Fri, May 15, 1:45 PM
- The FDA issues a warning that type 2 diabetic patients taking drugs called sodium-glucose contransporter-2 (SGLT-2) inhibitors to lower their blood sugar may have increased risk of developing ketoacidosis, a serious condition characterized by the buildup of acids, called ketones, in the blood that can be life-threatening if untreated for an extended period. It is caused by an insulin deficiency which forces cells to burn fat for energy instead of glucose which produces ketones.
- The agency is investigating the issue to determine if the safety risk warrants changes to the labeling of currently approved medications. There were 20 reported cases of ketoacidosis in the period from March 2013 to June 6, 2014, all of which required emergency room visits or hospitalization.
- SGLT-2 inhibitors cleared for sale in the U.S. are Johnson & Johnson's (JNJ) Invokana (canagliflozin) and Invokamet (canagliflozin/metformin); AstraZeneca's (AZN -1.4%) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin); Eli Lilly (LLY -0.5%) and Boehringer Ingelheim's Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).
Wed, May 13, 8:53 AM
- FibroGen (NASDAQ:FGEN) earns a $15M milestone payment from collaboration partner AstraZeneca (NYSE:AZN) based on the completion of roxadustat non-clinical carcinogenicity studies. The results of two separate two-year studies in rats and mice showed no evidence of roxadustat-related effect on mortality or carcinogenicity. Non-clinical carcinogenicity data, part of small molecule drug development, are typically required by regulatory agencies as a component of marketing applications.
- Roxadustat is an orally available hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates red blood cell production. It is being developed as a treatment for anemia in patients with chronic kidney disease. Two Phase 3 trials are in process for the indication.
- Previously: AstraZeneca signs collaboration deal with Fibrogen to develop anemia drug (July 31, 2013)
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Wed, May 6, 8:35 AM
- Thinly-traded micro cap Ardelyx (NASDAQ:ARDX) is down 26% premarket on light turnover in response to its announcement that a Phase 2a clinical trial evaluating its lead product candidate tenapanor in patients with Stage 3 chronic kidney disease (CKD) who also had type 2 diabetes and albuminuria (excess protein in the urine) failed to achieve its primary efficacy endpoint of decreasing the urinary albumin-creatinine ratio compared to placebo.
- The specific endpoint of the 154-subject study was a statistically significant decrease in the albumin-creatinine ratio from baseline to Week 12 versus placebo. The test group showed a 16% reduction compared to 11% for control.
- The company entered into a collaboration agreement with AstraZeneca (NYSE:AZN) in October 2012 to develop and commercialize tenapanor. AstraZeneca is currently reviewing the data from this trial along with results from other studies to determine a path forward. It is obligated to inform Ardelyx no later than June 29 if it decides to cease development of tenapanor. If it decides to pursue only the irritable bowel syndrome with constipation (IBS-C) indication, Ardelyx will be entitled to a $10M milestone payment. If it decides to pursue additional indications, it will be entitled to a $20M milestone.
- Ardelyx President & CEO Mike Raab says, "Should AstraZeneca decide to return the program to us, we seek to be in a position to initiate a Phase 3 clinical program for tenapanor in IBS-C in the fourth quarter of 2015. Additionally, we intend to be prepared to continue the development of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis."
Wed, Apr. 29, 8:51 AM
- AstraZeneca's (NYSE:AZN) supplemental New Drug Application (sNDA) for Brilinta (ticagrelor) for the expanded population of patients with a history of heart attack has been accepted by the FDA under Priority Review. The PDUFA date will be in Q3.
- The submission is based on the results from the 21,000-patient PEGASUS-TIMI 54 outcomes trial that assessed ticagrelor plus low-dose aspirin compared to placebo plus low-dose aspirin for the chronic secondary prevention of atherothrombotic events in patients who had a heart attack one to three years prior to enrolling in the study.
- Brilinta is currently cleared to reduce the rate of thrombotic cardiovascular events (blood clots) in patients with unstable angina and ST/non-ST-elevation myocardial infarction.
