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

    Medivation Rises On Cancer Drug Data, AstraZeneca Buyout Rumor


    Shares of drugmaker Medivation (MDVN) hit an eight-month high Monday after it reported successful early-stage cancer data as buyout rumors continued to circle the company.

    On Sunday at the annual meeting of the American Association for Cancer Research, Medivation said that its drug candidate talazoparib, combined with low-dose chemotherapy, produced a clinical benefit in 23 of 40 patients with heavily pretreated cancers. The company noted that four of seven patients with ovarian cancer showed objective responses, or tumor shrinkage.

    At the same time, the Times of London reported that big British pharma AstraZeneca (AZN) is said to be preparing a bid for Medivation, which currently holds a stellar IBD Composite Rating of 97 thanks to strong growth of its sole marketed product, prostate-cancer drug Xtandi. Late last month, Medivation reportedly hired bankers to deal with buyout attempts, and last week it was said to have rebuffed a bid from Sanofi (SNY).

    Medivation stock rose 4%, above 53, near midday trading on the stock market today. It hit 54.55 intraday. The last time it cracked 54 was back in early August, before biotech stocks crashed.

    Stifel analyst Thomas Shrader wrote that the latest cancer data will likely make Medivation play even harder to get.

    “It’s hard to draw too much out of such a small data set from a single center — but these data will only make the company less interested in being acquired without very significant upside to the current value of the Xtandi franchise and at least conditional upside to the current value of the talazoparib franchise,” Shrader wrote in a research note.
     

  2. anonymous

    anonymous Guest

    AstraZeneca commits ‘hundreds of millions’ to sequencing genomes of 2M people over 10 years

    Pharmaceutical giant AstraZeneca today unveiled a ten-year project to sequence the genomes of two million people — with top-tier medical and tech partnerships and a nine-figure price tag. The resulting database would be the largest of its kind, and would be used to hunt rare genes that may contribute to diseases.

    AstraZeneca is dipping into its own stores for the first big source of data: 500,000 patients have participated in its clinical trials, and their biological materials will furnish the first quarter of the goal amount.

    The actual sequencing will be done by Human Longevity Inc, a genomics company started by Craig Venter that has raised $300 million since 2014. HLI already has about 26,000 genomes, and has stated that it plans to get to a million by 2020.

    The University of Helsinki will be contributing genomes as well, but also medical records for Finland’s geographically-isolated population. The idea is that interesting or rare genes shuffled or lost over centuries of humanity’s travel and intermarriage may still be present there.


    Scientific teams where the reams of data will be sifted through for correlations and drug targets will be established at AstraZeneca itself as well as at theWellcome Trust’s Sanger Institute in Hinxton, U.K.

    Although the full cost of the endeavor was not disclosed, AstraZeneca’s EVP of innovative medicines told Naturethat it was in the “hundreds of millions,” and Science reported Venter’s comment that it had taken over a year of negotiation to settle.
     
  3. anonymous

    anonymous Guest

    Another white huge white elephant. In my time I've seen cDNA library sequencing (also from Craig Venter!), gene expression arrays and the first genome sequencing project. All of them sold as 'big data' that will 'unlock the genome' and help identify new drug targets. All of them cost huge amounts of money and all have disappointed, as will this. The genome is not just the DNA sequence there are also methylation patterns which play a vital role and these change over time and location - none of this will be captured just by genome sequencing.
     
  4. anonymous

    anonymous Guest

    The CIO is ex-AZ.
     
  5. anonymous

    anonymous Guest

    Gout out?

    Ironwood to pay up to $256M plus royalties for U.S. rights to gout drug

    Apr 26, 2016, 7:02am EDT

    Ironwood Pharmaceuticals has announced it’s paying up to $265 million in upfront and milestone fees, plus royalties, to British drug company AstraZeneca for exclusive U.S. rights to an FDA-approved drug for patients with gout.

