disease. The American Heart Association estimated that during 1998 1.1 million patients would have a new or recurrent heart attack and 350,000 of these would die as a result. It is estimated that the U.S. healthcare system spends approximately $171 billion annually on the care and treatment of patients with cardiovascular diseases.
Collateral Therapeutics (CLTX) is focused on the discovery, development and commercialization of non-surgical gene therapy products for the treatment of cardiovascular diseases, including coronary artery disease, peripheral vascular disease, congestive heart failure and heart attack.
The Company's initial gene therapy products under investigation are designed to promote and enhance angiogenesis, a natural biological process which results in the growth of additional blood vessels, to restore adequate levels of blood flow to oxygen-deprived tissues.
The Company's initial angiogenic product is for the treatment of coronary artery disease. ThePhase I/II clinical trial began in May 1998 pursuant to a commercial Investigational New Drug application filed with the U.S. Food and Drug Administration in December 1997 by the Company's strategic partner, Schering AG, Germany. Collateral is currently developing five additional non-surgical cardiovascular gene therapy products.
The Company has assembled a broad portfolio of therapeutic genes which were exclusively licensed or internally discovered and for which either patents have been issued or patent applications have been filed for use in the development of cardiovascular gene therapy products. The Company's portfolio includes numerous proprietary human genes
in the Fibroblast Growth Factor (FGF) and Vascular Endothelial Growth Factor (VEGF) gene families to be used in the Company's gene therapy products. In addition, the Company has filed patent applications with the United States Patent and Trademark Office (PTO) with respect to other therapeutic genes including human adenylylcyclase VI (ACVI)
for use in the Company's adrenergic signaling technology.
The Company intends to focus on research and development of products while leveraging its technology through the establishment of product development, manufacturing and marketing collaborations with select pharmaceutical and biotechnology companies. The Company has a strategic collaboration with Schering AG covering angiogenic gene therapy products. Under this collaboration, Schering AG has made equity investments in the Company. In addition, the collaboration provides for Schering AG, subject to certain conditions, to pay research support through 2001, to make additional payments upon the Company satisfying certain research, development and commercialization milestones and
to make royalty payments to the Company based on worldwide net sales of angiogenic gene therapy products developed under the collaboration. This collaboration was structured to provide the Company with financial resources and product development support to enable the Company to determine the safety and efficacy of at least three angiogenic gene therapy products. For other products, the Company intends to select
development and/or commercialization partners after the Company has completed preclinical research with respect to each such product. The Company expects that, in the event of successful commercialization of its products, royalties on worldwide sales of such products could generate significant revenues in the long term.
The key elements of the Company's strategy are to: (i) develop a new paradigm for the treatment of cardiovascular diseases; (ii) maintain technological leadership by focusing resources exclusively on cardiovascular gene therapy; (iii) continue to expand, enhance and
protect its proprietary technology, including methods of gene therapy and the Company's therapeutic genes; and (iv) leverage its technology through the establishment of strategic collaborations. |
