-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, R/iPkxf4hBaBtpy5x1cRIF9PmzMb9/EggDPBkWn5uynvB0Z3zqzA8emJo4ergsps e9hR/SoLMoURHoxEQ0I2LA== 0000927016-02-004600.txt : 20020918 0000927016-02-004600.hdr.sgml : 20020918 20020918171548 ACCESSION NUMBER: 0000927016-02-004600 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020918 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020918 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CURAGEN CORP CENTRAL INDEX KEY: 0001030653 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 061331400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23223 FILM NUMBER: 02767179 BUSINESS ADDRESS: STREET 1: 555 LONG WHARF DRIVE STREET 2: 11TH FL CITY: NEW HAVEN STATE: CT ZIP: 06511 BUSINESS PHONE: 2034013330 8-K 1 d8k.txt FORM 8-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 -------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 -------------- Date of Report (Date of earliest event reported): September 18, 2002 CuraGen Corporation (Exact name of registrant as specified in its charter) Delaware 0-23223 06-1331400 - -------------------------------------------------------------------------------- (State or other (Commission (IRS Employer jurisdiction of File Number) Identification No.) incorporation) 555 Long Wharf Drive, 11th Floor New Haven, Connecticut 06511 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (203) 401-3330 - -------------------------------------------------------------------------------- Item 5. Other Events and Regulation FD Disclosure. On September 18, 2002, the Registrant issued a press release announcing that scientists of the Registrant, in collaboration with Bayer AG's toxicologists, have developed an innovative technology capable of predicting a drug compound's potential for toxicity. The Predictive Toxicogenomics Screen(TM) evaluates drug compound toxicities using very small quantities of compounds that are available immediately after high-throughput drug screening and well in advance of the expensive drug scale-up required for mammalian safety experiments. Utilizing the Predictive Toxicogenomics Screen early in the drug development process, scientists are able to rank-order compounds by their predicted safety profiles. Registrant and Bayer scientists have completed evaluating more than 150 preclinical drug compounds with the Predictive Toxicogenomics Screen and have ranked these compounds according to their potential for toxicity. Based upon the success achieved through the initial application of this predictive technology, Registrant and Bayer scientists are now applying the technology to conduct drug toxicity evaluations on Bayer's small molecule research pipeline. The Registrant received a milestone payment of $2.9 million from Bayer for successfully developing this technology and industrializing it into a high-throughput format. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1. Item 7. Financial Statements and Exhibits. (c) The following exhibits are filed with this report: Exhibit Number Description - -------------- ----------- 99.1 Press release of Registrant dated September 18, 2002. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CURAGEN CORPORATION (Registrant) Date: September 18, 2002 By: /s/ David M. Wurzer ------------------------------------- Name: David M. Wurzer Title: Executive Vice President and Chief Financial Officer 3 EX-99.1 3 dex991.txt PRESS RELEASE Exhibit 99.1 [CURAGEN CORPORATION LOGO] - -------------------------------------------------------------------------------- Contacts: Bayer: CuraGen Corporation: - -------- Christina Sehnert Mark R. Vincent +49 214/30-66102 1-888-GENOMICS www.bayer.com www.curagen.com - -------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE - --------------------- CuraGen and Bayer Identify Key Markers of Liver Toxicity and Create Industrialized, Predictive Toxicogenomics Screen - -New Technology To Identify Potential Drug Toxicities Moves to Production Phase- Leverkusen, Germany and New Haven, CT, USA - September 18, 2002 - Bayer AG (NYSE: BAY), an international, research-based group with major businesses in healthcare, agriculture, polymers and specialty chemicals, and CuraGen Corporation (NASDAQ: CRGN), an integrated genomics-based pharmaceutical company, today announced that CuraGen scientists, in collaboration with Bayer's toxicologists, have developed an innovative technology capable of predicting a drug compound's potential for toxicity. The Predictive Toxicogenomics Screen(TM) evaluates drug compound toxicities using very small quantities of compounds that are available immediately after high-throughput drug screening and well in advance of the expensive drug scale-up required for mammalian safety experiments. Utilizing the Predictive Toxicogenomics Screen early in the drug development process, scientists are able to rank-order compounds by their predicted safety profiles. By providing scientists with additional insight into a drug's toxicity, this pioneering technology is capable of generating information that can potentially save millions of dollars in research and development expenses. Bayer and CuraGen scientists have completed evaluating more than 150 preclinical drug compounds with the Predictive Toxicogenomics Screen and have ranked these