AZ News from The Street 2014

Discussion in 'AstraZeneca' started by Anonymous, Jan 2, 2014 at 10:34 AM.

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  1. Anonymous

    Anonymous Guest

    But that's the AZ way, buy and destroy.
     

  2. Anonymous

    Anonymous Guest

    That's true everywhere, not just Japan.
     
  3. Anonymous

    Anonymous Guest

    They will love the stack rank and yank culture of the U.S. Those of us who made it to the top love to beat the shit out of people and torture them in by putting them in a constant state of panic that someone, somewhere will take a disliking to them and put them on their hit list. Nobody sticks up for anyone here. It is strictly eat or be eaten.
     
  4. Anonymous

    Anonymous Guest

    AstraZeneca digs into new Cambridge home with MRC drug deal

    By Ben Hirschler

    CAMBRIDGE, England, March 31 (Reuters) - AstraZeneca , which will complete its move to Cambridge by 2016, is already putting down roots in the ecosystem of the university city as it seeks to revitalise its drug research.

    Britain's second-biggest pharmaceuticals group said on Monday it had struck an unique deal with the state-funded Medical Research Council (MRC) under which academic scientists will work alongside its staff at its new Cambridge site.

    Transplanting AstraZeneca to the university city in the east of England forms the centrepiece of a $2.5 billion restructuring plan by Chief Executive Pascal Soriot, who hopes closer links with academia will spark ideas and innovation.

    AstraZeneca has suffered a dry period in drug discovery in recent years and badly needs to find new medicines to replace blockbusters like Nexium for heartburn and Crestor for high cholesterol that will lose patent protection in a few years.

    The initial five-year MRC collaboration, which was welcomed by British science minister David Willetts, may provide part of the answer by finding early leads for new drugs.

    Within the AstraZeneca MRC UK Centre for Lead Discovery, the academics will get access to more than 2 million compounds in AstraZeneca's library and have the use of high-tech screening equipment to study diseases and possible treatments.

    Their research proposals will be assessed by the MRC, which will fund up to 15 projects a year and AstraZeneca will have the first option to license any resulting drug discovery programmes.

    Mike Snowden, head of discovery sciences at AstraZeneca, said the MRC agreement was a "flagship" deal but the firm would also strike other academic tie-ups from its new home base.

    "The strategy is to share science," he said. "Cambridge is a hotspot for bioscience. That's why we're moving there and it certainly makes it easier to work with people like the MRC, who have their Laboratory of Molecular Biology next to where we work."

    AstraZeneca's $500-million corporate headquarters and R&D centre in Cambridge will put some 2,000 staff within walking distance of university scientists and academic labs when it is completed in two years time.

    In July, AstraZeneca agreed another deal with the university and Cancer Research UK specifically to seek out new cancer-fighting drugs.

    Other large drugmakers have built research outposts in life science centres like Cambridge, Boston and San Francisco - but none have undertaken such a wholesale move of operations.

    The strategy is not without risks, especially if the upheaval disrupts current research projects or results in key staff leaving the company. A smooth transition is seen as a key test for CEO Soriot as he tries to change the culture at AstraZeneca to put science at the centre of its activities.

    AstraZeneca currently has a limited research presence in Cambridge via its biotech unit, MedImmune. Most R&D has been carried out at a site in Alderley Park, near Manchester, which AstraZeneca is now selling.
     
  5. Anonymous

    Anonymous Guest

    I'll bet they will publish lots of papers!! Drugs, not so much.
     
  6. Anonymous

    Anonymous Guest

    Update on Pfizer's OTC Nexium 24HR
    Zacks By Zacks Equity Research
    18 hours ago

    Pipeline updates are eagerly awaited by investors in the biotech/pharma space. An insight into late-stage candidates (including regulatory approval) targeting lucrative markets often influence their investment decisions on a particular stock.

    Late last week, Pfizer (PFE) announced that it has received the U.S. Food and Drug Administration :)FDA) approval for its over-the-counter (OTC.TO) version of AstraZeneca's (AZN) Nexium 24HR. Nexium is approved for the treatment of the symptoms of gastroesophageal reflux disease :)GERD).

