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AbbVie Outlines Long-Term Strategic and Financial Objectives; Company Positioned for Strong Performance

On October 30, 2015 AbbVie (NYSE:ABBV) reported the company’s long-term strategic and financial objectives, including expectations for growth and other financial metrics over its long-range plan, through 2020 (Press release, AbbVie, OCT 30, 2015, View Source;p=RssLanding&cat=news&id=2104612 [SID:1234507848]).

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"AbbVie is well-positioned to deliver strong top- and bottom-line performance through 2020 and beyond," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We have built a strong foundation, establishing growth platforms in some of the largest and most attractive market segments. And, we have a robust and compelling pipeline which will contribute significantly to our performance over our long-range-plan."

Based on continued strong performance from its existing portfolio of on-market products, including its flagship brands HUMIRA and IMBRUVICA, as well as growth from pipeline products, the company is providing guidance for total company sales of approximately $37 billion in 2020. This reflects roughly 10 percent sales growth, on average, over the five year period. This guidance includes estimated global HUMIRA sales of more than $18 billion in 2020, which the company believes appropriately captures the expected biosimilar dynamics globally. Additionally, the company is projecting its IMBRUVICA revenue will reach approximately $5 billion in 2020, driven by continued growth within the hematologic oncology market.

Since becoming independent, the company’s significant focus on operating efficiencies has resulted in strong improvement of its gross and operating margin profiles. AbbVie is committed to driving continued expansion of operating margin, and is targeting an adjusted operating margin of greater than 50 percent by 2020, with an average of 100-200 basis points of improvement per year. In 2014, AbbVie’s adjusted operating margin was 36.2 percent. Expansion will be driven primarily by ongoing cost savings initiatives, product mix and a reduction in royalty expense associated with HUMIRA in 2017 and 2018. Additionally, the company will drive continued sales leverage from a rapidly growing top-line.

"Our commitment to top-line growth and continued operating margin expansion will drive double-digit earnings-per-share growth on average through 2020," said Richard A. Gonzalez. "AbbVie’s fundamental strategy is strong and we are well-positioned to deliver top-tier financial performance in the years to come."

Company Issues Strong Full-Year 2016 Outlook

AbbVie is issuing diluted earnings-per-share guidance for the full-year 2016 of $4.90 to $5.10 on an adjusted basis. This outlook represents strong double-digit growth versus 2015 and positions AbbVie to be among the industry leaders for growth again next year.

The company will quantify 2016 intangible asset amortization expense and other specified items at a future date.

Company Announces Plans to Host R&D Day

Through internal research and development efforts and strategic licensing and acquisition activities, the company has built a robust pipeline of medicines, with the potential to deliver nearly $30 billion in nominal sales by 2024 (excluding new HUMIRA indications, new IMBRUVICA indications and next-generation HCV, which are considered on-market products for this calculation).

The company is on track to launch more than 20 new products or indications through 2020, including seven approvals that will contribute in 2016 and beyond, including:

IMBRUVICA indication expansion, including first-line chronic lymphocytic leukemia (CLL)
HUMIRA indication expansion, including hidradenitis suppurativa (HS) and uveitis
VIEKIRA approval for genotype 1B patients in Japan
Venetoclax for relapsed/refractory CLL patients with the 17p genetic mutation
Zinbryta for relapsing remitting multiple sclerosis
Elotuzumab for relapsed/refractory multiple myeloma
AbbVie plans to host an R&D Pipeline Review in Chicago during the 2016 ASCO (Free ASCO Whitepaper) meeting. At the event, the company will provide comprehensive detail regarding its research and development programs, including its core programs in immunology, oncology, virology and neurology, in addition to its late stage efforts in women’s health and renal disease, as well as the company’s outlook on the commercial potential of these assets.

Company Declares 12 Percent Dividend Increase

AbbVie also announced today that its board declared an increase in the company’s quarterly cash dividend from $0.51 per share to $0.57 per share beginning with the dividend payable on February 16, 2016 to shareholders of record as of January 15, 2016. This reflects an increase of approximately 12 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since becoming an independent company in 2013, AbbVie has increased its dividend by more than 42 percent.

AbbVie Reports Third-Quarter 2015 Financial Results

On October 30, 2015 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2015 (Press release, AbbVie, OCT 30, 2015, View Source;p=RssLanding&cat=news&id=2104614 [SID:1234507847]).

"We are pleased with our outperformance in the third quarter and our progress year-to-date. We’ve driven strong commercial, operational and R&D execution, resulting in industry-leading top- and bottom-line performance," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are well-positioned to deliver robust EPS growth in 2015 and beyond, and we continue to make significant progress advancing our pipeline and other strategic actions that will help AbbVie achieve top-tier growth over the long term."

