AZ News from the Street 2015

Discussion in 'AstraZeneca' started by Anonymous, Jan 5, 2015 at 1:35 PM.

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  1. Anonymous

    Anonymous Guest

    Shake-up at AstraZeneca as two immuno-oncology leaders leave
    Reuters
    1 hour ago

    * Immune-boosting cancer drugs critical to company's future

    * Iannone named new head of immuno-oncology drug development

    * Next up, Astra awaiting clinical trial news on Brilinta

    LONDON, Jan 5 (Reuters) - AstraZeneca has appointed a new leader for its all-important immuno-oncology drug development operation after the departure of the previous head for personal reasons, the British-based drugmaker said on Monday.

    Rachel Humphrey left the company at the end November and was replaced last month by Robert Iannone, a member of the global medicines development team, a spokeswoman said in response to inquiries. Her departure was not announced at the time.

    Humphrey's exit coincides with the loss of another leader in immuno-oncology, albeit from a different part of the firm. Peter Emtage, who was involved in early research at AstraZeneca's unit MedImmune, was appointed to a senior position at biotech company Intrexon on Dec. 4.

    AstraZeneca said the two departures were a coincidence and the company's work in immuno-oncology was proceeding at full steam, with no problems with any programmes. "It's business as usual," the spokeswoman said.

    The drugmaker, which saw off a $118 billion takeover attempt by Pfizer last year, is banking on new cancer medicines to help revive its fortunes.

    It is also hoping for an imminent boost to its heart drug Brilinta from results of a clinical trial - known as PEGASUS - assessing the medicine's use in patients who experienced a heart attack 1-3 years ago. That group could more than double the number of patients eligible for Brilinta.
     

  2. Anonymous

    Anonymous Guest

    Reading in between the lines. AZ is totally fucked up beyond repair. The smart ones leave and the desperate ones replace them.
     
  3. Anonymous

    Anonymous Guest

    Gee... did they do badly on their scorecards or something?
     
  4. Anonymous

    Anonymous Guest

    maybe they gagged on the kool-aid
     
  5. Anonymous

    Anonymous Guest

    PEGASUS-TIMI 54 Study of BRILINTA® Meets Primary Endpoint in Both 60mg and 90mg Doses

    BRILINTA 60mg and 90mg demonstrate statistically significant reduction in major cardiovascular thrombotic events in patients with a history of heart attack
    Business Wire
    AstraZeneca 3 hours ago

    WILMINGTON, Del.--(BUSINESS WIRE)--

    AstraZeneca (AZN) today announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA® (ticagrelor) tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke.

    Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing.

    Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “We are very pleased with the top line results of the PEGASUS-TIMI 54 study, the second positive major outcomes study in the PARTHENON program. The results build on existing understanding of the benefits of BRILINTA for patients with acute coronary syndrome and offer important clinical insights into its potential role for the longer term prevention of cardiovascular events. We look forward to presenting the data later this year.”

    The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events.

    Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities.

    The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.

    BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with PAD, stroke, diabetes or atherosclerosis.

    BRILINTA (90mg) is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention (PCI), it also reduces the rate of stent thrombosis.

    BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin > 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin > 100 mg daily.
     
  6. Anonymous

    Anonymous Guest

    Stakes High for AstraZeneca, Heart Drug Facing Tough Competition
    By Oliver Staley Jan 15, 2015 6:45 AM ET

    If AstraZeneca Plc (AZN) hopes to fend off another takeover attempt, it needs heart drug Brilinta to become a blockbuster. It has to overcome tough competition to get there.

    The second-largest U.K. drugmaker yesterday announced promising results for a trial of the anti-clotting pill, indicating that more patients could benefit from Brilinta, which has been a disappointment in the U.S. since its 2011 debut. AstraZeneca sold $283 million of the pill in 2013, yet has told investors that it can reach $3.5 billion in revenue by 2023.

    Chief Executive Officer Pascal Soriot identified the pill as one of five key growth areas while rebuffing Pfizer Inc.’s proposed acquisition last year. In May, Soriot said he could boost AstraZeneca’s annual revenue to $45 billion by 2023, a 75 percent gain over a decade. To get there, Brilinta will have to take market share from generic rivals favored by doctors.

