On August 4, 2015 Incyte Corporation (Nasdaq: INCY) today reported 2015 second-quarter financial results, including revenue from Jakafi (Press release, Incyte, AUG 4, 2015, View Source;p=RssLanding&cat=news&id=2075248 [SID:1234506992]).

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The Company highlighted the continued momentum in the commercialization of Jakafi in the U.S., as well as progress being made across its clinical portfolio, including the results of two pivotal trials of baricitinib that were presented with Eli Lilly and Company ("Lilly") at the 2015 European League Against Rheumatism (EULAR) meeting in June. In addition, positive proof-of-concept results from the novel:novel combination of Incyte’s PI3Kδ inhibitor INCB40093 and JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at both the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings in the second quarter of 2015.

"The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera," stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. "Recent data presented from our product candidates, and the progress we are making in recruiting multiple clinical trials, further illustrate the strength and diversity of our development portfolio."

Jakafi is approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

2015 Second-Quarter Financial Results

Revenues For the quarter ended June 30, 2015, net product revenues of Jakafi were $142 million as compared to $84 million for the same period in 2014, representing 69 percent growth. For the six months ended June 30, 2015, net product revenues of Jakafi were $258 million as compared to $154 million for the same period in 2014, representing 68 percent growth. For the quarter and six months ended June 30, 2015, product royalties from sales of Jakavi (ruxolitinib) outside of the United States received from Novartis, the Company’s collaborator, were $17 million and $33 million, respectively, as compared to $12 million and $22 million, respectively, for the same periods in 2014. For the quarter ended June 30, 2015, contract revenues were $3 million as compared to $3 million for the same period in 2014. For the six months ended June 30, 2015, contract revenues were $31 million as compared to $13 million for the same period in 2014. The $18 million increase in contract revenues for the six months ended June 30, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the quarter ended June 30, 2015, total revenues were $163 million as compared to $100 million for the same period in 2014. For the six months ended June 30, 2015, total revenues were $322 million as compared to $189 million for the same period in 2014.

Research and development expenses Research and development expenses for the quarter and six months ended June 30, 2015 were $112 million and $231 million, respectively, as compared to $85 million and $160 million, respectively, for the same periods in 2014. Included in research and development expenses for the quarter and six months ended June 30, 2015 were non-cash expenses related to equity awards to our employees of $10 million and $20 million respectively. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio. Also included in research and development expenses for the six months ended June 30, 2015 was the one-time upfront payment to Agenus related to our license, development and commercialization agreement.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and six months ended June 30, 2015 were $52 million and $97 million, respectively, as compared to $41 million and $78 million, respectively, for the same periods in 2014. Included in selling, general and administrative expenses for the quarter and six months ended June 30, 2015 were non-cash expenses related to equity awards to our employees of $7 million and $15 million respectively. Increased selling, general and administrative expenses reflected additional costs related to the commercialization of Jakafi.

Unrealized gain on long term investment Unrealized gain on long term investment of $27 million for the quarter and six months ended June 30, 2015 represents the fair market value adjustment of the Company’s investment in Agenus.

Net income / (loss) Net income for the quarter ended June 30, 2015 was $9 million, or $0.05 per basic and diluted share, as compared to a net loss of $37 million, or $0.22 per basic and diluted share, for the same period in 2014. Net loss for the six months ended June 30, 2015 was $9 million, or $0.05 per basic and diluted share as compared to a net loss of $71 million, or $0.43 per basic and diluted share, for the same period in 2014.

Cash, cash equivalents and marketable securities position As of June 30, 2015, cash, cash equivalents and marketable securities totaled $627 million, as compared to $600 million as of December 31, 2014.

2015 Financial Guidance

Product Update

Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor

Follow-up results from the pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting, showing 83% of patients were still receiving ruxolitinib at a median exposure of 111 weeks.

The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in second line metastatic pancreatic cancer are ongoing. Three Phase II trials of ruxolitinib are ongoing in colorectal, breast and non-small cell lung cancer (NSCLC) patients.

baricitinib – JAK1 and JAK2 Inhibitor

In June 2015, the Company and Lilly presented five abstracts for baricitinib, including oral presentations of data from the pivotal RA-BEACON and RA-BUILD studies, at the 2015 EULAR meeting. The Company and Lilly expect to share results of two further Phase III studies in various disclosures in late 2015.