Third-Quarter Results

Worldwide sales were $5.944 billion in the third quarter, up 18.4 percent year-over-year. On an operational basis, sales increased 26.2 percent, excluding a 7.8 percent unfavorable impact from foreign exchange rate fluctuations.

Third-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products. Global HUMIRA sales increased 19.6 percent on an operational basis, or 12.1 percent including the impact of foreign exchange rate fluctuations. Strong U.S. HUMIRA growth of 30.4 percent was driven by continued momentum across all three major market categories, rheumatology, dermatology and gastroenterology. International HUMIRA sales in the third quarter grew 7.1 percent on an operational basis, nearly double the rate of growth reported in the second quarter. Reported international HUMIRA sales growth in the quarter was reduced by 16 percent due to unfavorable foreign exchange.

Third-quarter global IMBRUVICA sales were $304 million with U.S. sales of $267 million and international profit sharing of $37 million for the quarter.

Total company sales growth was also driven by $469 million in global VIEKIRA sales, now approved in 61 countries with additional approvals anticipated throughout the remainder of 2015 and into 2016, as well as strong operational growth from Duodopa, Creon and Lupron.

The adjusted gross margin ratio in the third quarter was 83.3 percent, excluding intangible asset amortization and other specified items. Gross margin expansion of 220 basis points was driven by product mix, operating efficiencies and the impact of foreign exchange rates. The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 80.4 percent.
Adjusted selling, general and administrative (SG&A) expense was 23.0 percent of sales in the third quarter. On a GAAP basis, SG&A was 24.8 percent of sales.

Adjusted research and development (R&D) was 15.4 percent of sales in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline assets. On a GAAP basis, R&D was 23.8 percent of sales.

The adjusted operating margin in the third quarter was 44.9 percent, compared to 38.5 percent in third-quarter 2014. On a GAAP basis, the operating margin was 31.7 percent.

Net interest expense was $197 million dollars, reflecting the impact of debt issued in connection with the Pharmacyclics acquisition. The adjusted tax rate was 21.9 percent in the quarter and 24.8 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.13 in the third quarter, up nearly 27 percent. Diluted earnings per share were $0.74 on a GAAP basis.

Announced company’s long-term strategic and financial objectives, including expectations for growth and other financial metrics such as sales targets, operating margin objectives and earnings-per-share growth over our long-range plan. Provided 2016 earnings per share guidance and confirmed intention to host a comprehensive R&D Pipeline Review in Chicago during the 2016 ASCO (Free ASCO Whitepaper) meeting (see separate release issued this morning).

Key Events from the Third Quarter

AbbVie announced that 34 abstracts from its chronic hepatitis C clinical development program have been accepted for presentation at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco from November 13-17, 2015. New clinical studies will be presented on AbbVie’s next-generation HCV medicines, ABT-493 and ABT-530, focused on investigating pan-genotypic, ribavirin (RBV)-free, once-daily treatment options that may allow for shorter treatment durations of as little as eight weeks. Presentations will also highlight new data from Phase 3b studies of AbbVie’s VIEKIRA PAK, taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis.

The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Viekirax as a new interferon and RBV-free treatment option for adult patients with chronic GT1 HCV infection, including those with compensated liver cirrhosis. Viekirax consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily. Japan has one of the highest rates of hepatitis C infection in the industrialized world, with approximately 1.5 to 2 million people living with HCV, making it the second largest HCV market globally.

Results from a Phase 2 clinical trial of ABT-494, AbbVie’s internally developed selective JAK1 inhibitor, in rheumatoid arthritis (RA) met its primary endpoint, achieving ACR20 response at week 12, in patients with inadequate response to either methotrexate or TNF inhibitors (ACR20 responses up to 82 percent and ACR50 responses up to 50 percent; ACR20 up to 73 percent and ACR50 responses up to 44 percent, respectively). With the potential to be a best-in-class therapy with an overall favorable safety profile, AbbVie intends to advance a once-daily formulation of ABT-494 into Phase 3 studies for RA by the end of 2015.
AbbVie reported top-line results from a Phase 2b safety and efficacy study of elagolix in patients with uterine fibroids. Preliminary results from the six-month study demonstrated that all of the elagolix treatment arms met the composite primary endpoint. The company plans to move into Phase 3 development in the first quarter of 2016. Elagolix is also in Phase 3 development for the treatment of endometriosis.

AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on results from the head-to-head Phase 3 RESONATE-2 study, which evaluated efficacy and safety of IMBRUVICA versus traditional chemotherapy, chlorambucil, in treatment-naïve chronic lymphocytic leukemia (CLL) patients aged 65 years or older. The RESONATE study (PCYC-1112) found that treatment with IMBRUVICA improved progression-free survival (primary endpoint) and multiple secondary endpoints, including overall survival and overall response rate when used in treatment-naïve patients with CLL. These data have been submitted for publication in a peer-reviewed medical journal and will be presented at an upcoming medical meeting.

Results from a Phase 2 study of venetoclax (ABT-199) found that AbbVie’s investigational medicine met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion genetic mutation. These data are under regulatory review by the FDA and will be submitted to the European Medicines Agency (EMA) before year-end. Full results from the trial will be presented at an upcoming medical meeting.

AbbVie announced that the FDA and European Commission (EC) approved HUMIRA (adalimumab) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adult patients. HUMIRA is the first and only approved therapy for people with this chronic, painful inflammatory skin disease in both the U.S. and European Union (EU). HS affects approximately 1 percent of the adult patient population worldwide, with fewer than 200,000 patients in the United States.

The FDA accepted a Biologics License Application (BLA) for elotuzumab, an investigational treatment in patients with relapsed/refractory multiple myeloma, for priority review. Elotuzumab was previously granted breakthrough therapy designation by the FDA and validated by the EMA for accelerated assessment in the EU. Regulatory submissions were based on results from the ELOQUENT-2 trial which found that treatment with elotuzumab in combination with lenalidomide and dexamethasone demonstrated a 30 percent reduction in disease progression.

During the quarter, the FDA approved AbbVie’s TECHNIVIE in combination with RBV for the treatment of adults with genotype 4 (GT4) HCV in the United States. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection.

AbbVie Raises Full-Year 2015 Outlook

AbbVie is raising its adjusted diluted earnings-per-share guidance for the full-year 2015 to $4.26 to $4.28. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $1.10 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. AbbVie’s diluted earnings-per-share guidance is $3.16 to $3.18 on a GAAP basis.

What is NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial and Follow Its Development on 1stOncology

NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) is a clinical trial that analyzes patients’ tumors to determine whether they contain genetic abnormalities for which a targeted drug exists (that is, "actionable mutations") and assigns treatment based on the abnormality (Company Web Page, National Cancer Institute, OCT 30, 2015, View Source [SID:1234507863]).

NCI-MATCH seeks to determine whether treating cancers according to their molecular abnormalities will show evidence of effectiveness.

NCI-MATCH can add new treatments or drop treatments over time. Each treatment will be used in a unique arm, or substudy, of the trial.

The trial opened for enrollment in August 2015 with 10 arms. Each arm will enroll adults 18 years of age and older with advanced solid tumors and lymphomas that are no longer responding (or never responded) to standard therapy and have begun to grow. Additional arms are expected to open for enrollment later in 2015 and early in 2016.

NCI-MATCH investigators plan to obtain tumor biopsy specimens from as many as 3,000 patients initially. The specimens will undergo DNA sequencing to identify those that have genetic abnormalities that may respond to the targeted drugs selected for the trial. The drugs included in the trial have all either been approved by the U.S. Food and Drug Administration (FDA) for another cancer indication or are still being tested in other clinical trials but have shown some effectiveness against tumors with a particular genetic alteration(s). It is anticipated that more than 20 drugs will ultimately be tested, each in a different arm of the trial.
How NCI-MATCH Is Unique

NCI-MATCH, which is coordinated by the ECOG-ACRIN Cancer Research GroupExit Disclaimer, has national reach and is opening at clinical sites across the United States that participate in NCI’s National Clinical Trials Network. Therefore, patients may not need to travel far from home to enroll in the trial. The trial also employs the expertise of the NCI and of specialized investigators and scientists within NCI-Designated Cancer Centers and networks who are at the cutting edge of precision medicine in oncology, as well as clinical oncologist and community practices that are experienced in clinical trials, such as those that are part of the NCI Community Oncology Research Program.

NCI-MATCH uses an advanced DNA sequencing test that has been extensively validated across four certified laboratories for high consistency of results. The investigators in the chosen laboratories are among those with the most expertise in these types of assays. The trial will also use standard procedures for the collection of specimens and for preparing specimens for analysis.

The trial will have many more drugs available than most other trials. Many pharmaceutical companies are collaborating in NCI-MATCH and have also contributed their expertise.

