AZ News From The Street 2016

I have seen mug shots of the FBI ten most wanted that look more honest than him.

 

Movantik?? It's no more than a pimple on Pascal's greedy ass! Neuroscience is dead, plain and simple. I don't see how in the hell they need anyone from Neuro! XR is gone in a few months too! Why do they need Neuro! AZ quit CNS research years ago! YEARS AGO!

Movantik=Vimovo

 

can you hear the opening bell. should be interesting

 

AZ is up after reporting its 2Q earnings. Its all about managing expectations, what with non GAAP earnings beating the street. Of course, these are all non-recurring income additions.

Astrazeneca beats 2Q profit forecasts
AP
July 28, 2016
LONDON (AP) _ Astrazeneca PLC (AZN) on Thursday reported a second-quarter loss of $3 million, after reporting a profit in the same period a year earlier.

On a per-share basis, the London-based company said it had a loss of less than 1 cent. Earnings, adjusted for non-recurring costs and amortization costs, came to 83 cents per share.

The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for earnings of 42 cents per share.

The pharmaceutical posted revenue of $5.6 billion in the period.

Astrazeneca shares have dropped 2 percent since the beginning of the year. The stock has increased nearly 2 percent in the last 12 months.

 

Novartis potential takeover of AZ rumor included, note, not a merger:

AstraZeneca (AZN) Stock Up After Q2 Earnings, Revenue Beat
AstraZeneca (AZN) stock is increasing this afternoon after the company reported better-than-expected results before today's market open.
Annie Palmer
Jul28,20162:13PMEDT

NEW YORK (TheStreet) -- Shares of AstraZeneca (AZN) are jumping 7.83% to $34.01 in afternoon trading today after the biopharmaceutical company posted better-than-expected results for the second quarter before today's market open.

The company reported earnings of 83 cents per share, beating analysts estimates of 76 cents per share. Revenue came in at $5.6 billion, above analysts' projected $5.56 billion.

Last year, AstraZeneca posted earnings of 60 cents per share on revenue of $6.31 billion.

Revenue fell 3% year-over-year in the second quarter, stemming from a 2% decline in product sales due to patent expiries such as Crestor, the company said.

Additionally, the company declined to say whether it may be a possible takeover target, Reuters reports. Novartis (NVS) has been rumored as a buyer, which could increase AstraZeneca's cancer drug operations and potential savings, according to Reuters.

Citi analysts believe AstraZeneca's biotech expertise and advanced immunotherapy cancer pipeline could make the company an attractive purchase for Novartis, Reuters reports.

 

GSK is handling its decline of Advair very well. Will AZ handle the inevitable decline of its Symbicort as well?


For the first time, GSK's respiratory newcomers offset Advair's decline
by Carly Helfand |
Aug 1, 2016 7:44am

Glaxo finally reached a milestone it’s been promising for a long time: Sales of its new respiratory launches are now more than making up for declines from aging COPD giant Advair.

In the second quarter, new respiratory meds pulled in £243 million, with ICS/LABA combo med Breo generating £146 million of the haul. Meanwhile, Advair sales--which have taken a beating over the past few years under payer pressure--dropped only £60 million for the period.

It’s good news for the drugmaker, which has faced plenty of criticism from those who doubted Breo and fellow newcomer Anoro could ever reach the blockbuster sales Glaxo had outlined. And a slow start for both meds did little to assuage their fears. Now, though, Breo--helped by improved coverage and an asthma indication it picked up last year--is coming into its own.

Of course, there’s a caveat when it comes to filling Advair’s shoes. The med hasn’t actually faced generic attackers in the U.S. yet, and while copycat drugmakers--including Mylan and the U.K.’s Vectura--are getting in line for approval, it’s unclear when they’ll win an all-clear from regulators.

Witty has stressed time and again, though, that the generic threat may not actually be so big. Because of aggressive payer tactics, GSK has already offered up deep price cuts on its star product, which he says have mimicked the genericization effect.

Knockoffs will definitely arrive after Witty hands over the chief exec reins in March, though, “and I will therefore spend my entire career as CEO of GSK saying the same thing, which is that the genericization of Advair is not going to be normal,” he told investors on the Q2 conference call.