    “It’s a pretty tall order in the face of generic competition,” said Nicholas Turner, an analyst with Mirabaud Securities Ltd. in London, who recommends selling AstraZeneca stock. “They’ve got their work cut out.”

    Other analysts are also skeptical that Brilinta, sold as Brilique in Europe, will be a powerhouse. Six analysts estimate it will generate average sales of $1.3 billion for 2020.
    Photographer: Victor J. Blue/Bloomberg

    AstraZeneca Plc Chief Executive Officer Pascal Soriot identified Brilinta as one of... Read More

    AstraZeneca dropped for a second day, declining 2.4 percent to 4,568.50 pence in London trading as of 11:37 a.m. That pares the stock’s gain to 22 percent over the past 12 months, similar to the advance in the Bloomberg Europe Pharmaceutical Index.
    Bellwether Drug

    “People are looking at Brilinta as a bit of a bellwether,” said Tom Keith-Roach, AstraZeneca’s vice-president in charge of the drug. “People are looking at whether we can deliver what we say we can deliver.”

    Oral antiplatelets such as Brilinta are a critical part of the therapy for heart attack victims to keep blood flowing, and for patients who have stents inserted into arteries.

    Aspirin is the cheapest and most commonly prescribed antiplatelet, though doctors typically prescribe a second drug as well. For about a decade, that has usually been clopidogrel, a drug sold as Plavix by Bristol-Myers Squibb Co. (BMY) and Sanofi that generated $9.9 billion in revenue in 2011. It has been available in generic versions since 2012.

    Because generic clopidogrel is far cheaper, costing about $12 a month compared to about $270 for Brilinta, AstraZeneca has invested millions in clinical trails to prove its drug is better. Almost 80,000 patients will be enrolled in five studies, the first of which was started in 2006, making it the largest program in the company’s history.
    Pegasus Results

    The second of those studies, called the Pegasus trial, yielded initial results announced yesterday that indicated patients may benefit from the drug more than a year after a heart attack. Patients currently take anti-clotting drugs for about a year after a heart attack, and then switch to aspirin alone.

    The latest “results will continue to build positive momentum and confidence behind the brand,” Keith-Roach said yesterday. “We’ll see consistent growth and strengthening momentum over the course of the next three or four years as these studies read out.”

    AstraZeneca’s hope is that sales of the drug will double or triple if it can be prescribed far beyond a year, Turner said. That assumes doctors won’t instead just put patients on generic clopidogrel, even though it’s not been proven in trials, he said.

    “It’s quite reasonable to assume that the positive result in Pegasus could be translated” to generics, he said.

    The full results of the Pegasus trial, which will be released later this year, will be critical for its sales, said Sam Fazeli, an analyst at Bloomberg Intelligence.
    Results ‘Critical’

    “It all depends on the strength of the data they get,” he said. “If they come out all guns blazing, it will be very hard for a doctor not to prescribe it.”

    So far, doctors in the U.S. have been wary, particularly as questions were raised starting in 2010 after U.S. and Canadian study participants fared worse than patients elsewhere in the initial trials. That led U.S. regulators to ask for more information and the U.S. Department of Justice began a probe in 2013.

    AstraZeneca said the results were probably affected by the higher doses of aspirin that U.S. patients took, and the drug was approved in the U.S. in 2011. The Department of Justice dropped its inquiry last year.
    Cost Pressure

    Cost is also a factor, said Oscar Cingolani, the associate director of the coronary care unit at Johns Hopkins Hospital in Baltimore. If patients aren’t going to take Brilinta because they can’t afford it, it makes sense to prescribe the lower-cost alternative, Cingolani said.

    Still, Brilinta -- whose chemical name is ticagrelor -- was suggested as the preferred option in new guidelines issued last year by the American Heart Association/American College of Cardiology for the treatment of heart attacks in which arteries aren’t completely blocked, as well as in unstable angina. The combined condition, called NSTE-ACS, affects more than 625,000 U.S. patients a year.

