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 takes $80 mln hit as U.S. spurns nasal flu vaccine

    Serves AZ right for dumping so many US jobs.
     

  2. anonymous

    anonymous Guest

    AZ, with the new oncology focus, doesn't even make the list of rivals, pathetic:


    Bristol nabs Opdivo 'breakthrough' in bladder cancer--and gears up for Roche showdown
    by Carly Helfand |
    Jun 27, 2016 11:48am

    Roche’s brand-new immuno-oncology med Tecentriq currently has the bladder cancer market all to itself--but that's not going to last long.

    Monday, Bristol-Myers Squibb's Opdivo nabbed a “breakthrough” tag from U.S. regulators, who will now speedily review the med for use in patients with advanced bladder cancer who have failed on platinum-based chemotherapy.

    That’s the same indication for which Roche snagged an FDA green light when it ushered Tecentriq onto the scene in May, and any regulatory success for Bristol will compromise Tecentriq’s position as the only checkpoint inhibitor in the bladder cancer market.

    But of course, Roche isn’t shying away from its rivals Opdivo and Merck's Keytruda. Back in April, the FDA granted Tecentriq a “breakthrough” designation in lung cancer, putting it in line for a quick thumbs up.

    Lung cancer was the second battleground for Opdivo and Keytruda after the pair first established their presence in the melanoma field, and the meds’ makers have been racing to get ahead through winning additional indications, moving into earlier lines of therapy, and grabbing approval in new locations.

    On that front, Keytruda got its own boost Monday thanks to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended the product as a treatment for patients with advanced NSCLC who have gone through one or more chemo regimens.
     
  3. anonymous

    anonymous Guest

    4:41 am AstraZeneca receives EC marketing authorization for Zavicefta (AZN) :

    Co announced that the European Commission has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.

    The approval includes intravenous use of Zavicefta for the treatment of adult patients suffering from complicated intra-abdominal infections; Complicated urinary tract infections, including pyelonephritis; hospital-acquired pneumonia, including ventilator associated pneumonia; and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options
     
  4. anonymous

    anonymous Guest

    Not likely, but I guess its worth a shot:


    AstraZeneca’s cholesterol-drug gambit is the latest tactic from a company skilled at them
    Written by
    Oliver Staley
    8 hours ago

    AstraZeneca, the UK drug maker, is trying to extend patent protection for Crestor, its blockbuster cholesterol drug. If it pulls it off the long-shot gambit, it will be another deft maneuver from a company skilled at getting out of tight scrapes.

    Astra received FDA approval to use Crestor to treat children with extremely high levels of “bad” cholesterol, a rare condition, according to a New York Times report June 28. The company now wants to use that new treatment to extend its patent clock, which expires in July, for another seven years by classifying Crestor as an “orphan drug,” and invoking a special designation created by Congress to give drug makers the incentive to cure rare diseases. Critics have cried foul. The courts haven’t favored drug makers with similar claims.

    “AstraZeneca believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US,” Michele Mexiell, a spokeswoman, wrote in an email. Because it doesn’t expect an FDA decision before its patent expires, the company has filed suit to block generic competition, she said.

    AstraZeneca has often wrapped itself in high-minded science while employing street-fighting tactics to protect its bottom line. The court battles didn’t start with CEO Pascal Soriot, a Frenchman who joined from Roche in 2012, but he’s embraced them. Soriot grew up in a gritty suburb north of Paris, he told the Financial Times, and he’s not afraid to throw a punch.

    Along with attempting to extend the patent life of Crestor, AstraZeneca has gone to court repeatedly to fend off competition for Nexium, its lucrative purple heartburn pill. In 2008, it engineered a “pay-for-delay “scheme with generic manufacturer Ranbaxy to keep its version of the drug from reaching the market for six years. Once the floodgates of generic competition opened, Astra sued the Indian company Dr. Reddy’s for selling purple versions of the pill (Dr. Reddy’s settled, and its pill is now blue).

