On February 11, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported that the first patient has been enrolled in a clinical study evaluating Lymphoseek (technetium Tc 99m tilmanocept) injection in women with known cervical cancer (Press release, Navidea Biopharmaceuticals, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137497 [SID:1234509037]). The study, funded by a Fast-track grant from the National Institutes of Health (NIH), National Cancer Institute (NCI; 1R44CA180390-01) will assess the use of Lymphoseek in sentinel lymph node biopsy (SLNB) during cervical cancer surgery in support of the existing Lymphoseek label in lymphatic mapping. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Enrollment is currently planned in up to six sites throughout the U.S. The first patient has been enrolled by the principal investigator, Michael M. Frumovitz, M.D., M.P.H., Associate Professor, Department of Gynecologic Oncology and Reproductive Medicine, at The University of Texas MD Anderson Cancer Center.

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"This important study could potentially advance the use of SLNB procedures in cervical cancer. Clinical experience and published results using Lymphoseek in other cancer types demonstrate that imaging using Lymphoseek may enable detection of suspicious nodes not previously possible," said Frederick Cope, Ph.D., M.S., F.A.C.N., C.N.S., Senior Vice President and Chief Scientific Officer of Navidea. "Improving current practice in lymph node mapping and sentinel node detection in cervical cancer surgery may lead to less extensive, more focused surgical procedures. More reliable bilateral SLN identification may decrease the cost and morbidity of complete lymph node dissection in women with early stage cervical cancer."

"There is currently a growing focus on sentinel lymph node biopsy (SLNB) procedures in gynecologic cancers. Lymphoseek has been safely and efficaciously used in SLNB and mapping procedures in over 50,000 patients to date," said Rick Gonzalez, President and Chief Executive Officer of Navidea. "With Lymphoseek’s immunodiagnostic properties of selective receptor targeting and improved patient experience, we believe that this study and others like it may accelerate the adoption of lymphatic mapping and SLNB using Lymphoseek in cervical cancer and other solid tumor areas with the intent of improving patient outcomes and reducing post-surgical morbidities in patients undergoing these procedures."

This multi-center, prospective, open-label study is designed to evaluate Lymphoseek in patients with known cancer of the cervix. The trial intends to enroll up to 40 women with International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1 staging. Subjects will receive a single dose of Tc99m tilmanocept administered peritumorally approximately 1-2 hours before surgery. The results will report per-patient false negative rates and compare the pathology status of Lymphoseek-identified sentinel lymph nodes relative to the pathology status of non-sentinel lymph nodes in nodal staging of patients. Additionally, the study will report sensitivity, negative predictive value, and accuracy. Concordance and reverse concordance of identified nodes will be reported for the cases that use both Lymphoseek and a dye. Information on the protocol for this study (NAV3-19) can be found at: View Source;rank=5.

About Cervical Cancer

Cervical cancer is usually a slow-growing cancer that affects ~12,000 new patients each year in the U.S. Worldwide, the World Health Organization notes that cervical cancer is both the fourth most common cause of cancer and the fourth most common cause of death from cancer in women. Globally in 2012, it was estimated that there were 528,000 new cases of cervical cancer, and 266,000 deaths.

About Sentinel Lymph Node Biopsy1

A sentinel lymph node is defined as the first lymph node to which cancer cells are most likely to spread from a primary tumor. Sometimes, there can be more than one sentinel lymph node. A sentinel lymph node biopsy (SLNB) is a procedure in which the sentinel lymph node is identified using an imaging agent such as Lymphoseek, removed, and examined to determine whether cancer cells are present. A negative SLNB result suggests that cancer has not developed the ability to spread to nearby lymph nodes or other organs. A positive SLNB result indicates that cancer is present in the sentinel lymph node and may be present in other nearby lymph nodes or organs. This information helps a doctor determine the stage of the cancer and develop an appropriate treatment plan. SLNB may also help some patients avoid more extensive lymph node surgery and post-surgical complications such as lymphedema, or tissue swelling. SLNB is most commonly used to help stage breast cancer, melanoma and head and neck cancers. SLNB is also being evaluated along with lymphatic mapping in other cancer types, including cervical, endometrial, anal, colorectal, gastric, esophageal, thyroid, and non-small cell lung cancer.

Source: 1National Cancer Institute. View Source; accessed February 10, 2016.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On February 11, 2016 Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) reported results for the year and the quarter ended December 31, 2015 (Press release, Teva, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137498 [SID:1234509038]).

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GAAP and non-GAAP earnings include the dilutive impact of the December 2015 equity offerings to finance the Actavis Generics acquisition

Exchange rate fluctuations reduced 2015 revenues by $1.3 billion but non-GAAP operating income by $163 million, reflecting Teva’s balanced global business model.

First quarter 2016 revenues expected to be $4.7-$4.9 billion; non-GAAP EPS, adjusted to exclude the impact of the December 2015 equity offerings, is expected to be $1.32-$1.36.

"2015 was a year of exceptional strategic, operational and financial performance for Teva", stated Erez Vigodman, President and CEO of Teva.

"Our strong focus on solidifying the foundation of Teva and improving the fundamentals of our business is manifesting itself in the consistent improvement of our operating and financial results.