    We remind investors that in Aug 2012, Pfizer acquired exclusive worldwide rights from AstraZeneca to market OTC Nexium. Per the terms of the agreement, AstraZeneca received an upfront payment of $250 million from Pfizer and will further receive milestone and royalty payments on product launches and sales.

    Pfizer plans to work with AstraZeneca to launch the product in the U.S. Pfizer expects to launch the drug in Europe and other countries later this year.

    Our Take

    We view this agreement as beneficial for both Pfizer and AstraZeneca. While the deal will boost Pfizer’s consumer health segment sales once OTC Nexium 24HR is launched, it will also ensure that AstraZeneca continues generating revenues from Nexium even after its genericization.

    Nexium generated sales of approximately $3.9 billion in 2013, accounting for more than 15% of AstraZeneca’s total revenues. However, the company expects Nexium sales to decline in 2014 due to generic competition, which is expected at the end of May. We remind investors that AstraZeneca is entangled in patent litigation related to Nexium with several generic companies including Kremers Urban Pharmaceuticals Inc., a subsidiary of UCB (UCBJF).
     
  7. Anonymous

    Anonymous Guest

    Chance Ranbaxy Nexium Generic Launch Delayed
    Apr. 4, 2014 7:38 AM ET


    Summary
    •Ranbaxy launch of generic copies of Nexium may be delayed by about 6 months or more.
    •Incremental Profits for Ranbaxy from Nexium generics will be much lower than anticipated because of the delay.
    •Even if they launch it timely, I expect profits to be about 50 percent lower than expectations.
    •AstraZeneca currently accounts for a Nexium generic entry in its annual guidance for FY-14 will benefit and revise its guidance upwards.

    Ranbaxy (OTC:RBXZF) stock is up 30 percent from the new lows it created last month. This time the rally is in expectation of superlative gains from launch of Nexium generics expected in May 27 2014 (as per settlement agreement with AstraZeneca (AZN) ). In 2013, Nexium generated $2.1b in annual sales and the street is widely expecting Ranbaxy to reap a bonanza ($250m in incremental profits) as it has a first to file 180-days exclusivity on it.

    But I feel investors are missing on the details and are being carried away as

    1) There is a strong chance that Ranbaxy may not be able to launch Nexium Generics timely and in that case AstraZeneca would be able to restore their brand exclusivity for a longer duration which might lead them to raise their guidance for the year.

    2) Resulting profits for Ranbaxy from launch of generic copies Nexium generics will be significantly less due to recent changes in competitive dynamics

    3)A delay in launch which will further aggravate the impact of these changing competitive dynamics

    There is a strong chance that Ranbaxy may not be able to launch Nexium Generics timely and in that case AstraZeneca would be able to restore their brand exclusivity for a longer duration

    Ranbaxy may be able to launch Nexium generics only by end of this year and not in May 2014 as widely anticipated. In January this year, Ranbaxy received a import alert on its API manufacturing facility at Toansa in India.

    Besides Toansa, Ranbaxy has three other USFDA approved facilities (Dewas, Poanta Sahib, Mohali) which also have been banned for selling products in the US because of poor manufacturing practices. Thus effectively all of Ranbaxy's USFDA approved plants in India are under import alert now. So under the present situation Ranbaxy has just one USFDA approved facility which is Ohm's laboratory in the US and this is a formulation manufacturing plant (no API).

    This implies Ranbaxy would be forced to source API from a third party and get it manufactured in its US plant which is Ohm's laboratories. But in order to do so Ranbaxy would need to get its ANDA approved from Ohm's lab which may or may not be possible in the limited time frame (uptil May 27, 2014). The USFDA takes on an average 18 months to approve a fresh ANDA. Hence it is unlikely that Ranbaxy would be able to launch Nexium generics anytime now.

    Resulting profits for Ranbaxy from launch of generic copies Nexium generics will be significantly less due to recent changes in competitive dynamics

    In 2013 Nexium generated $2.1b in annual sales. The sales in 2014 will be reduced by as much as 60 percent from current levels for the following reasons.