Because it is difficult to perform molecularly targeted clinical trials except in the most prevalent types of cancer, NCI-MATCH is designed to be able to detect responses to the inhibition of driver mutations in more than one tumor type. Such findings can then be followed up with additional clinical trials to learn more about the effect of the drug on patients whose tumors have the targeted mutation.

Read more at View Source

Celgene’s VIDAZA® (Azacitidine for Injection) Approved by the European Commission as New Treatment for Elderly Patients with Acute Myeloid Leukaemia

On October 30, 2015 Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG) reported that the European Commission (EC) has approved VIDAZA (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT) (Press release, Celgene, OCT 30, 2015, View Source [SID:1234507850]).

The VIDAZA Marketing Authorisation has been updated to include this new indication in AML, covering patients who have > 30% myeloblasts according to the WHO classification; previously, the indication covered AML patients with < 30% blasts.

Myeloblasts are white cells in the bone marrow; in AML, their functioning is disrupted and results in numerous non-functioning white cells, which can potentially interfere with the body’s ability to control infections and can lead to anaemia and haemorrhages.

For many patients, AML is typically associated with a poor prognosis particularly for those patients who cannot tolerate potentially curative therapies like stem cell transplantation. In Europe, more than 14,000 people suffer from AML, and most of these patients will die within less than one year. As an acute leukaemia, AML progresses rapidly and is typically fatal within months if stem cell transplantation is not an option. In elderly patients ( > 65 years), overall survival with AML has not improved in more than 40 years1, and there is a clear need for treatments that can support this patient population.

"Today’s announcement brings hope to patients with AML, particularly the elderly and more frail patients who cannot undergo intensive therapies such as stem cell transplantation," said Hervé Dombret, M.D., Chief, Blood Disease Department (Leukaemia Unit), University Hospital Saint-Louis, AP-HP, Paris, France. "Azacitidine has demonstrated a median overall survival of 10.4 months in these patients, which is a clinically relevant benefit and gives us a new treatment option in a previously underserved group of patients."

Adds Tuomo Pätsi, President of Celgene in Europe, Middle East and Africa (EMEA): "Celgene is committed to bringing innovative medicines to patients with haematological diseases including AML. The approval of VIDAZA in this segment of AML patients now gives us a new opportunity to help these patients and underscores our commitment to delivering medicines that can have a significant impact on patients with severe and debilitating diseases. Our next step will be to work with each of the member countries to provide access to VIDAZA in this indication, ensuring that patients who can benefit from its use have the opportunity to do so."

The EC decision is based on data from AML-001, a global, multi-centre, randomized, open-label pivotal study of patients at least 65 years old with newly diagnosed or secondary AML with > 30% bone marrow blasts. VIDAZA plus best supportive care (n=241) was compared with conventional care regimens (n=247). Median overall survival (OS), the primary endpoint of the study, was 10.4 months (95% CI 8.0-12.7 months) for patients receiving azacitidine compared with 6.5 months (95% CI: 5.0-8.6) for patients receiving conventional treatment regimens (HR=0.85 [95% CI 0.69, 1.03], stratified log-rank p=0.1009). One-year survival rates with azacitidine and conventional treatment regimens were 46.5% and 34.2%, respectively (difference 12.3% [95% CI: 3.5% – 21%]).

In the study, grade 3-4 anaemia, neutropenia, febrile neutropenia, and thrombocytopenia rates, respectively, were 16%, 26%, 28%, and 24% with azacitidine; 5%, 5%, 28%, 5% with best supportive care; 23%, 25%, 30%, 28% with low-dose Ara-Cytarabine; and 14%, 33%, 31%, 21% with intensive chemotherapy.

The EC decision for the use of VIDAZA in adult patients with AML who are not eligible for HSCT follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in September 2015. Additionally, because this new therapeutic indication brings significant clinical benefit in comparison with existing therapies as determined through the Regulatory Review process, VIDAZA will receive extended market protection in all its indications for an additional year throughout the European Economic Area.

Today’s approval marks the fourth new product or extension of the indication approved by the EC in the EU for Celgene in 2015. Celgene received approvals in the first quarter of the year for REVLIMID in newly diagnosed multiple myeloma in adult patients ineligible for transplantation; OTEZLA, the first phosphodiesterase-4 (PDE-4) inhibitor in psoriasis and psoriatic arthritis; and ABRAXANE in non-small cell lung cancer.

