Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes


16 September 2016

Positive results from the Phase III DURATION-8 trial confirmed that Bydureon (exenatide extended-release formulation) 2mg once weekly, combining with Forxiga (dapagliflozin) 10mg once daily significantly reduced blood sugar as measured by HbA1c, versus the individual medicines alone in patients with type-2 diabetes ineffectively controlled on metformin. The results were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany, and simultaneously published in the journal ‘The Lancet Diabetes & Endocrinology’.

“Because of the progressive nature of type-2 diabetes, patients often require multiple antidiabetic medicines to achieve and maintain glycaemic control. The results of DURATION-8 show that combining medicines that work in different ways can significantly reduce HbA1c, as well as weight and systolic blood pressure,” said Serge A. Jabbour, MD, FACP, FACE, Professor of Medicine, Director of the Division of Endocrinology and Director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,

“With DURATION-8, AstraZeneca is the first company to highlight the potential benefits of combining a GLP-1 receptor agonist and SGLT-2 inhibitor as a highly-effective treatment alternative to existing non-insulin therapies for patients with severe, uncontrolled type-2 diabetes. Further, it reinforces our commitment to pushing the boundaries of science in the treatment of a disease that affects an estimated 415 million adults worldwide,” said Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca.


Pfizer Gets Positive CHMP Opinion for IBRANCE® (palbociclib) in Combination with Endocrine Therapy for The Treatment of HR+/HER2- Metastatic Breast Cancer in Europe

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

September 16, 2016

Pfizer Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that IBRANCE® (palbociclib) be granted marketing authorization in the European Union (EU) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. This positive opinion from CHMP is for IBRANCE to be used in combination with fulvestrant in women who have received prior endocrine therapy, as well as in combination with an aromatase inhibitor. European Commission (EC) will now review The CHMP’s opinion.

Mace Rothenberg, M.D., chief development officer, Pfizer Oncology, said: “Today’s opinion by the CHMP to recommend marketing authorization of IBRANCE in the EU is an important step toward expanding treatment options for women in Europe with HR+/HER2- metastatic breast cancer, and a step toward a potential new standard of care for this cancer. The opinion is supported by robust data with consistent results observed across three separate randomized trials in which the addition of IBRANCE to standard endocrine therapy resulted in significant prolongation of progression-free survival compared to endocrine therapy alone.”

“There have been only modest improvements in the prognosis of patients with metastatic breast cancer in Europe over the past three decades, underscoring the need for new treatment advances. We look forward to working with the EC as they conduct their review, with the goal of bringing this first-in-class medicine to appropriate patients across the EU,” said Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology.

Janssen Submits Marketing Authorisation Application to European Medicines Agency for Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1


Sep 12, 2016

Janssen-Cilag International NV (Janssen) has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA), which seeks approval for a new once-daily darunavir-based single tablet regimen (STR). This tablet would be the first protease inhibitor (PI)-based STR option (D/C/F/TAF FDC) if approved, indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight of at least 40 kg).

This new treatment would be the combination of the protease inhibitor, darunavir (DRV, D, 800 mg), with the pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg), tenofovir alafenamide (TAF 10 mg), and the nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200 mg) in one single tablet.

Lawrence M. Blatt, Ph.D., global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma, Inc., said: “Darunavir is an extensively used HIV protease inhibitor in the European Union. We are excited to take this important step in our efforts to offer simpler solutions for people living with HIV. Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. Eliminating the need for separate tablets will not only be convenient for people living with HIV but is likely to lead to improved treatment adherence.”

Janssen submits application to European Union seeking approval of sirukumab for rheumatoid arthritis


Sep 12, 2016

Janssen-Cilag International NV (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis (RA). Approximately 6.2 million Europeans are affected by RA, which is a chronic, systemic inflammatory condition. Sirukumab is a human monoclonal IgG1 kappa antibody targeting IL-6, a naturally occurring protein that is believed to play a key role in autoimmune conditions like RA.

Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC, said: “At Janssen, we are committed to continued innovation in the field of rheumatoid arthritis through new therapeutic options, like sirukumab, that address the medical needs of people living with moderately to severely active rheumatoid arthritis. We look forward to collaborating with the European health authorities with the goal of bringing sirukumab to patients living with rheumatoid arthritis who may benefit from this new biologic therapy.”

Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Metformin and Sitagliptin for the Treatment of Type 2 Diabetes


September 15, 2016

Merck, in partnership with Pfizer Inc., has announced that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 15 mg and 5 mg daily doses of ertugliflozin revealed meaningfully greater reductions in A1C of 0.69 percent and 0.76 percent, respectively, in comparison with placebo (p<0.001, for both comparisons), when added to patients on a background of stable metformin (≥1500 mg/day) and sitagliptin (100 mg/day). For the first time, these study results were presented during an oral session at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.

By the end of 2016, Merck and Pfizer plan to submit New Drug Applications to the U.S. Food and Drug Administration for ertugliflozin and two fixed-dose combinations (ertugliflozin plus JANUVIA® (sitagliptin) and ertugliflozin plus metformin), with additional regulatory submissions outside of the U.S. to follow in 2017.

Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck, said: “It is encouraging to see further data from the VERTIS clinical development program in support of combining ertugliflozin, an SGLT2 inhibitor, with the DPP-4 inhibitor sitagliptin, which was first approved 10 years ago.”