compounds according to their potential for toxicity. Based upon the success achieved through the initial application of this predictive technology, Bayer and CuraGen scientists are now applying the technology to conduct drug toxicity evaluations on Bayer's small molecule research pipeline. CuraGen received a milestone payment of $2.9 million from Bayer for successfully developing this technology and industrializing it into a high-throughput format. "The development of CuraGen's Predictive Toxicogenomics Screen is an excellent example of how CuraGen can industrialize complex technologies and apply them in a high-throughput manner to address the bottlenecks constraining drug development. The combined expertise of Bayer's toxicologists with CuraGen's scientists, engineers and bioinformaticians was critical to the successful development of this technology," stated Michael P. McKenna, Ph.D., Vice-President of Collaborative Research for CuraGen Corporation. "We are now looking forward to applying this technology to CuraGen's and Bayer's drug development programs, and offering it as a service to our collaborative partners. We believe the adoption of this screen will offer a significant competitive advantage in pharmaceutical development," added Dr. McKenna. - MORE - CuraGen's industrialized Predictive Toxicogenomics Screen enables inexpensive cellular screening of thousands of compounds annually, and provides results on nine different modes of liver toxicity. Evidence of liver toxicity is one of the primary reasons that drug compounds fail during preclinical development. Nearly 75% of pharmaceutical research and development expenditures are devoted to developing drugs that never reach the market. Detailed information generated by this screen can be used by scientists to prioritize compounds based upon their potential for toxicity, in order to avoid work on compounds that are likely to fail in safety tests later in development. CuraGen and Bayer scientists developed this unique assay by analyzing more than 100 known toxic compounds and identifying marker genes whose activity correlates with specific modes of liver toxicity. These genes have been subcategorized into marker sets predictive of nine specific liver histopathologies, including cholestasis, necrosis, or hypertrophy, and have been affixed to gene expression microarrays for use in high-throughput comparative analysis. Drug compounds under review are applied in extremely small quantities to primary hepatocyte cells in vitro. The cellular activity of these dosed compounds is then evaluated against the proprietary toxicity markers. The results of this comparison provide scientists with a rank-ordered list of compounds based upon their potential for toxicity, which can be used in determining which compounds have the highest likelihood for successful clinical development. CuraGen Corporation has been a pioneer in the field of pharmacogenomics, which includes the study of how drugs work, why drugs fail, and which characteristics are indicative of drug toxicity. CuraGen's expertise stems from pharmacogenomic research conducted with many of the world's leading pharmaceutical companies in prioritizing portions of their drug pipelines. CuraGen Corporation (NASDAQ: CRGN) is a genomics-based pharmaceutical company. CuraGen's integrated, functional genomic technologies and Internet-based bioinformatic systems are designed to generate comprehensive information about genes, human genetic variations, gene expression, protein interactions, protein pathways, and potential drugs that affect these pathways. The Company is applying its industrialized genomic technologies, informatics, and validation technologies to develop protein, antibody, and small molecule therapeutics to treat obesity and diabetes, cancer, inflammatory diseases, and central nervous system (CNS) disorders. CuraGen is headquartered in New Haven, CT. Additional information is available at www.curagen.com. This press release may contain forward-looking statements including statements about CuraGen applying its predictive toxicogenomics screen to address the bottlenecks constraining drug development, and the ability of the predictive toxicogenomics screen to offer a significant competitive advantage in pharmaceutical development. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. CuraGen cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: CuraGen's expectation that it will incur operating losses in the near future, the early stage of development of CuraGen's products and technologies, uncertainties related to preclinical and clinical testing and trials, uncertainties and adverse results relating to CuraGen's ability to obtain regulatory approval for its products in development, uncertainties surrounding the availability of additional funding, CuraGen's reliance on research collaborations and strategic alliances, the actions of competitors, the development of competing technologies, CuraGen's ability to protect its patents and proprietary rights, patent infringement actions and uncertainties relating to commercialization rights. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2001 for a description of these risks. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. - ### - -----END PRIVACY-ENHANCED MESSAGE-----