On February 14, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated the first-in-human ("FIH") Phase I clinical trial of HMPL-453 in Australia (Press release, Hutchison China MediTech, FEB 14, 2017, http://www.chi-med.com/initiates-fih-trial-of-fgfr-inhibitor-hmpl-453/ [SID1234517720]). HMPL-453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor ("FGFR"). The first drug dose was administered on February 14, 2017.

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FGFRs are a sub-family of receptor tyrosine kinases. Activation of FGFR signaling pathways is central to several biological processes, including angiogenesis, tissue growth and repair. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as, conferring resistance to anti-tumor therapies. To date, there are no approved therapies specifically targeting the FGFR signaling pathway.

The FIH dose-escalation trial aims to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HMPL-453 in patients with advanced or metastatic solid malignancies, who have failed or are unable to tolerate standard therapies or for whom no standard therapies exist. This open-label study consists of two preliminary phases, a dose-escalation (stage 1) and a dose-expansion stage (stage 2).

In pre-clinical studies, HMPL-453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02966171.

On February 14, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) and AstraZeneca PLC ("AstraZeneca") reported that they will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma ("PRCC") at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO-GU"), to be held in Orlando, Florida from February 16 to 18, 2017 (Press release, Hutchison China MediTech, FEB 14, 2017, http://www.chi-med.com/savolitinib-prcc-at-2017-asco-gu/ [SID1234517719]). Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.

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PRCC, the second most common histologic subtype of renal cell carcinoma ("RCC"), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy.

"There is a clear unmet medical need in PRCC," said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. "The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated." He added, "These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma."

"We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options," said Christian Hogg, Chief Executive Officer of Chi-Med. "With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib."

The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows:

Presentation Title: A Single-Arm Biomarker-Based Phase II Trial of Savolitinib in Patients with Advanced Papillary Renal Cell Cancer
Authors: Toni K. Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y. C. Heng, Thomas Powles, Melanie M. Frigault, Edwin Clark, Amir Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, Sumanta Kumar Pal
Abstract No: 436
Session: Session C: Penile, Urethral, and Testicular Cancers; Renal Cell Cancer
Date & Time: Saturday, February 18, 2017, 7:00 AM-7:55 AM and 11:30 AM-1:00 PM (EST)


Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO (Free ASCO Whitepaper)-GU is available at gucasym.org.

Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC.

Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers.



ABSTRACT
A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC)

Toni K. Choueiri1, Elizabeth Plimack2, Hendrik-Tobias Arkenau3, Eric Jonasch4, Daniel Y. C. Heng5, Thomas Powles6, Melanie M. Frigault7, Edwin Clark7, Amir Handzel7, Humphrey Gardner7, Shethah Morgan8, Laurence Albiges9, Sumanta Kumar Pal10

1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US

Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition ("MET") inhibitor (IC50 of 4 nM). MET and its ligand, hepatocyte growth factor ("HGF"), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015).

Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate ("ORR") is the primary endpoint. Progression-Free Survival ("PFS") & Duration of Response are secondary endpoints. Patient Reported Outcome ("PRO") and Health-Related Quality of Life ("HRQoL") questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine, Inc., US).

Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1–7.0) vs. 1.4 months (95% CI: 1.4–2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events ("AEs") leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests ("LFTs") (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings.

Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC.



About the Unmet Medical Need in c-Met-Driven PRCC Patients
Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC ("ccRCC") is the most common, accounting for 75-80% of RCC.

PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification).

The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients.

On February 14, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, reported that enrollment of an investigator initiated Phase 1 clinical trial with 131-I-MIP-1095 (1095) has begun at MSK (Press release, Progenics Pharmaceuticals, FEB 14, 2017, View Source [SID1234517717]). 1095 is one of Progenics’ PSMA-targeted small molecule radiopharmaceutical candidates being developed for the treatment of metastatic prostate cancer.

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1095 is designed to bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is expressed in greater than 95% of prostate cancer cells, and upon binding, internalized by the prostate cancer cells where its iodine-131 beta particles kill the tumor cells. When administered under a compassionate use setting, 1095 was well tolerated and demonstrated markedly reduced PSA levels and bone pain in a group of heavily-pretreated advanced prostate cancer patients (N=28) following a single cycle of treatment.1

"MIP 1095 holds the promise of optimizing tumor-specific delivery of radiation, with the added potential benefit of rapid clearance of the molecule and its radioactive payload that can minimize radiation exposure to normal tissues," said Michael J. Morris, MD of Memorial Sloan Kettering Cancer Center, and lead investigator of the study. "The totality of the preclinical and compassionate use data provides strong support for 1095 in metastatic castration-resistant prostate cancer, and I look forward to further evaluating this drug in the clinical setting."

