Oct. 7, 2015, 1:48 PM
- In a regulatory filing, AstraZeneca (AZN -0.1%) reports that it has completed its divestment of Caprelsa (vandetanib) to Genzyme (SNY -1.7%). Under the terms of the deal, AstraZeneca received an upfront payment of $165M and is eligible to receive sales-based milestones of up to $135M.
- Caprelsa, indicated for the treatment of thyroid cancer, posted sales of $48M in 2014.
- Previously: AstraZeneca sells Caprelsa to Sanofi for up $300M (July 27)
Sep. 25, 2015, 7:55 AM
- Top-line results from a Phase 3 clinical trial, called SUSTAIN3, showed that Novo Nordisk's (NYSE:NVO) long-acting GLP-1 analogue, semaglutide, was much more effective in lowering HbA1c levels in type 2 diabetics than AstraZeneca's (NYSE:AZN) BYDUREON (exenatide extended-release for injectable suspension). The study assessed the safety and efficacy of 1.0 mg semaglutide compared to 2.0 mg exenatide once-weekly for 56 weeks added to 1-2 oral antidiabetic drugs in 813 patients with type 2 diabetes.
- The trial successfully achieved its primary endpoint of showing the superiority of semaglutide in lowering HbA1c levels. From a mean baseline of 8.4%, patients receiving semaglutide showed a mean improvement of 1.5% versus 0.9% in the exenatide arm. 66% of patients treated with semaglutide achieved the treatment target of HbA1c below 7% compared to 40% of patients treated with exenatide.
- Patients receiving semaglutide also demonstrated a statistically significant average loss in weight compared to exenatide. From a mean baseline of 96 kg, the semaglutide cohort experienced a mean weight loss of 5.6 kg versus 1.8 kg in the exenatide cohort.
- Novo intends to announce the top-line results from its four remaining SUSTAIN trials in the next few quarters.
Sep. 22, 2015, 9:31 AM
- AstraZeneca (NYSE:AZN) is getting creative in its quest to identify promising new cancer drug cocktails. The company will rely on crowd sourcing to accelerate its hunt for such combinations. The initiative is part of the DREAM Challenge, an open innovation non-profit biology project wherein scientists pool ideas and analyze data.
- The company will release preclinical data on more that 50 of its compounds, including ~10,000 tested combinations measuring the drugs' ability to kill cancer cells from different tumor types, that will be matched with genomic information from the Wellcome Trust Sanger Institute.
- Scientists with winning predictions for the best new drug combinations will have their ideas submitted for publication in Nature Biotechnology.
Sep. 14, 2015, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Sep. 11, 2015, 7:34 AM
- AstraZeneca (NYSE:AZN) purchases a biologics bulk manufacturing facility from Amgen (NASDAQ:AMGN) for an undisclosed sum. The site, located in Boulder, CO, will eventually double AZN's U.S. manufacturing capacity for biologics. It is expected to be licensed and operational by late 2017, after refurbishment and infrastructure improvements are made.
Sep. 8, 2015, 7:40 AM
- The FDA clears privately held Wellstat Therapeutics' XURIDEN (uridine triacetate) for the treatment of hereditary orotic aciduria (HOA), a rare, potentially life-threatening genetic disorder in which sufferers cannot synthesize adequate amounts of uridine which leads to excessive excretion of orotic acid in the urine. This leads to a type of anemia, failure to thrive, various developmental problems and episodes of crystalluria (crystals in the urine). It affects less than one in 1M newborns.
- XURIDEN is an analog of the organic compound pyrimidine. Oral administration of XURIDEN delivers four to seven times more uridine than oral administration of uridine itself. The commercial launch will commence in early 2016.
- The FDA also grants the company a Rare Pediatric Disease Priority Review Voucher, which provides the holder Priority Review for a future marketing application after giving the regulator only a 90-day notice. It is an asset that can be sold or transferred an unlimited number of times. The vouchers are quite valuable. AbbVie (NYSE:ABBV) bought one from United Therapeutics (NASDAQ:UTHR) in August for $350M.
- Wellstat will transfer its voucher to AstraZeneca (NYSE:AZN) per a September 2014 agreement. Financial terms are not disclosed.
Sep. 4, 2015, 7:49 AM
- The FDA approves the use of AstraZeneca's (NYSE:AZN) BRILINTA (ticagrelor) at a new 60 mg dose for patients with a history of heart attack beyond the first year. The expanded indication means that BRILINTA is now cleared to reduce the rate of cardiovascular death, myocardial infarction (MI) (heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
- BRILINTA, an oral antiplatelet treatment for ACS, was previously approved for the treatment of patients who have had a recent heart attack or severe chest pain from insufficient oxygen flow to the heart or patients who have had a heart attack or chest pain who are being treated with medicines or procedures to open blocked arteries in the heart.
Sep. 1, 2015, 5:48 AM
- Valeant Pharmaceuticals (NYSE:VRX) is buying rights to AstraZeneca's (NYSE:AZN) late-stage experimental psoriasis drug brodalumab after it was dropped by Amgen (NASDAQ:AMGN) over concerns about the medicine's "suicidal" side effects.
- Valeant will make an upfront payment of $100M to AstraZeneca, with another $170M in prelaunch milestones and up to $175M following launch.
Aug. 24, 2015, 8:47 AM
- Peregrine Pharmaceuticals (NASDAQ:PPHM) and AstraZeneca (NYSE:AZN) announce plans for a cancer immunotherapy clinical trial collaboration to evaluate PPHM's investigational phosphatidylserine-signaling pathway inhibitor, bavituximab, in combination with AZN's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab.
- The companies say they will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors.
- PPHM +5.2%, AZN -1.2% premarket.
Aug. 20, 2015, 10:57 AM
- Advaxis (ADXS -3.8%) and AstraZeneca's (AZN -1.3%) MedImmune announce the initiation of a Phase 1/2 clinical trial evaluating Advaxis' axalimogene filolisbac (ADXS-HPV) in combination with MedImmune's durvalumab (MEDI4736) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
- The two-part open label study will evaluate the safety and efficacy of axalimogene filolisbac as monotherapy and in combination with durvalumab in ~66 subjects. Phase 1 will establish the maximum tolerated dose while Phase 2 will randomize patients to receive axalimogene filolisbac as monotherapy, durvalumab as monotherapy or the combination. The primary endpoints include objective response rate and progression-free survival. The estimated study completion date is December 2019.
- Axalimogene filolisbac is an immunotherapy based on the Advaxis Lm Technology, which uses live attenuated bioengineered Listeria bacteria to deliver a fusion protein inside cancer cells which then stimulates the immune system to attack the cancer.
- Durvalumab is a monoclonal antibody that binds to PD-L1 (programmed death- ligand 1), a transmembrane protein on cancer cells. PD-L1 suppresses the immune system by binding to the PD-1 receptor found on the surface of activated immune cells. Binding to PD-1 down-regulates the immune system by preventing the activation of T cells.
Aug. 20, 2015, 8:01 AM
- Top line results from a 7,000-subject clinical trial, called EMPA-REG OUTCOME, show that Jardiance (empagliflozin), when added to standard of care, was superior in lowering cardiovascular (CV) risk in type 2 diabetics. The primary endpoint was the time to first occurrence of either CV death, non-fatal myocardial infarction or non-fatal stroke. About half of the deaths of people with type 2 diabetes are caused by CV disease.
- Full results will be presented on September 17 at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
- Jardiance, co-developed by Boehringer Ingelheim and Eli Lilly (NYSE:LLY), is the only glucose-lowering drug that has demonstrated CV risk reduction. It was cleared in Europe in May 2014 and in the U.S. in July 2014.