    1) Generic competition has already entered Nexium and the longer the delay Ranbaxy makes to launch its generic version the larger will be its loss

    Amneal and Hanmi Pharma have already launched esomeprazole strontium which is a bioequivalent version of Nexium earlier this year. Esomeprazole strontium was developed by Korea based Hanmi and is being marketed by Amneal pharma which is one of the leading generic player in the US. Amneal launched the drug in December 2013 and by the time Ranbaxy would launch Amneal would have already carved a fair share - about 20 -40 percent depending on the extent of delay.

    Besides Ranbaxy would also need to offer a discount to existing versions which will again impact their potential profit margins.

    2) Pfizer has received approval for launching an OTC version of Nexium - Last week, the USFDA gave a nod to Pfizer for launching an OTC version of Nexium. Pfizer has in-licensed rights for OTC Nexium from AstraZeneca. Pfizer had paid $250m in upfront payment and promises royalties in addition to milestone payments to AstraZeneca on sales of OTC Nexium. In line with other OTC launches like Allegra and Zyrtec, Pfizer should be able to grab about 25 percent market share.

    3) AstraZeneca Direct to Patient program will affect sales of generic player - With an objective to retain a fair share of the Nexium pie its AstraZeneca has recently announced launch of "Nexium Direct" Program which has several benefits for consumers will take off the incentive for patients to shift to generics.
    1.Automatic refill
    2.24 hour patient support
    3.Free home delivery
    4.Commercially insured patients need not pay more $25 per month

    This means if patients choose to buy from AstraZeneca their effective cost might even be less than a generic drug. With Nexium Direct Program, AstraZeneca should be able to defend around 25 percent market share.

    Ranbaxy margins on Nexium Launch will be significantly compromised for two reasons

    Higher cost of manufacturing

    Since Ranbaxy will have to procure API from a third party and launch from their Ohm's lab facility, their effective margins could go as low as 30 - 35 percent as against the typical 50 percent expected in such launches. The cost of manufacturing at Ohm's lab would obviously cost Ranbaxy about 20 percent higher than if they had procured it from an Indian facility. They will also have to cough up a much higher price for sourcing API from a third part than if they had manufactured on their own. Hence the effective increase in cost of sales should be around 30 - 40 percent

    Limited Pricing Power

    Ranbaxy will have to price its drug competitively keeping in view

    1) presence of esomeprazole strontium on the market

    2) OTC Nexium cost

    3) Availability of Nexium at a significantly cost effective price because of Nexium Direct program from AstraZeneca.
     
  8. Anonymous

    Anonymous Guest

    GLP-1 coming competition news:


    Glaxo's Tanzeum Approved in the U.S.
    Zacks By Zacks Equity Research
    15 hours ago

    FDA approves Tanzeum to treat type 2 diabetes theflyonthewall.com Halozyme Study Under Clinical Hold Zacks Good News for Keryx Zacks Repros Completes Enrollment for Androxal Study Zacks Glaxo Stops MAGE-A3 Lung Cancer Study Zacks
    GlaxoSmithKline’s (GSK) diabetes drug, (EU trade name: Eperzan), gained approval in the U.S. as an adjunct to diet and exercise in adults suffering from type II diabetes.

    The U.S. Food and Drug Administration :)FDA) approved Tanzeum, a glucagon-like peptide-1 receptor agonist (GLP-1), on the basis of encouraging data from eight phase III trials. Glaxo expects to launch the once-weekly drug in the U.S. in the third quarter of this year.

    We remind investors that last month Tanzeum was also approved by the European Medicines Agency. Glaxo expects to launch the drug in the third and fourth quarters of this year in several countries in Europe. Launches are expected to continue thereafter in other European countries.

    However, Tanzeum’s label will include a boxed warning regarding potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC.V). Use of GLP-1 receptor agonists have been found (at clinically relevant exposures) to be associated with thyroid C-cell tumors in rodent studies.

    The FDA has requested Glaxo to conduct additional post-marketing studies on Tanzeum evaluating the risk of MTC. The FDA has also asked for a study evaluating the use of the drug in pediatric patients and a cardiovascular outcomes trial.

    Meanwhile, Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy with communication plan regarding serious risks associated with Tanzeum.

