AZ News From The Street 2016

Discussion in 'AstraZeneca' started by anonymous, Jan 4, 2016 at 10:06 AM.

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  1. anonymous

    anonymous Guest

    AstraZeneca plc AZN announced that the FDA has accepted for review its complete re-submission of the new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate).

    The company is looking to get ZS-9 approved for the treatment of hyperkalemia (high potassium level in the blood serum).

    The regulatory agency has classified the re-submission as a complete class 2 response. This means that it may include a presentation to an advisory committee and require a re-inspection of its manufacturing facility. A review of the class 2 resubmissions usually takes six months from the receipt date.

    We remind investors that AstraZeneca had received a complete response letter from the FDA for ZS-9 in May 2016. The CRL had cited observations from a pre-approval manufacturing inspection and the receipt of new data, which was yet to be reviewed.

    An approval would be a major boost for the company. Hyperkalemia represents a huge market given the addressable patient population of approximately 3 million in the U.S. We note that the approval of Relypsa, Inc.’s Veltassa in the U.S. in Oct 2015 marked the first drug in more than 50 years to be indicated for the treatment of hyperkalemia.

    Meanwhile, ZS-9 is currently under review in the EU and Australia, with responses expected in the first half of 2017.

    ZS-9 became part of AstraZeneca’s pipeline following the Dec 2015 acquisition of ZS Pharma.
     

  2. anonymous

    anonymous Guest

    It sounds like this all went so well !!

    Oct 20, 2016 @ 10:00 AM
    Cloud-Centered IT Transformation At AstraZeneca
    Jason Bloomberg ,

    During his three years as CIO of pharmaceutical giant AstraZeneca (NYSE:AZN), David Smoley has been overseeing a massive insourcing effort.

    When he joined the organization, AstraZeneca was outsourcing nearly 70% of the IT organization to about ten third-party providers.

    He brought much of IT in-house at locations around the globe, including Chennai in India and Guadalajara, Mexico as well as creating technology labs in Silicon Valley, Cambridge UK, and Shanghai.

    The payback from these efforts has been remarkable. “We saved hundreds of millions of dollars just bringing that work in,” Smoley says.

    However, insourcing was only half the battle. The other half: moving most of the IT effort to the cloud.

    [​IMG]
    AstraZeneca CIO David Smoley (image credit: AstraZeneca)

    AstraZeneca’s Business Case for the Cloud

    As a large enterprise in a heavily regulated industry, AstraZeneca faced substantial internal resistance to moving to the cloud – but this institutional inertia didn’t deter Smoley. “We set some crazy goals,” he explains. “We’re going to be twice as good for half the cost.”

    The starting point: addressing the existing mess. “Application development, maintenance, infrastructure, security, and help desk were all different vendors,” Smoley says. “It was incredibly complex. From a change perspective, the first thing we did was email.”

    Recommended by Forbes
    AstraZeneca considered cloud-based enterprise email solutions from both Google GOOGL +0.04% and Microsoft MSFT -0.76%, but Smoley’s team found that Google was less enterprise-oriented. As a result, they went with Microsoft Office 365.

    Moving human resources technology to the cloud was also an early win with the selection of Workday WDAY -0.02%. “Office 365 and Workday are the ‘tip of the spear’ for enabling change in both the IT organization and the business,” Smoley explains.

    These two applications were only the starting point for what would prove to be a comprehensive IT transformation – but the combination of CEO support and a manifest need for change gave Smoley the mandate he required.

    His efforts expanded to a broad inventory consolidation, replacing numerous older applications with ServiceNow, Box (NYSE:BOX), and Salesforce.com CRM -0.45%, in addition to Office 365 and Workday. However, Smoley is quick to point out that this consolidation wasn’t a cloud strategy per se. “We didn’t implement these just to implement cloud,” he says. “Each addressed a business problem.”

    ServiceNow (NYSE:NOW), for example, helped pull together disparate service management efforts scattered across the global organization. “We use ServiceNow for provisioning of IT kit,” Smoley says. “ServiceNow provides a single source of truth for incidents, problems, and other fundamentals of running an IT shop around the world.” AstraZeneca is now expanding its use of ServiceNow for the HR and facilities departments.

    Box has also proven quite versatile, providing file synching, sharing, and collaboration, as well as focusing on HIPAA requirements for document retention and archiving. “Box has been fabulous,” Smoley says, “Supporting compliance with laws and regulations and tracking violations.”