    “When it comes to the bottom line, reducing complications, morbidity and mortality, ticagrelor stands out,” said Ezra Amsterdam, a professor at the University of California at Davis and the chair of the committee that wrote the guidelines.

    Brilinta is important for more than just AstraZeneca’s sales. It’s also a test of the company’s ability to sell a specialty drug in a market with tougher regulations and resistance to higher prices.
    Poor Sales

    Sales were poor when Brilinta debuted in 2011 in part because the company had to learn how to sell to hospital systems that make prescribing decisions, said AstraZeneca’s Keith-Roach.

    AstraZeneca didn’t support the drug with the necessary resources when it debuted, and now is spending on developing its sales force and educating doctors, he said.

    “This has been a massive change in our organization,” Keith-Roach said. “We have basically ripped up the playbook, and written a new one.”

    The company now has a sales force of about 2,000 pushing the pill. The goal is to reach the decision makers who add Brilinta to hospital emergency room protocols, and not just the doctors who treat patients, he said.

    To effectively unleash its army of salespeople, AstraZeneca needs powerful results from Pegasus and from future studies, Fazeli said.

    “The drug isn’t going to start selling itself,” he said. “You need clinical data behind it.”
     
  7. Anonymous

    Anonymous Guest

    Well, somebody has woke up and smelled the coffee.
     
  8. Anonymous

    Anonymous Guest

    Notice they said it's most likely the results from Pegasus could seen with generics too. AZ is spending more money on Brilinta trials that it has on any other drug in the history of the company. Do you really think docs will see the results of these studies as being strictly applicable to Brilinta, and not any of the other meds?

    The pressure to use generics is increasing by the day. Frenchie will drive AZ into the ground. It will be interesting to see the 2013 AZ full year results in a few weeks. How long can we go with reps running into each other in the field like bowling pins every day? A layoff has to happen.
     
  9. Anonymous

    Anonymous Guest

    The question you are raising as to whether these are class effects or if they drug specific effects can only be proven by running expensive clinical studies. No one is ever going to do a clinical study on these benefits for the generics, except for possibly the NIH, which is unlikely. That is the difference between conjecture and fact. New entry patented competitor drugs may prove that they also have these outcome benefits with there own studies down the road. If the drug prescribed (generic) is proven to have a poorer outcome than the patented drug, then the prescribers are opening themselves up to legal liability if they use that inferior drug. They will have to switch to the better drug despite the cost advantage, at least as long as the patient has insurance to pay for it. Positive outcomes in clinical studies will drive more general use of this drug whether the payors like it or not.
     
  10. Anonymous

    Anonymous Guest

    While you can sue someone for any reason, winning a case requires more than a lawyer with a pen. No way a doctors or PA willl be found negligent for Rxing a drug you term "inferior" in the same class. The FDA rules on safety and efficacy, not relative measures of either one.

    That's the other side of all of the me too products out there, and Rx companies use it to the hilt, changing a methyl group on a statin or impotence drug or whatever until there are six drugs in the class, spending billions in clinical trials and marketing, only -- only -- to get a piece of the market share and make money. Every company can make the case that their drug is better than the other guys. I could sell pravachol because it is better tolerated so patients are more likely to be compliant and it's the pleitropic effects that are important about statins, right?

    Meanwhile, there are still big time killers in other parts of the world than the US that are ignored by commercial Rx companies because no one in the undeveloped world can pay $200.00 a month for a nosespray or restless leg syndrome or whatever else pharma does under the Patient Health First slogan.
     
  11. Anonymous

    Anonymous Guest


    Well said- it makes me sad to be in this industry sometimes.
     
  12. Anonymous

    Anonymous Guest

    Wow, am I glad I left the industry. What POS it turned into. Studies are all so well designed that everything is a me too from sales models on what to spew to the pills the reps push.
     
  13. Anonymous

    Anonymous Guest

    It's because the pharmas and sr leaders are clueless, and do only what the consultants tell them to do, which has nice benefit for ZS associates which is basically running the entire pharma industry, except for actually making the pils themselves. The more dysfunction, the better for ZS. It also helps pad senior mgmnt resumes that they led through an era of big change. Too funny.
     
