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Jazz Pharmaceuticals and Pfenex Enter into a Worldwide License and Option Agreement Related to Product Candidates in Early Development for Hematological Malignancies

On July 28, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Pfenex Inc. (NYSE MKT: PFNX) reported an agreement under which Pfenex granted Jazz Pharmaceuticals worldwide rights to develop and commercialize multiple early stage hematology product candidates (Press release, Jazz Pharmaceuticals, JUL 28, 2016, View Source [SID:1234514100]). The agreement also includes an option for Jazz Pharmaceuticals to negotiate a license for a recombinant pegaspargase product candidate with Pfenex. This early development stage collaboration demonstrates Jazz Pharmaceuticals’ focus on identifying innovative technologies that may lead to the development of important therapeutic options for patients with hematological malignancies.

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Under the agreement, Pfenex will receive upfront and option payments totaling $15 million and may be eligible to receive additional payments of up to $166 million based on the achievement of certain development-, regulatory-, and sales-related milestones, including up to $41 million for certain non-sales-related milestones. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration. Both parties will be contributing to development efforts.

"The collaboration with Pfenex, including access to its unique protein expression technology, demonstrates our emphasis on diversifying and strengthening our portfolio to provide improved therapeutic options for patients." said Karen Smith M.D., Ph.D, global head of research and development and chief medical officer at Jazz Pharmaceuticals plc. "We look forward to working with Pfenex on the development of multiple product candidates that have the potential to broaden our hematology/oncology portfolio."

"Our collaboration with Jazz further validates Pfenex’s product development capability enabled by our protein expression platform technology. We look forward to working with Jazz on these assets in support of further advancement in clinical development," said Bertrand C. Liang, chief executive officer of Pfenex.

Pfizer and Western Oncolytics Announce Immuno-Oncology Research Collaboration to Investigate Novel Oncolytic Virus Technology

On July 28, 2016 Pfizer Inc. (NYSE:PFE) and Western Oncolytics reported that they have entered into a development collaboration, license and option agreement to advance Western Oncolytics’ novel oncolytic vaccinia virus, WO-12 (Press release, Pfizer, JUL 28, 2016, View Source [SID:1234514099]).

Oncolytic viruses are viruses engineered to kill cancer cells while sparing healthy cells, which subsequently elicits anti-cancer immune responses. This collaboration in oncolytic virus development adds another novel technology platform to Pfizer’s cancer vaccine efforts and provides an additional tool to bolster its immuno-oncology portfolio.

Under the terms of the agreement, Pfizer and Western Oncolytics will collaborate on preclinical and clinical development of WO-12 through Phase I trials. Following completion of Phase I trials, Pfizer has an exclusive option to acquire WO-12. Financial terms of the agreement were not disclosed.

"Our goal is to combine WO-12 with our portfolio of promising investigational immunotherapies to explore how these novel combinations could help further enhance the body’s immune response in fighting cancer cells," said James Merson, Ph.D., Chief Scientific Officer, Vaccine Immunotherapeutics at Pfizer. "We believe that the real advances in immuno-oncology will come from novel combinations, and cancer fighting viruses and vaccines could play a key role in helping transform cancer treatment and potentially enable us to treat more patients."

WO-12 is a preclinical investigational oncolytic virus. As an in vivo vaccine, it has the potential to be delivered directly to the tumor (intratumoral) or intravenously. More specifically, it is a virus engineered to replicate primarily in cancer cells while delivering several therapeutic genes that modulate the immune system to enhance efficacy against a range of cancers. By replicating inside cancer cells, it is designed to both kill the cancer cell and releases tumor antigens that direct the immune system to recognize the antigens and kill additional cancer cells. WO-12 has potential applications across multiple tumor types.

"We believe this collaboration will create a unique opportunity to accelerate and expand the clinical testing of WO-12 as well as to examine potential combinations with other immunotherapies in the Pfizer portfolio," said Steve Thorne, PhD, Chief Scientific Officer of Western Oncolytics and inventor of WO-12.

Kurt Rote, CEO of Western Oncolytics, added, "We have been very impressed with the expertise and commitment to success from everyone at Pfizer, and are excited to be partnering this promising therapy with a shared vision of improving the way patients are treated."

Adaptimmune Receives Access to Priority Medicines (PRIME) Regulatory Support for its SPEAR® T-cell Therapy Targeting NY-ESO for Treatment of Soft Tissue Sarcoma

On July 28, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that the European Medicines Agency (EMA) has granted access to its newly-established Priority Medicines (PRIME) regulatory initiative for the company’s SPEAR T-cell therapy targeting NY-ESO for the treatment of HLA-A0201, HLA-A0205, or HLA-A0206 allele positive patients with inoperable or metastatic synovial sarcoma who have received prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigen (Press release, Adaptimmune, JUL 28, 2016, View Source [SID:1234514096]).