Once the company was put on solid footing, we took the offensive and through a series of compelling acquisitions, partnerships and bold strategic moves, we are transforming Teva.

We are building a new company with a solid foundation, significantly enhanced financial profile, excellent generic business, promising specialty franchises and pipeline and diversified net revenues and profit streams. We are positioned to offer top line and bottom line growth and to continue the transformation of our business model, serving hundreds of millions of patients in the world on a daily basis and unlocking significant value for our shareholders."

Vigodman continued, "In 2016, our main focus will be closing and integrating the Actavis Generics, Rimsa and Takeda BV deals, fully capturing first year synergies, and continuing to deliver on the promise in our specialty pipeline through launches, submissions and other important clinical milestones, in conjunction with potential measures we will take to further augment our core therapeutic areas.

Teva is well positioned to become a pharmaceutical company that can truly make a difference in our world."

Full Year 2015 Results

Revenues in 2015 amounted to $19.7 billion, down 3% compared to 2014. Excluding the impact of foreign exchange fluctuations, revenues increased 4%.

Exchange rate differences (net of profits from certain hedging transactions) between 2015 and 2014 decreased our revenues by $1.3 billion, our non-GAAP operating income by $163 million and our GAAP operating income by $95 million.

Non-GAAP gross profit was $12.2 billion in 2015, up 1% compared to 2014. Non-GAAP gross profit margin was 62.2% in 2015, compared to 59.9% in 2014. GAAP gross profit was $11.4 billion in 2015, up 3% compared to 2014. GAAP gross profit margin was 57.8% in 2015, compared to 54.5% in 2014.

Research and Development (R&D) expenditures (excluding equity compensation expenses, purchase of in-process R&D and certain other items) in 2015 amounted to $1.4 billion, up 3% compared to 2014. R&D expenses were 7.3% of revenues, compared to 6.9% in 2014. R&D expenses related to our generic medicines segment amounted to $513 million, compared to $512 million in 2014. In local currency terms, expenses increased 4%. R&D expenses related to our specialty medicines segment amounted to $918 million, compared to $872 million in 2014. In local currency terms, expenses increased 7%.

Selling and Marketing (S&M) expenditures (excluding amortization of purchased intangible assets, equity compensation expenses and certain other items) amounted to $3.4 billion, or 17.4% of revenues, in 2015, compared to $3.8 billion, or 18.6% of revenues, in 2014. S&M expenses related to our generic medicines segment amounted to $1.3 billion, compared to $1.6 billion in 2014. In local currency terms, S&M expenses related to our generics medicines segment decreased 6%. S&M expenses related to our specialty medicines segment amounted to $1.9 billion, compared to $2.0 billion in 2014. In local currency terms, S&M expenses related to our specialty medicines segment increased 2%.

General and Administrative (G&A) expenditures (excluding equity compensation expenses) amounted to $1.2 billion in 2015, or 6.0% of revenues, compared to $1.2 billion, or 5.8% of revenues, in 2014.

Non-GAAP operating income was $6.2 billion, up 6% compared to 2014. GAAP operating income was $3.4 billion in 2015, a decrease of 15% compared to 2014.

We calculate EBITDA as non-GAAP operating income (which excludes amortization and certain other items) plus depreciation expenses for the period. In 2015, depreciation amounted to $447 million, compared to $452 million in 2014. EBITDA for 2015 amounted to $6.6 billion, up 6% compared to $6.3 billion in 2014.

Non-GAAP financial expenses amounted to $223 million in 2015, compared to $306 million in 2014. GAAP financial expenses for 2015 amounted to $1.0 billion, compared to $313 million in 2014.

Non-GAAP income taxes for 2015 amounted to $1.3 billion on pre-tax non-GAAP income of $6.0 billion, for an annual tax rate of 21%. Non-GAAP income taxes in 2014 were $1.1 billion on pre-tax non-GAAP income of $5.5 billion, for an annual tax rate of 20%. GAAP income taxes for 2015 amounted to $634 million, or 27% on pre-tax income of $2.4 billion. In 2014, income taxes amounted to $591 million, or 16%, on pre-tax income of $3.6 billion.

Non-GAAP net income attributable to Teva was $4.7 billion, up 6% compared to $4.4 billion in 2014. GAAP net income attributable to Teva was $1.6 billion in 2015, compared to $3.1 billion in 2014.

The weighted average outstanding shares for 2015 for the fully diluted earnings per share calculation on a non-GAAP basis was 867 million. Excluding the impact of the December 2015 equity offerings to finance the Actavis Generics acquisition, the weighted average outstanding shares for the fully diluted earnings per share calculation on a non-GAAP basis was 860 million. The weighted average outstanding shares for the fully diluted earnings per share calculation on a GAAP basis was 864 million.

Non-GAAP diluted EPS, excluding the impact of the December 2015 equity offerings, was $5.46, up 6% compared to non-GAAP diluted EPS of $5.14 in 2014. Non-GAAP diluted EPS was $5.42 in 2015. GAAP diluted EPS was $1.82 in 2015, compared to $3.56 in 2014.