The company isn’t taking any chances, though; it’s continuing to stock its respiratory pipeline with future backups. Last week, it announced it would shell out up to £175 million ($230 million) to get its hands on a Phase I severe asthma candidate from Johnson & Johnson’s Janssen.

 

Getting our butts kicked, again

 

It seems to be a pattern

 

This mostly may be due to drop in the British Pound post Brexit, but on the London Exchange AZ is hitting highs. The US ADR for AZ is also tracking this move somewhat also, so far anyway. The recent BMS Cancer drug trial failure is also another temporary factor.

AstraZeneca hits 2014 Pfizer bid price, helped by Bristol's woes
August 5, 2016
By Ben Hirschler

LONDON (Reuters) - AstraZeneca (AZN.L) shares hit a record high on Friday, breaching for the first time the 55 pounds a share level offered by Pfizer (PFE.N) in 2014 during the U.S. group's abortive $100 billion attempt to buy the drugmaker.

The British firm's stock has been on a roll recently, helped by a falling pound and speculation that Switzerland's Novartis (NOVN.S) might be next to launch a bid. However, the shares were lifted to a high of 55.05 pounds by the misfortunes of Bristol-Myers Squibb (BMY.N).

The failure of Bristol's immunotherapy drug Opdivo to slow disease progression in previously untreated patients with lung cancer as hoped was seen by investors as good news for rivals Merck & Co (MRK.N) and AstraZeneca.

Analysts at Leerink, Jefferies and Deutsche Bank said the negative result with Opdivo increased the potential market opportunity for AstraZeneca's keenly watched combination of durvalumab and tremelimumab.

Crucial clinical trial results with durvalumab, both on its own and in combination with tremelimumab, are due next year.

Chief Executive Pascal Soriot believes AstraZeneca can become a major player in cancer drugs that bolster the immune system. And its ability to carve out billions of dollars in potential sales hinges not only on the effectiveness of its own products but on the competitive profile of rivals.

Cancer is currently the hottest area of research across the drugs industry and some analysts believe this could make AstraZeneca a takeover target once again, with speculation turning last week to Novartis as a bidder.

 

soriot for prezident!!!

 

Sell high now to Novartis or GSK!!

 

AZ cancer trial fails to meet end point as well:

Shares of Array BioPharma Inc. ARRY, -21.72% slumped 11% in premarket trade Tuesday, on news that a late-stage trial of a treatment for lung cancer failed to meet its primary goal. The news was revealed by AstraZeneca AZN, -1.04% which owns the exclusive rights to the drug from Array. It said the Phase III trial of selumetinib, in combination with docetaxel chemotherapy as a second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer failed to meet its primary endpoint. Array has received $26.5 million in upfront and milestone payments for the drug and could earn up to $70 million more in milestone payments and royalties. Last week, Bristol-Myers Squibb Co. said its lung cancer treatment failed a late-stage trial, sending its stock sharply lower. AstraZeneca shares were down 1.5%.

 

Non small cell lung cancer is a really difficult disease to stop. Many have failed before and many more will do so in the future no doubt. Expectations are unrealistically much too high for a drug to have success in this arena.

 

Yet ANOTHER oncology failure for AZ! Pascal survives no matter what happens! His cronies on the Board all kiss each other's ass, and cover for each other's failures! GET RID OF THE FRENCH FOOL!


http://endpts.com/now-a-two-time-loser-astrazenecas-hopes-for-selumetinib-dwindle-after-another-phiii-flop/

 

Lilly combo breast cancer study with the AZ drug Faslodex fails to show enough efficacy to end the study early for an application for early approval.

Lilly Breast Cancer Drug Study Rolls On, Pushing Back Launch Date
AMY REEVES
August 10, 2016

Big pharma Eli Lilly (LLY) fell in early trading Wednesday when its breast cancer drug didn't prove to be the knockout that investors had hoped for. An outside committee conducted an interim analysis of Monarch-2, a late-stage trial of Lilly's drug abemaciclib combined with fulvestrant (AstraZeneca's (AZN) Faslodex) in advanced or metastatic breast cancer. If the drug was showing enough efficacy already, then the trial would have been stopped early, and Lilly could have gone ahead and filed for FDA approval. But the committee recommended that the study continue to its previously planned completion point.