    The drug, called Zurampic, is approved for patients with hyperuricemia associated with uncontrolled gout. It’s pending a U.S. launch in the second half of this year, and assuming today’s license deal goes through as planned, it will be the second for Kendall Square-based Ironwood (Nasdaq: IRWD). Ironwood’s first drug, Linzess, launched in 2012, is partnered with Irish drug giant Allergan (NYSE: AGN) and saw total worldwide sales of $455 million last year. The company says the drug is on track to hit $1 billion in sales by 2020.

    Zurampic (also called lesinurad) was approved in December, but due to FDA safety concerns, AstraZeneca (NYSE: AZ) still must run a post-marketing study, according to BioPharma Dive. The website cites worldwide revenues estimates for the drug of revenue estimates being “in the $350 million range” as per Thomson Reuters Cortellis, but did not specify how much of that would likely come from U.S. sales.

    AstraZeneca plans to seek further approval of Zurampic in combination with a generic gout drug called allopurinol later this year, and under the deal, Ironwood would also have exclusive rights to that drug if approved.

    “With focused investment into the gout franchise over time, we believe we can maximize cash flows and accelerate our progress as a top-performing commercial biotechnology company,” said Tom McCourt, Ironwood’s chief commercial officer, in a statement. “Following this transaction, we expect to execute on at least five new launches in the U.S. by 2020, beginning with Zurampic in the second half of 2016 and continuing with, if approved, 72 mcg linaclotide in 2017 and a lesinurad-allopurinol fixed-dose combination in 2018.”

    Ironwood’s payments include $100 million up front, to be paid from the $439 million of cash and equivalents holdings the company reported having as of Dec. 31. It will also pay another $165 million in sales and other milestones as well as “tiered single-digit royalties on product sales.”

    The company upped its estimate for cash usage for operations for the year from less than $60 million to less than $70 million, but says it remains on track to become “cash flow positive” sometime in 2018. In 2015, the company reported a net loss of $143 million.
     
  6. anonymous

    anonymous Guest

    !
     
  7. anonymous

    anonymous Guest

    not a biggie, but something new for the bag in respiratory:


    BEVESPI AEROSPHERE(TM) Approved by the US FDA for Patients With COPD
    Demonstrated Superior Improvement in Lung Function Versus Mono-Components and Placebo
    AstraZeneca 20 hours ago


    • Hear from Tosh Butt, Vice President, US Respiratory, AstraZeneca
      WILMINGTON, DE--(Marketwired - April 25, 2016) - AstraZeneca today announced that the US Food and Drug Administration has approved BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated to treat asthma or for the relief of acute bronchospasm.

      Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: "With the approval of BEVESPI AEROSPHERE we are pleased to provide patients with the first LAMA/LABA in a pressurized metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, enabling patients to breathe better and may help them be more active."

      BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial program, which demonstrated that BEVESPI AEROSPHERE achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p < 0.001) versus its mono-components and placebo.

      LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. The most common adverse reactions with BEVESPI AEROSPHERE were urinary tract infection and cough.

      BEVESPI AEROSPHERE is the first product approved using AstraZeneca's Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

     
  8. anonymous

    anonymous Guest

    cost cutting and all in on cancer drugs:

    AstraZeneca cuts costs and doubles down on cancer drugs
    3 hours ago
    • By Ben Hirschler

      LONDON, April 29 (Reuters) - AstraZeneca is to cut costs by $1 billion and increase its focus on cancer treatments after underlying earnings, hit by drug patent expiries, fell 12 percent in the first quarter, broadly in line with analyst expectations.

      Chief Executive Pascal Soriot said on Friday he would sharpen the prioritisation of investments and increase spending in oncology while cutting commercial and manufacturing operations.

      The result would be a "material decline" in spending on commercial activities this year and next, with net annualised savings of $1.1 billion by the end of 2017. The changes will involve a $1.5 billion one-off restructuring charge.

      There will be job losses, reflecting the fact that specialist cancer drugs require smaller sales forces than ones sold to general practitioners. AstraZeneca declined to give numbers but said most of the job cuts would be outside Britain.

      The drugmaker, which saw off a takeover attempt by Pfizer in 2014, is forecast by analysts to suffer a trough in earnings in 2016 and 2017 as it continues to be hit by loss of exclusivity on key products.