Cash flow from operations generated during 2015 amounted to $5.5 billion, compared to $5.1 billion in 2014, up 8%. Free cash flow, excluding net capital expenditures, amounted to $4.9 billion compared to $4.3 billion in 2014, an increase of 15%.

Cash and investments at December 31, 2015 increased to $8.4 billion, compared to $2.0 billion at September 30, 2015 and $2.6 billion at December 31, 2014, mainly due to proceeds from the December 2015 equity offerings to finance the Actavis Generics acquisition.

Shareholders’ equity was $29.9 billion at December 31, 2015, compared to $22.9 billion at September 30, 2015 and $23.4 billion at December 31, 2014

At December 31, 2015, the fully diluted share count for calculating Teva’s market capitalization was approximately 991 million.

Non-GAAP information: Net non-GAAP adjustments in 2015 amounted to $3.1 billion. Non-GAAP net income and non-GAAP EPS for the year were adjusted to exclude the following items:

Amortization of purchased intangible assets totaling $838 million, of which $808 million is included in cost of goods sold and the remaining $30 million in selling and marketing expenses;
Financial expenses of $777 million, mainly reflecting the decline in the price of our Mylan shares during the third quarter of 2015;
Legal settlements and loss contingencies of $631 million, mainly related to the modafinil settlement;
Contingent consideration of $399 million, mainly related to the positive trial results of TEV-48125 in both chronic and episodic migraine prevention and to the FDA approval of Bendeka;
Impairment of long-lived assets of $361 million;
Acquisition expenses of $211 million;
Restructuring expenses of $183 million;
Equity compensation of $112 million;
Costs related to regulatory actions taken in facilities of $36 million;
Purchase of in process R&D and other items of $51 million;
Related tax benefit of $631 million; and
Net impairment of equity investment and minority interest changes of $140 million, mainly related to the impairment of our investment in Mesoblast.
Teva believes that excluding such items facilitates investors’ understanding of its business. See the attached tables for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures.

Fourth Quarter 2015 Results

Revenues in the fourth quarter of 2015 amounted to $4.9 billion, down 6% compared to the fourth quarter of 2014. Excluding the impact of foreign exchange fluctuations, revenues declined 1%.

Exchange rate differences (net of profits from certain hedging transactions) between the fourth quarter of 2015 and the fourth quarter of 2014 decreased our revenues by $259 million, our non-GAAP operating income by $44 million and our GAAP operating income by $33 million.

Non-GAAP gross profit was $3.1 billion in the fourth quarter of 2015, down 4% from the fourth quarter of 2014. Non-GAAP gross profit margin was 62.6% in the fourth quarter of 2015, compared to 61.3% in the fourth quarter of 2014. GAAP gross profit was $2.8 billion in the fourth quarter of 2015, down 1% compared to the fourth quarter of 2014. GAAP gross profit margin was 58.3% in the quarter, compared to 55.9% in the fourth quarter of 2014.

Research and Development (R&D) expenditures (excluding equity compensation expenses, purchase of in-process R&D and certain other items) in the fourth quarter of 2015 amounted to $395 million, an increase of 14% compared to $347 million in the fourth quarter of 2014. R&D expenses were 8.1% of revenues in the quarter, compared to 6.7% in the fourth quarter of 2014. R&D expenses related to our generic medicines segment amounted to $136 million, compared to $131 million in the fourth quarter of 2014. In local currency terms, expenses increased 6% as a result of additional development activities of complex products for the U.S. market. R&D expenses related to our specialty medicines segment amounted to $263 million, compared to $214 million in the fourth quarter of 2014. In local currency terms, expenses increased 24%, mainly as a result of investments in the assets acquired via the Labrys and Auspex deals and due to a milestone payment which was received in the comparable quarter of 2014.

Selling and Marketing (S&M) expenditures (excluding amortization of purchased intangible assets, equity compensation expenses and certain other items) amounted to $898 million, or 18.4% of revenues, in the fourth quarter of 2015, compared to $990 million, or 19.2% of revenues, in the fourth quarter of 2014. S&M expenses related to our generic medicines segment amounted to $300 million, a decrease of 22% compared to $383 million in the fourth quarter of 2014. In local currency terms, S&M expenses decreased 12% mainly due to lower royalties related to our sales of budesonide (Pulmicort) in the United States. S&M expenses related to our specialty medicines segment amounted to $561 million, an increase of 4% compared to $542 million in the fourth quarter of 2014. In local currency terms, S&M expenses increased 7%. The higher expenses related to our specialty medicines were mainly due to launch preparation and support for several new products.

General and Administrative (G&A) expenditures (excluding equity compensation expenses) amounted to $280 million in the fourth quarter of 2015, or 5.7% of revenues, compared to $310 million and 6.0% in the fourth quarter of 2014. In local currency terms, G&A expenses decreased 3%.

Quarterly non-GAAP operating income was $1.5 billion, down 3% compared to the fourth quarter of 2014. Quarterly GAAP operating income was $0.9 billion in the fourth quarter of 2015, a decrease of 1% compared to the fourth quarter of 2014.

