Wilmington, Del. — (Business Wire) — Incyte Corporation (Nasdaq: INCY) today reported full year and fourth quarter 2007 financial results, and announced its 2008 financial guidance and key objectives and plans for its rapidly expanding clinical pipeline.
Paul A. Friedman, M.D., President and CEO of Incyte, state, “Over the past year, we’ve worked intensively to advance a number of our internally-discovered compounds through proof-of-concept clinical trials and are now in the enviable position of having multiple programs advance into Phase II development. The JAK inhibitor program is currently our highest priority. It has already generated impressive proof-of-concept clinical results in multiple indications and is one that we believe we can commercialize on our own. We plan to further expand the JAK program in early 2008 by initiating two additional Phase II trials, one in multiple myeloma and a second in hormone refractory prostate cancer patients.
“Our other product candidates for type 2 diabetes, breast cancer and HIV have also demonstrated promising early efficacy and safety results. The additional clinical data we expect to generate from these programs during 2008 should help us maximize their therapeutic and commercial potential, make sound decisions regarding the formationof partnerships, and create substantial value for our shareholders.”
— For INCB18424, our lead JAK inhibitor compound in Phase II development, we announced:
— Additional positive clinical results involving an expanded cohort of 21 patients from an ongoing Phase I/II trial in myelofibrosis in which all patients have experienced significant reductions in spleen size and marked improvements in their constitutionals symptoms and quality of life
— Positive preliminary results obtained from an ongoing 28-day Phase IIa placebo controlled dose-ranging trial in rheumatoid arthritis (RA) in which three of four patients completing the 28 day study acheived ACR50 criteria, two of whom also met ACR90 criteria, one within two weeks
— Additonal positive clinical results from a 28-day Phase IIa trial with the topical form of INCB18424 in mild-to-moderate psoriasis patients in which the compound was extremely well tolerated and provided comparable efficacy to the potent topical steroid, Diprolene(R)
— For INCB13739, our 11beta-HSD1 inhibitor that is being developed for type 2 diabetes, we reported additional positive clinical results from the Phase IIa 28-day hyperinsulinemic clamp study demonstrating improvements in six different measures of glucose control and cardiovascular risk, including fasting plasma glucose, LDL cholesterol, total cholesterol, triglycerides, clamp-measured liver glucose production, and clamp-measured peripheral glucose uptake
— For INCB19602, our recently announced lead HM74a agonist that we intend to develop as a treatment for type 2 diabetes, we completed a single-dose Phase I trial in healthy volunteers in which low and well tolerated doses dramatically reduced free fatty acid levels and did not cause any of the cutaneous flushing that is seen with the currently available HM74a agonist, niacin
— For INCB7839, our sheddase inhibitor that is being developed for metastatic breast cancer, we presented clinical results at the San Antonio Breast Cancer Symposium demonstrating that four of the five HER2+ breast cancer patients in the study who had previously failed trastuzumab (Herceptin(R)) containing regimens, achieved stable disease for 2-4 months, suggesting that INCB7839 represents a potentially important new class of targeted breast cancer therapy.
2008 Key Program Objectives
JAK Inhibitor Program
— Complete discussions with the FDA regarding a registration strategy for the myelofibrosis indication in the first half and initiate Phase II/III trials in the second half of 2008
— Present results from the Phase I/II trial in myelofibrosis patients at ASCO in June 2008
— Complete the 28-day Phase IIa trial in RA and present results from this trial at EULAR in June 2008
— Initiate a six-month Phase IIb oral RA trial in the second half of 2008
— Initiate a 28-day Phase IIa oral trial in psoriasis patients in the first half of 2008
–Complete required safety trials and initiate a three-month Phase IIb trial using the topical form of INCB18424 in mild-to-moderate psoriasis patients in the second half of 2008
— Initiate a Phase II trial in polycythemia vera and essential thrombocytemia patients in mid-2008
— Expand the current JAK inhibitor clinical development program
— Initiate a Phase II trial in multiple myeloma patients in the first quarter of 2008
— Initiate a Phase II trial in prostate cancer patients in the first quarter of 2008
INCB28050, follow on JAK inhibitor
— Complete preclinical safety and initiate Phase I trials in mid-2008