    Our Take

    Type II diabetes affects approximately 24 million people in the U.S., thus representing a lucrative market. Tanzeum’s once-weekly treatment regimen for type II diabetes provides patients with a more convenient treatment option over the daily dosing regime of GLP-1 products including Novo Nordisk’s (NVO) Victoza among others.

    However, we are concerned about the potential MTC related risks associated with Tanzeum. We believe this can limit the drug’s sales significantly.

    Additionally, we note that AstraZeneca (AZN) already markets Bydureon, a GLP-1 receptor agonist with once weekly dosing. Apart from that, several big pharma companies have GLP-1 candidates (semaglutide) with once weekly dosing in late-stage development.
     
  9. Anonymous

    Anonymous Guest

    Ain't that the truth????
     
  10. Anonymous

    Anonymous Guest

    This has been the plan for years. All we do is reorg every 18 months. Sales force is way too big. Motivated? They work 20 hours a week at best. But we just keep spending, moving sites around. Thats Pascals legacy. Check it out.
     
  11. Anonymous

    Anonymous Guest

    Pfizer Said to Have Held Now-Dormant Talks to Buy AstraZeneca
    By Drew Armstrong and Aaron Kirchfeld Apr 21, 2014 9:41 AM ET



    Pfizer Inc. (PFE), the world’s biggest drugmaker, held informal, now-discontinued talks with AstraZeneca Plc about possibly buying the London-based maker of asthma and heart drugs, said two people familiar with the matter.

    The companies aren’t currently negotiating, said the people, who asked not to be identified. One said the talks happened several months ago and there are no plans to resume. The discussions were first reported yesterday by London’s Sunday Times, whose unnamed bank and industry sources said New York-based Pfizer made a tentative approach about a takeover valuing AstraZeneca at more than 60 billion pounds ($101 billion).

    If revived, such an acquisition would be among the largest ever in the industry. Pfizer has reorganized its business over the past three years, shuttering some research projects and emphasizing others. A deal with AstraZeneca (AZN) would add early-stage drugs in a field of cancer treatments that use the body’s own immune cells to recognize and attack cancer.

    “We don’t comment on market speculation or rumors,” said Andrew Topen, a Pfizer spokesman, in an e-mail. Esra Erkal-Paler, am AstraZeneca spokeswoman, declined to comment.

    American depositary receipts for AstraZeneca gained 5.9 percent to $67.26 at 9:37 a.m. New York time. Pfizer rose less than 1 percent to $30.50, after increasing about 35 percent in the last two years as it benefited from the revamping that focused it into three units: two for new drugs, and one for older products.

    Pfizer Inc.’s stock has gained 34 percent in the last two years.

    AstraZeneca Treatments

    AstraZeneca in January announced an agreement with Immunocore Limited to develop the new cancer treatments that use the body’s own immune cells, and it also has several of its own immune-based drugs being tested in multiple cancers. The company’s shares have risen about 32 percent over two years, even as sales have fallen from $33.6 billion in 2011 to $25.7 billion last year, with further losses projected by some analysts as drugs lose patent protection.

    While a deal would be highly accretive through cost cutting, Pfizer shareholders may have doubts about AstraZeneca’s pipeline as well as its eroding revenue, said Mark Schoenebaum, an analyst with ISI Group LLC.

    “The consensus AstraZeneca model is hugely dependent on pipeline assumptions, as the base business will deteriorate massively by 2020 as several key products go off patent,” he said in a note to clients.

    Mega-Mergers

    A merger of this reported size would top Pfizer’s 2000 purchase of Warner-Lambert Co. for $87 billion, the industry’s largest deal, according to data compiled by Bloomberg. Pfizer has been at the center of the biggest drugmaker mega-mergers, making up three of the 10 deals worth more than $30 billion in the last two decades.

    It would also provide a use for Pfizer’s cash from profits that have been stashed overseas instead of being brought back to the U.S., where they would be taxed at a higher rate. Pfizer had $69 billion in untaxed cash overseas as of last month, according to data compiled by Bloomberg.