In the United States, VIDAZA is not indicated for treatment of patients with AML. VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anaemia (RA) or refractory anaemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Hypersensitivity to the active substance, or to any of the excipients

Advanced malignant hepatic tumours

Breastfeeding

WARNINGS AND PRECAUTIONS:

Haematological toxicity: Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles. Complete blood counts should be performed to monitor response and toxicity, as required but at least prior to each treatment cycle. A dose reduction may be required. Patients should be advised to promptly report febrile episodes. Patients and physicians are also advised to be observant for signs and symptoms of bleeding.

Hepatic impairment: No formal studies have been conducted in patients with hepatic impairment. Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, and should be carefully monitored. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors.

Renal impairment: Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents. If unexplained reductions in serum bicarbonate ( < 20 mmol/l) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed. The patients should be advised to report oliguria and anuria to the health care provider immediately. Although no clinically relevant differences in the frequency of adverse reactions were noted between subjects with normal renal function compared to those with renal impairment, patients with renal impairment should be closely monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney.

Laboratory tests: Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle. Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle.

Cardiac and pulmonary disease: Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration study and therefore the safety and efficacy of Vidaza in these patients has not been established. Recent data from a clinical trial in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with Vidaza. It is therefore advised to exercise caution when prescribing Vidaza to these patients. Cardiopulmonary assessment before and during the treatment with Vidaza should be considered.

Necrotising fasciitis: Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza. Vidaza therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.

Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment. There is no adequate data on the use of azacitidine in pregnant women. Studies in mice have shown reproductive toxicity. Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester unless clearly necessary. The advantages of treatment should be weighed against the possible risk for the foetus in every individual case

USE IN SPECIFIC POPULATIONS:

Pediatric population (0 – 17 years): The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established. No data are available

Elderly patients: No specific dose adjustments are recommended for the elderly. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function

Renal impairment: Azacitidine can be administered to patients with renal impairment without initial dose adjustment.

Hepatic impairment: Patients with severe hepatic organ impairment should be carefully monitored for adverse events. No specific modification to the starting dose is recommended for patients with hepatic impairment prior to starting treatment; subsequent dose modifications should be based on haematology laboratory values. Vidaza is contraindicated in patients with advanced malignant hepatic tumours.

ADVERSE REACTIONS:

The most commonly reported adverse reactions with azacitidine treatment were haematological reactions including thrombocytopenia, neutropenia, febrile neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events including nausea, vomiting, constipation and diarrhoea (usually Grade 1-2) or injection site reactions and pyrexia (usually Grade 1-2). Other side-effects seen on treatment with Vidaza are listed in the SPC.

Please refer to the Summary of Product Characteristics for full European prescribing information.

About Acute Myeloid Leukaemia

For many patients, AML is a disease that is associated with a poor prognosis and deteriorating quality of life. AML patients tend to be older with poor-risk features; as such, a large proportion are ineligible for intensive but potentially curative therapies, and while there have been some advances recently, treatment options remain limited. Celgene is committed to providing breakthrough treatments and innovative technologies for patients with AML, including those with a poor prognosis. Multiple Celgene products are under investigation and are at various stages of development in AML.

Celator® Pharmaceuticals to Present Data at the AACR-NCI-EORTC International Conference

On October 29, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that data from applying the CombiPlex technology platform to drug combinations incorporating molecularly targeted agents (MTAs) will be presented at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held in Boston, MA on November 5-9, 2015 (Press release, Celator Pharmaceuticals, OCT 29, 2015, View Source [SID:1234507842]).

CombiPlex is well-positioned to address the challenges with the development of combination drug candidates. Nano-scale delivery systems coordinate the pharmacokinetics (PK) of drug combinations after administration so that the optimal ratio of the two drugs is exposed to tumor cells for prolonged times while reducing drug exposure and toxicity to normal tissues.

Celator is applying this technology to create new drug combinations that target pathways associated with tumor cell growth and/or resistance to treatment. Such MTAs are being widely pursued with an increasing focus on combining agents that target multiple cellular pathways in order to improve therapeutic responses.

Celator’s efforts have focused on two combinations: the heat shock protein 90 inhibitor AUY922 combined with docetaxel and the MEK inhibitor selumetinib combined with the Akt inhibitor ipatasertib.

The poster presentation information is listed below:

Presentation Title: Coordinated delivery of anticancer drug combinations incorporating molecularly targeted agents provides markedly increased plasma drug exposure, decreased toxicity and increased efficacy in preclinical tumor models
Date: Saturday, November 7, 2015
Time: 12:30 p.m. to 3:30 p.m.
Session Title: Drug Delivery
Location: Exhibit Hall C-D
Abstract Number: B34

The poster will be available on Celator’s website (www.celatorpharma.com) at the conclusion of the conference.