We calculate EBITDA as non-GAAP operating income (which excludes amortization and certain other items) plus depreciation expenses for the period. In the fourth quarter of 2015, depreciation amounted to $116 million, compared to $112 million in the fourth quarter of 2014. EBITDA for the fourth quarter of 2015 amounted to $1.6 billion, down 2% compared to the fourth quarter of 2014.

Non-GAAP financial expenses amounted to $68 million in the fourth quarter of 2015, compared to $69 million in the fourth quarter of 2014. GAAP financial expenses for the fourth quarter of 2015 amounted to $70 million, as in the fourth quarter of 2014.

Non-GAAP income taxes for the fourth quarter of 2015 amounted to $289 million on pre-tax non-GAAP income of $1.4 billion, for a quarterly tax rate of 21%. Non-GAAP income taxes in the fourth quarter of 2014 were $308 million on pre-tax non-GAAP income of $1.5 billion, for a quarterly tax rate of 21%. GAAP income taxes for the fourth quarter of 2015 amounted to $249 million, or 29%, on pre-tax income of $861 million. In the fourth quarter of 2014, income taxes amounted to $186 million, or 21%, on pre-tax income of $0.9 billion.

Non-GAAP net income attributable to Teva was $1.1 billion, down 1% compared to the fourth quarter of 2014. GAAP net income attributable to Teva was $500 million in the fourth quarter of 2015, compared to $687 million in the fourth quarter of 2014.

For the fourth quarter of 2015, the weighted average outstanding shares for the fully diluted earnings per share calculation on a non-GAAP basis was 888 million. Excluding the impact of the December 2015 equity offerings to finance the Actavis Generics acquisition, the weighted average outstanding shares for the fully diluted earnings per share calculation on a non-GAAP basis was 861 million. The weighted average outstanding shares for the fully diluted earnings per share calculation on a GAAP basis was 875 million.

Excluding the impact of the December 2015 equity offerings, non-GAAP diluted EPS was $1.32, compared to $1.33 in the fourth quarter of 2014. Quarterly Non-GAAP diluted EPS was $1.28. GAAP diluted EPS was $0.55 in the fourth quarter of 2015, compared to $0.80 in the fourth quarter of 2014.

Cash flow from operations generated during the fourth quarter of 2015 amounted to $1.6 billion, compared to $1.8 billion in the fourth quarter of 2014, a decrease of 8%. The decrease was mainly due to lower GAAP net income. Free cash flow, excluding net capital expenditures, amounted to $1.4 billion compared to $1.5 billion in the fourth quarter of 2014, a decrease of 8%.

Non-GAAP information: Net non-GAAP adjustments in the fourth quarter of 2015 amounted to $636 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:

Amortization of purchased intangible assets totaling $201 million, of which $194 million is included in cost of goods sold and the remaining $7 million in selling and marketing expenses;
Legal settlements and loss contingencies of $100 million;
Contingent consideration of $70 million;
Restructuring expenses of $62 million;
Equity compensation of $30 million;
Impairment of long-lived assets of $28 million;
Acquisition expenses of $17 million;
Costs associated with cancellation of R&D projects and other items of $44 million;
Related tax benefit of $40 million; and
Net impairment of equity investment of $124 million, mainly related to the impairment of our investment in Mesoblast.
Teva believes that excluding such items facilitates investors’ understanding of its business. See the attached tables for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures.

Segment Results for the Fourth Quarter 2015

Generic Medicines Segment

Beginning in 2015, expenses related to equity compensation are excluded from our segment results. The data presented have been conformed to reflect the exclusion of equity compensation expenses for all periods.

Generic Medicines Revenues

Generic medicines revenues in the fourth quarter of 2015 amounted to $2.3 billion, a decrease of 9% compared to the fourth quarter of 2014. In local currency terms, revenues decreased 3%.

Generic revenues consisted of:

U.S. revenues of $1.0 billion, a decrease of 15% compared to the fourth quarter of 2014. The decrease resulted mainly from a decline in sales of omega-3-acid ethyl esters (Lovaza), budesonide (Pulmicort) and capecitabine (Xeloda).
European revenues of $700 million, a decrease of 8%, but an increase of 2% in local currency terms, compared to the fourth quarter of 2014. The increase in local currency terms resulted mainly from our strategy of pursuing profitable and sustainable business in the region, with increases in France, Switzerland and Germany partially offset by decreases in Spain, the U.K. and Italy. This strategy continues to lead to notable improvements in the profitability of our European generics business.
ROW revenues of $561 million, an increase of 5%, or 18% in local currency terms, compared to the fourth quarter of 2014. The increase in local currency terms was mainly due to higher revenues in Russia and Latin America, which were partially offset by lower revenues in Canada and Japan.
API sales to third parties of $202 million (which are included in the revenues by market above), an increase of 13%, compared to the fourth quarter of 2014. The increase is due to higher sales across all regions.
Generic medicines revenues comprised 46% of our total revenues in the quarter, compared to 48% in the fourth quarter of 2014.