“We are pleased to share these new data on investigational ertugliflozin with the scientific community, following the first presentations of Phase 3 data for ertugliflozin at the American Diabetes Association’s 76th Scientific Sessions in June. Type 2 diabetes is a progressive disease and these study results help support the clinical profile of ertugliflozin as an add-on therapy for patients who may require multiple treatment combinations to help reach their blood sugar goals,” said James Rusnak, M.D., Ph.D., chief development officer, cardiovascular & metabolics, Pfizer.



Bristol-Myers Squibb’s ORENCIA® (abatacept) is Approved by European Commission for the Treatment of Adult Patients with Rheumatoid Arthritis


September 6, 2016

Bristol-Myers Squibb Company has announced that the European Commission has approved ORENCIA ® (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, combined with methotrexate (MTX), for treating highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. Through this approval, ORENCIA has turned out as the first biologic therapy with an indication in the European Union (EU) specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease. This approval permits the expanded marketing of ORENCIA in all 28 Member States of the EU.

Brian J. Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb, said: “Across the globe we remain committed to advancing care for those living with RA. The European Commission’s approval of ORENCIA in the EU for MTX-naive RA patients who have highly active and progressive disease is a testament to Bristol-Myers Squibb’s commitment to advancing the science of earlier identification of patients with progressive RA prior to their suffering debilitating joint damage.”

FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

Merck Igea Luca Dezzani

Merck Igea Luca Dezzani

September 7, 2016

Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Priority Review.  KEYTRUDA® is Merck’s anti-PD-1 therapy that is used as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In addition, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA®.

The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study. It showed that KEYTRUDA monotherapy resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more). Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive KEYTRUDA.

Dr. Roger M. Perlmutter, president, Merck Research Laboratories, said: “Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with KEYTRUDA compared to chemotherapy is welcome news. We appreciate the opportunity to work with regulatory authorities to make KEYTRUDA a first-line treatment option in non-small cell lung cancer.”

AstraZeneca and PEPFAR begin partnership across HIV and hypertension services in Africa


8 September 2016

Biopharmaceutical company AstraZeneca and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) have announced a $10 million, five-year global public-private partnership that will expand access to HIV/AIDS and hypertension services by offering them in an integrated way at existing HIV/AIDS sites supported by PEPFAR, starting in Kenya.

For AstraZeneca, the sizable patient reach of PEPFAR represents an opportunity to screen for hypertension during clinical triage. For PEPFAR, the ability to make hypertension screening available to men alongside HIV/AIDS services supports efforts to identify harder-to-reach patients for HIV testing, particularly males aged 25-50, and provide proper referral to HIV/AIDS treatment. Using joint implementation, both programs are expected to increase their impact.

“AstraZeneca shares PEPFAR’s vision of improving the health and lives of underserved communities in sub-Saharan Africa. Increasing rates of hypertension and cardiovascular disease in the region threaten individuals, families and communities, and burden already-stressed health systems. We are honored and proud to join with PEPFAR to improve access to vital testing and treatment which help stem the tide of both hypertension and HIV/AIDS,” said Mark Mallon, EVP International, member of the Senior Executive Team and Healthy Heart Africa (HHA) sponsor at AstraZeneca.

Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and Special Representative for Global Health Diplomacy, said: “Together, we have made remarkable progress in the global response to HIV/AIDS. Yet, we need innovative approaches to better identify and serve harder to reach populations, including men, who too often only present for care when they are very ill. Through this new partnership with AstraZeneca we will enhance our ability to deliver earlier and more effective HIV/AIDS testing and treatment for working-age men in two high-prevalence counties in Kenya.”

BLINCYTO® (blinatumomab) is Approved by FDA for Use in Pediatric Patients with Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Amgen Igea Luca Dezzani

Amgen Igea Luca Dezzani

Sept. 1, 2016

Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may depend upon verification of clinical benefits in subsequent trials.

The approval is based on results from the Phase 1/2 ‘205, an open-label, single-arm, multicenter trial, which evaluated the safety and efficacy of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.

BLINCYTO was granted conditional marketing authorization in the European Union in November, 2015 for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.

Amgen and Servier Extend Omecamtiv Mecarbil Collaboration in Chronic Heart Failure


Sept. 1, 2016

Amgen and Servier have announced that their cardiovascular collaboration advances, with the decision of Servier to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, as well in as the Commonwealth of Independent States, including Russia. The pharma companies also announced that the omecamtiv mecarbil Phase 3 development program will move forward in collaboration with Cytokinetics.

As per the terms of the agreement, Servier will make a $10 million option exercise payment, as well as future milestone and royalty payments, to Amgen. Servier will also assume a share of the development costs. The decision to advance omecamtiv mecarbil into Phase 3 was based on positive results from COSMIC-HF, a Phase 2 trial evaluating the treatment in patients with chronic heart failure

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “We are very pleased to strengthen our collaboration with Servier and for the continued advancement of the novel cardiac myosin activator omecamtiv mecarbil. We are working closely with our research collaborators and regulators on the Phase 3 outcomes study for omecamtiv mecarbil and look forward to assessing the potential of this unique therapy to benefit patients with chronic heart failure worldwide.”

“Omecamtiv mecarbil is a very innovative approach to treating chronic heart failure, bringing new hope to patients suffering from this severe condition. We are pleased to collaborate with Amgen in the late stage of its clinical development for omecamtiv mecarbil,” said Emmanuel Canet, M.D., Ph.D., executive vice-president of Research and Development at Servier.