      Its biggest seller, the cholesterol fighter Crestor, will face generic competition in the all-important U.S. market from next week.

      Deutsche Bank analyst Richard Parkes said the detailed cost savings plan "should help investors become more comfortable over AstraZeneca's ability to bridge the upcoming Crestor patent cliff".

      Soriot is betting on new medicines to revitalise the business, particularly in cancer, but these will take time to prove themselves. They also need investment.

      "When you have all these great opportunities you have to then support them," he told reporters. "This is where the investment is going - it is more clinical trials, essentially, and launch preparation."

      Soriot said there would be increased news about its new medicines in 2016, including a number of regulatory decisions and data readouts, particularly in oncology.

      HIGH BAR FOR M&A

      The British group has bought in products to bolster its new drug line-up, including the recent acquisitions of ZS Pharma and Acerta Pharma, but Soriot said he was setting a high bar for future deals as the company's pipeline was now full.

      He declined to comment specifically on whether AstraZeneca would consider getting into a bidding war with Sanofi over U.S. cancer treatment specialist Medivation.

      To free resources for investment, AstraZeneca has been selling off rights to non-core drugs and such "externalisation" deals helped to boost revenue by $550 million in the first quarter. AstraZeneca agreed a further deal this week to sell rights to its new gout drug for up to $265 million.

      Soriot believes he can build a business with annual sales of at least $45 billion by 2023, up from $24.7 billion in 2015, though many analysts question this target, which was first set out during the takeover battle with Pfizer.

      He has high hopes in the hot cancer area of immuno-oncology but here AstraZeneca is competing with several tough rivals, including Bristol-Myers Squibb, whose drug Opdivo has established strong early leadership.

      First-quarter revenue at the British drug company rose 1 percent in dollar terms to $6.12 billion, generating core earnings per share, which exclude certain items, of 95 cents.

      Industry analysts had on average forecast quarterly revenue of $5.93 billion and earnings of 94 cents a share, according to Thomson Reuters.

      AstraZeneca reiterated that it expected a low to mid single-digit percentage decline in both revenue and core earnings at constant exchange rates for the full year.
     
  9. anonymous

    anonymous Guest

    I would anticipate that the biggest cuts in sales won't occur until after Crestor goes off exclusivity and the sales actually drop. They won't want to leave even a dime on the table. These things take some time, so it probably won't happen immediately, even for most of those who eventually will be let go. Support groups will be cut first most likely. Good luck in your job search for those who will need to do it.
     
  10. anonymous

    anonymous Guest

    Not everything is completely rosy in oncology either:


    AstraZeneca

    Major sellers in peril:

    AstraZeneca PLC (NYSE: AZN) generated $704 million from its breast cancer drug Faslodex (fulvestrant) during 2015, about 3% of its annual revenues. The FDA approved the drug in 2002, and just last month approved an extended indication that will see the drug used in combination with palbociclib for the treatment of women with HR+, HER2-, advanced or metastatic breast cancer. Despite the agency’s willingness to approve the drug, however, it has a major drawback. It can’t be taken orally. For this reason, patients must undergo administration by intramuscular injection, usually once a month. This has obvious drawbacks, including cost, inpatient requirement and the poor drug toxicity associated with systemic administration.

    So where’s the threat? A company called Atossa Genetics Inc. (NASDAQ: ATOS) is developing an alternative formulation of fulvestrant designed for administration directly into mammary ducts. According to Atossa, this type of intraductal delivery can reduce the number of drug administrations currently required from three to one and increase the potency of the drug that actually reaches the cancerous tissue by 20,000 times. Further, the company believes it can produce and sell the drug at a much reduced cost to the current intramuscular injection Faslodex, which comes in at around $140,000 a year on average.
     
  11. anonymous

    anonymous Guest

  12. anonymous

    anonymous Guest

    AZ might not do much R&D any more, but they do have plenty of lawyers to sue.

    That poor generic company, couldn't they have found a better diabetes drug to copy.

    Even we can't sell that one.
     
