Top-Line Results from Phase 3 Study Announced by Amgen and Allergan Evaluating ABP 980 in Patients with Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer


July 21, 2016

Amgen and Allergan plc have announced results from a Phase 3 study that evaluates safety and efficacy of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. Based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR), the results ruled out inferiority compared to trastuzumab but could not rule out superiority. The primary endpoint had a pre-specified equivalence margin of +/- 13 percent and the observed upper end of the confidence interval was 13.4 percent.

As said by Sean E. Harper, M.D., executive vice president of Research and Development at Amgen: “We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities. Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we’ve generated supports ABP 980 as highly similar to the reference product.”

“These results provide significant clinical evidence that ABP 980 could be an important biosimilar treatment option for patients with HER2-positive early breast cancer. Allergan is committed to the continued development of ABP 980 and other biosimilars that provide safe, high-quality and effective therapies in key disease areas,” said David Nicholson, chief research and development officer, Allergan.


Antibiotic Zavicefta of AstraZeneca met primary endpoints in Phase III trial for treating hospital-acquired pneumonia


21 July 2016

AstraZeneca has announced that the results were positive from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for treating a broad range of serious Gram-negative bacterial infections in hospitalized patients. Zavicefta has been developed in response to the urgent need for new antibiotics for treating serious infections that are increasingly becoming resistant to current antibiotics commonly used for serious infections, such as polymixins and carbapenems, including colistin.

The REPROVE trial evaluated the effectiveness of Zavicefta (ceftazidime-avibactam) compared with meropenem for treating adult patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (ceftazidime-avibactam). Zavicefta met the primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). Safety observed in the trial was consistent with the known safety profiles of both antibiotics. It is expected that full results from REPROVE will be presented at future scientific meetings.

“The positive results from this important Phase III trial validate our science-led approach and confirm the effectiveness of Zavicefta in treating hospital-acquired pneumonia, providing patients and physicians with a much-needed new treatment option in the fight against antibiotic-resistant pathogens,” said Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit.

AstraZeneca’s Tagrisso met primary endpoint in phase III 2nd-line lung cancer trial


18 July 2016

AstraZeneca has announced that the Phase III AURA3 trial met its primary endpoint that demonstrates superior progression-free survival (PFS) in comparison to standard platinum-based doublet chemotherapy. The AURA3 randomized trial assessed the safety and efficacy of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials. At an upcoming medical meeting, the results of a full evaluation of AURA3 data, including an analysis of overall survival (OS), will be presented.

“These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer. We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

PREZISTA® (darunavir) of Janssen is Approved by U.S. FDA for Use in Pregnant Women with HIV


July 18, 2016

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has announced that the U.S. Food and Drug Administration (FDA) has approved PREZISTA® (darunavir) to be used during pregnancy and the postpartum period. Previously, a human immunodeficiency virus (HIV-1) protease inhibitor, PREZISTA® was indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV. Clinical data demonstrates that PREZISTA® taken with ritonavir has been found to be well-tolerated during pregnancy and the postpartum period.

No reports were found about mother-to-child HIV transmission among the 29 women who continued therapy through delivery. Nor were there any new clinically relevant safety findings compared with the known safety profile of PREZISTA®/ritonavir in HIV-1 infected adults.

Richard Nettles, Vice President, Medical Affairs, Janssen Therapeutics, said: “Many HIV treatments have limited data available to support their use during pregnancy. This expansion of our label is an important advancement in addressing the needs of women living with HIV, and it demonstrates that PREZISTA® is a safe and effective treatment for pregnant women living with this disease. We are proud to be able to provide an option for physicians and mothers who are trying to determine the best approach for HIV treatment.”

Roche updates on phase III study of Gazyva/Gazyvaro in people with previously untreated diffuse large B-cell lymphoma

Roche Igea Luca Dezzani

Roche Igea Luca Dezzani

18 July 2016

Roche has announced that the phase III GOYA study that evaluates Gazyva®/Gazyvaro® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint to significantly reduce the risk of disease worsening or death compared to MabThera/Rituxan (rituximab) plus CHOP chemotherapy (R-CHOP). It was observed that adverse events with MabThera/Rituxan and Gazyva/Gazyvaro were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. At an upcoming medical meeting, data from the GOYA study will be presented.

Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, said: “Two previous studies showed Gazyva/Gazyvaro helped people with previously untreated follicular lymphoma or chronic lymphocytic leukaemia live longer without their disease worsening compared to MabThera/Rituxan, when each was combined with chemotherapy. We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care. We will continue to analyze the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients.”


Amgen and Daiichi Sankyo Announce Agreement for Commercializing Biosimilars in Japan

Amgen-Daiichi Sanko

July 13, 2016

Amgen and Daiichi Sankyo Company, Limited have announced the execution of an exclusive agreement for commercializing nine biosimilars in Japan. This deal comprises several biosimilars in late-stage development, including biosimilars of adalimumab, trastuzumab, and bevacizumab.