    A purchase of AstraZeneca could also potentially allow Pfizer to move its tax domicile to the U.K. through a so-called inversion transaction, a move that has allowed other U.S. drugmakers to lower their tax bill.

    AstraZeneca shares in London rose 0.6 percent to close at 3,781.50 pence on April 17, giving the company a market value of 47.7 billion pounds. The London stock market was closed for a holiday April 18 and today.

    Merger Comments

    Since taking over in 2010, Pfizer Chief Executive Officer Ian Read’s answers to whether or not he would pursue a mega-merger such as a deal with AstraZeneca have shifted.

    On a January conference call in 2012 he said, “I’m very disinclined to be looking at any possibility of another mega-acquisition. You never say never, but we have all of the science we need.”

    In July 2013, when Read was asked on another conference call about the size of deals he might pursue, he replied: “We’ll look at any type of acquisition -- never say never to a larger acquisition that made sense.”

    Schoenebaum said there were signs Pfizer could pursue a large target. “Pfizer has been signaling since last summer that, in theory, the company would not be opposed to a larger M&A deal if the numbers made sense,” Schoenebaum said
     
  12. Anonymous

    Anonymous Guest

    Dormant, discontinued mean nothing.
     
  13. Anonymous

    Anonymous Guest

    AstraZeneca cancer pipeline seen as draw for Pfizer
    By Ben Hirschler

    LONDON, April 21 (Reuters) - Pfizer may come back to bid for British drug company AstraZeneca after its reported 60 billion pound ($101 billion) takeover approach was rejected, since a deal could make sense for the U.S. pharmaceuticals giant as it seeks to build up its cancer franchise.

    In addition to adding promising - though still risky - experimental medicines known as immunotherapies that boost the body's immune system to fight tumours, acquiring AstraZeneca could also generate significant cost savings, according to industry analysts.

    As a result, a deal at around a 25 percent premium to the current share price funded by cash, cheap debt and some stock could boost Pfizer earnings immediately, they believe.

    Both companies have declined to comment on a report in the Sunday Times, which cited senior investment bankers and industry sources saying that Pfizer approached the British pharmaceuticals group about a deal. The newspaper said no talks were currently under way after AstraZeneca resisted the approach.

    Citi analyst Andrew Baum said he believed the report was "very likely genuine" and Pfizer could return to the fray, given the attractiveness of AstraZeneca's pipeline of cancer drugs, its expertise in autoimmune diseases and the scope for taking out costs.

    "We anticipate Pfizer to push aggressively ahead with a second approach," Baum wrote in a research note on Monday, adding that AstraZeneca might seek to structure any deal as a merger of equals as a defence strategy.

    Pfizer has a long track record of making major acquisitions, with the $68 billion purchase of Wyeth in 2009 its last major deal, after earlier acquisitions of Pharmacia and Warner Lambert.

    The drugmaker has more recently been divesting certain operations and mega-mergers have fallen out of fashion in the pharmaceuticals industry following scepticism about how well some of them have worked. But Chief Executive Ian Read has said he would still consider a large deal that made sense.

    Read also has an incentive to buy assets overseas rather than in the United States since Pfizer has tens of billions of dollars accumulated through foreign subsidiaries, which if repatriated to the U.S. would be heavily taxed.

    A Pfizer move on AstraZeneca might flush out other bidders. U.S. biotech giant Amgen already has a tie up with AstraZeneca in autoimmune medicines to treat diseases like psoriasis and severe asthma.

    Novartis and larger GlaxoSmithKline have also been mentioned in the past as potential suitors, although GSK has in recent years said publicly it is not interested in making a large acquisition, while Novartis is in the middle of strategic review and already has a presence in cancer immunotherapy.

    Mark Schoenebaum, an analyst at ISI, agreed cancer immunotherapy was likely the main lure for Pfizer, since the field is expected to become one of the biggest areas of modern medicine in the next few years.

    However, Mark Clark at Deutsche Bank said Pfizer would be making something of a "leap of faith" since AstraZeneca's most exciting cancer drugs are still at an early stage of development.

    Pfizer has a highly promising breast cancer drug in late-stage development called palbociclib but otherwise its cancer portfolio is relatively weak.