    Salesforce is also an integral part of AstraZeneca’s cloud strategy, especially in support of its intranet, dubbed Nucleus. When Smoley joined AstraZeneca, its intranet was a mess. “It was a hodgepodge of linked sites, third parties, different countries,” Smoley reports. “You couldn’t find stuff.”

    AstraZeneca consolidated its various intranet sites onto Force.com from Salesforce, along with the Sinequa platform for search capabilities and Stantive OrchestraCMS for content management. Today, Nucleus supports mobile phone and laptop access anywhere in the world in multiple languages.

    Keeping Nucleus up to date, however, is a fast-moving target, according to Smoley. “We started in the science area, prioritizing and indexing key data sets with Sinequa,” he says. “We’re now in the process of rolling out Salesforce and Veeva CRM.” Veeva CRM is a customer relationship management app for life sciences that runs on Salesforce.

    IT Transformation Beyond Software-as-a-Service

    SaaS applications form the core of AstraZeneca’s IT transformation, but the changes don’t stop there. Infrastructure-as-a-Service from Amazon.com AMZN -0.74% also plays an important role. “We partner with folks like Amazon to make it easy for scientists to get access to compute and storage without swiping their credit cards,” Smoley explains.

    Adding Amazon’s compute and storage to the mix helps promote an environment of self-provisioning across an ecosystem of tools including Amazon, ServiceNow, VMware, and others. ServiceNow, for example, provides a single service management interface for scientists to provision and manage their Amazon cloud instances.

    Combined with the success of Nucleus, the broader cloud-centered IT transformation story is one of self-service. “End-users no longer need IT or HR people to explain things,” Smoley says.

    Now that AstraZeneca’s transition to the cloud is largely in place, it is seeing broad business benefits across the organization. Cloud-based solutions enabled AstraZeneca to implement work faster than legacy tools would have allowed.

    The company is also taking advantage of the efficiency of the cloud model, including a reduction in capital expenditure, the ability to scale up and down, and the fact that it needs fewer people to support apps like Workday or ServiceNow as compared to SAP.

    Today, investment in IT innovation continues, with large bets on mobile, data and cybersecurity, among others – bets that leverage ongoing business successes, for example, the ability to support a record number of regulatory submissions. “We built a solid foundation for performance,” Smoley says. “Now we’re getting into strategic discussions with the business.”

    There is an important lesson here for any enterprise struggling with its own digital transformation: if a company as large as AstraZeneca in an industry as heavily regulated as pharma can do it, so can you. As David Smoley says, “just go for it.”
     
  3. anonymous

    anonymous Guest

    Wow, Smoley is hot!
     
  4. anonymous

    anonymous Guest

    Pricing transparency, rebates, PBM's:

    http://finance.yahoo.com/news/heres-50-drug-ends-costing-150119658.html

    Excerpt:
    "In the case of acid reflux, the drug in question is Nexium, and it serves as an illustration of the pharmacists' chief complaint.

    Nexium comes in many forms, including a less potent over-the-counter version. That costs between $25 and $50.

    There's also a prescription version with twice the strength. If you're getting that one through Medicare Part D, the government's program for prescription drugs, it could cost as much as $700."
     
  5. anonymous

    anonymous Guest

    It did all go perfectly swell, at least according to Smoley anyway
     
  6. anonymous

    anonymous Guest

    Cancer Phase 3 news:

    AstraZeneca today announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of LYNPARZATM (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer.1 Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with LYNPARZA compared to placebo and provide additional evidence to support the potential use of LYNPARZA in this patient population.

    Importantly, the median PFS in the LYNPARZA arm of SOLO-2 substantially exceeded that observed in the Phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).2

    Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are pleased with the robust improvement in progression-free survival demonstrated by LYNPARZA in the SOLO-2 trial. We will work with regulatory authorities to make LYNPARZA tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of LYNPARZA, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”

    Initial findings demonstrate that safety profile with LYNPARZA tablets was consistent with previous studies.2 Full results of SOLO-2 will be presented at a forthcoming medical meeting.

    Today’s positive results follow the Fast Track Designation for LYNPARZA by the US FDA earlier this year, in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.3

    LYNPARZA is the first PARP inhibitor approved in the US. LYNPARZA capsules (400mg twice daily) are FDA-approved as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. LYNPARZA is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.4 LYNPARZA tablets are an investigational formulation and are not FDA-approved for any use.1
     
  7. anonymous

    anonymous Guest

    Possible cancer setback for head and neck trial:

    AstraZeneca pauses two cancer drug trials' enrolment due to bleeding

    By Ben Hirschler | LONDON

    AstraZeneca's high hopes for cancer immunotherapy were dented on Thursday as the recruitment of new patients with head and neck cancer into two clinical studies was put on hold, following instances of bleeding.

    The drugmaker said the U.S. Food and Drug Administration (FDA) had placed a partial hold on enrollment into the final-stage Phase III trials involving two of its immune system-boosting drugs, although the studies are still continuing with existing patients.

    Trials of durvalumab and tremelimumab in different cancer types are also progressing as planned. Durvalumab is being tested on its own and with tremelimumab in various cancers.

    Expectations for the combination treatment have been building in particular in lung cancer, where the two-drug cocktail is being tested in a broad range of patients as an alternative to initial chemotherapy.

    News of the problems in head and neck cancer first surfaced on the website clinicaltrials.gov, run by the U.S. National Institutes of Health, which said one of the trials, known as KESTREL, had been "suspended".

    "The trial is not suspended," an AstraZeneca spokeswoman said. "We have a pause or a partial clinical hold on enrollment of new patients."

    Shares in AstraZeneca fell more than 4 percent in U.S. trading on concerns that the setback might signal wider problems for durvalumab.

    AstraZeneca sought to play down concerns, however, stressing that pivotal data in lung cancer were still expected in the first half of 2017.

    It also said that bleeding was a known complication in treating head and neck cancer, given the proximity of tumors to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation.

    Merck's rival immunotherapy drug Keytruda is already approved for head and neck squamous cell carcinoma, the same condition that AstraZeneca is testing for.

    Bernstein analyst Tim Anderson said there was some reference in the medical literature to a decrease in blood platelets, which are needed for clotting, when patients were given so-called CTLA4 drugs like tremelimumab, although cases were rare.

    Both Anderson and Deutsche Bank's Richard Parkes said it was unclear if bleeding constituted a real drug side effect or not.

    AstraZeneca said it had submitted its analysis of bleeding events to the FDA for review and would work to provide the required information to resume new patient enrollment as soon as possible.
     
  8. anonymous

    anonymous Guest

    Competition is fierce in the cancer therapy arena:

    Merck’s Keytruda Gets Highly-Awaited FDA Nod for 1st Line Lung Cancer Setting: In addition to reporting strong third quarter results, Merck got a boost with the earlier-than-expected FDA approval of its anti-PD-1 therapy Keytruda for the first-line non-small cell lung cancer (NSCLC) setting. This is a very important milestone for Merck as the company looks set to enjoy a head-start in this setting.

    Keytruda sales should improve sharply with the first-line NSCLC indication. Keytruda’s label was also updated to include KEYNOTE-010 data which means that patients expressing any level of PD-L1 are eligible for Keytruda in a second-line NSCLC setting.

    AstraZeneca’s Durvalumab on Partial Clinical Hold: AstraZeneca’s AZN durvalumab was placed on partial clinical hold by the FDA for head and neck squamous cell carcinoma (HNSCC). This means that new patients cannot be enrolled in studies evaluating only durvalumab or durvalumab in combination with tremelimumab or other medicines for HNSCC. The hold does not affect studies evaluating durvalumab for other types of cancer.

    The FDA’s decision to place a partial clinical hold was based on AstraZeneca’s decision to pause enrolment of new HNSCC patients while a detailed analysis of adverse events related to bleeding observed in a couple of phase III studies was being conducted. The analysis has been submitted by the company to the agency.

    Meanwhile, AstraZeneca reported positive data from a late-stage study evaluating Lynparza as maintenance treatment for women with BRCA-mutated metastatic ovarian cancer.
     
  9. anonymous

    anonymous Guest

    Once upon a time, ICI and then Zeneca were the leaders in oncology:


    Intent on fending off future Tesaro rival, AZ touts new PhIII Lynparza data
    by Tracy Staton |
    Oct 26, 2016 9:09am

    AstraZeneca doesn’t want any other PARP inhibitor to steal a march on its first-to-market Lynparza. With Tesaro hoping to do just that with ovarian cancer candidate niraparib, AZ is trumpeting some new survival data on its own med.

    The U.K. drug giant said Lynparza, approved on the strength of a Phase II trial, delivered even better progression-free survival results in a Phase III ovarian cancer study, dubbed SOLO-2. Median progression-free survival in Lynparza patients “substantially exceeded” that shown in the mid-stage trial, AstraZeneca said in a Wednesday release.

    Details are yet to come, so we won’t know just how substantially Lynparza exceeded its previous score until the wraps are off. But Lynparza will need as much ammo as it can get as other PARP inhibitors hit the market.

    In Phase II, Lynparza delivered a median progression-free survival of 11.2 months, compared with 4.3 months among placebo patients. So, beating that number would help AstraZeneca sharpen its case to prepare for Tesaro’s niraparib--which put up a 15.5-month PFS advantage in its own recently released trial.

    The patient populations tested were different for the two meds, which means the numbers don’t lend themselves to direct comparisons, but doctors tend to consider them nonetheless when deciding among treatments for their patients. Lynparza's currently approved formula is a capsule, and the latest study tested a tablet form.

    AstraZeneca put a $2 billion sales target on Lynparza when it was approved in December 2014--a goal that depends on new indications. In its current market--BRCA-positive patients who’ve relapsed after three rounds of chemo--Lynparza put up $98 million in first-half sales this year, up from $54 million over the same period of 2015.

    Lynparza is now on the FDA’s fast track for second-line use, which would open it up to a much larger group of women. It’s also a “breakthrough” drug at the FDA in prostate cancer, and is under testing in breast cancer, among several others.

    Meanwhile, Medivation (which Pfizer is buying) and Novartis each have PARP meds on their way, though neither of those is close to an ovarian cancer nod. But Medivation’s talazoparib could be a head-to-head rival for Lynparza soon enough; it’s on its way to a prostate cancer app.

    The most immediate threat comes from Tesaro: It’s wrapping up its rolling submission to the FDA on niraparib, which posted a 21-month progression-free survival stat for BRCA-positive patients in a trial unveiled earlier this month at the European Society for Medical Oncology meeting. That was 15.5 months longer than the result for placebo patients.

    That’s an unprecedented survival advantage, the niraparib trial’s lead author, Dr. Mansoor Raza Mirza of Copenhagen University, said at the time. "We have never seen such large benefits in progression-free survival in recurrent ovarian cancer,” he said.

    The Tesaro med also performed--albeit in a less-impressive way--in patients who didn’t test positive for the BRCA mutation. The company says it’s going to go for an FDA approval to treat patients regardless of their BRCA status.

    AstraZeneca is testing Lynparza in BRCA-negative patients, too, and no wonder--the BRCA-positive group is just 10% to 15% of ovarian cancer patients. But in the meantime, AZ is happy to tout the SOLO-2 data.

    “We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial," EVP Sean Bohen said in Wednesday's statement. "We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”
     
  10. anonymous

    anonymous Guest

    To cover SET bonuses
     
  11. anonymous

    anonymous Guest

    AstraZeneca Stocks Slips as Third-Quarter Crestor Sales, Earnings Disappoint

    AstraZeneca saw a 44% decline in Crestor sales as generic brands challenge the company's cholesterol blockbuster.
    Martin Baccardax

    AstraZeneca (AZN) shares extended declines Thursday in London after the company said sales of its blockbuster Crestor drug fell sharply in the face of generic competition.

    Britain's second-biggest drugsmaker reported earnings per share of $0.80, up 32% from the same period last year and ahead of analysts' forecasts of $0.74 per share. But sales of Crestor, its key cholesterol blockbuster drug, fell 44% from the same quarter last year to $688 million, the company said, while sales of Symbicort dropped 17% to $697 million.

    Core EPS, the company said, was up 28% to $1.32. Profit before tax, however, fell 27% to 676 million and missed analysts' expectations of $731 million. Total group revenues slipped 4% to $5.7 billion, largely in-line with forecasts.

    AstraZeneca shares fell 4.13% in London by 12:30 GMT, against a broader FTSE 100 gain, to trade at 4,394 pence each. The stock has fallen 15% over the past three months, outpacing an 8.4% decline for the FTSE 350 Healthcare Index.