Generic Medicines Gross Profit

Gross profit from our generic medicines segment in the fourth quarter of 2015 amounted to $1.0 billion, a decrease of 7% compared to the fourth quarter of 2014. The lower gross profit was mainly a result of lower sales of budesonide (Pulmicort) in the United States. In addition, exchange rate movements in our ROW and European markets had a negative impact on our gross profit. This decrease was partially offset by higher gross profit of our API business.

Gross profit margin for our generic medicines segment in the fourth quarter of 2015 increased to 44.8%, from 43.9% in the fourth quarter of 2014.

Generic Medicines Profit

Our generic medicines segment generated profit of $576 million in the fourth quarter of 2015, an increase of 1% compared to the fourth quarter of 2014. Generic medicines profitability as a percentage of generic medicines revenues was 25.5% in the fourth quarter of 2015, up from 23.0% in the fourth quarter of 2014. The increase was primarily due to the reduction in S&M expenses, partially offset by lower gross profit.

Specialty Medicines Segment

Beginning in 2015, expenses related to equity compensation are excluded from our segment results. The data presented have been conformed to reflect the exclusion of equity compensation expenses for all periods.

Specialty Medicines Revenues

Specialty medicines revenues in the fourth quarter of 2015 amounted to $2.1 billion, down 6% compared to the fourth quarter of 2014. In local currency terms, revenues decreased 3%. U.S. specialty medicines revenues amounted to $1.6 billion, up 1% compared to the fourth quarter of 2014. European specialty medicines revenues amounted to $366 million, a decrease of 18%, or 8% in local currency terms, compared to the fourth quarter of 2014. ROW specialty revenues amounted to $108 million, down 35%, or 21% in local currency terms, compared to the fourth quarter of 2014.

Specialty medicines revenues comprised 44% of our total revenues in the quarter, similar to the fourth quarter of 2014.

The decrease in specialty medicines revenues compared to the fourth quarter of 2014 was primarily due to lower sales of Copaxone and Azilect, which were partially offset by higher revenues of our respiratory products.

Global sales of Copaxone (20 mg/mL and 40 mg/mL), the leading multiple sclerosis therapy in the U.S. and globally, amounted to $1.0 billion, a decrease of 14% compared to the fourth quarter of 2014.

In the United States, sales of Copaxone amounted to $760 million, a decrease of 9% compared to the fourth quarter of 2014. The decrease was mainly due to lower sales volume partially offset by favorable pricing fluctuations. At the end of the fourth quarter of 2015, according to December 2015 IMS data, our U.S. market shares for the Copaxone products in terms of new and total prescriptions were 26.5% and 30.0%, respectively. Copaxone 40 mg/mL accounted for 78% of total Copaxone prescriptions in the U.S.

Sales of Copaxone outside the United States amounted to $200 million, a decrease of 30%, or 18% in local currency terms, compared to the fourth quarter of 2014. The decrease in local currency terms was due to smaller tender volumes in Russia as well as lower volumes sold in Europe due to increased competition.

Our global Azilect revenues amounted to $80 million, a decrease of 26% compared to the fourth quarter of 2014. In local currency terms, sales decreased 25%. Global in-market sales amounted to $129 million, down 9% due to generic competition in Europe, as well as in preparation for the return of marketing rights to Teva from Lundbeck.

Sales of our respiratory products amounted to $326 million, up 29% compared to the fourth quarter of 2014. ProAir revenues in the quarter amounted to $148 million, up 23% compared to the fourth quarter of 2014, due to volume growth and positive price effects. QVAR global revenues amounted to $119 million in the fourth quarter of 2015, up 55% compared to the fourth quarter of 2014, due to volume growth and positive price effects.

Sales of our oncology products amounted to $318 million in the fourth quarter of 2015, down 5% from the fourth quarter of 2014. Sales of Treanda amounted to $198 million, a decrease of 12% compared to the fourth quarter of 2014, which was partially offset by higher sales of our G-CSF products.

Specialty Medicines Gross Profit

Gross profit from our specialty medicines segment amounted to $1.9 billion, a decrease of $101 million compared to the fourth quarter of 2014. Gross profit margin for our specialty medicines segment in the fourth quarter of 2015 was 87.7%, compared to 87.2% in the fourth quarter of 2014.

Specialty Medicines Profit

Our specialty medicines segment profit amounted to $1.0 billion in the fourth quarter of 2015, down 14% compared to the fourth quarter of 2014, due to lower gross profit, higher R&D expenses and higher S&M expenses.

Specialty medicines profit as a percentage of segment revenues was 48.8% in the fourth quarter of 2015, down from 53.5% in the fourth quarter of 2014.

Beginning in 2015, expenses related to our equity compensation are excluded from our franchise results. The data presented have been conformed to reflect the exclusion of equity compensation expenses for all periods.

Other Activities

Our OTC revenues related to PGT amounted to $316 million, an increase of 39% compared to $228 million in the fourth quarter of 2014. In local currency terms, revenues increased 54%. The increase in local currency terms was mainly due to higher sales in Latin America. PGT’s in-market sales amounted to $450 million in the fourth quarter of 2015, an increase of 21%, or 40% in local currency terms, compared to the fourth quarter of 2014.