The PRIME initiative provides support to optimize regulatory applications and accelerate the review of medicines that address a high unmet need.

"Access to the PRIME initiative represents an important regulatory opportunity for us. It can provide early engagement on the development program with potential for accelerated assessment of data to companies like Adaptimmune who are developing new treatment modalities for patients in Europe with few or no treatment options," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "Our NY-ESO SPEAR T-cell therapy may help to address the significant unmet medical need of metastatic or unresectable synovial sarcoma. We look forward to working closely with the EMA throughout its clinical evaluation."

Adaptimmune recently announced that the European Commission had designated its NY-ESO SPEAR T-cell therapy as an orphan medicinal product for the treatment of soft tissue sarcoma. The company has already received orphan drug designation and Breakthrough Therapy designation for its NY-ESO SPEAR T-cell therapy from the U.S. Food and Drug Administration.

The PRIME initiative focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. The criteria for the PRIME initiative require a medicine to show its potential to benefit patients with unmet medical needs based on early clinical data. The initiative offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications, and provides appointment of a rapporteur, early dialogue on the overall development plan and regulatory strategy, scientific advice at key development milestones, a dedicated point of contact, and the potential to qualify products for accelerated assessment at the time of an application for marketing authorization.

Adaptimmune’s SPEAR T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers.

AbbVie Announces Initiation of Phase 3 Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma

On July 28, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported the initiation of a Phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and have received one to three prior lines of therapy (Press release, AbbVie, JUL 28, 2016, View Source [SID:1234514095]). The combination of venetoclax, bortezomib and dexamethasone will be compared to treatment with bortezomib, dexamethasone and placebo.1 Bortezomib, a proteasome inhibitor, and dexamethasone, a corticosteroid, are both common therapies used to treat symptomatic multiple myeloma.3

Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S.

"We have a comprehensive development strategy for venetoclax, with several ongoing clinical trials across a range of hematologic malignancies and multiple lines of therapy as a single agent and in combination with other medicines," said Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie. "This Phase 3 trial represents our commitment to identifying the full potential of this therapy through our clinical development program and is an important step in our goal to provide a possible treatment for multiple myeloma patients."

The randomized, double-blind, placebo-controlled, Phase 3 clinical trial aims to recruit approximately 240 patients. The primary efficacy endpoint of the trial is progression-free survival (PFS). Secondary pre-specified outcome measures include overall survival (OS), objective response rate (ORR) and duration of response (DoR), as well as other efficacy and safety outcome measures.1 More information on the Phase 3 trial is available at www.clinicaltrials.gov (NCT02755597).

Multiple myeloma is the second most common blood cancer and begins in plasma cells in the bone marrow. When plasma cells in the marrow become cancerous, they can grow uncontrollably and produce abnormal proteins (m proteins) which can cause tumors, typically developing in the bone. When a patient has multiple plasma cell tumors, they have multiple myeloma.2

About VENCLEXTA (venetoclax) in the U.S.
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor currently approved as VENCLEXTA (venetoclax) tablets in the U.S. and indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.4 The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.4

The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells. VENCLEXTA was designed to selectively inhibit the BCL-2 protein.4

VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group. Together, the companies are committed to BCL-2 research with VENCLEXTA, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with early phase studies in several cancers. VENCLEXTA is under evaluation by Health Authorities in multiple countries, and not approved for markets outside of the U.S. AbbVie is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.

The full prescribing information for VENCLEXTA can be found here.

Patient Assistance Program
For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking VENCLEXTA in the U.S.

U.S. Important Safety Information
What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other, causing serious side effects
Do not start new medicines during treatment with VENCLEXTA without first talking with your doctor
What should I tell my doctor before taking VENCLEXTA?
Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you:

Have kidney or liver problems
Have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium
Have a history of high uric acid levels in your blood or gout
Are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA until your doctor tells you it is okay
Are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA
Are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

Low white blood cell count (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your doctor will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your doctor right away if you have a fever or any signs of an infection
The most common side effects of VENCLEXTA include diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Please see full Prescribing Information, including Medication Guide.

Celgene Reports Second Quarter 2016 Operating and Financial Results

On July 28, 2016 Celgene Corporation (NASDAQ:CELG) reported net product sales of $2,745 million for the second quarter of 2016, a 22 percent increase from the same period in 2015 (Press release, Celgene, JUL 28, 2016, View Source [SID:1234514089]).