In April 2015, positive proof-of-concept data for baricitinib for the treatment of patients with diabetic nephropathy (diabetic kidney disease) were presented by Lilly at the scientific sessions of the American Diabetes Association.

epacadostat (INCB24360) – IDO1 Inhibitor

Four clinical trials to evaluate epacadostat in combination with immune checkpoint inhibitors are all recruiting patients. These trials are evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab), AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, MEDI4736, Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab), and Roche/Genentech’s investigational PD-L1 inhibitor, MPDL3280A.

INCB39110 & INCB52793 – JAK1-Selective Inhibitors

In May 2015, initial results of the combination of INCB39110 plus INCB40093, Incyte’s PI3Kδ inhibitor, in patients with B-cell malignancies were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting. INCB39110 is also in a Phase II trial in NSCLC patients, in combination with erlotinib, and in a Phase II trial, in combination with gemcitabine and nab-paclitaxel, in patients with pancreatic cancer.

The Company’s second JAK1-selective inhibitor, INCB52793, is in a Phase I/II monotherapy dose-escalation trial in advanced malignancies.

INCB40093 & INCB50465 – PI3Kδ Inhibitors

Initial results of the combination of INCB40093 and the JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting.

INCB50465 is a highly-potent PI3Kδ inhibitor, and an open-label, dose-escalation study of INCB50465 in subjects with previously treated B-cell malignancies has been initiated.

capmatinib (INC280) – c-MET Inhibitor

Capmatinib is being investigated by Novartis in a variety of solid tumors, including advanced c-MET positive hepatocellular carcinoma and c-MET positive/EGFR-TKI-resistant NSCLC, as well as in combination, including with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), in a Phase II trial of patients with NSCLC.

INCB54828 – FGFR Inhibitor

INCB54828 is in an open-label, dose-escalation study in subjects with advanced malignancies.

INCB54329 – BRD Inhibitor

In the second quarter of 2015, the Company initiated an open-label, dose-escalation study of INCB54329 in subjects with advanced malignancies.

On August 4, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that two abstracts summarizing data from studies in Europe and the U.K. of treatment with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) will be presented at the upcoming European Association of Dermato Oncology (EADO) annual congress, which will be held in Marseille, France, October 28-31, 2015 (Press release, Delcath Systems, AUG 4, 2015, View Source;p=RssLanding&cat=news&id=2075366 [SID:1234506991]).

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The abstracts are:

Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, a study conducted at Leiden University Medical Center in the Netherlands.
Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience, a study conducted at Southampton University in the United Kingdom.

On August 4, 2015 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported financial results for the second quarter ending June 30, 2015 (Filing, 6-K, Compugen, AUG 4, 2015, View Source [SID:1234506990]).

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Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "The use of our powerful predictive discovery infrastructure has given rise to a novel immune checkpoint based target portfolio, which we believe provides the basis for a next wave of immuno-oncology drugs. Furthermore, we believe that the data to date from our five highest priority checkpoint programs, in addition to our two partnered programs, indicate that these programs potentially address multiple cancer types and different modes of action."

Dr. Cohen-Dayag, continued, "Our highest priority programs include myeloid specific novel immune checkpoint candidates identified within the tumor microenvironment of multiple cancers. Although in recent years there has been growing recognition of the importance of myeloid cells in cancer immunology, this area still represents an unexplored frontier of cancer immunotherapy. Therefore, we believe our programs could have a significant impact upon the cancer immunology field."

Dr. Cohen-Dayag concluded, "We believe that our current portfolio of programs, supported by our broadly applicable predictive target discovery infrastructure, has the potential to result in a sustainable and growing pipeline of first-in-class product candidates sequentially reaching the clinic, both by internal development and through early stage collaborations. In this regard, we remain on target to meet our previously stated objective of having at least one IND relating to a Compugen-discovered checkpoint filed during the first half of 2017."