Other revenues amounted to $194 million in the fourth quarter of 2015, mostly from the distribution of third-party products in Israel and Hungary, compared to revenues of $228 million, in the fourth quarter of 2014.

Financial Outlook

Pending the closing of the Actavis Generics acquisition, we are providing revenue and non-GAAP EPS guidance for the first quarter 2016. Full year 2016 guidance will be provided shortly after the Actavis Generics closing.

We continue to work toward satisfying all conditions in order to complete the acquisition by the end of the first quarter of 2016; however, it is possible that closing may be slightly delayed.

We expect revenues for the first quarter of 2016 to be $4.7-$4.9 billion.
Non-GAAP EPS is expected to be $1.16-1.20. Excluding the impact of the December 2015 equity offerings, non-GAAP EPS is expected to be $1.32-$1.36.
Cash flow from operating activities for the first quarter of 2016 is expected to be $1.2-$1.3 billion.
These estimates reflect management`s current expectations for Teva’s performance in 2016. Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors. In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects. The non-GAAP data presented by Teva are the results used by Teva’s management and board of directors to evaluate the operational performance of the company, to compare against the company’s work plans and budgets, and ultimately to evaluate the performance of management. Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP results, because management believes such data provides useful information to investors.

Dividend

On February 8, 2016, the Board of Directors declared a cash dividend of $0.34 for the fourth quarter of 2015. For holders of our ordinary shares that are traded on the Tel Aviv Stock Exchange, the dividend will be converted into new Israeli shekels based on the official exchange rate as of February 11, 2016.

The record date will be February 29, 2016, and the payment date will be March 14, 2016. Tax will be withheld at a rate of 15%.

On February 11, 2016 Incyte Corporation (Nasdaq: INCY) reported 2015 fourth-quarter and year-end financial results, highlighting strong revenue growth driven by increased Jakafi (ruxolitinib) sales in the U.S. as well as growing ex-U.S. Jakavi (ruxolitinib) royalties from Novartis. Additionally, Incyte provided financial guidance for 2016 (Press release, Incyte, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137496 [SID:1234509039]).

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Incyte’s strong position in the field of JAK inhibition is demonstrated by the ongoing commercial success of Jakafi and by the recent submissions, by Eli Lilly and Company, seeking regulatory approval of baricitinib for the treatment of rheumatoid arthritis. Baricitinib was licensed to Lilly by Incyte, and met the primary endpoint in all four of its global Phase 3 studies. If approved, Lilly expects to launch baricitinib in early 2017. In addition, epacadostat, Incyte’s first-in-class IDO1 inhibitor, is expected to enter Phase 3 during the first half of 2016 in first-line advanced or metastatic melanoma in combination with Merck & Co’s pembrolizumab. Multiple Phase 2, tumor-specific, expansion cohorts of epacadostat in combination with anti-PD-1 and anti-PD-L1 checkpoint modulators are also underway.

"The momentum of Jakafi, now into its fifth year of commercialization, continues to be strong, and, pending regulatory approval, we look forward to a second important source of revenue from baricitinib," stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. "Despite the outcome of the JANUS program, our development portfolio remains robust, comprised of 13 candidates against 10 molecular targets, demonstrating Incyte’s commitment to innovation and the productivity of our drug discovery and development engine."

2015 Fourth-Quarter and Full-Year Financial Results

Revenues For the quarter ended December 31, 2015, net product revenues of Jakafi were $182 million as compared to $106 million for the same period in 2014, representing 72 percent growth. For the full year ended December 31, 2015, net product revenues of Jakafi were $601 million as compared to $358 million for the same period in 2014, representing 68 percent growth. For the quarter and full year ended December 31, 2015, product royalties from sales of Jakavi outside of the United States received from Novartis were $24 million and $75 million, respectively, as compared to $15 million and $49 million, respectively, for the same periods in 2014. For the quarter ended December 31, 2015, contract revenues were $38 million as compared to $3 million for the same period in 2014. The $35 million increase in contract revenues for the quarter ended December 31, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the full year ended December 31, 2015, contract revenues were $78 million as compared to $105 million for the same period in 2014. The $27 million decrease in contract revenues for the full year ended December 31, 2015 compared to the same period in 2014 relates to a decrease in milestone payments earned from Novartis. For the quarter ended December 31, 2015, total revenues were $244 million as compared to $124 million for the same period in 2014. For the full year ended December 31, 2015, total revenues were $754 million as compared to $511 million for the same period in 2014.

Year Over Year Revenue Growth

Research and development expenses Research and development expenses for the quarter and full year ended December 31, 2015 were $117 million and $480 million, respectively, as compared to $99 million and $348 million, respectively, for the same periods in 2014. Included in research and development expenses for the quarter and full year ended December 31, 2015 were non-cash expenses related to equity awards to our employees of $10 million and $40 million, respectively. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio, including costs related to external alliances. Also included in research and development expenses for the full year ended December 31, 2015 was the one-time upfront payment to Agenus related to our license, development and commercialization agreement and the one-time upfront payment to Jiangsu Hengrui Medicine Co., Ltd. (Hengrui) related to our global license and collaboration agreement.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and full year ended December 31, 2015 were $52 million and $197 million, respectively, as compared to $48 million and $166 million, respectively, for the same periods in 2014. Included in selling, general and administrative expenses for the quarter and full year ended December 31, 2015 were non-cash expenses related to equity awards to our employees of $8 million and $30 million, respectively. Increased selling, general and administrative expenses are driven primarily by additional costs related to the commercialization of Jakafi.
Unrealized loss on long term investment Unrealized loss on long term investment of $0 million and $5 million, respectively, for the quarter and full year ended December 31, 2015 represents the fair market value adjustments of the Company’s investment in Agenus.

