Medivir licenses exclusive rights to MIV-802 for Greater China to Ascletis
Stockholm, Sweden and Hangzhou, China— Medivir AB (Nasdaq Stockholm: MVIR) and Ascletis today announce that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize Medivir’s nucleotide polymerase inhibitor for hepatitis C, MIV-802 (Ascletis code: ASC21), in Greater China.Under the terms of the agreement, Medivir received an upfront payment, and is entitled to receive milestones based on successful development through commercial launch and tiered royalties on net sales of MIV-802 containing products. Ascletis will fund clinical development, manufacturing and commercialization of MIV-802 in Greater China.“We are pleased to have Ascletis as a partner with their track record in advancing development of pharmaceuticals in Greater China and their portfolio of antivirals with which to create a combination drug against hepatitis C” said Christine Lind, CEO of Medivir.“Ascletis has filed an NDA in China for its first HCV NS3/4A medicine, danoprevir, at the end of 2016 and has an HCV NS5A inhibitor in the late stage clinical development. By acquiring MIV-802, a nucleotide NS5B inhibitor, Asceltis is committed to treating, eventually eliminating, hepatitis C in greater China with its multiple leading antiviral combinations including MIV-802,” said Dr. Jinzi J. Wu, CEO of Ascletis.For further information, please contact: Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580 Jianjiong Wang, Associate Director, Corporate Affairs, mobile: +86 181 0650 1929. Email: firstname.lastname@example.orgAbout MIV-802 MIV-802 is a potent, pangenotypic nucleotide inhibitor of the HCV NS5B polymerase. Hepatitis C treatments comprise combinations of pharmaceuticals with different antiviral mechanisms. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors, non-nucleoside NS5B inhibitors, and NS5A inhibitors.About Medivir Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.About Ascletis Ascletis is a leading biotechnology company dedicated to discovering, developing and commercializing new treatments for liver diseases. Ascletis has assembled an entrepreneurial management and senior scientific team with a track record of successful pharmaceutical discovery and development at major global pharmaceutical companies. To date the company has added four late-stage candidates to its product portfolio: Danoprevir (ASC08), an NDA-filed HCV protease inhibitor, licensed from Roche; Ravidasvir (ASC16), phase II completed HCV NS5A inhibitor, licensed from Presidio Pharmaceuticals; ASC06, a clinical stage, first-in-class, RNAi therapeutic for the treatment of liver cancers, licensed from Alnylam Pharmaceuticals; and ASC09, a phase IIa completed HIV protease inhibitor, licensed from Janssen, a Johnson & Johnson company. For more information, please visit www.ascletis.com or www.ascletis.com.cn
Medivir initiates clinical study of birinapant in combination with KEYTRUDA® (pembrolizumab) in patients with treatment-refractory solid tumours
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the first patient has been enrolled in the company’s phase I/II study of birinapant in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), which is marketed by MSD (known as Merck & Co., Inc, Kenilworth, NJ, USA in the US and Canada). The objectives of the study are to evaluate the safety, tolerability and preliminary efficacy of this combination in patients with treatment-resistant solid tumours.About the study The multicentre, single arm, open label study, which is primarily being run in the US, will be conducted in two parts. In the initial dose escalation (phase I) part of the study, the objective is to identify the recommended phase II dose of birinapant for use in combination with KEYTRUDA®. This is to be achieved by administering increasing doses of birinapant in combination with the approved dose of KEYTRUDA® to cohorts of up to 6 patients with refractory solid tumours.Once the recommended phase II dose has been identified, the second part of the study will begin. The primary objective of the phase II part is to evaluate the safety and tolerability of birinapant in combination with KEYTRUDA® in several cohorts. Each cohort will be made up of patients with the same treatment refractory tumour type. An important secondary objective in the phase II part is the preliminary evaluation of the efficacy of the combination in each of the cohorts.Under the terms of the agreement between Medivir and MSD (through a subsidiary), MSD will provide KEYTRUDA® for this study at no cost to Medivir. Medivir retains full rights to birinapant. Additional details were not disclosed.“The approval of immune check-point inhibitors constituted a remarkable leap forward for many cancer patients, but there still remains a substantial opportunity to improve outcomes. Recent preclinical data have provided a strong scientific rationale for combining birinapant with immune checkpoint inhibitors such as KEYTRUDA®. We are therefore very pleased to enrol the first patient in this combination study, which will allow us to determine its safety and tolerability, as well as its potential efficacy, in patients with solid tumours who have no further treatment options,” said John Öhd, Chief Medical Officer at Medivir.About birinapant Birinapant is a parenterally administered bivalent peptidomimetic of the SMAC protein (Second Mitochondria-derived Activator of Caspases) and is therefore known as a SMAC mimetic compound. Birinapant binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), which both enables apoptosis (programmed cell death) in tumour cells, and activates the immune system, enhancing its attack on the tumour. Birinapant has the potential, through its actions on tumour cells and cells of the immune system, to improve the treatment of several types of cancer when used in combination with other drugs including checkpoint inhibitors and DNA damaging agents.For further information, please contact: Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580 John Öhd, CMO Medivir AB, mobile +46 (0) 725 296 200Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.30 CET on 18 August 2017.About Medivir Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet the unmet medical needs of cancer patients. Medivir is listed on the Nasdaq Stockholm Mid Cap List.KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
New Pathology Atlas maps the genes involved in cancer to accelerate progress in personalized cancer medicine
New Pathology Atlas maps the genes involved in cancer to accelerate progress in personalized cancer medicine FRI, AUG 18, 2017 01:53 EST A new Pathology Atlas is launched today with an analysis of all human genes in all major cancers showing the consequence of their corresponding protein levels for overall patient survival. The difference in expression patterns of individual cancers observed in the study strongly reinforces the need for personalized cancer treatment based on precision medicine. In addition, the systems level approach used to construct the Pathology Atlas demonstrates the power of “big data” to change how medical research is performed.The dream of personalized treatment for cancer patients takes a major step forward today with the launch by Swedish researchers of the Human Pathology Atlas. Published in Science1, the Atlas is based on the analysis of 17 main cancer types using data from 8,000 patients. In addition, a new concept for showing patient survival data is introduced, called Interactive Survival Scatter plots, and the atlas includes more than 400,000 such plots. A national supercomputer center was used to analyze more than 2.5 petabytes of underlying publicly available data from the Cancer Genome Atlas (TCGA) to generate more than 900,000 survival plots describing the consequence of RNA and protein levels on clinical survival. The Pathology Atlas also contains 5 million pathology-based images generated by the Human Protein Atlas consortium.Professor Mathias Uhlen, Director of the Human Protein Atlas consortium and leader of the Pathology Atlas effort says: “This study differs from earlier cancer investigations, since it is not focused on the mutations in cancers, but the downstream effects of such mutations across all protein-coding genes. We show, for the first time, the influence of the gene expression levels demonstrating the power of “big data” to change how medical research is performed. It also shows the advantage of open access policies in science in which researchers share data with each other to allow integration of huge amounts of data from different sources.”The Research Article in Science1reports several important findings related to cancer biology and treatment. Firstly, a large fraction of genes is differentially expressed in cancers - and in many cases - have an impact on overall patient survival. The research also showed that gene expression patterns of individual tumors varied considerably, and could exceed the variation observed between different cancer types. Shorter patient survival was generally associated with up-regulation of genes involved in mitosis and cell growth, and down-regulation of genes involved in cellular differentiation. The data allowed the researchers to generate personalized genome-scale metabolic models for cancer patients to identify key genes involved in tumor growth.The work depends heavily on the supercomputing power available to the Human Protein Atlas consortium through the Science for Life Laboratory (SciLifeLab). According to Dr Adil Mardinoglu, SciLifeLab Fellow and leader of the systems biology effort in the project: “We are now in possession of incredibly powerful systems biology tools for medical research, allowing, for the first time, genome-wide analysis of individual patients with regards to the consequence of their expression profiles for clinical survival.”The Pathology Atlas team also looked to demonstrate the utility of the new tool in two particular cancers. “For lung and colorectal cancer, a selection of prognostic genes identified in the Atlas were also analyzed in independent, prospective cancer cohorts using immunohistochemistry to validate the gene expression patterns at the protein level,” says Fredrik Ponten, Professor in Pathology of Uppsala University. ”We are pleased to provide a stand-alone open-access resource for cancer researchers worldwide, which we hope will help accelerate their efforts to find the biomarkers needed to develop personalized cancer treatments.”The Pathology Atlas is available via an interactive open-access database ( www.proteinatlas.org/pathology) .1Uhlen et al “A Pathology Atlas of human cancer transcriptomes” Science (August 17, 2017) accessed on-line at:http://dx.doi.org/10.1126/science.aan2507For more information, contact:Mathias Uhlén, Professor, Science for Life Laboratory, KTHPhone: +46 8 790 9987(secretary)E-mail: email@example.comCristina Al-khalili, Communications, Human Protein AtlasTel: +46 8 790 98 93E-mail: firstname.lastname@example.org
On Aug. 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. With the addition of the new indication, a tablet formulation of olaparib is introduced. FDA approved olaparib capsules in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Today, FDA also approved olaparib tablets for this indication. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network.The approval in the maintenance setting was based on two randomized, placebo-controlled, double-blind, multicenter trials in patients with recurrent ovarian cancers who were in response to platinum-based therapy.SOLO-2 (NCT01874353) randomized 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo. SOLO-2 demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) in patients randomized to olaparib compared with those who received placebo, with a hazard ratio (HR) of 0.30 (95% CI: 0.22, 0.41; p<0.0001). The estimated median PFS was 19.1 and 5.5 months in the olaparib and placebo arms, respectively.Study 19 (NCT00753545) randomized 265 patients regardless of BRCA status (1:1) to receive olaparib capsules 400 mg orally twice daily or placebo. Study 19 demonstrated a statistically significant improvement in investigator-assessed PFS in patients treated with olaparib vs. placebo with a HR of 0.35 (95% CI: 0.25, 0.49; p<0.0001). The estimated median PFS was 8.4 months and 4.8 months in the olaparib and placebo arms, respectively.The most common adverse reactions (≥20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, nasopharyngitis, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis. The most common laboratory abnormalities (≥25%) were decrease in hemoglobin, increase in mean corpuscular volume, decrease in lymphocytes, decrease in leukocytes, decrease in absolute neutrophil count, increase in serum creatinine, and decrease in platelets.The recommended olaparib tablet dose for both the maintenance therapy and later line treatment setting is 300 mg (two 150 mg tablets) taken orally twice daily with or without food.Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf.FDA granted this application Fast Track status. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).Follow the Oncology Center of Excellence on Twitter @FDAOncologydisclaimer icon.Check out recent approvals at the OCE’s new podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.), available at www.fda.gov/DISCO.Approved Drugs Hematology/Oncology (Cancer) Approvals & Safety Notifications Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease.Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.The safety and efficacy of Besponsa were studied in a randomized trial of 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments. Patients were randomized to receive treatment with Besponsa or an alternative chemotherapy regimen. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR). Of the 218 evaluated patients, 35.8 percent who received Besponsa experienced CR for a median 8.0 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.Common side effects of Besponsa include low levels of platelets (thrombocytopenia), low levels of certain white blood cells (neutropenia, leukopenia), infection, low levels of red blood cells (anemia), fatigue, severe bleeding (hemorrhage), fever (pyrexia), nausea, headache, low levels of white blood cells with fever (febrile neutropenia), liver damage (transaminases and/or gamma-glutamyltransferase increased), abdominal pain and high levels of bilirubin in the blood (hyperbilirubinemia).The prescribing information for Besponsa includes a boxed warning that severe liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease [VOD] or sinusoidal obstruction syndrome), occurred in some patients who took Besponsa. If hepatotoxicity occurs, doctors should pause treatment or reduce the dose of Besponsa. If VOD occurs, patients should stop taking Besponsa and be given standard VOD treatment, if severe.The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.Other serious side effects of Besponsa include a decrease in blood cell and platelet production (myelosuppression), infusion-related reactions and problems with the heart’s electrical pulses (QT interval prolongation). Women who are pregnant or breastfeeding should not take Besponsa because it may cause harm to a developing fetus or a newborn baby.The FDA granted this application Priority Review and Breakthrough Therapy designations. Besponsa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.The FDA granted the approval of Besponsa to Pfizer Inc.The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.###
FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, M.D. “By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”There are two primary blood diagnostic tests: nucleic acid tests that identify infection by confirming the presence of a virus’ genetic material (RNA) and serological tests that identify proteins (antibodies) produced by the body's immune system when it detects harmful organisms, such as Zika virus, in the blood. Serological tests are especially important because there is often a small window when the virus’ genetic material is detectable. However, development of these types of tests has been particularly challenging because antibodies produced by the body to fight Zika virus are difficult to differentiate from antibodies produced to fight related viruses, such as dengue and West Nile viruses.The FDA’s sample panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. Although the panel is not for research purposes, diagnostic developers can use these samples to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue viruses. Using the same serological panel to evaluate different devices available under Emergency Use Authorization (EUA) will help public health professionals compare the performance of different Zika virus tests.The FDA panel is available to developers who have interacted with the FDA through the pre-EUA process and have devices that are in the final stages of validation. To date, the FDA has granted EUAs to three serological tests for detection of recent Zika virus infection (in chronological order): Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM Assay. Other developers interested in requesting a panel may contact the agency.The panel was prepared using samples from Zika virus-infected individuals provided by Blood Systems Research Institute (BSRI) from a study supported by Contract No. HHSN268201100001I from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). The content of this press release is solely the FDA’s responsibility and does not necessarily represent the official views of BSRI, the NHLBI, or the NIH. The samples from individuals infected with dengue and West Nile virus were obtained separately by the FDA.The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
EndoPredict(R) Receives Positive Coverage Decisions From Medicare and Anthem
Brings Total Coverage to Over 90 Percent of Breast Cancer Patients SALT LAKE CITY, Aug. 17, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, announced today that Palmetto GBA, the Medicare contractor who oversees the MolDx program and Anthem, Inc., one of the largest private insurers in the country, have announced positive coverage decisions for EndoPredict® testing. "We now have nearly full coverage for EndoPredict testing in the United States which was accomplished in an unprecedented time of less than six months after our launch," said Mark C. Capone, president and CEO, Myriad Genetics. "We believe this rapid expansion of coverage reflects the strong scientific evidence and compelling head-to-head data where the EndoPredict test markedly outperformed the leading first-generation test, and the value of avoiding frustrating and costly intermediate results." Following the full implementation of these decisions, Myriad will now have coverage for over 90 percent of breast cancer patients. "We are seeing increased physician interest in EndoPredict testing and broad reimbursement only strengthens their conviction to use a second generation test with clear superiority in predicting recurrence in the critical five to ten year timeframe," said Johnathan Lancaster M.D., Ph.D., chief medical officer, Myriad Genetics. About EndoPredict EndoPredict is a next-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients with breast cancer. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 15,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com. About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Amgen And Humana Partner For Improved Health Outcomes And Efficiency
Partnership to Target Multiple Serious Diseases Using Real World Data Studies THOUSAND OAKS, Calif. and LOUISVILLE, Ky. , Aug. 17, 2017 /PRNewswire/ -- Two of the nation's leading health organizations, health and well-being company Humana Inc. (NYSE: HUM) and biotechnology company Amgen (NASDAQ:AMGN), have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members. In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected over the term of the agreement. Both organizations are committed to expanding the work into further therapeutic areas where the partnership can bring value to both Amgen and Humana. The goal is the same across all projects: deliver increased value to patients and the health care system by focusing on working to improve quality and outcomes in the context of total health care costs. The collaboration will initially target multiple serious conditions, including cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases and cancer. Researchers will combine available sources of real world evidence (RWE) with data from wearable technology, digital apps and Bluetooth-enabled drug delivery devices. Prospective observational studies are also planned. Planned research will identify patients whose serious medical conditions are likely to result in an adverse patient outcome, which may lead to development of algorithms that can predict risk and drive to early intervention. The partnership will also dive deeply into specific therapeutic areas, from defining the burden of osteoporatic fractures to understanding the impact of wearable technology on medication adherence for inflammatory diseases. "The rising cost of disease is challenging the sustainability of our health care system in the U.S., and is motivating innovators to urgently develop new therapeutic options and partner on opportunities to improve the quality and efficiency of care and reduce financial burden to the system," said Joshua Ofman , M.D., M.S.H.S., senior vice president of Global Value, Access & Policy at Amgen . "It is our hope that this collaboration with Humana, a first of its kind for Amgen , will cultivate value-based, integrated approaches to care that will focus on patients and benefit the healthcare system more broadly." "Humana is focused on the holistic health of our members and by teaming up with Amgen we can study new ways to improve the health outcomes for our members," said Laura Happe , Pharm.D. M.P.H., chief pharmacy officer for Humana. "At the same time, we hope this research results in new tools and technology that support our provider partners who are on the journey to population health and value-based care." Amgen and Humana have proven experience in value-based initiatives. Globally, Amgen has engaged in more than 75 distinct value-based programs that have focused on improving clinical outcomes, patient experience and population health. As of June 30, 2017 , Humana has 1.8 million individual Medicare Advantage members and 142,000 commercial members who are cared for by 50,700 primary care providers, in more than 900 value-based relationships across 43 states and Puerto Rico . By focusing on quality and health, Humana experienced 20 percent lower costs in total in 2015 for members who were treated by providers in a value-based reimbursement model setting versus an estimation of original fee-for-service Medicare costs using CMS Limited Data Set Files. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Amgen and Value-Based Programs As a collaborative partner within the healthcare system, Amgen believes that engaging in value-based programs with stakeholders creates mutually beneficial opportunities to improve costs, quality of care and the patient experience. Globally, Amgen is engaged in over 75 distinct, value-based projects, spanning disease state collaborations, risk sharing, cost-cap guarantee, pay-for-performance and outcomes-based agreements.