This Phase 1 open-label dose-escalation study will enroll approximately 40 patients with mCRPC who have demonstrated tumor avidity to 1095. The primary objectives of this study include determination of maximum tolerated dose, safety and tolerability, biodistribution, and efficacy. Findings from this trial will guide the decision of an optimal dose for a Phase 2 trial.

"The initiation of this trial reflects our commitment to advancing PSMA-targeted candidates that have the potential to transform how prostate cancer is detected, managed and treated," said Mark Baker, CEO of Progenics. "The insights we gain from this trial will help guide the design of the future clinical development program of 1095."

About 1095

Progenics’ small molecule therapeutic candidate 1095 is designed to bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is expressed in >95% of prostate cancer cells, and upon binding, to be internalized by the prostate cancer cells, where its iodine-131 beta particles kill the malignant cell. The ability to specifically deliver radiation to prostate cancer cells anywhere in the body allows a commonly used therapy (radiation) to be used with precision to attack systemic disease. Preclinical data has shown high tumor uptake and a favorable tumor to kidney discrimination yielding a lethal radiation dose to the tumor while minimizing normal tissue dose. In human prostate cancer mouse models, the compound, administered in single or multiple dose schedules, significantly reduced tumor burden for a prolonged period of time and enhanced survival with no significant signs of toxicity. When used in a compassionate use setting, 1095 markedly reduced PSA levels and bone pain in a group of 22 heavily-pretreated advanced prostate cancer patients.

On February 14, 2017 Incyte Corporation (Nasdaq:INCY) reported 2016 fourth-quarter and year-end financial results, highlighting strong revenue growth driven by increased sales of Jakafi (ruxolitinib) in the U.S. and Iclusig (ponatinib) in Europe, and royalties from ex-U.S. sales of Jakavi (ruxolitinib) by Novartis (Press release, Incyte, FEB 14, 2017, View Source [SID1234517714]).

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Additionally, Incyte is providing financial guidance for 2017.

“We have had a very productive year at Incyte, during which we expanded our geographic footprint to include Europe and further advanced our clinical portfolio, including the recently announced expansion of the epacadostat development program,” stated Hervé Hoppenot, Incyte’s Chief Executive Officer. “Having now surpassed $1 billion in total annual revenue for the first time, we believe we are in a strong position to execute on our discovery and development objectives and build a global biopharmaceutical company bringing medicines to patients in need.”
Baricitinib, a potential new oral treatment for patients with rheumatoid arthritis (RA) licensed to Eli Lilly and Company (Lilly), is now approved in Europe as Olumiant and is under regulatory review globally. The European approval of Olumiant triggers a $65 million payment to Incyte from Lilly, and Incyte is eligible to receive additional potential milestone payments, as well as royalties on sales of Olumiant. Incyte has recently opted into co-development of multiple new indications for baricitinib, including psoriatic arthritis, in which Lilly is expected to begin a Phase 3 trial in 2017.

Incyte continues to expand its development portfolio—the Company anticipates the initiation of new pivotal trials in at least six indications from its broad late-stage portfolio during 2017 and is conducting four Phase 2 trials which, if successful, could also potentially act as registration-enabling studies. Two recent strategic collaborations have added to Incyte’s early-stage R&D programs—the alliance with Merus provides access to bispecific drug discovery and the licensing agreement with Calithera adds INCB01158, a first-in-class oral arginase inhibitor, to Incyte’s immuno-oncology development portfolio.

Portfolio Update
Cancer – Targeted Therapies
The pivotal program investigating ruxolitinib as a treatment for patients with graft-versus-host disease (GVHD) has begun. REACH1, the pivotal Phase 2 trial in patients with steroid-refractory acute GVHD, enrolled its first patient in December 2016; the REACH2 and REACH3 randomized Phase 3 trials in steroid-refractory acute and steroid-refractory chronic GVHD, respectively, are expected to begin in 2017 in collaboration with Novartis.
A pivotal program of ruxolitinib as a treatment for patients with essential thrombocythemia is also expected to begin in 2017.
Itacitinib (formerly INCB39110), Incyte’s selective JAK1 inhibitor, is anticipated to enter a global pivotal development program for the treatment of patients with treatment-naïve acute GVHD during 2017.
In January 2017, Incyte disclosed its FGFR4 inhibitor discovery program, the lead molecule from which, INCB62079, is expected to enter proof-of-concept clinical trials during 2017.

