At Incyte, we believe that innovation and the discovery of new products creates long-term value for patients and society, as well as for our employees and our shareholders. It is our commitment to these objectives that has enabled us to make significant progress in the last year. During 2016, we saw continued growth in the number of patients being treated with Jakafi® (ruxolitinib), our JAK1/JAK2 inhibitor, and we also added Iclusig® (ponatinib) to our commercial portfolio as part of our European transaction with ARIAD Pharmaceuticals, Inc. In February 2017, with Eli Lilly & Company, we announced the European approval of Olumiant® (baricitinib).
I believe that we are on track to reach our goal of becoming a world-class, global biopharmaceutical organization. For the first time in the history of our company, Incyte’s total yearly revenue surpassed $1 billion in 2016. Our revenue growth this past year was largely fueled by Jakafi sales in the U.S. which, in turn, was driven in large part by the growing base of MF and PV patients that are benefitting from this treatment. The revenue generated by our products allows us to continue to reinvest in our portfolio—we expect that the investments we are making today will position us for long-term success.
We have a broad and diversified selection of clinical candidates in our growing portfolio, the majority of which were created in our own laboratories in Wilmington, DE, which is further testament to our commitment to innovation.
We believe that our portfolio contains both first-in-class and best-in-class candidates and that it is both unique and unparalleled for a company of our size. It has also grown considerably in 2016. In last year’s Letter to Shareholders and Annual Report, we detailed 14 clinical candidates, more than half of which have since moved forward into the next stage of clinical development. We have also added four new clinical candidates resulting from our internal discovery efforts as well as licensing transactions in the last twelve months. I’ll now detail some of the major advances we have made and are planning across our portfolio.
Jakafi, first approved in 2011, has over a decade of expected patent protection remaining in the U.S. and we plan to use this opportunity to investigate its potential utility in other disease areas. These plans include a pivotal program in patients with steroid-refractory graft versus host disease (GVHD), which is underway, and a pivotal program in patients with essential thrombocythemia, which is planned to begin later this year.
Following positive proof-of-concept data published late last year, itacitinib, our selective JAK1 inhibitor, is expected to begin a pivotal program in patients with treatment-naïve acute GVHD this year.
We believe that IDO1 enzyme inhibition could represent an exciting new therapeutic combination option for patients with cancer. To that end, our robust ECHO (Epacadostat Clinical development in Hematology and Oncology) program is investigating epacadostat, our IDO1 enzyme inhibitor, in combination with checkpoint inhibitors, vaccines, chemotherapy, and epigenetic therapies. ECHO-301, a Phase 3 trial of epacadostat in combination with pembrolizumab in patients with unresectable or metastatic melanoma is ongoing, and we look forward to sharing those data once available. Earlier this year, we announced significant expansions of the ECHO program, and during 2017 we expect to initiate pivotal trials of epacadostat in combination with pembrolizumab in four new tumor types and epacadostat in combination with nivolumab in two tumor types.
Over the last 12 months, we initiated four Phase 2 trials that, if successful, may be registration-enabling. Our FGFR1/2/3 inhibitor, INCB54828, is being studied across three different trials in patients with bladder cancer, cholangiocarcinoma, and 8p11 MPNs respectively. The fourth potentially-pivotal Phase 2 trial is the CITADEL-202 study of our PI3kδ inhibitor, INCB50465, which recently began in patients with diffuse large B-cell lymphoma (DLBCL).
Our early-stage targeted portfolio also progressed well last year, including the addition of a second BRD inhibitor, INCB57643, and our LSD1 inhibitor, INCB59872, into clinical trials. We expect our FGFR4 inhibitor, INCB62079, to enter clinical trials this year, and dose-escalation trials for our first BRD inhibitor, INCB54329, and our PIM inhibitor, INCB53914, are ongoing.
Within our early-stage immuno-therapy portfolio, dose-escalation trials of INCB01158, the arginase inhibitor we recently licensed from Calithera, INCAGN1876, our anti-GITR agonist, and INCAGN1949, our anti-OX40 agonist, are all ongoing. We continue to perform a thorough assessment of the profile of our PD-1 inhibitor, INCSHR1210, before determining whether to enroll any additional subjects.
Our development program for a topical formulation of ruxolitinib continues to progress and is currently being studied in patients with alopecia areata and with atopic dermatitis. A trial in patients with vitiligo is expected to begin in the coming months.
I’ll finish the portfolio review with an update on our partnered programs. Baricitinib, marketed as Olumiant by Eli Lilly, was recently approved in Europe for the treatment of patients with rheumatoid arthritis. In April 2017, the FDA issued a complete response letter (CRL) for baricitinib. In the letter, the FDA indicated that additional clinical data are needed to determine the most appropriate doses as well as to further characterize safety concerns across treatment arms. We, along with Lilly, disagree with the agency’s conclusions and we currently expect that Lilly plans to now engage with the FDA to discuss their concerns in an effort to and determine a potential path forward. Capmatinib, the c-MET inhibitor which we licensed to Novartis, is currently in a Phase 1b/2 trial in patients with lung cancer, data from which are expected in 2017.
Since last year’s Annual Report we have announced three strategic transactions, which strengthened Incyte in important ways.
In December last year, we announced a strategic collaboration with Merus NV, which provides us with long-term access to its leading bispecifics technology, Biclonics, for up to 11 programs.
Earlier this year, we announced a collaboration with Calithera Biosciences that gave us exclusive development and commercialization rights to INCB01158, the first-in-class, oral arginase inhibitor. We believe that arginase is an important target within the tumor microenvironment and could have a role in combination with other immuno-oncology therapies in our portfolio, including epacadostat.
The third transaction was the acquisition of ARIAD Pharmaceutical’s European business which immediately expanded our footprint in Europe, adding significant experience, resources and relationships to our existing European organization. We are thrilled to have welcomed this group into our Incyte family. The expansion and addition to our European team leaves us well-positioned to maximize the potential of our broad development portfolio.
With a strong financial position driven by expected revenues from Jakafi and Iclusig and royalties from Jakavi and Olumiant, we will continue to invest in the long-term success of Incyte. Looking forward, we have taken the first steps towards expanding our company into the Asia-Pacific region, with initial plans for a clinical development team in Japan. We are also looking forward to moving into our newly expanded global headquarters in Wilmington, DE.
I would like to close by thanking my Incyte colleagues, who, as we strive to discover and develop innovative medicines for patients in need, are our greatest asset. I would also like to sincerely thank and recognize the patients, families, researchers, and physicians who participate in and help to conduct our clinical trials. Together, through our shared focus on innovation and a dedication to scientific excellence, we will seek to transform the future of cancer treatment.
Chairman, President and CEO
1. Ex-U.S. rights to ruxolitinib licensed to Novartis, commercialized by Novartis as Jakavi
2. Worldwide rights to baricitinib licensed to Lilly
3. Intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis
4. Patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea
5. Chronic myeloid leukemia (CML) and Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of certain second generation BCR-ABL inhibitors and all patients who have the T315I mutation
6. Moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs