WASHINGTON--(EON: Enhanced Online News)--Today, the Senate released a new draft of the Better Care Reconciliation Act (BCRA), including an amendment that would allow insurance companies to offer plans not in compliance with critical patient protections in current law. Ten patient advocacy organizations, representing millions of Americans, issued the following statement today in response:Under the amendment, insurance companies would be allowed to charge higher premiums to people based on their health status—in addition to opting out of other patient protections in current law, such as the guarantee of essential health benefits and the prohibition on annual and lifetime coverage caps. Separating healthy enrollees from those with pre-existing conditions will also lead to severe instability of the insurance market. This is unacceptable for our patients.Even without this amendment, the revised underlying legislation would still be devastating for patients everywhere – an infant diagnosed with cystic fibrosis, a woman who has experienced postpartum depression, or an adult who develops cancer. Millions of people who battle chronic diseases or disabilities, like heart disease, lung disease, or diabetes, would be negatively impacted by this legislation. Patients need a health care bill that does not jeopardize their access to necessary treatments and care.We urge Congress to defeat the BCRA as written and any other bill that fails to protect patients’ access to affordable, accessible, and adequate health care coverage.Signers: American Cancer Society Cancer Action Network American Diabetes Association American Heart Association American Lung Association Cystic Fibrosis Foundation March of Dimes Muscular Dystrophy Association National Health Council National Organization for Rare Disorders WomenHeart: The National Coalition for Women with Heart DiseaseContactsCystic Fibrosis Foundation Jessica Rowlands, 240-482-2857 Senior Director, Communications and Media Relations firstname.lastname@example.org
Mayo Clinic, nference Launch a Startup to Discover, Develop Treatments for Diseases with Unmet Medical Need
CAMBRIDGE, Mass. & ROCHESTER, Minn.--(EON: Enhanced Online News)--Today, Mayo Clinic and nference launch a startup company for drug development that will be powered by clinical expertise and artificial intelligence (AI). The company, named Qrativ (pronounced cure-a-tiv) will combine nference’s AI-driven knowledge synthesis platform with Mayo Clinic’s medical expertise and clinical data. Qrativ seeks to discover and develop treatments for diseases with unmet medical need. This effort is being boosted by an .3 million Series A financing supported by Matrix Capital Management, Matrix Partners and Mayo Clinic. Qrativ’s initial focus will be on rare diseases and highly targeted patient populations.The explosion of new data regarding the biology of disease has far outpaced the human ability to consume and make sense of it, creating a challenge for scientists working to translate biomedical data into new treatments.“In the last three years, the AI field has gained incredible momentum driven by major breakthroughs in deep learning neural networks,” says Murali Aravamudan, co-founder and Chief Executive Officer of Qrativ and nference. “Our core technology based on a neural network ensemble identifies nascent drug-disease, drug-gene and other therapeutically-relevant associations from the vast biomedical literature. The spatio-temporal signals are triangulated with real-world phenotypic and molecular evidence amassed from systemic and longitudinal patient care, which we believe can significantly accelerate drug discovery and development.”Uncovering potential new therapeutic indications for drugs that is powered by AI is still rare in today’s drug development process.“The ingenuity of Qrativ is that it will combine clinical insight and clinical need from Mayo Clinic with robust informatics capabilities,” says Andrew Badley, M.D., co-founder and Chief Medical Officer of Qrativ. “By taking into account genomic predictors of both desired treatment response and unwanted toxicity, Qrativ will be able to identify potential drug candidates more swiftly. This will enable us to use nference’s big data capabilities to define highly targeted patient populations and then leverage the deep clinical expertise of Mayo clinicians to design and implement optimal proof of concept trials to meet the unmet needs of our patients.”The company’s Darwin.ai platform will combine nference’s knowledge synthesis platform with the clinical expertise of Mayo Clinic physicians and scientists.It has been shown that drugs have been successfully repurposed for rare diseases in the past, but this course of action has typically happened late in the development process and not in a systematic manner. Systematic drug repurposing starting in the early stages of drug development could identify and accelerate new treatments for diseases with unmet medical need.“This is a bold step for Mayo Clinic and complements our patient-centered care approach with an innovative way to uncover new therapeutic indications for drugs in the collective industry pipeline,” adds Dr. Badley who also is Director of the Office of Translation to Practice at Mayo Clinic. “It enables us to search for all possible uses of a drug starting at the early stages of development. That’s why we call this approach ‘drug purposing’ and not ‘repurposing.’ Through these collaborations, we hope to maximize every drug’s potential for as many patients and diseases as possible.”“Solving unmet needs of the patients requires a union of forces,” says Clark Otley, M.D., Medical Director, Department of Business Development at Mayo Clinic. “This collaboration is an example of our commitment to swiftly bring effective life-changing therapies to patients.”The Qrativ management team brings together clinical leadership from Mayo Clinic and a team of successful serial entrepreneurs from the tech and biotech worlds, and biology and genomic researchers out of Harvard Medical School and Massachusetts Institute of Technology. Qrativ will be led by Murali Aravamudan; Dr. Badley; Venky Soundararajan, Ph.D., co-founder and Chief Scientific Officer of Qrativ and nference; and Agustin Lopez Marquez, Vice President, Business Development and Marketing of Qrativ and nference.Mayo Clinic and Dr. Andrew Badley have a financial interest in Qrativ. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.About Qrativ Qrativ is reinventing the way treatments for diseases with unmet medical need are discovered and developed. Formed by Mayo Clinic and nference, Qrativ combines nference’s knowledge synthesis platform, and Mayo Clinic’s medical expertise and clinical data to enable systematic drug purposing. Starting in the early stages of drug development, Qrativ partners can leverage the company’s drug purposing platform, Darwin.ai, to search for all possible uses of a drug candidate, including identifying potential rare disease indications and find subsets of patients who may respond favorably to a given candidate. Through these partnerships, Qrativ will aim to maximize every drug’s potential for as many patients and diseases as possible. For more information, visit qrativ.bio.About Mayo Clinic Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit mayoclinic.org/about-mayo-clinic or newsnetwork.mayoclinic.org.About nference Powered by its artificial intelligence software platform, nferX, nference's mission is to synthesize the exponentially growing biomedical knowledge. nferX uses state-of-the-art neural networks (shallow and deep learning models) for real-time, automated extraction of knowledge from the commercial, scientific and regulatory body of literature. The platform enables a diverse set of applications ranging from R&D to commercial strategy and operations in the life sciences ecosystem. The long-term goal of the nferX platform is to become the connecting fabric of the various silos of information that exist across health care. Founded by Murali Aravamudan and Venky Soundararajan, Ph.D., nference is led by a multidisciplinary team of serial entrepreneurs from the tech and biotech worlds and PhDs in Biology/Genomics from MIT and Harvard Medical School. The investors in nference are Matrix Partners and Matrix Capital Management. For more information, visit nference.ai.ContactsMayo Clinic Public Affairs Duska Anastasijevic, 507-284-5005 email@example.com or nference Kari Watson, 781-235-3060 firstname.lastname@example.org
Biogen to Present Data at Alzheimer's Association International Conference® 2017 (AAIC®)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) will present data from its Alzheimer’s disease programs at the Alzheimer's Association International Conference® 2017 (AAIC®) in London, July 16 - 20, 2017.The planned poster presentations include:Change from Baseline in Clinical Dementia Rating Scale Cognitive and Functional Domains in PRIME, a Randomized Phase 1b Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab (BIIB037). Poster 1-053: July 16, 2017, 9:30 a.m. GMT+1. This new post-hoc analysis shows the change in the cognitive and functional subscores, which are derived from the previously reported clinical dementia rating (CDR) score for the overall and early Alzheimer’s disease populations in the 1, 3, 6 and 10 mg/kg aducanumab fixed-dosing cohorts in Phase 1b.This poster will be available concurrently with the session on the Investors section of the Biogen company website, www.Biogen.com. Signs and Symptoms of Alzheimer’s Disease Noted in Health Records up to 5 Years Prior to Diagnosis . Poster 2-275: July 17, 2017, 9:30 a.m. GMT+1. This analysis reports the documentation of cognitive and behavioral impairment from U.S. medical health records, prior to an Alzheimer’s disease diagnosis. About AducanumabAducanumab (BIIB037) is an investigational compound being developed for the treatment of early Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.
Vertex Announces Reimbursement Agreement in Italy for ORKAMBI(R) (Lumacaftor/Ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del Mutation
- Effective immediately, agreement enables hundreds of people in Italy to access this important medicine - - Recent pricing and reimbursement agreements have enabled broad access to ORKAMBI for thousands of eligible patients in multiple European countries; negotiations continue in a number of other countries, including France and the United Kingdom - LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco , or AIFA) has agreed to reimburse ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The agreement is published online in the Italian Official Gazette . Regional authorities will now begin implementation to provide the hundreds of eligible patients in Italy access to this important medicine. Recent European pricing and reimbursement agreements have enabled broad access to ORKAMBI for thousands of eligible patients in Austria , Denmark , Germany , Ireland , Italy and Luxembourg. Negotiations continue in a number of other countries where CF is prevalent, including France and the United Kingdom . "We are pleased to have reached this agreement on behalf of CF patients in Italy who have been waiting for this important medicine," said Simon Bedson , Senior Vice President and International General Manager at Vertex. "We continue negotiations with other countries including France and the United Kingdom , and we encourage these national health authorities and governments to work quickly with us to achieve reimbursement for all patients who may benefit." About ORKAMBI® (lumacaftor/ivacaftor) and the F508del mutation In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little-to-no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test. ORKAMBI is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface. ORKAMBI is available as tablets and is typically taken twice per day. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu. About CF CF is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America , Europe and Australia . CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the mid-to-late 20s.
European Medicines Agency Validates Gilead's Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
(BUSINESS WIRE)--Jul. 13, 2017-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the company's Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg; BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg; FTC/TAF) for the treatment of HIV-1 infection in adults has been fully validated and is now under evaluation by the European Medicines Agency (EMA). BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens. "This investigational single tablet regimen represents a potential advance in HIV treatment by combining the potency of an integrase inhibitor, bictegravir, with the demonstrated safety profile of the FTC/TAF backbone," said Norbert Bischofberger , PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences . "Gilead remains at the forefront of driving innovation in HIV, with our continued commitment to working to simplify and improve treatments for people living with HIV." The MAA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority at 48 weeks. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg; DTG); two in treatment-naïve patients and one in virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing DTG-containing antiretroviral regimen. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor. The BIC/FTC/TAF filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union , as well as Norway and Iceland . Gilead submitted a New Drug Application (NDA) for BIC/FTC/TAF in the United States on June 12, 2017 , and 48-week data from two Phase 3 studies investigating BIC/FTC/TAF compared to regimens containing DTG in treatment-naïve adult patients will be presented at the International AIDS Society Conference on HIV Science (IAS 2017), July 23-26, 2017 , in Paris . Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.
Second Phase 3 Study Shows KYPROLIS® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma
KYPROLIS, Lenalidomide and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Lenalidomide and Dexamethasone Patients Treated With the KYPROLIS-Based Regimen Survived 7.9 Months Longer Than Patients on Lenalidomide and Dexamethasone KYPROLIS-Based Regimens Are the First and Only to Demonstrate Improved Overall Survival Versus Today's Standards of Care in Two Phase 3 Studies in Relapsed Multiple Myeloma THOUSAND OAKS, Calif. , July 12, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive results from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of overall survival (OS), demonstrating that KYPROLIS® (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 - 0.95). Per protocol, patients received 18 cycles of KYPROLIS with Rd before continuing treatment with Rd alone to progression. This KRd regimen of twice-weekly KYPROLIS administered at 27 mg/m2 is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ASPIRE study. "For multiple myeloma patients, the first relapse is usually the most devastating," said David S. Siegel , M.D., Ph.D., chief of the Division of Multiple Myeloma at John Theurer Cancer Center in Hackensack, N.J. , and investigator on the ASPIRE trial. "These data clearly show that the addition of KYPROLIS - for just 18 cycles - to lenalidomide and dexamethasone at relapse gave patients a significantly improved chance of survival. With these results, this KYPROLIS regimen should be considered a new standard of care." "The ENDEAVOR study has already demonstrated that KYPROLIS is the superior proteasome inhibitor versus Velcade," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "This overall survival benefit from the ASPIRE trial further supports the importance of proteasome inhibition and duration of treatment with KYPROLIS in the treatment of relapsed multiple myeloma." Adverse events observed in this updated analysis were consistent with those previously reported for ASPIRE. The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis. Amgen recently announced OS results from the Phase 3 head-to-head ENDEAVOR trial, which showed KYPROLIS at 56 mg/m2 in combination with dexamethasone reduced the risk of death by 21 percent over Velcade® (bortezomib) and dexamethasone (Vd). Patients treated with KYPROLIS lived 7.6 months longer than those treated with Velcade (median OS 47.6 months for Kd versus 40.0 months for Vd, HR = 0.79, 95 percent CI, 0.65 - 0.96). The ASPIRE OS data will be submitted to a future medical conference, for publication, and to regulatory agencies worldwide to support a potential label update. The KYPROLIS clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. KYPROLIS is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations. About ASPIRE The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated KYPROLIS in combination with lenalidomide and dexamethasone, versus lenalidomide and dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included OS, overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. Patients were randomized to receive KYPROLIS (20 mg/m2 on days 1 and 2 of cycle one, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle one and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe and Israel. About ENDEAVOR The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated KYPROLIS in combination with low-dose dexamethasone (Kd), versus bortezomib with low-dose dexamethasone (Vd) in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. The primary analysis was published in The Lancet Oncology and is described in the Prescribing Information. Patients received treatment until progression with KYPROLIS as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treatment cycles, along with low-dose dexamethasone (20 mg). For cycle one only, KYPROLIS was administered at 20 mg/m2 on days 1 and 2, and if tolerated was escalated to 56 mg/m2 from day 8 cycle one onwards. Patients who received bortezomib (1.3 mg/m2) with low-dose dexamethasone (20 mg) were treated with bortezomib administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regional regulatory approval of bortezomib. More than 75 percent of the patients in the control arm received bortezomib subcutaneously. This study was conducted at 235 sites worldwide. For information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT01568866. About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers.2,3 In the U.S., there are nearly 95,000 people living with, or in remission from, multiple myeloma.4 Approximately 30,330 Americans are diagnosed with multiple myeloma each year and 12,650 patient deaths are reported on an annual basis.4 About KYPROLIS® (carfilzomib) Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.5 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.5,6 KYPROLIS is approved in the U.S. for the following: In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. KYPROLIS is also approved in Argentina , Australia , Bahrain , Canada , Hong Kong , Israel , Japan , Kuwait , Lebanon , Macao , Mexico , Thailand , Colombia , S. Korea, Canada , Qatar , Switzerland , United Arab Emirates , Turkey , Russia , Brazil , India , Oman and the European Union . Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
BLINCYTO is the First-and-Only Bispecific T Cell Engager (BiTE®) Immunotherapy to Demonstrate Superior Overall Survival Versus Standard of Care Chemotherapy Data From the Phase 3 TOWER Study Support Conversion From Accelerated to Full Approval Indication Expansion Underscores Need for Effective Treatment Options THOUSAND OAKS, Calif. , July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The approval converts BLINCYTO's accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval expands the indication of BLINCYTO for the treatment of relapsed or refractory B-cell precursor ALL in adults and children."For researchers and physicians, overall survival is the primary goal of treatment and the gold standard of outcomes, demonstrating a clear value to patients," said Anthony Stein , M.D., study investigator and co-director of the Gehr Family Center for Leukemia Research , City of Hope, Duarte, Calif. "Data from the TOWER study support the use of this single agent bispecific T cell engager immunotherapy, the first to demonstrate superior overall survival in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL, offering a much needed alternative with significantly improved outcomes over standard of care chemotherapy." BLINCYTO, the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL, was previously granted breakthrough therapy designation and accelerated approval. It is also the first-and-only FDA -approved CD19-directed CD3 bispecific T cell engager (BiTE®) immunotherapy, and the first bispecific antibody construct from Amgen's BiTE® platform. "Relapsed or refractory ALL is often a lethal disease, with a median overall survival of just four months on standard of care chemotherapy," said Bijal D. Shah , M.D., medical oncologist, Moffitt Cancer Center , Tampa, Fla. "As a physician, my goal is to identify treatments that improve response rates in patients with aggressive hematologic malignancies. BLINCYTO is an option that has been shown to help these high-risk patients fight their disease." The approval is based on results from the TOWER study, which found that BLINCYTO demonstrated a superior improvement in median OS over standard of care (SOC) chemotherapy, nearly doubling median OS. The study showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO versus four months (95 percent CI: 2.9, 5.3) for SOC (hazard ratio for death=0.71; p=0.012). The approval is also based on data from the Phase 2 ALCANTARA study, which evaluated the efficacy of BLINCYTO in adult patients with Ph+ relapsed or refractory B-cell precursor ALL. "We are pleased that the FDA has granted full approval for BLINCYTO, marking a significant milestone for certain patients with relapsed or refractory ALL," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "This approval supports the use of BLINCYTO in a broader spectrum of patients, including those with few options to date, such as Philadelphia chromosome-positive patients, and reinforces the potential of the BiTE® platform as a novel approach to immuno-oncology." The FDA -approved prescribing information for BLINCYTO includes a boxed warning for cytokine release syndrome and neurologic toxicities. BLINCYTO is also under a risk evaluation and mitigation strategy (REMS) program in the U.S. Safety results among patients who received BLINCYTO were comparable to those seen in the Phase 2 studies in adult patients with Ph- relapsed or refractory B-cell precursor ALL. For the most common adverse events (greater than or equal to 10 percent incidence rate) in the BLINCYTO arm, six events (pyrexia, infusion-related reaction, cough, cytokine release syndrome, tremor, decreased immunoglobulins) occurred at an incidence rate that was at least five percent higher for BLINCYTO compared to SOC chemotherapy. On May 3, 2017 , the FDA also approved the sBLA for the administration of BLINCYTO to be infused over seven days with preservative, adding to the previously approved administration options for infusion over 24 and 48 hours preservative-free, and allowing physicians to customize a treatment plan to fit the needs of their patients. The BLINCYTO intravenous bag for a seven-day infusion contains Bacteriostatic 0.9 percent Sodium Chloride, USP (containing 0.9 percent benzyl alcohol), which permits continuous intravenous infusion of BLINCYTO at 28 mcg/day or 15 mcg/m2/day for a total of seven days. The seven-day infusion is not recommended for patients weighing less than 22 kg due to the risk of serious and sometimes fatal adverse events associated with benzyl alcohol in pediatric patients. Please see the full prescribing information for BLINCYTO for more information. ALL is a rare and rapidly progressing cancer of the blood and bone marrow.1,2 Currently, there is no broadly accepted standard treatment regimen for adult patients with relapsed or refractory ALL beyond chemotherapy.3 Adults with relapsed or refractory ALL typically have a very poor prognosis, with a median OS of three to five months.4 In adult ALL, approximately 75 percent is B-cell precursor ALL, of which 75-80 percent is Ph- and roughly half will be refractory to treatment or experience relapse.5 About the TOWER Study The TOWER study was a Phase 3, randomized, active-controlled, open-label study investigating the efficacy of BLINCYTO versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL. The study enrolled a difficult-to-treat patient population which included patients from several stages of relapse. In the BLINCYTO arm, this included 35 percent of patients that had relapsed post-allogenic hematopoietic stem cell transplant (alloHSCT), and excluded those with late first relapse (=12 months after initial remission). Patients were randomized in a 2:1 ratio to receive BLINCYTO (n=271) or treatment with investigator choice of SOC chemotherapy (n=134). The determination of efficacy was based on OS. Per the recommendation of an independent data monitoring committee, Amgen ended the study early for evidence of superior efficacy in the BLINCYTO arm versus SOC chemotherapy. These results were published in The New England Journal of Medicine . About the ALCANTARA Study The ALCANTARA study was a Phase 2, single-arm, multicenter, open-label study investigating the efficacy of BLINCYTO in 45 adult patients with Ph+ B-cell precursor ALL, who had relapsed after or were refractory to at least one second-generation or later tyrosine kinase inhibitor (TKI), or were intolerant to second-generation or later TKIs and intolerant or refractory to imatinib. BLINCYTO was administered in 28-day cycles by continuous intravenous infusion. Efficacy was based on the complete remission rate, duration of complete remission and proportion of patients with an MRD-negative complete remission or complete remission with partial hematologic recovery within two cycles. Results of the study, one of the largest conducted in this patient population, were published in the Journal of Clinical Oncology . About BLINCYTO® (blinatumomab) BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In November 2015 , BLINCYTO was granted conditional marketing authorization in the EU for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL. Additional regulatory applications for BLINCYTO are underway and have been submitted to health authorities worldwide. About BiTE® Technology Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com. BLINCYTO® U.S. Product Safety Information
Cialis exclusivity is now expected to end at the earliest on September 27, 2018INDIANAPOLIS, July 12, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis® (tadalafil) unit dose patent. This patent was previously set to expire on April 26, 2020. As part of the agreement, Cialis exclusivity is now expected to end at the earliest on September 27, 2018."The unit dose patent for Cialis is valid and infringed by companies seeking to market a generic version of Cialis. This is a royalty-bearing license agreement that provides us with more certainty regarding our U.S. exclusivity," said Michael J. Harrington, senior vice president and general counsel for Lilly. "Protection of intellectual property and the assurance of market exclusivity are extremely important to Lilly as we work to support the development of the next generation of innovative medicines."Patent expiration for Adcirca (tadalafil) is still expected on November 21, 2017, or on May 21, 2018, if the U.S. Food and Drug Administration grants the company's application for pediatric exclusivity.There will be no change to the company's 2017 financial guidance or mid-term expectations through the remainder of the decade as a result of