    When Soriot took over Astra, the company had little more than a handful of medicines nearing patent expiration, and few drugs in its pipeline. Soriot invested in drug development and rebranded Astra as a “science-led company.” He moved the company’s headquarters from London to Cambridge, and into a new $500 million complex at the center of the UK’s life science community. Under Soriot, the company unearthed innovative new cancer drugs and made aggressive moves into treatments for heart attacks and diabetes.

    AstraZeneca’s turnaround and newly attractive pipeline drew the attention of US drug giant Pfizer, which was on the hunt for a foreign pharma company it could acquire for a tax inversion. In 2014, Pfizer offered $117 billion for the company, a significant premium for shareholders. But Soriot doubled down on Astra’s prospects and promised investors that revenue would grow to $45 billion as a standalone company, nearly double 2014 sales.

    He also maneuvered Pfizer into a political dust-up, rallying politicians against the buyout by invoking the threat to UK’s science industry. At one point, testifying before Parliament, he suggested lives would be risked by the disruption of Pfizer’s bid on Astra’s drug development. “What will we tell the person whose father died from lung cancer because one of our medicines was delayed because, essentially, in the meantime, our two companies were involved in saving taxes or saving costs?” he said.

    Soriot’s tactics worked. Pfizer eventually backed off.

    But Soriot still has a $45 billion promise to keep. That means squeezing everything the company can out of Crestor and Nexium, while hoping its new drugs—including Lynparza for ovarian cancer and Tagrisso for lung cancer—develop into blockbusters. AstraZeneca’s investors now want to tie Soriot’s pay to his ability to reach that revenue target, putting him in yet another tight jam for him to escape.
     
  5. anonymous

    anonymous Guest

    AZ cuts ties with Valeant in Europe with a payout. Valeant needs the cash right now as they are possibly imploding.

    Valeant Pharmaceuticals Announces New Licensing Arrangement For Brodalumab In Europe
    Valeant Pharmaceuticals International, Inc. 8 hours ago
    • Valeant Receives Upfront Payment & Milestone Payments from AstraZeneca In Exchange for Termination of European Rights to Brodalumab

      LAVAL, Quebec, July 1, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX:VRX) ("Valeant") today announced that its affiliate and AstraZeneca (LSE/SSE/NYSE: AZN) have amended Valeant's license for brodalumab, an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis, to terminate Valeant's right to develop and commercialize brodalumab in Europe.

      In August 2015, AstraZeneca and Valeant entered into an agreement granting Valeant an exclusive license to develop and commercialize brodalumab globally, other than in Japan and certain other Asian countries. Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the U.S, as well as the remainder of the territory outside of Europe. As consideration for the termination of the European rights, AstraZeneca will pay to Valeant an upfront payment and certain sales-based milestone payments and, in addition, one of the pre-launch milestones payable by Valeant to AstraZeneca under the original license has been reduced.

      With the termination of Valeant's licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting LEO Pharma the exclusive rights to develop and commercialize brodalumab in Europe.

      On January 25, 2016, Valeant announced that the U.S. Food and Drug Administration (FDA) had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant for brodalumab injection for the treatment of moderate-to-severe plaque psoriasis and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016. In addition, the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant's BLA on July 19, 2016.

      "We are pleased with this new licensing arrangement for brodalumab, which enables us to more sharply focus our efforts on delivering this important treatment to patients in the U.S. and other key markets, while providing us with immediate value and significant ongoing exposure to the treatment's commercialization in Europe," said Joseph C. Papa, chairman and chief executive officer of Valeant. "Our current focus is on the upcoming advisory panel, where we will have the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about this novel antibody we are developing."

      About brodalumab

      Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

      Safety Information

      The most common adverse reactions in the clinical studies were headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. Suicidal ideation and behavior and serious infections have been reported in the studies.

