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Incyte to Discontinue Development of DFC (Reverset) as a Treatment for HIV
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Press announcement from Incyte
Conference Call Scheduled for 8:30 a.m. ET Today
WILMINGTON, Del., Apr 03, 2006 (BUSINESS WIRE) -- Incyte Corporation (Nasdaq: INCY) announced today its decision to discontinue the development of DFC (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. 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 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. In Study 901, the long term extension study to Study 203, we have had 5 recent cases of grade 4 hyperlipasemia, including one case of pancreatitis. The patient with pancreatitis also had hypertriglyceridemia, another risk factor for pancreatitis. Last week we received data listings on which patients in Study 901 had stopped 3TC or FTC, which patients had never taken it and which continued to take 3TC or FTC. In study 901 there have now been a total of 8 cases of hyperlipasemia in subjects taking 200 mg DFC and we found that 7 of these cases were in patients not taking 3TC or FTC. There are a total 20 subjects not taking 3TC or FTC, of whom 17 have stopped these drugs for at least 16 weeks, which is the time when the risk of hyperlipasemia starts. So the incidence of Grade 4 hyperlipasemia with DFC, as we planned to use it in Study 204 and in future studies is now about 40%, which is unacceptably high. The incidence in patients who continued to take 3TC or FTC was 2% (1 in 46) but DFC is not adequately effective when used with 3TC or FTC. Lower doses were not effective in treatment experienced patients.
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 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 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 CCR2 antagonists. 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 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, 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 within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act 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 for the year ended December 31, 2005. Incyte disclaims any intent or obligation to update these forward-looking statements.
SOURCE: Incyte Corporation
Incyte Corporation
Pamela M. Murphy, 302-498-6944
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