Net income / (loss) Net income for the quarter ended December 31, 2015 was $55 million, or $0.30 per basic and $0.29 per diluted share, as compared to net loss of $37 million, or $0.22 per basic and diluted share, respectively, for the same period in 2014. Net income for the full year ended December 31, 2015 was $7 million, or $0.04 per basic and $0.03 per diluted share as compared to a net loss of $48 million, or $0.29 per basic and diluted share, for the same period in 2014.

Cash, cash equivalents and marketable securities position As of December 31, 2015, cash, cash equivalents and marketable securities totaled $708 million, as compared to $600 million as of December 31, 2014.

2016 Financial Guidance

Portfolio Update

JAK Inhibitors
A New Drug Application (NDA) and a Marketing Authorization Application (MAA) have been submitted by Lilly to the U.S. Food and Drug Administration and the European Medicines Agency, respectively, for baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Lilly. These submissions triggered $35 million (NDA, as previously disclosed) and $20 million (MAA) in milestone payment obligations from Lilly to Incyte. Incyte expects to recognize both in full in the first quarter of 2016. Incyte expects to earn global regulatory milestones and will also be eligible for royalties on global net sales of baricitinib.
As previously announced, the clinical development program investigating the hypothesis that JAK inhibition may benefit patients with solid tumors and high levels of systemic inflammation has been discontinued. All commercial activities with Jakafi, and all investigational activities of JAK inhibition outside this hypothesis, are unaffected.
Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of combination studies evaluating INCB39110, a selective JAK1 inhibitor, with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) that will assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential for JAK1 inhibition to improve the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.
INCB39110 is also in a proof-of-concept trial for the treatment of patients with graft versus host disease.
Incyte’s second selective JAK1 inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.

IDO1 Inhibitor
The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.
The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016.
During 2016, Incyte expects to have recruited over 600 patients into Phase 2 expansion cohorts investigating the safety and efficacy of epacadostat in combination with anti-PD-1 and anti-PD-L1 agents.

Additional Programs
With two of our new programs expected to enter the clinic in the coming months, Incyte will have a total of 13 development molecules in pivotal and proof-of-concept trials across a variety of oncology and non-oncology indications. Below is a portfolio summary, in addition to Incyte’s JAK inhibitor franchise and its IDO1 inhibitor epacadostat.

About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor 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.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.

On February 11, 2016 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported its financial results for the quarter and year ended December 31, 2015 (Press release, Neurocrine Biosciences, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137766 [SID:1234509048]).

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For the fourth quarter of 2015, the Company reported a net loss of $29.3 million, or $0.34 loss per share, compared to a net loss of $19.4 million, or $0.26 loss per share for the same period in 2014. For the year ended December 31, 2015, the Company reported a net loss of $88.9 million, or $1.05 loss per share, as compared to a net loss of $60.5 million, or $0.81 loss per share for 2014. The increase in net loss for the fourth quarter and full year results primarily from increased research and development expenses in connection with the Company’s advancing clinical stage pipeline, valbenazine pre-commercialization activities for tardive dyskinesia and higher share-based compensation expense as detailed below.

The Company’s balance sheet at December 31, 2015 reflected total assets of $474.8 million, including cash, investments and receivables of $464.3 million compared with balances at December 31, 2014 of $243.0 million and $232.6 million, respectively.

"We begin 2016 with positive top-line data from our partner AbbVie in the second Phase III study of elagolix in endometriosis coupled with the start of two Phase III studies of elagolix in uterine fibroids," said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. "Recently we reported a highly positive Phase III study of valbenazine in tardive dyskinesia and now look forward to filing our valbenazine NDA for tardive dyskinesia with the FDA this year. We have also initiated two Phase II studies of valbenazine in Tourette syndrome with data on these expected around the end of the year. Additionally, we have NBI-640756, our drug candidate for essential tremor, in the clinic and we look to add yet another new compound to our clinical pipeline later this year."

Research and development expenses were $21.8 million during the fourth quarter of 2015, compared to $15.5 million for the same period in 2014. For the year ended December 31, 2015, research and development expenses were $81.5 million, compared to $46.4 million for all of 2014. The increase in research and development expense was due to higher external clinical development expenses and associated internal costs related to NBI-98854, which initiated Phase III development in the second half of 2014, as well as preparations for a potential New Drug Application filing in 2016. Additionally, year-to-date share-based compensation expense increased by $7.9 million from 2014 levels primarily due to performance-based restricted stock units.