  13. anonymous

    anonymous Guest

    What will AZ spend this 2.2 billion on, acquisitions? restructuring charges?


    AstraZeneca Leads 5.5 Billion-Euro Bond Binge After Holidays
    Sally Bakewell @sallybakewell1
    May 9, 2016 — 4:31 AM EDT Updated on May 9, 2016 — 12:21 PM EDT

    AstraZeneca Plc led a 5.5 billion-euro ($6.3 billion) flurry of bond offerings, kicking off a week that Deutsche Bank AG said would unleash a wave of pent-up sales.

    “We’re expecting an unusually busy week,” said Helene Jolly, a director in debt syndicate at Deutsche Bank in London. “These are extremely attractive funding conditions.”

    Airbus Group SE and Royal Dutch Shell Plc also issued bonds in the single currency, data compiled by Bloomberg show. U.S. commodity company Bunge Ltd. and Spanish insurer Mapfre SA also hired banks for potential sales, according to people familiar with the matter who asked not to be identified because they’re not authorized to speak publicly.

    Borrowing costs for investment-grade companies have fallen to the lowest in a year as the European Central Bank prepares to start purchasing corporate debt next month under its expanded stimulus program. Highly rated firms have sold about 70 billion euros of securities since the ECB outlined the plan on March 10, surpassing the 49 billion euros of bonds sold this year up to that point, according to data compiled by Bloomberg.

    “Everything has tightened in anticipation of the ECB’s corporate bond buying,” said Jolly. Some companies held back offering plans over the past few weeks because of earnings blackouts and national holidays in Europe, she said.

    Market ‘Nirvana’
    Investors demand an average yield of about 1 percent to hold euro-denominated bonds of investment-grade companies, Bank of America Merrill Lynch index data show. The yield dipped below that level for the first time in February last year, just before the ECB’s quantitative-easing program began.

    Sinking borrowing costs should help create a “nirvana” for borrowers, Suki Mann, founder of bond-market commentator CreditMarketDaily.com, wrote in a note. “They are already fantastic on a historical relative basis and we believe will stay that way through the whole of this year, at minimum,” Mann said.

    AstraZeneca sold 2.2 billion euros of securities in a three-part deal, while Shell sold 1.75 billion euros of bonds due in eight and 12 years, according to data compiled by Bloomberg. Officials at AstraZeneca couldn’t immediately comment on the sale when contacted and Shell declined to comment.
     
  14. anonymous

    anonymous Guest

  15. anonymous

    anonymous Guest

    new oncology approval for orphan drug status:

    AstraZeneca drug wins orphan status in thyroid cancer

    • London11:35 AM EDT

      LONDON, May 12 (Reuters) - An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special "orphan" status in the United States for a type of thyroid cancer.

      The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries, said on Thursday the decision showed the potential importance of selumetinib for some patients.

      Orphan status is awarded to medicines promising significant benefit in treating rare, life-threatening diseases and the designation provides companies with special development and market exclusivity incentives.

      AstraZeneca's drug is being tested for patients with advanced differentiated thyroid cancer who fail to respond adequately to radioactive iodine.

      Selumetinib, which belongs to a class of cancer drugs known as MEK inhibitors, failed to meet its goal in a late-stage trial for uveal melanoma in July 2015.

      The drug is also being investigated as a treatment for advanced non-small cell lung cancer. However, it is viewed by analysts as less important commercially than AstraZeneca's recently launched cancer drugs Tagrisso and Lynparza, and its experimental product durvalumab.
     
  16. anonymous

    anonymous Guest

    So why are they spending money on the expensive studies needed in this enterprise year when there are layoffs?
     
  17. anonymous

    anonymous Guest

    :(
    Didnt plan to. The products are ready for testing much sooner than expected. Sadly long term it is the right decision. Short term we are screwed
     
  18. anonymous

    anonymous Guest

    Asthma drug looks good, sales forecasts vary:

    AstraZeneca asthma drug hits goal, to enter competitive market
    6 hours ago
    • By Ben Hirschler


      LONDON (Reuters) - AstraZeneca's (AZN.L) drive to rebuild its portfolio of new medicines received a boost with positive results for an experimental biotech drug for severe asthma that the company previously flagged as a potential $2 billion-a-year seller.