- Related tickers: (NYSE:SNY) (NYSE:NVO) (NYSE:AZN)
Aug. 13, 2015, 7:35 AM
- Data from a Phase 2a clinical trial assessing FibroGen's (NASDAQ:FGEN) lead product candidate, roxadustat, in patients with chronic kidney disease (CKD)-associated anemia show responder rates that increase in a dose-dependent way. The results were published in Nephrology Dialysis Transplantation.
- The study enrolled 116 subjects with CKD-associated anemia who were not undergoing dialysis. Of this group, 96 were evaluable for efficacy. Four doses of roxadustat were tested (0.7, 1.0, 1.5 and 2.0 mg/kg) compared to placebo. Baseline characteristics were similar between the test arms and control arm. The responder rates (increased hemoglobin levels) ranged from 30% in the 0.7 mg/kg arm to 100% in the 2.0 mg/kg arm. The median time to response ranged from 42 days (1 mg/kg) to 14 days (2 mg/kg).
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
Aug. 10, 2015, 5:30 AM
- AstraZeneca (NYSE:AZN) has landed its third deal in less than a week aimed at bolstering its cancer drug pipeline by signing up rights to an experimental immunotherapy from Inovio Pharmaceuticals (NASDAQ:INO).
- Depending on the success of INO-3112 (which targets cancers caused by human papillomavirus types 16 and 18), Inovio will get $27.5M upfront and potential future payments of up to $700M,
- The deal builds on last week's immuno-oncology tie-ups with Sosei subsidiary Heptares and Mirati.
- INO +9.4% premarket
Aug. 6, 2015, 7:18 AM
- AstraZeneca (NYSE:AZN) acquires the exclusive global rights to develop, manufacture and commercialize HTL-1071, a small molecule adenosine A2A receptor antagonist, from Heptares Therapeutics, a wholly-owned subsidiary of Japanese biopharmaceutical firm Sosei Group. The companies will also collaborate to discover additional A2A receptor-blocking compounds. AZN will evaluate the assets across a range of cancers, including combinations with its existing portfolio of immunotherapies.
- Under the terms of the agreement, Heptares is eligible to receive more that $500M including an upfront payment of $10M, development and commercialization milestones and up to double-digit royalties on net sales.
Aug. 3, 2015, 6:55 AM
- AstraZeneca (NYSE:AZN) and Isis Pharmaceuticals (NASDAQ:ISIS) build upon their existing partnership by establishing a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. Under the terms of the agreement, ISIS will receive an upfront fee of $65M, development and regulatory milestones and tiered double-digit royalties on net commercial sales.
- Antisense drugs are short, chemically modified, single-stranded nucleic acids that target RNA. They are designed to inhibit the production of disease-causing proteins.
Jul. 30, 2015, 9:00 AM
- AstraZeneca (NYSE:AZN) Q2 results ($M): Total Revenues: 6,307 (-6.7%); Product Sales: 5,836 (-9.6%); U.S.: 2,356 (-3.4%); Europe: 1,261 (-23.1%); Established ROW: 785 (-14.3%); Japan: 522 (-9.8%); China: 583 (+11.3%); Emerging Markets: 1,434 (-1.8%).
- Sales by segment: Cardiovascular & Metabolic: 2,452 (-4.4%); Oncology: 707 (-6.7%); Respiratory, Inflammation & Autoimmunity: 1,225 (+1.1%); Infection, Neuroscience & GI: 1,452 (-24.3%).
- Key Product Sales: Crestor: 1,310 (-9.7%); Symbicort: 842 (-9.3%); Nexium: 647 (-33.4%); Onglyza: 208 (-12.6%).
- Net Income: 696 (-9.1%); EPS: 0.55 (-10.0%); CF Ops: 1,080 (-48.1%).
- Shares are up 2% premarket on modest volume.
AstraZeneca Plc is a global research-based biopharmaceutical company, which primarily focuses on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. The... More
Industry: Drug Manufacturers - Major
Country: United Kingdom
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