Revenues for the second quarter of 2015 and six months ending June 30, 2015 were $0.2 million and $0.7 million respectively, compared with $2.0 million and $4.1 million for the comparable periods in 2014. The decrease in revenues is attributable mainly to the milestone payment in the amount of $1.2 million received in the second quarter of 2014 and a reduction in the recognition of the non-refundable upfront payment for the second quarter of 2015 and six months ending June 30, 2015, both under the August 2013 collaboration and license agreement with Bayer.

Net loss for the second quarter of 2015 was $6.8 million, or $0.14 per diluted share, compared with a net loss of $2.3 million, or $0.07 per diluted share, for the comparable period in 2014. Net loss for the six months ending June 30, 2015 was $13.0 million, or $0.26 per diluted share, compared with a net loss of $4.2 million, or $0.09 per diluted share, for the comparable period in 2014. The significant increase in net loss for the comparable periods, largely relates to a decrease in revenues as noted above, and an increase in the Company’s discovery and development activities relating to its Pipeline Program candidates.

As of June 30, 2015, cash, cash related accounts, short-term and long-term bank deposits totaled $95.7 million with no debt compared with $108.4 million as of December 31, 2014. The Company previously estimated gross cash expenditures in 2015 to be in the range of $31 million to $33 million.

On August 4, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported a charitable donation to The Leukemia & Lymphoma Society (LLS) (Press release, Bristol-Myers Squibb, AUG 4, 2015, View Source [SID:1234506989]). The donation will provide financial assistance for chronic myeloid leukemia (CML) patients who need help paying for Polymerase Chain Reaction (PCR) testing, an important tool used in the diagnosis and monitoring of CML. The donation will also support LLS CML awareness activities focused on educating patients, caregivers and healthcare providers about the importance of continued monitoring with PCR testing.

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"Routine PCR testing is critical because oncologists rely on the results to determine their patients’ clinical status of early and ongoing response to CML treatment and to help detect when patients are potentially becoming resistant to treatment, which may allow for earlier intervention," said Louis J. DeGennaro, LLS’s president and CEO. "Research indicates that early response to treatment and careful monitoring correlate with better overall survival rates."

The PCR test is used both in the diagnosis of CML and to monitor for cancerous cells after treatment has begun. It is the most sensitive testing method available, with the ability to detect a single cancerous cell among one million healthy cells. Recommendations suggest that a CML patient should receive a PCR test every three months for the first three years after diagnosis, and every three to six months thereafter based on how well their treatment is working. The average cost of a PCR test is $345 and can be as high as $500 per test. The program will assist insured and uninsured patients with out-of-pocket costs for PCR testing. The donation will also fund national CML awareness activities that will be undertaken by LLS’s 56 chapters, as well as grassroots efforts through local networks of patients, volunteers and healthcare institutions.

"With the life expectancy of more CML patients increasing, the need for routine PCR testing is very important to ensure optimal treatment results," said Laura Bessen, MD, vice president, head of U.S. Medical, Bristol-Myers Squibb. "Bristol-Myers Squibb is committed to helping patients living with CML have access to this important test and to also help patients better understand why the testing is important for their long-term prognosis."

LLS will also partner with The Max Foundation, Cancer Support Community and the National CML Society to facilitate ongoing promotion and awareness about the PCR Financial Assistance and Awareness Program.

To find out more about the PCR Financial Assistance and Awareness Program or to apply, call LLS at (877) 614-9242 or visit www.LLS.org/PCR.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which the body produces an uncontrolled number of abnormal white blood cells. According to LLS, approximately 33,990 people in the United States are living with CML. An estimated 5,980 new cases of CML were diagnosed in 2014. CML occurs when pieces from two different chromosomes (chromosomes 9, 22) break off and attach to each other. The newly formed chromosome is commonly called the Philadelphia chromosome. The abnormal formation of this chromosome creates an unwanted gene, called BCR-ABL. This gene is responsible for the production of the BCR-ABL protein, which triggers the development of abnormal white bloods cells, leading to CML. There is no known cause for why this genetic change occurs.