Indication Status Update
Ruxolitinib (JAK1/JAK2) Steroid-refractory acute GVHD Pivotal (REACH1) trial underway; Phase 3 (REACH2) trial expected to begin in 2017
Ruxolitinib (JAK1/JAK2) Steroid-refractory chronic GVHD Phase 3 (REACH3) trial expected to begin in 2017
Ruxolitinib (JAK1/JAK2) Essential thrombocythemia Pivotal program expected to begin in 2017
Itacitinib (JAK1) Treatment-naïve acute GVHD Pivotal program expected to begin in 2017
Itacitinib (JAK1) Non-small cell lung cancer Phase 1/2 in combination with osimertinib (EGFR)
INCB52793 (JAK1) Advanced malignancies Phase 1/2 dose-escalation
INCB50465 (PI3Kδ) Diffuse large B cell lymphoma Phase 2 (CITADEL-202) expected to begin in first half of 2017
INCB54828 (FGFR1/2/3) Bladder cancer, cholangiocarcinoma; 8p11 MPNs Phase 2
INCB54329 (BRD) Advanced malignancies Phase 1/2 dose-escalation
INCB57643 (BRD) Advanced malignancies Phase 1/2 dose-escalation
INCB53914 (PIM) Advanced malignancies Phase 1/2 dose-escalation
INCB59872 (LSD1) Acute myeloid leukemia, small cell lung cancer Phase 1/2 dose-escalation
INCB62079 (FGFR4) Hepatocellular carcinoma Phase 1/2 dose-escalation expected to begin in 2017

Cancer – Immune Therapies
In January 2017, Incyte and Merck announced the decision to expand the clinical development program investigating epacadostat with pembrolizumab, and plan to initiate Phase 3 trials of the combination in four additional tumors beyond melanoma: non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma of the head and neck. These Phase 3 trials are expected to begin in 2017.
In January 2017, Incyte announced that it licensed worldwide rights from Calithera Biosciences to develop and commercialize INCB01158, a first-in-class, oral arginase inhibitor in hematology and oncology indications.
In February 2017, Incyte and Agenus announced an amended agreement, converting the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs, with Incyte now responsible for global development and commercialization.

Indication Status Update
Epacadostat (IDO1) Unresectable or metastatic melanoma Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1)
NSCLC, renal, bladder and head & neck cancer Phase 3 in combination with pembrolizumab (PD-1) expected to begin in 2017
Multiple tumor types Phase 2 (ECHO-202) expansion cohorts in combination with pembrolizumab (PD-1)
Multiple tumor types Phase 2 (ECHO-204) expansion cohorts in combination with nivolumab (PD-1)
Multiple tumor types Phase 2 (ECHO-203) expansion cohorts in combination with durvalumab (PD-L1)
NSCLC, bladder cancer Phase 1/2 (ECHO-110) dose-escalation in combination with atezolizumab (PD-L1)
INCB01158 (ARG, co-developed with Calithera)
Solid tumors Phase 1/2 dose-escalation
INCSHR1210 (PD-1, licensed from Hengrui)
Solid tumors Phase 1/2 dose-escalation completed; enrollment suspended
INCAGN1876 (GITR) Solid tumors Phase 1/2 dose-escalation
INCAGN1949 (OX40) Solid tumors Phase 1/2 dose-escalation

PD-1 platform study Solid tumors Phase 1/2, pembrolizumab (PD-1) in combination with itacitinib (JAK1) or INCB50465 (PI3Kδ)
JAK1 platform study Solid tumors Phase 1/2, itacitinib (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ)

Non-oncology
A Phase 2 trial of topical ruxolitinib for the treatment of patients with atopic dermatitis has recently been initiated, and a Phase 2 trial in patients with vitiligo is expected to begin during 2017.

Indication Status Update
Topical ruxolitinib (JAK1/JAK2) Alopecia areata, atopic dermatitis Phase 2
Vitiligo Phase 2 expected to begin in 2017

Partnered
In February 2017, the European Commission approved baricitinib – which will be marketed as Olumiant – for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). In January 2017, the FDA extended the review period for the new drug application (NDA) for baricitinib by three months to allow time to review additional data analyses submitted by Lilly.
Lilly has announced its intention to initiate a Phase 3 program investigating baricitinib as a treatment for patients with psoriatic arthritis during 2017, and Incyte has opted into co-development in this indication. Incyte has also opted into co-development in axial spondyloarthritis and atopic dermatitis, should Lilly decide to progress into a pivotal program in these indications.
Novartis anticipates submitting an NDA for capmatinib, Incyte’s potent and selective c-MET inhibitor, in 2018.