    "Notably, Pfizer appears to be nowhere in the important field of immuno-oncology, which Bristol-Myers Squibb, Roche, Merck & Co and AstraZeneca currently dominate," Schoenebaum said.

    Bristol, Roche and Merck are viewed as being ahead of AstraZeneca in the new cancer field but the British firm believes it can make up ground by pioneering drug combinations, including the use of a medicine known as tremelimumab that it licensed from Pfizer.

    AstraZeneca and its rivals will present the latest clinical data on promising new cancer drugs at the May 30-June 3 annual meeting of the American Society of Clinical Oncology.

    The London market was closed on Monday for Easter but the talk of Pfizer's interest in AstraZeneca is likely to overshadow dealings when trade resumes on Tuesday.

    AstraZeneca Chief Executive Pascal Soriot, who has been credited for progress in rebuilding the company's new drug pipeline since taking over in 2012, fuelling a rally in the shares, will also come under pressure to address the reported Pfizer approach when he presents half-year results on Thursday.

    Speculation over such a takeover, which would be potentially the biggest ever foreign takeover of a British company, is likely to trigger concerns about jobs in Britain's pharmaceuticals sector, which is viewed as a key industry by the government but which has been under pressure.

    AstraZeneca has already laid off thousands of scientists and other staff as it shrinks its cost base to cope with a fall in sales due to patent losses on blockbuster medicines.

    With heartburn treatment Nexium losing U.S. patent protection next month and cholesterol fighter Crestor facing patent expiry in 2016, the decline in sales is expected to continue for several years.

    In an attempt to reshape the company, Soriot is currently moving its research and corporate headquarters to Cambridge, England. Pfizer has also made the university city a research hub after shuttering a large research site in Sandwich, southern England.

    The Cambridge connection is only one link between Pfizer and AstraZeneca, highlighting how the companies know each other well.

    AstraZeneca's head of innovative medicines Mene Pangalos also used to work at Pfizer and the two firms are familiar with each other's products from working together on projects, such as a pioneering of a new kind of clinical trial for cancer drugs announced last we announced last week.
     
  14. Anonymous

    Anonymous Guest

    I wouldn't count on that. That was only an initial offer, but it was already at a 20% premium to today's inflated AZ stock price. Market movements in the next few days will show both sides what the final successful offer needs to be as far as a price tag. Plus, Pfizer gets a huge discount buy using cash already parked overseas that has so far any avoided US taxes. They already have $70 billion cash stashed over in London that they could apply to the sale immediately, the rest of the cost could be paid with Pfizer shares. They will then probably re-headquarter the merged company in the UK for future tax reasons after this AZ purchase transaction is completed. This is just the vehicle they need to maximize the value of their overseas cash. GSK may also be a potential target that Pfizer could use to accomplish a very similar result, but GSK might just be too big for even Pfizer to swallow. Roche and Novartis might be other targets, but its not as advantageous for taxes to be headquartered in Switzerland and Roche is already partially owned by Novartis anyway. Sanofi-Aventis is headquartered in France, so that's out. Face it, AZ is really the ideal play for Pfizer to accomplish its goals, so it will probably eventually happen at some price.
     
  15. Anonymous

    Anonymous Guest

    Was the recent stock price rise that seemed to ignore the earnings due to insider trading? In this corrupt stock market, it almost surely was due to information being leaked. Well, to crack down on that we will prosecute Martha Stewart as an example. For you real market movers and shakers, never mind those silly rules, they're only for the little people.
     
  16. Anonymous

    Anonymous Guest

    don't worry, it's business as usual.
     
  17. Anonymous

    Anonymous Guest

    Stock price is back below $67.00 per share after today's trading. Either the deal is off so the premium is gone, or the Pfizer offer was already priced plenty high enough and AZ should just accept it quickly.
     
  18. Anonymous

    Anonymous Guest

    I hope they accept quickly so we can get the show on the road.
     
  19. Anonymous

    Anonymous Guest

    The company is just a shell at this point. Sell quickly before anyone on the outside realizes it.
     
  20. Anonymous

    Anonymous Guest

    It looks like Pfizer did figure that one out.