    "The performance in the third quarter was in line with our expectations, reflecting the transitional impact from the first full quarter of generic competition to Crestor in the US," CEO Pascal Soriot said. "We sharpened significantly our focus on our three therapy areas, by prioritising our portfolio through externalisation and divestments. This focus, underpinned by our productivity initiatives, supported the rapid reduction in SG&A costs."
     
  12. anonymous

    anonymous Guest

    Drug firm AstraZeneca sees 3rd quarter earnings fall 12 pct
    Associated Press
    November 10, 2016

    LONDON (AP) — Anglo-Swedish drugmaker AstraZeneca said Thursday that its third-quarter earnings fell 12 percent as its blockbuster cholesterol drug Crestor faced its first full quarter of competition in the United States from generic alternatives.

    Operating profit declined to $1.03 billion from $1.17 billion in the same period a year earlier. Net income, which includes finance expenses and a one-time tax benefit of $319 million, rose 32 percent to $1.01 billion.

    AstraZeneca has been cutting costs so it can devote more resources to cancer drugs. Sales of cancer treatments rose 19 percent to $867 million, driven by the introduction of the lung cancer drug Tagrisso and the ovarian cancer drug Lynparza.

    U.S. sales of Crestor fell 82 percent to $124 million after generic competitors went on sale in July.

    It remains unclear what impact the election of Donald Trump as U.S. president might have on pharmaceutical giants like AstraZeneca. The Republican leader has pledged to roll back Obamacare, the U.S. program to help individuals get health insurance.

    During a call with analysts, CEO Pascal Soriot said he didn't want to speculate on what the "new landscape" would look like, but that he hoped any new legislation would include policy that supports innovation.

    "We also believe that we will have to continue to deal with price pressure," he said.
     
  13. anonymous

    anonymous Guest

    AstraZeneca PLC (ADR) (AZN) Retreats On Some Durvalumab Plans

    AstraZeneca PLC (ADR) (NYSE:AZN) will no longer seek early regulatory review of its drug candidate durvalumab in patients with head and neck cancers. Durvalumab is a checkpoint inhibitor (PD-L1) that is also being studied as a potential treatment for other forms of cancers including lung cancer and urothelial bladder cancer. As per an earlier update, AstraZeneca had said that it was interested in pursuing accelerated regulatory review of the candidate specifically for head and neck squamous cell carcinoma (HNSCC) so that it could bring it to market quickly. But with the FDA already having approved a checkpoint inhibitor for HNSCC and durvalumab suffering trial setbacks in HNSCC patients, AstraZeneca
     
  14. anonymous

    anonymous Guest

    Nobody really cares about the pediatric indication. If they did, they would have run this study many years ago. Its nice it was a positive result. A positive or a negative result simply means 6 more months of additional patent protection. Start counting it down....tic tic tic....


    AstraZeneca PLC AZN announced phase III study results for its well-known product for asthma, Symbicort. The study showed that the drug improves lung function in pediatric asthma patients aged six to twelve years. Results from CHASE 3 phase III study evaluated Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms versus budesonide 80 micrograms, in pediatric patients.

    The CHASE 3 study was conducted by the company after FDA asked for additional data on budesonide and formoterol, particularly regarding the impact of different doses, in pediatric asthma patients between six and twelve years of age.

    AstraZeneca has been making significant progress with its pipeline. Promising pipeline candidates dealing with asthma include benralizumab for asthma and chronic obstructive pulmonary disease (COPD) and tralokinumab for asthma and atopic dermatitis.

    AstraZeneca is working on bolstering its pipeline and is looking for suitable acquisitions and deals. In order to strengthen its respiratory portfolio, AstraZeneca acquired rights to Allergan plc’s AGN branded respiratory business in the U.S. and Canada in Mar 2015.

    In May 2016, AstraZeneca acquired Takeda Pharmaceutical Company Limited’s TKPYY core respiratory business, thereby gaining global rights to Daliresp/Daxas
     
  15. anonymous

    anonymous Guest

    Game on!

    U.S. FDA lifts hold on AstraZeneca head and neck cancer trials
    Reuters
    November 22, 2016
    LONDON, Nov 22 (Reuters) - U.S. officials have given a green light for two clinical trials testing AstraZeneca's cancer immunotherapy drug durvalumab in head and neck cancer to resume recruiting patients, lifting a hold imposed following cases of bleeding.