Fri, Apr. 24, 10:51 AM
- AstraZeneca (AZN -2%) and Innate Pharma SA (OTCPK:IPHYF) establish a collaboration to accelerate and broaden the development of Innate's proprietary anti-NKG2A antibody, IPH2201, including the combination with MEDI4736, a PD-L1 checkpoint inhibitor.
- The initial plan includes Phase 2 studies of the combination in solid tumors, multiple Phase 2s involving IPH2201 as monotherapy and in combination with currently approved treatments across a range of cancers and the development of associated biomarkers.
- Under the terms of the agreement, Innate will receive an initial payment of $250M, $100M prior to the initiation of Phase 3 development, regulatory- and sales-based milestones and double digit royalties. Innate has the right to co-promote in Europe for a 50% profit share. AstraZeneca will have exclusive global rights to commercialize IPH2201 in combination with MEDI4736 as well as access to IPH2201 in monotherapy and other combinations in certain treatment areas.
- IPH2201 is a humanized IgG4 antibody, an immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic NK (natural killer) and CD8 T lymphocytes. Blocking the inhibitory function of CD94/NKG2A enhances the ability of NK and T cells to kill cancer cells.
- MEDI4736 is a human monoclonal antibody that binds to PD-L1, a protein found on the surface of cancer cells that allows them to avoid detection by the immune system. Binding to PD-L1 enables T cells to recognize and kill cancer cells.
Fri, Apr. 24, 8:15 AM
- Celgene (NASDAQ:CELG) subsidiary Celgene International II Sarl and AstraZeneca (NYSE:AZN) subsidiary MedImmune enter into a strategic collaboration to develop and commercialize MEDI4736, MedImmune's human monoclonal antibody against programmed cell death ligand 1 (PD-L1), for hematologic malignancies. PD-L1 is a protein found on the surface of cancer cells that enable them to avoid detection by the immune system. Binding to PD-L1 enables T cells to recognize and kill cancer cells.
- The partnership will explore the potential for combination therapies of MED4736 and Celgene's pipeline product candidates in blood cancers.
- Under the terms of the agreement, Celgene will make an upfront payment of $450M. It will lead clinical development for all clinical trials and pay all costs associated with the trials through 2016. Afterward, it will be responsible for 75% of the costs. Celgene has global commercialization rights to MEDI4736 for hematology indications and will receive royalty rates starting at 70% of worldwide sales in hematology, gradually decreasing to 50% over time.
- Yesterday, MedImmune announced a collaboration with Juno Therapeutics to develop MEDI4736 with a CAR-T therapy for non-Hodgkin lymphoma.
- Previously: Juno and AstraZeneca team up in combo treatment for blood cancer (April 23)
Fri, Apr. 24, 6:16 AM
Thu, Apr. 23, 5:30 PM
Thu, Apr. 23, 1:00 PM
- Juno Therapeutics (JUNO +1.7%) and AstraZeneca's (AZN -0.3%) MedImmune enter into a collaboration to explore the potential of the combination of one of Juno's CD19-directed chimeric antigen receptor (CAR)-T cell candidates with MedImmune's investigational programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitor, MEDI4736, for the treatment of non-Hodgkin lymphoma.
- Under the initial development plan, both companies will explore the safety, tolerability and preliminary efficacy of the combination therapy by co-funding a Phase 1b study, expected to commence later this year. The firms will also explore the combination of MEDI4736 with a next-generation CD19-directed CAR-T developed by Juno.
- MEDI4736 is a human monoclonal antibody that binds to PD-L1, a protein on the surface of cancer cells that enables them to avoid detection by the immune system. Blocking PD-LI enables the immune system to identify and kill the cancer cells.
- Juno's CAR-T technology genetically engineers a patient's T cells to recognize and kill cancer cells by inserting a gene for a particular CAR into the T cell, enabling it to recognize a specific protein on the surface of the cancer cell.
- Financial details are not disclosed.
