Cytyc and Digene Announce Exclusive Co-Promotion Agreement.Business/Technology Editors & Health/Medical Writers BOXBOROUGH, Mass. & GAITHERSBURG, Md.--(BW HealthWire)--Jan. 18, 2001 Cytyc Corporation (Nasdaq:CYTC) and Digene Corporation (Nasdaq:DIGE DIGE Differential In-Gel Electrophoresis DIGE Direct-Injection Gasoline Engine ) today announced an exclusive, co-promotion agreement in the United States and Puerto Rico for up to two-and-one-half years. The companies will promote the benefits of testing for human papillomavirus human papillomavirus (HPV), any of a family of more than 60 viruses that cause various growths, including plantar warts and genital warts, a sexually transmitted disease. Detectable warts can be or removed, usually by chemicals, freezing, or laser, but often recur. (HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) ) with Digene's Hybrid Capture(R) 2 HPV Test directly from Cytyc's ThinPrep(R) Pap Test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. (TM) collection vial. Initially, the program will focus on establishing HPV DNA testing DNA testing Analysis of DNA (the genetic component of cells) in order to determine changes in genes that may indicate a specific disorder. Mentioned in: Acoustic Neuroma, Retinoblastoma, Von Willebrand Disease , using the residual material in ThinPrep Pap Test vials, as the optimal patient management strategy for borderline cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components. results. Cytyc's extensive physician sales force will promote the ThinPrep/HC2 HPV triage triage Division of patients for priority of care, usually into three categories: those who will not survive even with treatment; those who will survive without treatment; and those whose survival depends on treatment. strategy to the 30,000 practicing OB/GYNs in the United States. "The ThinPrep Pap Test and HC2 test together provide the most accurate method for cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. screening," said Evan Jones, chairman and chief executive officer of Digene Corporation. "We expect the combined benefits of these two products will be further validated in the National Cancer Institute's ALTS ALTS Association for Local Telecommunications Services ALTS Aarhus Lawn Tennis Selskab (Denmark) ALTS Annotated Labeled Transition System ALTS Analogue Line Terminating Subsystem ALTS Automatic Laser Tracking System trial. The ALTS results are expected to be published shortly. By collaborating with Cytyc's extensive physician sales organization we expect the adoption of our two technologies to continue to accelerate." Digene's HC2 is the only FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved test for HPV and the ThinPrep Pap Test is the only liquid-based cervical cancer screening technology currently approved by the FDA for HPV testing directly from the vial. "The ThinPrep Pap Test continues to gain market share now representing more than one-third of the Pap tests in the United States annually," said Patrick J. Sullivan, president and chief executive officer of Cytyc Corporation. "This mutually beneficial agreement provides a cooperative strategy to promote the clinical and cost benefits of HPV testing directly from the ThinPrep vial for management of patients with borderline cervical abnormalities." Mr. Jones added, "This agreement allows Digene and Cytyc to capitalize on the growing success of programs offering HPV reflex testing directly from the ThinPrep Pap Test vial that have been established with Cytyc's and Digene's laboratory customers in the United States. In addition, if we are able to achieve FDA approval for use of our test as a primary screen in conjunction with the ThinPrep Pap Test, we will work together to market the combined use of HC2 HPV Test and the ThinPrep Pap Test for primary screening in the United States." Mr. Sullivan concluded, "We are very pleased to expand our collaboration with Digene. We believe that this co-promotion agreement will benefit both companies. We are optimistic that we may be able to expand our marketing and sales cooperation into international markets, and potentially in new areas of research and development in the future as well." The management of Digene Corporation and Cytyc Corporation will hold a conference call to discuss this announcement at 11:00am EST EST electroshock therapy. EST abbr. electroshock therapy today. Please dial (800) 374-0727 (international participants please dial 706-634-2339) at least 10 minutes prior to the start time and use conference passcode 828225. A replay of this call will be available two hours after completion of the live call by dialing (800) 642-1687 (international participants please dial 706-645-9291) and use conference passcode 828225. Digene Corporation, based in Gaithersburg, Maryland, develops, manufactures and markets proprietary DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic testing systems for the screening, monitoring and diagnosis of human diseases. Digene's primary focus is in women's cancers and infectious diseases where the Company's lead product is the only FDA approved test for human papillomavirus, or HPV, which is the cause of greater than 99% of cervical cancer cases. The Digene HPV Test is used in the U.S. as an adjunct to the Pap smear Pap smear or Papanicolaou smear Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S. for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear. Cytyc Corporation develops, manufactures, and markets the ThinPrep(R) System for medical diagnostic applications. The ThinPrep System consists of the ThinPrep(R) 2000 Processor, ThinPrep(R) 3000 Processor, and related reagents, filters, and other supplies. Cytyc(R), ThinPrep(R), and PreservCyt(R) are registered trademarks and ThinPrep(R) Pap Test(TM) is a trademark of Cytyc Corporation. FOR DIGENE INVESTORS This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the Company's actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians, the extent of reimbursement for the HPV Test by third party payors, the success of the strategy and plan of Digene and Cytyc, the timing and actual results of the ALTS trial publication, and failure to receive FDA approval of the HC2 HPV test for primary screening, as well as other factors discussed in the Company's Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the Company's annual and quarterly reports filed with the Securities and Exchange Commission. FOR CYTYC INVESTORS Forward-looking statements in this press release are made pursuant to the provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, Cytyc's and Digene's promotional and other operational strategies and objectives, expectations regarding clinical results, product plans and performance, and statements regarding management's expectations for future growth and objectives for future management and operations, constitute forward-looking statements which involve risks and uncertainties which could cause actual results to differ, including, without limitation, risks associated with the Company's dependence on a single product, uncertainty of market acceptance and additional cost, dependence on proprietary technology, dependence on timely and adequate levels of third-party reimbursement, dependence on key personnel, management of growth, limited marketing and sales experience, and limited number of customers and lengthy sales cycle, as well as risks of downturns in economic conditions generally, and in the healthcare industry specifically, risks associated with competition and competitive pricing pressures, potential liabilities and costs associated with litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and other risks detailed in the Company's filings with the Securities and Exchange Commission, including in its 1999 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Commission. |
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