     
  6. anonymous

    anonymous Guest

    Nothing new for AZ, they have already been caught by the FDA in the US several times for various marketing rules violations. All employees then have to take a series of video ethics tests as part of the serial settlement agreements. You know the kind, AZ does not admit to any wrongdoing, but it will agree to pay a relatively large fine (but less than they earned by making the rules violations) and agree to implement ethics training procedures to prevent a reoccurrence. AZ is by no means alone in the area, Pfizer is even worse. It is considered by pharma management as just another cost of doing business in the "ethical" pharmaceuticals arena.
     
  7. anonymous

    anonymous Guest

    They always take out a few lower down the food chain to show good faith but promote with a wink and a nod the people who are really guilty of this kind of illegal or unethical stuff. We have had Product leads and NSDs who have actively supported off label promotion and were never touched.
     
  8. anonymous

    anonymous Guest

    Profits First
     
  9. anonymous

    anonymous Guest

    Hardball is being played right now in the oncology company and product acquisition arena. How high is too high to pay?



    Sanofi Plays Hardball…And Loses
    By Gillian Tan

    When it comes to dealmaking, hardball tactics can backfire -- as Sanofi is finding out.

    Late Tuesday, the French drugmaker dropped hostile efforts to acquire oncology specialist Medivation after being granted access to its target's confidential data.

    The bad news? They're not the only ones: Medivation said it has opened its books to other parties. These include Pfizer, Celgene and Amgen, according to CNBC and Reuters. The fact that it's so coveted means Sanofi likely has no choice but to lift its offer yet again in order to add Xtandi, Medivation's FDA-approved prostate-cancer drug, to its portfolio.

    A competitive process could have been avoided from the get-go. Rather than offering $52.50 a share back in April and then attempting to replace Medivation's board after its advances were rejected, Sanofi could have made a bid that was compelling enough to gain the recommendation of that same board. Instead, it established bad blood with management who have spurned its latest offer of $58 a share (plus a contingent value right worth $3 at most) and effectively put Medivation within the grasp of other suitors.

    As I wrote in April, Sanofi can afford $70 a share without factoring in synergies -- or well north of that, depending on estimated cost savings. And if the French behemoth chooses not to pay up to strike an accretive deal, it faces punishment by investors who have identified that the company needs to do something to boost its profitability. Its EPS is expected to grow at a compounded annual rate of just 5.6 percent between 2015 and 2020, trailing the sector median of 9.3 percent, according to Oddo Securities.

    Medivation may well slip through Sanofi's grips. If so, Sanofi's shareholders can only hope the drugmaker learns from its mistakes.
     
  10. anonymous

    anonymous Guest

    here is another Biotech getting buyout interest, this time from Roche:


    BioMarin rises again on buzz of a potential takeover--this time from Roche
    by Carly Helfand |
    Jul 8, 2016 8:27am

    BioMarin shares climbed more than 10% Thursday on talk of a potential takeover. And if that scenario sounds familiar, that’s because it is.

    This time, the rumored interested buyer is Roche, according to the Betaville blog, whose sources say a deal for between $130 and $150 per share could be in the works. While it’s still unclear whether Roche ($RHHBY) has put forth a formal offer or held talks with BioMarin ($BMRN), one source said those processes may have been placed on hold on account of the Brexit vote and its impact on the markets.

    It’s not the first time Betaville writer Ben Harrington has reported BioMarin interest from the Swiss pharma giant. Back in 2013, the blog said the Basel-based drugmaker was eyeing a $13.5 billion transaction for the San Rafael, CA-based company, fueling chatter that Roche CEO Severin Schwan tamped down not long thereafter.

    For Roche, a cancer heavyweight, a buyout of BioMarin would beef up its rare-disease offerings, which currently include idiopathic pulmonary fibrosis med Esbriet. More recently, though, the buzzed-about potential buyer has been Sanofi ($SNY), which Betaville said last month could be sizing up BioMarin as a potential backup if its quest to buy Medivation ($MDVN) fails.

    Lately, though, Sanofi’s taken a step in the right direction toward snagging its longtime target. Earlier this week, it agreed to drop a hostile pursuit of the California maker of prostate cancer star Xtandi after the company opened up its books.