Net product sales growth includes a 1 percent negative impact from currency exchange effects. Second quarter total revenue increased 21 percent to $2,754 million compared to $2,278 million in the second quarter of 2015.

Net income for the second quarter of 2016 based on U.S. GAAP (Generally Accepted Accounting Principles), was $598 million or $0.75 per diluted share compared to $356 million or $0.43 per diluted share in the second quarter of 2015. Adjusted net income for the second quarter of 2016 was $1,152 million or $1.44 per diluted share compared to $1,019 million or $1.23 per diluted share for the second quarter of 2015.

“Our first-half 2016 operating results were outstanding and we are pleased with the progress made advancing many key corporate objectives,” said Mark J. Alles, Chief Executive Officer of Celgene Corporation. “This strong momentum increases our confidence in our near- and longer-term outlook as we continue to invest in innovative research and the development of transformational therapies for patients worldwide.”

Second Quarter 2016 Financial Highlights

Unless otherwise stated, all comparisons are for the second quarter of 2016 compared to the second quarter of 2015. The adjusted operating expense categories presented below exclude share-based employee compensation expense, upfront collaboration expense and a litigation-related loss contingency accrual expense. Please see the attached Reconciliation of GAAP to Adjusted Net Income for further information.

Net Product Sales Performance

REVLIMID sales for the second quarter increased 18 percent year-over-year to $1,701 million and were driven by new patient market share gains and increased duration. U.S. sales of $1,080 million and international sales of $621 million increased 24 percent and 9 percent year-over-year, respectively.

POMALYST/IMNOVID sales for the second quarter were $318 million, an increase of 35 percent year-over-year. U.S. sales were $185 million and international sales were $133 million, an increase of 29 percent and 46 percent year-over-year, respectively. POMALYST/IMNOVID sales grew due to increased volume from duration gains.

ABRAXANE sales for the second quarter were $249 million, a 2 percent increase year-over-year. U.S. sales of $175 million increased 3 percent year-over-year. International sales were $74 million.

OTEZLA sales for the second quarter were $242 million, a 170 percent increase year-over-year. U.S. sales were $217 million and international sales were $25 million. Sales were driven by market share gains and increased prescriber adoption.

In the second quarter, all other product sales, which include THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product in the U.S., were $235 million compared to $242 million in the second quarter of 2015.

Research and Development (R&D)

On a GAAP basis, R&D expenses were $949 million for the second quarter of 2016 compared to $1,110 million for the same period in 2015. The change was primarily driven by a decrease in upfront collaboration expenses compared to the previous year, partially offset by early research and clinical trial activity related to the acquisitions of Receptos, Inc. and Quanticel Pharmaceuticals, Inc. that closed in the second half of 2015. Adjusted R&D expenses were $601 million for the second quarter of 2016 compared to $477 million for the second quarter of 2015. Adjusted R&D does not include upfront collaboration expenses but does reflect the increase in early research and clinical trial activity.

Selling, General, and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $732 million for the second quarter of 2016 compared to $617 million for the same period in 2015. The increase was primarily due to a loss contingency accrual expense of $100 million related to a contractual dispute. Adjusted SG&A expenses were $547 million for the second quarter of 2016 compared to $541 million for the second quarter of 2015.

Cash, Cash Equivalents, and Marketable Securities

Operating cash flow was $936 million in the second quarter of 2016. Celgene ended the quarter with approximately $6.4 billion in cash, cash equivalents and marketable securities.

In the second quarter of 2016, Celgene purchased approximately 3.4 million of its shares at a total cost of approximately $343 million. In June 2016, the share repurchase authorization was increased by an additional authorization of $3 billion. As of June 30, 2016, the Company had approximately $5.1 billion remaining under the stock repurchase program.

2016 Guidance Updated

Previous 2016
Guidance
Updated 2016
Guidance
Net Product Sales
Total $10.75B-$11.0B Approximately $11.0B
REVLIMID Approximately $6.7B Approximately $6.8B
GAAP diluted EPS $4.26 to $4.56 $3.82 to $4.05
Adjusted diluted EPS $5.60 to $5.70 $5.70 to $5.75
GAAP operating margin Approximately 42% Approximately 37%
Adjusted operating margin Approximately 53.5% Approximately 54.0%
Weighted average diluted shares 811M 806M
Net product sales guidance for POMALYST/IMNOVID, ABRAXANE and OTEZLA remain unchanged.