      Benralizumab, which is likely to reach the market next year, was well tolerated and succeeded in reducing asthma attacks in two pivotal late-stage clinical trials, the drugmaker said on Tuesday.

      While it will be entering a competitive market, behind recently approved treatments such as GlaxoSmithKline's (GSK.L) Nucala and Teva's (TEVA.TA) Cinqair, AstraZeneca thinks benralizumab has the potential to be the best in class.

      Analysts are not yet convinced and consensus annual sales forecasts for benralizumab currently stand at just $450 million by 2021, according to Thomson Reuters Cortellis, well below the $2 billion predicted by AstraZeneca in 2014.

      The company gave its bullish forecast for benralizumab, along with many other pipeline products, at the time of Pfizer's (PFE.N) unsuccessful attempt to acquire it.

      Tom Keith-Roach, head of AstraZeneca's respiratory, inflammation and autoimmune business, declined to give an update on sales expectations but told Reuters that the drug's unique mechanism of action should position it well against rivals.

      Benralizumab works directly against cells in the body driving inflammation called eosinophils, leading to their rapid depletion, while rival medicines work less directly.

      Deutsche Bank analyst Richard Parkes said the market for severe asthma drugs could grow to be worth more than $7 billion a year and detailed results on benralizumab, potentially at a medical meeting in September, would be important in determining its commercial potential.

      AstraZeneca said it planned to submit benralizumab for regulatory approval in the United States and Europe in the second half of 2016.

      Like the other injectable asthma drugs, AstraZeneca's product is designed for patients who have a history of severe attacks despite taking existing medications.

      AstraZeneca badly needs new drugs to drive future sales growth as it struggles with a wave of patent expiries on older medicines, such as its cholesterol fighter Crestor and stomach acid pill Nexium.

      Most attention is focused on its oncology drug portfolio but the company also has a long history in respiratory medicine and sees it as an important therapeutic area for the future.

      Benralizumab was originally licensed from a unit of Kyowa Hakko Kirin (4151.T). The Japanese company retains rights to the medicine in Japan and certain other Asian countries, but AstraZeneca has an option to acquire the Japanese rights once the drug is approved. AstraZeneca already has the rights elsewhere.
     
  19. anonymous

    anonymous Guest

    More info on oncology drug trial success:



    AstraZeneca's Severe Asthma Drug Positive in Phase III
    By Zacks Equity Research 4 hours ago
    • AstraZeneca plc AZN announced positive data from two pivotal phase III studies – SIROCCO and CALIMA – on its respiratory disease candidate, benralizumab, for the treatment of severe asthma.

      These randomized, double-blind, parallel-group, placebo-controlled studies evaluated the safety and efficacy of benralizumab as an add-on therapy in the treatment of severe uncontrolled asthma with eosinophilic inflammation in patients aged 12 years and older.

      The study met its primary endpoint. Data demonstrated significant reduction in the annual asthma exacerbation rate compared to placebo. The candidate was generally well tolerated too. Full results from the studies will be presented at a medical conference later.

      AstraZeneca expects to file for regulatory approval in both the U.S. and the EU in the second half of 2016.

      Benralizumab is also being evaluated in the phase III VOYAGER program for the treatment of patients with severe chronic obstructive pulmonary disease (COPD).

      We remind investors that AstraZeneca has in-licensed the drug from BioWa, Inc., a subsidiary of Kyowa Hakko Kirin Co., Ltd., in all countries except Japan and certain other Asian countries. In Jul 2015, AstraZeneca inked an agreement with Kyowa Hakko Kirin for an exclusive option to commercialize the candidate in Japan, in both asthma and COPD indications.

      Benralizumab is expected to face competition from GlaxoSmithKline plc’s GSK Nucala and Teva Pharmaceutical Industries Limited’s TEVA Cinqair once it hits the market.

      As per the company’s press release, about 315 million individuals in the world suffer from asthma, which will likely increase to 400 million by 2020.