    Of course, it’s still entirely possible that Sanofi will lose out on its prize--especially considering that Medivation inked confidentiality pacts with “a number of parties” interested in a potential tie-up. Pfizer ($PFE), AstraZeneca ($AZN), Amgen ($AMGN), Gilead ($GILD), Celgene ($CELG) and Novartis ($NVS) have all reportedly been taking a look at a deal for the San Francisco outfit.
     
  11. anonymous

    anonymous Guest

    AZ could jump into the Medivation fray with $10B bid: Report
    by Carly Helfand |
    Jul 11, 2016 11:50am

    While several drugmakers may be circling coveted buyout target Medivation, so far, Sanofi is the only one that’s come through with a bid. But that could all be changing soon.

    AstraZeneca is considering putting forth its own offer of £7.7 billion ($10 billion), The Sunday Times reports. According to the British newspaper, AZ scoped out Medivation earlier in the year, and it’s still interested in potentially making a move.

    It’s easy to see why AZ--and plenty of its peers--may want to snap up the San Francisco drugmaker. Medivation has something special in Xtandi, a prostate cancer pill that’s already on the market--and racking up blockbuster sales. Plus, it’s got a shiny pipeline prospect in talazoparib, a candidate CEO David Hung has touted as a “best-in-class” PARP inhibitor.

    AstraZeneca, which is working to notch a turnaround, could certainly use the cancer revenues; it’s marked oncology as a key field that’ll help dig it out of its slump and hit the hefty sales projections it put up when it was trying to evade hostile suitor Pfizer back in 2014. It also already boasts a prostate cancer-fighter--Zoladex--and it’s investigating PARP med Lynparza in that area, too, so there’s a “significant fit” for Xtandi in its portfolio, Credit Suisse analysts wrote recently.

    But plenty of AZ’s rivals think they’ve got their own fit with Medivation, with eager Sanofi among them. The French pharma giant dropped a hostile play last week after Medivation included it in a set of potential bidders it invited to the table, inking confidentiality agreements with “a number of parties.” Pfizer, Amgen, Gilead, Celgene and others have reportedly been eying a deal, too.

    And as The Telegraph pointed out in April, AZ and CEO Pascal Soriot have been known to avoid bidding wars; getting into one now could especially spook shareholders, considering an earlier promise from Soriot to largely avoid big buyouts.
     
  12. anonymous

    anonymous Guest

    Diabetes drug market changes:

    Diabetes sales rocket toward $60B, with Novo and Lilly's GLP-1s first in line for growth
    by Tracy Staton |
    Jul 11, 2016 7:37am

    Two sides of one coin will keep diabetes drug sales growing--big time--through 2025. The disease is growing fast around the world, and treatment arbiters advise a more aggressive approach to blood-sugar control.

    Combine those two drivers, and diabetes will account for almost $60 billion in 2025 sales across 9 major global markets, GlobalData analysts say in a recent report. That’s almost double the $31.2 billion in brand and generic sales recorded last year.

    But this rising tide of sales won’t lift all treatments equally, the analysts predict. Best positioned for growth? GLP-1 drugs, they say, which are poised to grow by 12.4% annually through the next decade. That’s good news for Novo Nordisk’s market-leading Victoza and Eli Lilly’s recent launch Trulicity, which is already grabbing share. Not to mention Novo’s once-weekly semaglutide, on track for FDA filing this year, and its once-daily oral form of that med, which GlobalData calls a “game-changer” for that class.

    The GLP-1s “in my opinion, should grow,” one European opinion leader told Global Data, “because basically, whenever they have been compared to insulin as an injectable treatment [for] type 2 diabetes, the results were at least as good, if not a little bit better.”

    The same doctor sees SGLT2 meds continuing to grow as well. And that growth spells trouble for the rival DPP-4 class, headed by Merck & Co.’s Januvia franchise. The GLP-1 gains--coupled with rapid shifts to SGLT2s such as Lilly’s Jardiance and Johnson & Johnson’s Invokana--mean DPP-4 drugs won’t grow nearly as quickly as they have in recent years, GlobalData’s report says.