Product and Pipeline Updates

Hematology/Oncology

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June, pooled data from a meta-analysis of overall survival (OS) in multiple myeloma patients receiving REVLIMID as maintenance treatment following autologous stem-cell transplant were presented. An application was submitted to the European Medicines Agency (EMA) in early June for the review of REVLIMID as maintenance treatment in newly diagnosed multiple myeloma (NDMM) patients after receiving an autologous stem-cell transplant. A decision on the application is expected in 2017. A submission in the U.S. is expected in the second half of 2016.

In July, the European Commission (EC) approved REVLIMID for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. REVLIMID is approved in the U.S. for the treatment of mantle cell lymphoma after relapse or progression on two prior therapies.

In June, the U.S. product insert for POMALYST was updated to include data from a pooled pharmacokinetics analysis of patients with relapsed and/or refractory multiple myeloma (RRMM) and impaired renal function. In Europe, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for IMNOVID based on the same data. The EC decision is expected in the third quarter.

In July, Celgene disclosed the top-line results of the phase III REMARC trial evaluating REVLIMID as maintenance therapy compared with placebo in patients with diffuse large B-cell lymphoma responding to treatment with rituximab in combination with standard chemotherapy. The full data set will be presented at a future medical congress.

In July, Celgene’s partner Juno Therapeutics provided preliminary data from the ongoing phase I trial with JCAR017 in patients with adult non-Hodgkin lymphoma (NHL). In ten patients evaluable for efficacy, an overall response rate of 80 percent and a complete response rate of 70 percent were seen. In thirteen patients evaluable for safety, the rate of severe neurotoxicity was 15 percent and the rate of cytokine release syndrome was zero percent. An update of the trial data is expected later in the year.

The FUSIONTM program evaluating durvalumab in hematological malignancies continues to advance with six early-stage trials enrolling. The trials are evaluating durvalumab as a single agent or in combination with novel agents in NDMM, RRMM, myelodysplastic syndromes, acute myeloid leukemia, NHL and chronic lymphocytic leukemia.

A phase II trial with CC-486 in combination with pembrolizumab in previously treated locally advanced or metastatic non-small cell lung cancer completed enrollment in the second quarter.

Inflammation & Immunology

Long-term data from the PALACE program evaluating OTEZLA in moderate-to-severe psoriatic arthritis were presented at the European League Against Rheumatism (EULAR) meeting in June. Included was three-year pooled efficacy and safety data from the phase III PALACE program, as well as pooled data on fatigue, HAQ-DI and BASDAI from PALACE 1-3.

The phase II proof-of-concept trial evaluating OTEZLA in atopic dermatitis has completed. Celgene is evaluating the data to determine next steps. The data will be published at a later date.

In May, the phase II TOUCHSTONE trial evaluating ozanimod induction and maintenance in patients with moderate-to-severe ulcerative colitis was published in The New England Journal of Medicine. Histologic data from the phase II TOUCHSTONE trial were presented at the Digestive Disease Week meeting in May. The phase III TRUE NORTH trial evaluating ozanimod in patients with moderate-to-severe ulcerative colitis continues to enroll with data expected in 2018.

The registration-enabling endoscopy trial (CD-001) with GED-0301 in patients with active Crohn’s disease completed enrollment. Top-line data from the 12-week portion of the trial is expected in the second half of 2016.

Business Update

In July, Celgene announced a strategic collaboration with Jounce Therapeutics, Inc. The collaboration includes options on Jounce’s lead product candidate, JTX-2011, targeting ICOS (the Inducible T cell CO-Stimulator), and up to four early-stage programs to be selected from a defined pool of B cell, T regulatory cell and tumor-associated macrophage targets emerging from Jounce’s research platform, and an additional option on a Jounce checkpoint immuno-oncology program.

In May, Celgene and Agios Pharmaceuticals, Inc. entered into a new global strategic collaboration for the discovery, development and commercialization of novel metabolic immuno-oncology therapies based on Agios’ innovative cellular metabolism research platform. In addition, Celgene transferred global development and commercialization rights to the AG-120 program to Agios.

Second Quarter 2016 Conference Call and Webcast Information

Celgene will host a conference call to discuss the second quarter of 2016 operational and financial performance on Thursday, July 28, 2016, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon July 28, 2016, until midnight ET August 4, 2016. To access the replay in the U.S., dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The participant passcode is 43057627.

About REVLIMID

In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Limitations of Use: REVLIMID is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

About ABRAXANE

In the U.S., ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also indicated for the first-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.

About POMALYST

In the U.S., POMALYST (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

About OTEZLA

In the U.S., OTEZLA (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis. OTEZLA is indicated in the U.S. for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.