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|Incyte Reports First-Quarter 2013 Financial Results; Updates Shareholders on Key Clinical Programs|
Conference Call Scheduled Today at
“We continue to see solid growth for Jakafi, which means that more
patients are experiencing the benefits of the first
First-Quarter 2013 Financial Results
Product Revenues and Royalties
For the quarter ended
Total revenues for the quarter ended
Net loss for the quarter ended
Non-Cash Stock Option Expense
Included in net loss for the quarter ended
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Interest expense for the quarter ended
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
Results of RESPONSE, a study in partnership with
A randomized Phase II trial of ruxolitinib in combination with capecitabine is ongoing with approximately 135 patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial). The primary endpoint is overall survival, with results expected in the second half of 2013.
An open-label Phase I trial of ruxolitinib in combination with
chemotherapy in patients with advanced solid tumors was initiated in
Multiple investigator-sponsored trials evaluating ruxolitinib are ongoing, including a Phase I/II trial in adults with advanced hematologic malignancies (acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome and chronic myelogenous leukemia); a Phase I/II trial in patients with relapsed or refractory acute leukemia; a Phase II trial in patients with lymphoma; and two Phase II trials in patients with breast cancer.
Baricitinib - a JAK1 and JAK2 Inhibitor
Lilly, our strategic partner for our second JAK1 and JAK 2 inhibitor, baricitinib, has several programs underway for this compound, including four Phase III trials in patients with rheumatoid arthritis, a Phase II trial in patients with moderate to severe psoriasis, and a Phase II trial in patients with diabetic nephropathy.
INC280 (formerly INCB28060) – a c-MET Inhibitor
This compound is licensed to
INCB24360 – an IDO1 Inhibitor
INCB24360 is currently in Phase I/II clinical development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer.
INCB39110 – a JAK1 Inhibitor
Three proof-of-concept studies evaluating INCB39110 in patients with myelofibrosis, psoriasis and rheumatoid arthritis are underway, with preliminary results expected in the second half of 2013. The results of these studies are expected to inform us as to the most appropriate indications for further development.
INCB47986 – a JAK1 Inhibitor
A second JAK1 inhibitor, INCB47986, recently entered Phase I clinical development.
Conference Call Information
If you are unable to participate, a replay of the conference call will
be available for 30 days. The replay dial-in number for
The conference call will also be webcast live and can be accessed at www.incyte.com under Investor Relations – Events and Webcasts.
Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.
Important Safety Information
For Full Prescribing Information for Jakafi, visit www.Jakafi.com.
Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements regarding expected variations in research and development expenses, our plans and expectations with respect to Jakafi® (ruxolitinib), including the potential efficacy and therapeutic and commercial value of Jakafi, our expectation of results from the RESPONSE trial evaluating ruxolitinib in PV in early 2014 and the filing of a supplemental new drug application in the first half of 2014, our plan to submit results from the RELIEF trial to support labeling claims on symptomatic benefit in PV, our expectation of results from the RECAP trial in the second half of 2013, our expectation that the Phase I trial of ruxolitinib in combination with chemotherapy in patients with advanced solid tumors will be completed in the second half of 2014 and our expectation of preliminary results from the three proof-of-concept studies evaluating INCB39110 in patients with myelofibrosis, psoriasis and rheumatoid arthritis in the second half of 2013 and these results being expected to inform us as to the most appropriate indications for further development, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of Jakafi,
the acceptance of Jakafi in the marketplace, risks related to market
competition, the results of further research and development, risks and
uncertainties associated with sales, marketing and distribution
requirements, risks that results of clinical trials may be unsuccessful
or insufficient to meet applicable regulatory standards, the ability to
enroll sufficient numbers of subjects in clinical trials, other market
or economic factors and technological advances, unanticipated delays,
the ability of
(1) Net of unamortized debt discount of
The information in the press releases should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.
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