Indication Status Update
Baricitinib (JAK1/JAK2, licensed to Lilly) Rheumatoid arthritis Approved in Europe; FDA review extended by three months
Psoriatic arthritis Phase 3 expected to begin in 2017
Atopic dermatitis, systemic lupus erythematosus Phase 2
Capmatinib (c-MET, licensed to Novartis) Non-small cell lung cancer, liver cancer Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation

2016 Fourth-Quarter and Full-Year Financial Results
Revenues For the quarter ended December 31, 2016, net product revenues of Jakafi were $238 million as compared to $182 million for the same period in 2015, representing 30 percent growth. For the full year ended December 31, 2016, net product revenues of Jakafi were $853 million as compared to $601 million for the same period in 2015, representing 42 percent growth.
For the quarter and seven month period ended December 31, 2016, net product revenues of Iclusig were $13 million and $30 million, respectively1.
For the quarter and full year ended December 31, 2016, product royalties from sales of Jakavi outside of the United States received from Novartis were $33 million and $111 million, respectively, as compared to $24 million and $75 million, respectively, for the same periods in 2015.
For the quarter and full year ended December 31, 2016, contract revenues were $43 million and $113 million, respectively, as compared to $38 million and $78 million, respectively, for the same periods in 2015. The increase in contract revenues for the full year ended December 31, 2016 relates to milestone payments earned.
For the quarter ended December 31, 2016, total revenues were $326 million as compared to $244 million for the same period in 2015. For the full year ended December 31, 2016, total revenues were $1,106 million as compared to $754 million for the same period in 2015.

Year Over Year Revenue Growth
(in thousands, unaudited)

Three Months Ended Twelve Months Ended
December 31, % December 31, %
2016 2015 Change 2016 2015 Change
Revenues:
Jakafi net product revenue $ 237,531 $ 182,021 30% $ 852,816 $ 601,015 42%
Iclusig net product revenue 12,867 – – 29,588 – –
Product royalty revenues 33,225 23,646 41% 110,711 74,821 48%
Contract revenues 42,869 38,214 – 112,512 77,857 –
Other revenues 6 – – 92 58 –
Total revenues $ 326,498 $ 243,881 34% $ 1,105,719 $ 753,751 47%

Research and development expenses Research and development expenses for the quarter and full year ended December 31, 2016 were $162 million and $582 million, respectively, as compared to $117 million and $480 million, respectively, for the same periods in 2015. Included in research and development expenses for the quarter and full year ended December 31, 2016 were non-cash expenses related to equity awards to our employees of $17 million and $60 million, respectively. The increase in research and development expenses for the full year ended December 31, 2016 was primarily due to the expansion of the Company’s clinical portfolio.
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and full year ended December 31, 2016 were $96 million and $303 million, respectively, as compared to $52 million and $197 million, respectively, for the same periods in 2015. Included in selling, general and administrative expenses for the quarter and full year ended December 31, 2016 were non-cash expenses related to equity awards to our employees of $10 million and $36 million, respectively. Increased selling, general and administrative expenses are driven primarily by additional costs related to the commercialization of Jakafi and the geographic expansion in Europe.
Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration of $7 million and $17 million for the quarter and seven month period ended December 31, 2016 represents the fair market value adjustments of the Company’s contingent liability related to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
Unrealized loss on long term investment Unrealized loss on long term investment for the quarter and full year ended December 31, 2016 were of $24 million and $3 million, respectively, as compared to $0 million and $5 million, respectively, for the same periods in 2015. The unrealized loss on long term investment represents the fair market value adjustments of the Company’s investment in Agenus.
Net income Net income for the quarter ended December 31, 2016 was $9 million, or $0.05 per basic and diluted share, as compared to net income of $55 million, or $0.30 per basic and $0.29 per diluted share for the same period in 2015. Net income for the full year ended December 31, 2016 was $104 million, or $0.55 per basic and $0.54 per diluted share, as compared to net income of $7 million, or $0.04 per basic and $0.03 per diluted share for the same period in 2015.
Cash, cash equivalents and marketable securities position As of December 31, 2016, cash, cash equivalents and marketable securities totaled $809 million, as compared to $708 million as of December 31, 2015.
2017 Financial Guidance
The Company has provided full year 2017 financial guidance, as detailed below.

Guidance
Jakafi net product revenues $1,020-$1,070 million
Iclusig net product revenues $60-$65 million
Research and development expenses: ongoing $785-$835 million
Research and development expenses: anticipated one-time items* $205 million
Selling, general and administrative expenses $340-$360 million
Change in fair value of acquisition-related contingent consideration $30-$35 million
* One-time items related to the amended Agenus collaboration, and the Merus and Calithera collaborations