General and administrative expenses increased from $5.0 million for the fourth quarter of 2014 to $8.9 million for the fourth quarter of 2015. For the year ended December 31, 2015 general and administrative expenses were $32.5 million, compared to $18.0 million for the prior year. The increase in general and administrative expense is primarily due to higher personnel related costs, including a $10.1 million increase in year-to-date share-based compensation expense primarily due to performance-based restricted stock units. Additionally, professional costs related to market research and pre-commercialization activities contributed to the overall increase in general and administrative expenses.

2016 Financial Guidance

The Company expects to have a cash burn of approximately $135 million to $145 million in 2016. The increase in cash burn from 2015 is primarily due to preparing for commercialization of valbenazine in tardive dyskinesia coupled with expansion and progression of the clinical pipeline. Revenues for 2016 are expected to be approximately $15 million. Expenses for 2016 should approximate $185 million to $195 million. The anticipated expenses include an estimated $30 million for share-based compensation expense.

Pipeline Highlights

Valbenazine Update

During the fourth quarter of 2015, the Company announced positive top-line results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder. The Kinect 3 study randomized 234 subjects to either placebo, once-daily 40mg of NBI-98854 (valbenazine), or once-daily 80mg of valbenazine for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. The AIMS ratings at Week 6 for the 80mg once-daily valbenazine intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (p<0.0001). During the six-week placebo-controlled treatment period valbenazine was generally well tolerated. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies.

In addition to the ongoing safety assessment of Kinect 3, the Company is also conducting a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia. As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.

The Company is also exploring valbenazine in Tourette syndrome. The initial Tourette’s clinical trial, the T-Force study, was an open-label, multi-dose, two-week evaluation of 28 subjects with Tourette syndrome. Children and adolescents enrolled in the trial are receiving a once-daily dose of valbenazine during a two-week treatment period to assess both the safety and tolerability of valbenazine. Valbenazine was generally safe and well tolerated. The Yale Global Tic Severity Scale was also assessed and after two weeks of treatment showed a mean reduction of 31% from baseline scores, with over half of the subjects considered clinical responders.

The Company recently announced the initiation of two Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 adults. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in adult Tourette patients. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 children and adolescents. Subjects will receive once-daily dosing of valbenazine during a six-week treatment period to assess the safety, tolerability and efficacy of valbenazine in pediatric Tourette patients. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week six.

Data from both of these Tourette studies is expected around year-end 2016.

Elagolix Update

AbbVie recently announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 New Drug Application filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing.

In September 2015, AbbVie announced positive top-line results from a Phase IIb clinical trial in women with heavy menstrual bleeding associated with uterine fibroids. The trial evaluated the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo. Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo (p<0.001). Among the most common adverse AEs were hot flush, headache, nausea, and vomiting. Some AEs such as hot flush were more frequent in the elagolix only treatment arms as compared to the placebo and elagolix with add-back therapy treatment arms. Bone mineral density loss associated with elagolix alone was attenuated when elagolix was co-administered with add-back therapy.

Essential Tremor Program (NBI-640756) Update

NBI-640756 for patients with essential tremor was discovered in the Neurocrine laboratories. The Company has initiated a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. The study is being conducted in multiple sequential cohorts of eight subjects per cohort. Top-line data from this Phase I study is expected in the first-half of 2016.

On Febrauary 11, 2016 Incyte Corporation (Nasdaq: INCY) reported its decision to discontinue the Phase 3 study (JANUS 1) of ruxolitinib or placebo in combination with capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer (Press release, Incyte, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137479 [SID:1234509040]).

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The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

Following these results, and the previously announced interim analysis of the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafinib in patients with metastatic colorectal cancer and high C-reactive protein (CRP), ongoing Incyte-sponsored trials of ruxolitinib in solid tumors will be discontinued, including the Phase 3 JANUS 2 study in pancreatic cancer, the Phase 2 sub-study in patients with metastatic colorectal cancer and low CRP and the Phase 2 studies in breast and lung cancer. Incyte’s dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer, will also be discontinued. Incyte will work with investigators to appropriately conclude these studies in a manner consistent with the best interest of each patient. Data from these studies will be analyzed and shared with the scientific community over the coming months.

Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of studies evaluating INCB39110 in combination with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) to assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential impact of JAK1 inhibition on improving the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.

"The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted. Unfortunately, the larger studies did not confirm this hypothesis," said Rich Levy, M.D., Chief Drug Development Officer of Incyte. "Moving forward, we remain focused on our strategy to invest in innovation and in our broad development portfolio, as we seek to deliver new medicines to patients with cancer and other diseases."

About JANUS 1
JANUS 1 (INCB 18424-362) was a randomized, double-blind, Phase 3 study of ruxolitinib or placebo in combination with capecitabine in patients with advanced or metastatic pancreatic cancer who had failed or were intolerant of first-line chemotherapy.

The primary objective of the study was to evaluate and compare the overall survival of patients treated with ruxolitinib in combination with capecitabine versus capecitabine alone. Secondary objectives evaluated and compared the efficacy of the two treatment groups with respect to progression-free survival, overall tumor response and duration of response, as well as safety and tolerability.

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor 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.

Ruxolitinib is not approved anywhere in the world as treatment for metastatic pancreatic cancer.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.