    The British drugmaker said on Tuesday that one of the late-stage Phase III trials had already re-opened for new patient enrolment and the second was expected to resume recruitment shortly.

    News of the partial hold on the trials, imposed at the end of last month, had spooked investors since durvalumab is AstraZeneca's most important pipeline medicine.

    (Reporting by Ben Hirschler; Editing by Mark Potter)
     
  16. anonymous

    anonymous Guest

    The competition in this area will be fierce. The best compound will get nearly all of the business if they are differentiated. Typically poor clinical trial designs by AZ almost assures that they will not have the the best label to be the "best" compound.
     
  17. anonymous

    anonymous Guest

    Have a look at Lilly today. How many recent new hires will be let go now that this disaster has arrived? This is our future too. Big Pharma is on life support and our jobs are no longer valued or necessary. One question, would you pay you what you make if you owned AZ?
     
  18. anonymous

    anonymous Guest

    Pay for delay is still AOK!

    AstraZeneca: Nexium Pay-For-Delay Win Upheld (AZN)
    Shobhit Seth
    Investopedia

    November 23, 2016
    A U.S. appeals court upheld the win for AstraZeneca Plc (AZN) and Ranbaxy Laboratories in a lawsuit where drug wholesalers and health plans had accused them of striking an illegal deal to delay the launch of a generic version of AstraZeneca's heartburn drug, Nexium. The 2012 class action lawsuit accused AstraZeneca of paying Ranbaxy $700 million to delay launching a generic version of Nexium, and to abandon its challenges to AstraZeneca patents, which had expired in 2014. AstraZeneca and Ranbaxy were the first companies to be tried for such deals, often referred to as "pay-for-delay." India-based Ranbaxy is a unit of Sun Pharmaceutical Industries Ltd. (See also: Big Pharma Faces 'Pay For Delay'
     
  19. anonymous

    anonymous Guest

    Another head to head battle with GSK this time for anemia.

    The AZ clinical trial was run in China? That is not a very diverse group is it?

    GSK chases Astra with start of big anaemia drug trials
    Reuters
    November 24, 2016

    LONDON, Nov 24 (Reuters) - GlaxoSmithKline has started pivotal trials of an experimental anaemia drug, chasing AstraZeneca in the race to develop a medicine that mimics the body's response to high altitude.

    GSK's daprodustat, given as a pill, is designed to displace injectable EPO products that are used widely in patients with chronic kidney disease. EPO, which boosts red blood cells, is also infamous as a doping agent in sport.

    The new drugs work by copying the body's response to hypoxia, or low oxygen levels, by increasing the natural production of EPO in the kidneys.

    GSK said on Thursday its two Phase III clinical studies would enrol a combined total of 7,500 patients with kidney disease.

    The trials will look at daprodustat's effect on anaemia and also assess cardiovascular safety, given the heart risks associated with current injectable EPO.

    AstraZeneca's roxadustat pill, which is being developed with FibroGen and Astellas, is already in a Phase III testing programme involving more than 8,000 patients. In China, the trials have been completed and roxadustat is now set for regulatory submission.

    (Reporting by Ben Hirschler; Editing by Alexander Smith)
     
  20. anonymous

    anonymous Guest

    Up to but not including:

    AstraZeneca in broad drug deal with Bicycle worth up to $1 bln
    Reuters
    December 1, 2016

    LONDON, Dec 1 (Reuters) - AstraZeneca has signed a wide-ranging deal with private biotech firm Bicycle Therapeutics to develop a novel class of small molecule medicines for treating respiratory, cardiovascular and metabolic diseases.

    The companies said on Thursday the alliance could potentially be worth more than $1 billion to Bicycle, if all planned programmes reach the market. This includes an undisclosed upfront payment.

    The early-stage research is focused on using Bicycle's so-called bicyclic peptide products, which have some of the characteristics of injectable antibody drugs but are small molecules that could be given as pills.

    For AstraZeneca, the deal expands its drug discovery capacity in core therapeutic areas outside oncology. Currently, most investors in the company are focused on its pipeline of experimental cancer treatments.

    Bicycle, which raised $32 million from investors in an initial funding round in 2014, was set up to capitalise on research initiated at the MRC Laboratory of Molecular Biology in

    Cambridge, England.

    (Reporting by Ben Hirschler; Editing by Keith Weir)