  14. Anonymous

    Anonymous Guest

    Seriously dude? You're chugging down the Kool-Aid believing what marketing and sales tells you to do to shill physicians to increase market share. Period
     
  15. Anonymous

    Anonymous Guest

    No kidding. What a Kool Aid Drinker if the PP really believes that dribble. Doctors are NOT going to switch to the higher cost alternative. I had many who said that the twice a day, the cost and availability were such issues they would never use B. They were more afraid of getting sued b/c a pt with a stent leaves the hospital and runs into an unaffordable situation, maybe going for a few days w/o their OAP, then the fact that B might be a hair better. You got to weigh that risk benefit: The risk of the pt running into cost issues and not filling their Rx verses the small benefit seen in a clinical trial. A trial is NOT real world.
     
  16. Anonymous

    Anonymous Guest

    If you think about it this is a system designed to fail.

    Hercule Soiroit was paid $1,000,000.00 before starting. Most people -- BY FAR -- most people work a lifetime for that, and he gets it before coming to work. Why why why would he want to change anything?

    As long as the ship stays away from the inevitable, he gat's paid, every two week, more than a rep (not a bad paycheck either) gets in three years.

    Why in the world would any sane man upset the cart?
     
  17. Anonymous

    Anonymous Guest

    Not the biggest fan of AZ by any means, but IMO Soriot has done quite a lot in trying to move AZ to a different direction. He could have made the jump to Pfizer, it would have been the easy way out, but he didn't do that. He has increased molecules for future drugs and still has a huge hole to fill with the patent cliff. The man is no fool. If he pulls it off and gets over the hump, my hat's off to him.
     
  18. Anonymous

    Anonymous Guest

    He is an egomaniacal, self-centered idiot! You don't turn down the kind of money Pfizer offered! He knew he would not be the CEO, which he couldn't stand, so he turned them down. The Board is obviously controlled by him. The shit hits the fan next year. We'll see what happens between now and then, and more importantly, after the patent expirations hit the bottom line.
     
  19. Anonymous

    Anonymous Guest

    Just the fear of legal liability is enough to get a prescribers attention. If outcomes are PROVEN to be better for a superior drug in a clinical trial that meets the primary endpoints, then you are going to open to legal liability if you don't at least offer to the patient use it. If the patient has a preventable event on the generic, a lawyer will be right on that case. If the patient fails to comply, that's going to be on them unless they at least ask for an alternative. Statins are a very poor analogy. Nobody needs any statin in an acute sense. If you don't take a statin you may have an issue in a few years for most patients. The linkage to the drug is going to be impossible to prove. People are seriously injured or they may even die from clots and bleeds, in real time. You would have a more provable case for that drug. The fear of being sued is enough. More proven improved outcomes will kick the old generics to the scrap heap for most insured patients. If you want this drug to ever succeed, then even more successful clinical trials are in fact going to be needed. Brilinta is NOT a me too drug, it is first in class, and more work is going to be needed to insure its clinical adoption. Even with statins, which are a poor analogy as I said earlier, really how many patients were actually still using the cheaper pravacol after the superstatins became available? A very low percentage, that is for sure.
     
  20. Anonymous

    Anonymous Guest

    Lawyers are already going after Plavix saying the like:

    "Plavix is a blood thinning drug used to prevent a blood clot, stroke or heart attack. This medication, however, may also cause severe bleeding in some patients who take the drug. Numerous lawsuits across the country allege that Plavix caused complications such as cerebral hemorrhaging (brain bleeding) and gastrointestinal hemorrhaging (abdominal bleeding). These claims are supported by several research studies showing that people who take Plavix have a higher rate of bleeding events compared to those not taking the drug."

    ...compared to those NOT taking the drug... Duh!

    But you know what? - over time the ambulance chasers are going to do the same thing with Brilinta - IF it gets enough share.

    Plavix is FDA approved and if it's appropriately used within indications, that's usually good enough. Still, lawyers are going to seek class action lawsuits against it.

    That other stuff you're spewin', have heard it a thousand times and it don't hold water.