According to the terms of the agreement, Amgen will remain responsible for developing and manufacturing the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan. However, Amgen will have a limited right to co-promote the products.

Scott Foraker, vice president and general manager of Biosimilars at Amgen, said: “Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide”.

Outside of Japan, Amgen will retain all additional distribution and commercialization rights for the biosimilar programs. Specific financial terms of the agreement were not revealed.

European Union Approves Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (daclizumab) for the Treatment of Multiple Sclerosis


Jul 05, 2016

Biogen and AbbVie have announced that the European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for treating adult patients with relapsing forms of multiple sclerosis (RMS). ZINBRYTA is a once-monthly, subcutaneous, self-administered injection.

Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, said: “Clinical data showed ZINBRYTA significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to AVONEX® (interferon beta-1a) intramuscular injection, providing a valuable new option for people with RMS. ZINBRYTA has an immunomodulatory mechanism of action (MOA) that regulates inflammation without broadly depleting the immune system, and immune cell effects are reversible within six months. This offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.”

“With the approval of ZINBRYTA in the European Union, we are providing a much needed treatment option for people living with MS. This is an important part of AbbVie’s ongoing commitment to advancing neuroscience research specifically in the area of MS,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

Bayer Expands its Drug Discovery Collaboration with X-Chem to Discover Novel Medicines


July 12, 2016

Bayer and X-Chem, Inc., a privately held biotechnology company that focuses on applying its innovative drug discovery capabilities to the generation of novel small molecule therapeutics, have entered into an expanded global collaboration for drug discovery across multiple therapeutic areas and target classes. This new agreement will extend Bayer’s access to X-Chem’s DEX™ technology which is based on DNA-encoded libraries of small molecules with more than 120 billion molecules. The main goal of the collaboration is to discover innovative lead structures for complex drug targets in areas of high unmet medical need.

“Bayer and X-Chem have built a strong relationship delivering outcomes that have exceeded expectations. Complementing our in-house expertise with technologies and know-how of excellent partners is an integral part of our innovation strategy at Bayer. We have identified the DEX™ platform as a highly valuable extension for our drug discovery efforts. We are looking forward to working with X-Chem on some of our highest-priority targets, for which X-Chem’s platform is ideally suited,” said Professor Andreas Busch, member of the Executive Committee of Bayer AG’s Pharmaceuticals Division and Head of Drug Discovery.

Rick Wagner, Ph.D., Chief Executive Officer of X-Chem, said: “X-Chem is making significant inroads toward the discovery of small molecule drug candidates using its ultra-large screening library. With multiple successes across our partnerships, the DEX™ platform has been broadly validated to deliver novel chemical entities against a wide array of targets, including difficult targets. We are fortunate to have Bayer as a major strategic partner, and we are looking forward to expanding this strong and successful relationship. X-Chem is excited to continue working with Bayer on a wider array of diseases and conditions with significant unmet medical needs.”

FDA Approves Prevnar 13® of Pfizer in Adults Age 18 Through 49

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

July 12, 2016

Pfizer Inc. has announced that Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received approval from U.S. Food and Drug Administration (FDA) for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older. This Prevnar 13 can be used for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan.

The expanded age indication now more closely aligns with the recommendations of 2012 U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices (ACIP) for adults 19 years of age and older with immunocompromising conditions (e.g., HIV, cancer, chronic renal failure), cerebral spinal fluid leak, functional or anatomic asplenia (e.g., sickle cell disease), and Cochlear implants.

Dr. Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines, said: “This expanded age indication in adults 18 to 49 offers an important public health benefit as appropriate vaccination against S. pneumoniae is critical to reducing the risk of pneumococcal disease, including in those with immunocompromising conditions.”


U.S. FDA Gives Rare Pediatric Disease Designation to AbbVie for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor


July 11, 2016

AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) that targets the epidermal growth factor receptor (EGFR) for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG). This is recognized as the highly aggressive and difficult to treat brain tumors found at the base of the brain.

Brainstem tumors are extremely rare among adults. However, they comprise approximately 10-15 percent of all pediatric brain tumors. DIPG is the most common subtype of tumor in this anatomical region and also the second most common malignant brain tumor of childhood. An estimated 200-400 children are affected each year in the United States with this sort of disease.

According to Gary Gordon, M.D., vice president, oncology clinical development, AbbVie: “Pediatric patients with high grade gliomas have a rare and fatal disease.2 This Rare Pediatric Designation, a first for AbbVie, is an important advancement as we continue to evaluate ABT-414 and its potential to help this group of patients who desperately need a new treatment option. The proposal of including a nested cohort within an adult global trial is an endeavor that we hope may bring more treatments to pediatric patients.”