    Insulin biosims will help boost sales in that category of meds, partly because patients are more likely to stick to lower-cost regimens. Eli Lilly and Boehringer Ingelheim’s knockoff of Sanofi’s top-selling basal insulin, Lantus, is set to hit the market in December, and Sanofi has a couple of biosims in development as well, GlobalData notes, citing top diabetes doctors.

    Right now, only a small number of patients are actually hitting blood glucose targets of 7% to 7.5% A1C levels, one of those doctors told the analytics firm. Doctors are pushing harder to hit those goals, so the number of people needing a second or third add-on drug will mushroom over the next 10 years. “[W]e’ll treat these people fairly aggressively” to get to those A1C levels, the doctor said, adding, “[W]e are not going to tolerate people after 8.5% and 9% like we used to.”

    Plus, despite public health campaigns and awareness campaigns, people will “continue to overeat and under-exercise and they are going to see their weight continue to go up, and therefore their need for more medications will go up with it,” the U.S. doctor said.

    What these doctors really want are new drugs that are more effective against the disease over the long term. Diabetes is “complicated” and “resilient,” another U.S. doctor said, so most patients have to switch drugs and add new ones as time goes on, because treatments tend to lose effectiveness after long use.

    But new classes of meds are a ways off, GlobalData notes, with the late-stage pipeline filled with follow-up drugs--such as Pfizer and Merck’s SGLT2 ertugliflozin--and novel meds in Phase II or earlier. There are just two first-in-class drugs in Phase III, the analysts point out, but 150 potential meds in Phase I and Phase II.
     
  13. anonymous

    anonymous Guest

    On the oncology front:


    AstraZeneca's lung cancer drug meets main goal in late-stage trial
    July 18, 2016


    July 18 (Reuters) - AstraZeneca Plc said its experimental lung cancer drug Tagrisso met its main goal in a late-stage study.

    The tablet, which has won early approval from both U.S. and European regulators, is one of several cancer medicines AstraZeneca hopes will rebuild its sales following patent losses on older drugs.

    AstraZeneca said Tagrisso showed superior progression-free survival compared to standard platinum-based chemotherapy.

    The trial assessed Tagrisso's efficacy and safety as a second-line treatment for certain kinds of lung cancer, the drugmaker said.

    Second-line therapies are used when initial, or first-line, treatments do not produce adequate results.

    AstraZeneca said a full evaluation of the data is ongoing.
     
  14. anonymous

    anonymous Guest

    AZ loses in D.C. court in bid to halt Crestor generics:


    Indian Firms Get Approval for Generics of AstraZeneca Drug
    Ari Altstedter
    July 20, 2016 — 1:20 AM EDT Updated on July 20, 2016 — 3:11 AM EDT

    • Aurobindo, Glenmark say they received approval to sell in U.S.
    • Both stocks climb on entry into $7 million a day market

    Indian drugmakers won U.S. approval to sell generic versions of the cholesterol pill Crestor, gaining permission to sell cheaper copies of an AstraZeneca Plc best-selling pill that brings in $7 million in U.S. sales every day.

    India’s Aurobindo Pharma Ltd., Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Ltd. received approval from the U.S. Food and Drug Administration to sell the generics, according to stock exchange statements from the companies on Wednesday.

    A federal judge in Washington, D.C., ruled against AstraZeneca’s request for a temporary ban on generic versions of the medicine on Tuesday. That means the $5 billion AstraZeneca saw in sales from Crestor last year could plunge to $3.5 billion this year as cheaper alternatives become available, according to analyst estimates compiled by Bloomberg.

    Aurobindo said in a statement that its successful application makes it eligible for 180 days of "shared exclusivity" selling the drug. The first copycat version of Crestor is already on the market from Allergan Plc’s Watson Pharmaceuticals after a settlement in a patent infringement suit gave the manufacturer sole rights to start selling its version in early May.