 

AstraZeneca bets another $140 mln on Moderna's "messenger" drugs

August 10, 2016
LONDON, Aug 10 (Reuters) - AstraZeneca has invested another $140 million in Moderna Therapeutics, the U.S. biotech "unicorn" which already has a cash pile of around $1 billion and is developing drugs based on a molecule known as messenger RNA.

The British drugmaker said on Wednesday that the new investment, part of a preferred-stock financing, lifted its stake in Moderna to 9 percent. AstraZeneca first invested in Moderna in 2013.

Messenger RNA (mRNA) carries the recipe for making proteins inside the body. Using it as a medicine could offer a new way to tackle many hard-to-treat diseases, from cancer to infections to heart and kidney disorders.

In effect mRNA serves as software that can be injected into the body to instruct ribosomes, the "3D-printers" found inside cells, to churn out the desired proteins.

Moderna's work is still at an early stage. It has two Phase I studies underway for mRNA-based infectious disease vaccines, and last month Moderna and AstraZeneca filed for approval to run another Phase I study of a vascular disease treatment.

Moderna also has strategic agreements with Alexion Pharmaceuticals, Merck and Vertex Pharmaceuticals.

(Reporting by Ben Hirschler; Editing by Greg Mahlich)

 

AstraZeneca wins UK cost approval for longer use of heart drug

LONDON, Aug 12 (Reuters) - Long term use of AstraZeneca's blood thinner Brilinta has been recommended as a cost-effective option for treating patients after a heart attack, Britain's healthcare cost watchdog NICE said on Friday.

Ticagrelor 60 mg -- sold in Britain as Brilique for just under 1 pound ($1.30) a pill -- could help "many thousands of people" when given twice a day alongside aspirin, the National Institute for Health and Care Excellence (NICE) said.

In the United States, the wholesale acquisition cost is $5.14 a pill, although most U.S. patients are eligible for savings programmes.

A higher 90 mg dose of Brilique is already recommended for 12 months after a heart attack. Now new NICE draft guidance supports continued use at a lower dose for a further three years to reduce the risk of fresh heart attacks or strokes.

The drug is an important driver of future sales for AstraZeneca, which believes it can eventually sell $3.5 billion a year. Global sales in the first half of 2016 were $395 million.

The low-dose version of the medicine was recommended for long-term use by the U.S. Food and Drug Administration in September 2015 and by European authorities in February 2016.

($1 = 0.7707 pounds) (Reporting by Ben Hirschler; Editing by Keith Weir)

 

Merck gives up on its Brilinta competitor:

Merck cuts 148 jobs after giving up on ex-blockbuster hopeful Zontivity
by Tracy Staton |
Aug 16, 2016 9:26am

Merck & Co. ($MRK) has come to the end of the line with Zontivity, a clot-busting med once tagged with $5 billion sales estimates. The drugmaker won't promote the drug anymore in the U.S., and it plans to cut loose 148 sales-and-marketing staffers tasked with the job.

The company hinted at the prospect of dropping Zontivity earlier this year, in its annual filing with the Securities and Exchange Commission. It disclosed its plans to cut its payroll in a WARN notice to the state of Pennsylvania.

Launched in the U.S. in May 2014, Zontivity is approved to prevent blood clots in patients with a history of heart attack, and it won new approvals in Europe last year. At the time, Merck was planning to roll out Zontivity in certain European countries this year--and was still working to promote the brand in the U.S.

But if “efforts to build product awareness in the United States or the launches in Europe are not successful,” Merck said in the SEC filing, the company might write off the drug, to the tune of $292 million as of December 31.

The drug has patent protection through 2027, the company says, and would be eligible for an additional 6 months of pediatric exclusivity. Merck does not break out sales for the drug in its securities filings; typically, that means the sales aren’t material to its finances--and hence comparatively small.

Merck acquired Zontivity, or vorapaxar, in its 2009 buyout of Schering-Plough. It was a first-in-class PAR-1 drug designed to compete with the old standby clot fighter warfarin in stroke patients, and analysts had pegged its peak sales as high as $5 billion per year.

But as clinical studies progressed, serious bleeding risks emerged, dashing hopes of an approval for stroke patients and limiting its potential market. Its 2014 approval included a “black box” warning about those bleeding risks. Merck remained confident, however, that Zontivity would have plenty of room to grow as a clot preventer in heart attack patients.