Fri, Apr. 17, 7:58 AM
- Based on an interim analysis of its ongoing AURA study, AstraZeneca's (NYSE:AZN) experimental cancer drug, AZD9291, demonstrated a median progression-free survival (PFS) of 13.5 months in patients with advanced epidermal growth factor receptor mutation positive (EGFR+) non-small cell lung cancer (NSCLC) who also have the T790M mutation. T790M-positive NSCLC patients with disease progression do not have effective treatment options. Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors (TKI) like erlotinib (Roche's Tarceva) or gefitinib (AZN's Iressa).
- The updated data also show an overall response rate of 54% (80 mg dose) and a median duration of response of 12.4 months. The data were presented at the European Lung Cancer Conference in Geneva, Switzerland.
- NSCLC is the most common form of lung cancer. The T790M mutation is responsible for up to 67% of EGFR TKI resistance in patients with advanced EGFR+ NSCLC.
- The company plans to submit its regulatory application in the U.S. this quarter. Management believes peak sales could reach $3B per year.
Fri, Apr. 17, 7:09 AM
- The FDA designates AstraZeneca's (NYSE:AZN) selumetinib an Orphan Drug for the treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults. The incidence is 4.3 cases per 1M people and peaks near the age of 70.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Wed, Apr. 15, 9:57 AM
- The FDA designates AstraZeneca's (AZN +1.4%) anti-CTLA-4 monoclonal antibody, tremelimumab, an Orphan Drug for the treatment of malignant mesothelioma, an aggressive cancer affecting the lining of the lungs and abdomen that is associated with asbestos exposure.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Tue, Apr. 14, 3:21 PM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee votes 14 -1 in favor of revising Onglyza's (saxagliptin) label to add new safety information. AstraZeneca's (AZN +3.3%) commercialization of the drug will continue unchanged.
- Previously: AstraZeneca diabetes med no riskier than placebo in CV outcomes study (April 10)
Mon, Apr. 13, 9:03 AM
- AstraZeneca (NYSE:AZN) signs a five-year agreement with PatientsLikeMe to provide access to the latter's 325K+ members. It intends to use the patient-reported data to help improve outcomes across its therapeutic areas. The initial focus will be on respiratory disease, lupus, diabetes and oncology.
- EVP, Global Medicines Development Briggs Morrison says, "Understanding what patients are experiencing every day and how they define the value of their treatments are fundamental to our ability to push the boundaries of science in developing the next-generation of medicines. Our partnership with PatientsLikeMe will help us to harness the important perspectives of patients through their advanced technology and real-world, real-time evidence to support our research and development programs."
- Financial terms are not disclosed.
Fri, Apr. 10, 11:51 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets on April 14 to review the data from a large scale cardiovascular (CV) outcomes trial that assessed if there was an effect on cardiovascular risk in type 2 diabetic patients taking AstraZeneca's (AZN -0.3%) saxagliptin [Onglyza (saxagliptin) or Kombiglyze XR (saxagliptin and metformin HCl)]. The Phase 4 study was a condition of the FDA's approval of the company's New Drug Application (NDA) in July 2009.
- The randomized, double-blind, placebo-controlled trial, called SAVOR, involved 16,492 high-CV risk patients with type 2 diabetes. The primary endpoint was the CV safety of saxagliptin as measured by the incidence of major adverse cardiac events (MACE). A MACE event was defined as CV death, non-fatal cardiac infarction (heart attack) or non-fatal ischemic stroke. The objective was to demonstrate saxagliptin's non-inferiority (no worse than) to placebo in its effect on CV risk.
- According to AstraZeneca's briefing document, SAVOR was successful in demonstrating saxagliptin's non-inferiority to placebo. There was also no statistical difference in the broader endpoint of the incidences of MACE and hospitalizations for unstable angina, heart failure or coronary revascularization between the groups.
- There was a higher incidence of all-cause mortality in the saxagliptin cohort, although it could not attributed to the drug. The study did show higher risk for hospitalization for heart failure (HF) in patients at increased risk for HF (those with a history of HF or renal impairment). A labeling change will most likely be required to address this subgroup.
- Briefing doc
AZN vs. ETF Alternatives
Other News & PR