Incyte to Discontinue Development of DFC as a Treatment for HIV; Conference Call Scheduled for 8:30 a.m. ET Today.WILMINGTON, Del. -- Incyte Corporation (Nasdaq: INCY) announced today its decision to discontinue dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: the development of DFC DFC - A dataflow language. ["Data Flow Language DFC: Design and Implementation", S. Toshio et al, Systems and Computers in Japan, 20(6):1- 10 (Jun 1989)]. (formerly Reverset), due to a recently observed increase in the frequency of grade 4 hyperlipasemia in patients receiving 200 mg DFC without 3TC or FTC FTC See Federal Trade Commission (FTC). . The increased incidence of grade 4 hyperlipasemia was observed in Study 901, the long-term extension of Incyte's first Phase IIb trial (Study 203). Hyperlipasemia is a marker of pancreatic pancreatic /pan·cre·at·ic/ (pan?kre-at´ik) pertaining to the pancreas. pancreatic pertaining to the pancreas. See also pancreatitis, diabetes mellitus, cystic pancreatic duct. inflammation. Study 901 included patients taking 100 mg or 200 mg DFC, with or without 3TC or FTC. As in Study 203 itself, approximately 70% of patients in Study 901 were on 3TC or FTC containing regimens. After the results of Study 203 became available demonstrating improved DFC efficacy in the absence of 3TC or FTC, over time, a fraction of Study 901 patients previously on 3TC or FTC were transitioned to regimens without 3TC or FTC. As this component of the patient safety database has expanded, it has now become apparent that the frequency of grade 4 hyperlipasemia in patients taking 200 mg DFC without 3TC or FTC is, in Incyte's view, unacceptably high. Based on these observations, Incyte believes it is in the best interests of patients to discontinue development of DFC and has decided to stop enrollment of the recently initiated Phase IIb trial (Study 204). Incyte will work with investigators and the U.S. Food & Drug Administration to determine the best approach for patients currently receiving DFC in Study 901 who may be obtaining benefit from DFC and have limited alternative options at this time. Paul A. Friedman, M.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Incyte, stated, "Our observed rate of grade 4 hyperlipasemia occurring in DFC treated patients who are no longer receiving 3TC or FTC as part of their regimen in Study 901 is now well above the 10% to 15% level that we believe is acceptable. This is an unfortunate and disappointing finding as we have seen clinically meaningful antiviral antiviral /an·ti·vi·ral/ (-vi´ral) destroying viruses or suppressing their replication, or an agent that so acts. an·ti·vi·ral adj. effects in patients taking the 200 mg dose of DFC without 3TC or FTC." Dr. Friedman continued, "Even though lower doses could be safer, those we've studied have not been effective and we believe it is in the best interest of patients to discontinue DFC's development." Changes to 2006 Financial Guidance As a result of today's announcement, Incyte is reducing its cash use guidance for 2006 to a range of $88 to $95 million from $98 to $105 million. Excluded from this cash use guidance are any possible in-licenses or purchases of products, the repurchase of any of its 5.5% Convertible Subordinated Notes, any activity related to its strategic investments and any funds received from its collaboration with Pfizer Inc. for CCR 1. CCR - condition code register. 2. CCR - (Database) concurrency control and recovery. 2 antagonists antagonists, n muscles that counterbalance agonists during specific movements. opioid Neurology A pain-attenuating peptide that occurs naturally in the brain, which induces analgesia by mimicking endogenous opioids at opioid . In addition the company now expects its research and development expense to range from $82 to $88 million versus its previous guidance of $92 and $98 million. All other 2006 financial guidance remains unchanged. For Patients Currently Receiving DFC in Clinical Trials Patients currently receiving DFC in a clinical trial are advised to contact the site where they receive DFC prior to discontinuing DFC or changing their HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. medication regimen because stopping DFC without replacing it with an appropriate alternative HIV medication may lead to development of resistance to other HIV medications they are taking. Investigators are being informed of detailed information about the new safety findings and have been instructed to schedule a study visit with each patient currently receiving DFC within 7 days. At this visit patients will discuss options for future treatment, including the option to continue on DFC until a more appropriate treatment regimen can be created. Conference Call Information Incyte will host a conference call to discuss this recent development at 8:30 a.m. ET today, April 3, 2006. The domestic dial-in number is 877-692-2592 and the international dial-in number is 973-582-2700. The conference ID number is 7234102. If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-519-4471 and the dial-in number for international callers is 973-341-3080. The replay pin number is 7234102. The conference call will also be webcast live and can be accessed at www.incyte.com under Investor Relations Investor relations The process by which the corporation communicates with its investors. , Events and Webcasts. About Incyte Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company with a growing pipeline of oral compounds to treat HIV, inflammation, cancer and diabetes. Forward Looking Statements Except for the historical information contained herein, the matters set forth in this press release, including financial guidance regarding changes in expected cash use and expenses for 2006 and the absence of change for other 2006 financial guidance items, are all forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions 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 subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, results of further research and development, the impact of competition and of technological advances, unanticipated delays, unanticipated cash requirements and the ability to raise additional capital, the ability to implement technological improvements, Incyte's ability to enroll a sufficient number of patients for its clinical trials, and other risks detailed from time to time in Incyte's filings with the Securities Exchange Commission, including its Annual Report on 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. for the year ended December 31, 2005. Incyte disclaims any intent or obligation to update these forward-looking statements. |
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