To: TomOrt who wrote (2428 ) 1/12/1999 8:43:00 AM From: jopawa Read Replies (1) | Respond to of 4676
Tuesday January 12, 5:45 am Eastern Time Company Press Release SOURCE: Isis Pharmaceuticals Isis and Abbott Establish Target Validation Collaboration; Marks Isis' First Antisense Target Validation Partnership CARLSBAD, Calif., Jan. 12 /PRNewswire/ -- Isis Pharmaceuticals (Nasdaq: ISIP - news) today announced that it has initiated a research collaboration with Abbott Laboratories [NYSE:ABT - news] to prioritize drug development targets using Isis' Antisense Target Validation (ATV) technology. This collaboration will enable Abbott to validate numerous gene targets in both in vivo and in vitro models, identify the function of these genes, prioritize these targets and develop drugs based on novel gene targets to treat a wide range of diseases. In the collaboration, Isis will use its proprietary Rapid Throughput Screening (RTS) technology to design, screen, synthesize and characterize inhibitors of gene targets provided by Abbott. Abbott will then use these antisense inhibitors to identify the function of the target, its molecular pathway and determine its role in disease. Isis will receive from Abbott an upfront fee, quarterly research fees, milestone payments and royalties on net sales of any Abbott non-antisense product arising from the collaboration. Isis will receive rights to Abbott genes to develop antisense drugs. With efforts well underway to sequence the more than 100,000 genes in the human genome, the ability to validate and functionalize gene targets, that is, to determine what role these genes play and their relevance to particular disease processes, has not kept pace with the explosion in raw genetic information. The exquisite specificity of antisense technology provides a unique ability to quickly and efficiently convert raw sequence data into valid information about the roles particular genes play in specific disease processes. Isis' proprietary techniques allow for potential inhibitors against gene targets to be rapidly screened. Optimized inhibitors can then be used to validate targets and determine their relevance to a particular disease. Isis' ATV program can help pharmaceutical companies streamline the process of evaluating the potential of selected genes as drug targets. ''We are excited to be working with Abbott, a leading pharmaceutical company, to create innovative products by applying antisense technology to genomic drug discovery,'' said B. Lynne Parshall, Executive Vice President and Chief Financial Officer of Isis. ''We believe this collaboration represents the first of many as other pharmaceutical companies discover the speed and efficiency of antisense as a tool for exploring and validating novel gene targets, in addition to its proven drug discovery and development utility.'' Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has six compounds in human clinical trials: Vitravene⢠(fomivirsen), to treat CMV-induced retinitis in AIDS patients, has been approved for marketing by the FDA and is currently undergoing regulatory review in Europe; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's disease, Phase II clinical trials for renal transplant rejection, rheumatoid arthritis and ulcerative colitis, and is being explored as a topical administration for psoriasis and an aerosol administration for asthma; ISIS 3521 is in Phase II trials as a treatment for cancer; ISIS 5132 is in Phase II clinical trials as a treatment for cancer; ISIS 2503 is in Phase I trials as a treatment for cancer; and ISIS 13312 is in Phase I/II clinical trials for the treatment of CMV retinitis in AIDS patients. The company also has several additional compounds in preclinical development. Isis' broad medicinal chemistry and biology research programs support efforts in both antisense and small molecule drug discovery.
This press release contains forward-looking statements concerning the agreement between Isis and Abbott. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. These and other risks concerning collaborations are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1997 which is on file with the U.S. Securities Exchange Commission, copies of which are available from the company. Vitravene⢠is a trademark of Novartis AG. Isis' Antisense Target Validation Program Isis Pharmaceuticals has established a genomics program focused on target validation to capitalize on the need for novel tools to improve the speed and efficiency of drug discovery and development. Isis' Antisense Target Validation (ATV) Program uses antisense technology to provide a more streamlined approach to the identification, functionalization and validation of novel gene targets that play a role in human disease. WHY ANTISENSE TARGET VALIDATION? The sequencing of the human genome and concurrent advances in molecular biology have enabled us to begin to understand the role of particular genes in human disease. These advances have the potential to revolutionize medicine and to redefine the way diseases are treated. The pharmaceutical industry requires new tools to analyze the plethora of gene sequence data to prioritize novel gene targets for drug discovery efforts. Traditional drug discovery efforts are expensive and time consuming. Without evidence that suppression of a gene target might have a therapeutic effect, it is difficult for pharmaceutical companies to mount such an expensive effort for every novel gene target that might be related to a disease. Rapid identification of gene target inhibitors to generate data regarding the role of a novel gene target in a disease process is crucial to the prioritization of gene targets for drug discovery. Traditional drug discovery activities lack specificity and therefore result in inhibitors that may modulate multiple gene targets, not just the target of interest. Isis' ability to rapidly produce highly specific antisense inhibitors, which are customized to inhibit only the gene target of interest, provides a highly valuable tool to determine the role of novel drug targets in disease. This tool allows pharmaceutical companies to avoid costly drug discovery programs targeting the wrong gene targets, and allows side-by-side comparison of the value of targeting various gene targets associated with a disease to allow crucial prioritizations to be made. ISIS' ATV PROGRAM Isis' ATV program produces highly specific antisense inhibitors of novel gene target expression. These highly specific inhibitors can be used in cellular assays and in animal models of disease to rapidly determine the pharmacological impact of inhibiting the expression of a single gene target and to determine the role of the targeted gene in human disease. Once a target has been shown to be important in a human disease either traditional drug discovery techniques or antisense drug design can be used to develop drugs to inhibit the novel gene targets. To take advantage of the use of antisense in functional genomics, Isis has established a proprietary, automated Rapid Throughput Screening (RTS) system, which streamlines the creation of optimized, target specific antisense inhibitors. Isis is using this system to build a large database of inhibitors to a hundred or more gene targets per year. Isis' expertise in antisense design allows it to rapidly identify active sites on a gene target even in circumstances when only a small fragment of the gene sequence is known. The rapid throughput design, synthesis and optimization of antisense oligonucleotides dramatically reduces the time required to validate novel gene targets. The pharmaceutical industry is increasingly recognizing the need for more flexible and versatile tools to bring speed and efficiency to drug discovery. Antisense is the most rational, rapid and efficient tool for validating novel gene targets and making use of the explosion of information coming from the genomics industry. Isis' ATV program will prove to be an invaluable tool to meet the needs of the pharmaceutical industry today. SOURCE: Isis Pharmaceuticals