    "This is a good approval but it all depends on how many others get approval," said Surajit Pal, an analyst covering Indian pharmaceutical stocks at Prabhudas Lilladher Pvt. in Mumbai, adding there will be at least four generic versions in the first wave of approvals though the general expectation is for six to share exclusive rights to sell the drug in the U.S. for the next 180 days.

    For AstraZeneca, the challenge to Crestor comes as the London-based company has seen a sharp drop in sales from the highs of 2011 because of patents expirations on top drugs. In Mumbai, Aurobindo shares were up as much as 4.3 percent, Glenmark rose as much as 3.1 percent and Sun Pharma added as much as 1.5 percent. AstraZeneca rose 0.6 percent to 4,560 pence at 8:04 a.m. in London trading.

    Calls to AstraZeneca’s media line were unanswered. Other Indian firms with tentative approvals for generic Crestor are Torrent Pharmaceuticals Ltd. and Alkem Laboratories Ltd. Queries asking whether these companies have also received final approvals via e-mail and telephone were not immediately returned.

    Outside of India, Apotex Corp., Mylan NV, Teva Pharmaceutical Industries Ltd., Endo International Plc-owned Par Pharmaceutical, and Sandoz AG all have applications for approval too, according to FDA data.
     
  15. anonymous

    anonymous Guest

    No post-Brexit exit for GSK and AstraZeneca, CEOs will say this week as biopharma rumors swirl
    by Tracy Staton |
    Jul 25, 2016 11:19am

    [​IMG]
    AstraZeneca CEO Pascal Soriot (left) and GlaxoSmithKline CEO Andrew Witty are expected to reassure worriers that their companies aren't leaving the U.K. in the wake of Brexit.


    Worried that GlaxoSmithKline or AstraZeneca might pull up their U.K. roots in the wake of Brexit? Rest easy, The Times of London reports. Both companies are set to reassure the world this week that they’re staying put.

    With longtime British homesteads--and CEOs tapped for input into exit negotiations with the EU--GSK and AstraZeneca didn’t appear to be likely candidates for leaving Britain. Indeed, with the British pound down on the Brexit vote, and big chunks of revenue sourced in the U.S., the companies stand to reap a currency boost to earnings, at least for now.

    Plus, AstraZeneca is in the throes of a massive construction project in Cambridge, England, with plans to lay out £330 million on a new R&D hub and headquarters in the university town.

    But Brexit has the world antsy. And that means GSK chief Andrew Witty and AstraZeneca CEO Pascal Soriot will speak to the question when announcing company earnings later this week, the Times says.

    Despite fears that pharma will be “ravaged” by the exit vote, Britain’s two Big Pharmas will “shrug off the impact of Brexit and confirm they plan to remain based in the U.K.,” the newspaper reported Monday.

    The companies’ assurances will come as pundits and industry experts are revisiting the Brexit vote, one month after the result that astonished many. Pharma-watchers and government officials worry that leaving the EU will put Britain at a disadvantage when it comes to retaining scientists and attracting new investment.

    According to The Pharma Letter, rumors are swirling that EU pharma executives are already declining job offers in Britain, and EU and U.S. recruiters are fishing for talent leaving the U.K.

    “The U.K. has been successful in science and innovation because it attracts excellent talent from overseas and it’s a huge amount of talent,” Dame Professor Jocelyn Bell Burnell, president of the Royal Society of Edinburgh, told the House of Lords last week (as quoted by Pharma Letter). “They are all very twitchy right now because they do not know what is going to happen. And if good opportunities show themselves elsewhere in Europe they will be off.”

    Another worry: Life Sciences Minister George Freeman has been reassigned, and there’s no word who’ll take his place--or whether his position will be filled at all. Freeman had been an advocate for the industry and, after the Brexit vote, established a working group to advise on the EU exit co-chaired by Witty and Soriot. Some industry officials now expect the position to be eliminated.

    The Association of the British Pharmaceutical Industry (ABPI) says it’s worried about losing Freeman, who was reassigned as new Prime Minister Theresa May took the government reins. “At a time of great uncertainty for the pharmaceutical industry we are eager to see who will take up the responsibility of progressing the good work that Freeman has started,” the ABPI said, including the steering group, which was tasked with addressing regulatory and funding issues associated with leaving the EU.

    The Bioindustry Association believes Freeman won’t be replaced, according to a Monday blog post. The group isn't waiting around, however; according to BioWorld, execs and lobbyists are working on a plan they’ll present to the government Sept. 6. "It is vitally important that we are getting ready as a sector," Steve Bates, CEO of the Bioindustry Association (BIA), said Monday. "We have to stay ahead of the curve and put our issues in an organized fashion to the key people.”

    In addition to GSK and AstraZeneca, a variety of other Big Pharmas are participating in that planning, including Johnson & Johnson’s Janssen unit, Pfizer, Merck & Co. and Novartis. According to the BIA blog post, the group will host a “town hall” meeting Wednesday to collect further input.
     
  16. anonymous

    anonymous Guest

    What Can Investors Expect from AstraZeneca’s 2Q16 Earnings?
    By Mike Benson | Jul 26, 2016 4:21 am EDT

    A look at AstraZeneca
    AstraZeneca (AZN) is one of the largest pharmaceuticals companies by revenues and is headquartered in London. The company’s business is spread over the entire medicine life cycle from research and development to manufacturing and supply of primary care and specialty care medicines. The company operates in more than 100 countries.

    [​IMG]




    AstraZeneca is set to release its 2Q16 earnings on July 28, 2016. Analysts estimate EPS (or earnings per share) of $0.83 and revenues of $5.6 billion for 2Q16 as compared to $6.3 billion for 2Q15. Further, analyst estimates show EPS of $1.15 at revenues of $5.82 billion for 3Q16 and EPS of $1.08 at revenues of $5.87 billion for 4Q16.


    Revenue estimates
    Analysts estimate the revenues for 2Q16 to fall by over 11% to $5,578 million. For the full year 2016, the revenues are estimated at $23.4 billion, a ~5% decline as compared to 2015 revenues. Also, the estimates show EPS of $3.99 for 2016.

    AstraZeneca’s valuation
    As on July 25, 2016, AstraZeneca (AZN) was trading at a forward PE multiple of ~15.6x as compared to the industry average of 16.3x. The company is trading at a higher PE than Sanofi (SNY), which trades at 13.8x, while other competitors like Novartis (NVS) and GlaxoSmithKline (GSK) are trading at a higher PE of 16.7x and 17.4x, respectively, as compared to AstraZeneca.

    Analyst recommendations
    AstraZeneca’s stock price has fallen by nearly 1% over the last 12 months. Analysts estimate that the stock has the potential to return ~25.5% over the next 12 months. Analysts’ recommendations show a 12-month targeted price of $39.05 per share compared to the last price of $31.15 per share as on July 25, 2016. Also, ~11% of analysts recommend a “buy,” 78% of the analysts recommend a “hold,” and 11% of the analysts recommend a “sell,” according to Bloomberg’s consensus. Changes in analysts’ estimates and recommendations are based on changing trends in the stock price.



    Part 2

    What Can Investors Expect from AstraZeneca’s 2Q16 Earnings? PART 2 OF 3
    Why Analysts Think AstraZeneca’s Revenues Will Fall in 2Q16
    By Mike Benson | Jul 26, 2016 4:21 am EDT
    AstraZeneca’s 2Q16 revenue
    AstraZeneca (AZN) reported an increase of 1% in its top line to $6.1 billion in its 1Q16 results. However, analyst estimates show a decline of over 11% in 2Q16 revenues for AstraZeneca. As discussed earlier, the company is set to release its earnings on July 28, 2016.

    [​IMG]




    The above graph shows the revenues of AstraZeneca in each quarter. As the company operates in over 100 countries and ~60% of total revenues come from outside US markets, the company has a great deal of exposure to currency risk.


    The growth platforms
    AstraZeneca reported a gradual shift in the percentage of contributions from key drugs like Nexium and Synagis to new products in growth platforms like Brilinta and new oncology products. The revenues from growth platforms contribute to over 50% of the company’s total revenues.

    Segment-wise performance
    AstraZeneca’s business is divided into four segments:

    • The cardiovascular and metabolic diseases segment contributes the most to overall revenues at ~38%. Analysts expect strong performances from Brilinta, Onglyza, Bydureon, and Farxiga to drive the growth of this segment for 2Q16 while there might be a decline in revenues of Byetta and legacy drugs Crestor and Atacand.
    • The infection, neuroscience, and gastrointestinal segment is the second largest revenue contributor for AstraZeneca, contributing ~22% of total revenues. The revenues for this segment are expected to decline following weak performances from drugs like Nexium and Seroquel.
    • The respiratory, inflammation, and autoimmunity segment is another important segment for AstraZeneca’s growth platform. The segment revenues are expected to increase for 2Q16, driven by Pulmicort and new products including Duaklir, Daliresp, and Tudorza. However, lower sales of Symbicort will offset the growth during 2Q16.
    • The oncology segment is now included in the growth platform. New products like Tagrisso and Lynparza are expected to drive the growth of this segment in coming years. Analysts expect the revenues to grow for 2Q16, driven by a strong performance of Faslodex, which will be offset by lower sales of the legacy products including Zoladex, Casodex, Arimidex, and Iressa. Iressa is exposed to competition from other EGFR inhibitors including Tykerb from Novartis (NVS), Erbitux from Eli Lilly (LLY), and Vectibix from Amgen (AMGN).

    Part 3

    What Can Investors Expect from AstraZeneca’s 2Q16 Earnings? PART 3 OF 3
    Which Growth Platforms Will Drive AstraZeneca’s 2Q16 Earnings?
    By Mike Benson | Jul 26, 2016 4:21 am EDT
    The growth platforms
    AstraZeneca (AZN) has classified certain products and regions as part of its growth platforms. The growth platforms include respiratory and diabetes products, Brilinta/Brilique, and regional sales from emerging markets and Japan. The company has also added its oncology franchise for the first time to the growth platforms due to new oncology products including Tagrisso and Lynparza.

    [​IMG]




    As discussed earlier, the growth platforms contribute over 50% of total revenues for AstraZeneca. In order to avoid duplication on a product and regional basis, the total product sales are adjusted for the growth platforms in this article.

    Expectations from growth platforms
    The expectations for each of the growth platforms during 2Q16 are as follows:

    • The respiratory product sales are expected to increase operationally due to revenues from the blockbuster drugs Symbicort and Pulmicort, as well as new products including Tudorza, Daliresp, and Duaklir.
    • Brilinta/Brilique, classified under the Cardiovascular and Metabolic Disease (or CVMD) segment of AstraZeneca, prevents blood clots in heart and blood vessels. Brilinta/Brilique revenues are expected to increase in 2Q16.
    • The diabetes franchise includes drugs like Onglyza, Bydureon, Byetta, and Farxiga. This franchise is expected to report operational growth during 2Q16.
    • New oncology products including Tagrisso for the treatment of lung cancer and Lynparza for the treatment of ovarian cancer are classified as growth platforms. Tagrisso sales are expected to be positive for 2Q16, following the approval of Tagrisso in Japan and increased demand in the US markets. The company is also expanding the markets for Lynparza.
    • Emerging markets and China will continue the double-digit year-over-year growth they have posted since 2014. The strong growth in emerging markets including China, Brazil, and Russia is mainly driven by the established products. The emerging markets are expected to have mid-to-high single digit growth for 2016.
    • Due to lower demand of Iressa and Nexium, the revenues from Japan are expected to decrease during 2Q16.
     
  17. anonymous

    anonymous Guest

    where is neuroscience in all this? Movantik ?!
     
  18. anonymous

    anonymous Guest

    you just answered your own question!!!!
     
  19. anonymous

    anonymous Guest

    gee, and all i could think was how hideous pascal the dear leader looks in that picture....