Since then, newer clot-fighters have hit the market, including AstraZeneca’s ($AZN) Brilinta, approved for post-heart attack treatment, and Eli Lilly’s ($LLY) Effient. There’s also a range of next-gen warfarin rivals, including Bristol-Myers Squibb ($BMY) and Pfizer’s ($PFE) Eliquis; Johnson & Johnson ($JNJ) and Bayer’s Xarelto; and Boehringer Ingelheim’s Pradaxa. Those drugs have bleeding risks of their own, but reversal agents are nearing the market.

The sales cuts come on the heels of R&D restructuring that will claim some jobs in Montgomery County as well. Drawn by drug development hotspots in Cambridge, MA, and San Francisco, the company is staffing up in those areas while winding down in Pennsylvania.

In the R&D restructuring, Merck will close one Pennsylvania facility and cut jobs elsewhere in discovery, preclinical research and early-stage stage development. Meanwhile, it’s building new labs in Cambridge, with plans to open them later this year. In South San Francisco, Merck is recruiting about 100 scientists for a facility that’s also set to get going by year’s end. It’s scouting for a long-term site in that area.

 

they actually spent R&D dollars on this tired old steroid product?

AZ trumpets positive COPD data to help Symbicort stand up to rivals
by Carly Helfand |
Aug 15, 2016 7:26am

The already crowded COPD field is only going to get more competitive going forward--but AstraZeneca is boasting new data it hopes will keep its player going strong.

Last week, the British drugmaker trumpeted top-line results from a study in which ICS/LABA drug Symbicort met its primary endpoint, beating out formoterol Turbuhaler at cutting down on exacerbations in patients with severe forms of the disease.

It’s good news for the company, which has been working to weasel market share away from GlaxoSmithKline giant Advair in the U.S. as it fights off a European Symbicort generic from Teva. The company plans to consider “additional regulatory submissions” based on the results of the study, it said.

Problem is, two of its fierce competitors have also recently touted exacerbation-reducing data. Back in May, Novartis’ Ultibro Breezhaler--a LAMA/LABA combo med approved in Europe--showed it could top Advair in that department, marking what the Swiss drugmaker’s CMO called “a shift away from therapies containing steroids for the optimal treatment of COPD patients."

But Symbicort’s fellow ICS/LABA drug, Breo--GSK’s Advair follow-up--posted exacerbation-cutting results of its own later in the month, showing that the product bested “usual care”--including LAMAs, LABAs and ICS regimens.

Meanwhile, all three drugmakers are bracing themselves for U.S. generic Advair competitors, which are on the way from copycats including Mylan. It’s unclear, though, when they’ll actually hit, and Glaxo chief Andrew Witty has suggested it could still be awhile.

In the interim, AZ is doing what it can to bolster the rest of its respiratory portfolio, which it needs to achieve the sky-high $45 billion sales target CEO Pascal Soriot has put up for 2023. It won an FDA green-light for LAMA/LABA contender Bevespi Aerosphere in April, and it’s hoping the co-suspension technology in its inhaler device will help set it apart from the other LAMA/LABAs--including GlaxoSmithKline’s slow-starting Anoro Ellipta--that beat it to the U.S. market.

And it’s not stopping there with the new tech: It’s also applying it to “a range” of inhaled cocktail therapies in its pipeline, including a fixed-dose LAMA/LABA/ICS triple combo.

Separately, AZ last week released positive results for Symbicort in pediatric asthma, which it generated to fulfill the terms of a complete response letter the FDA issued in 2009.

 

MedImmune won't be impacted by AstraZeneca sale of antibiotic business to Pfizer
Aug 25, 2016, 6:36am EDT

Pharmaceutical giant AstraZeneca's agreement to sell much of its antibiotics business won't impact operations at MedImmune, its Gaithersburg-based research and development arm, officials confirmed Wednesday.

MedImmune's infectious disease and vaccine portfolio for AstraZeneca (NYSE: AZN) is focused exclusively on biologics, while AstraZeneca's deal with Pfizer Inc. — worth up to $1.6 billion — is specific to its small molecule antibiotics business. Additionally, there is no production in AstraZeneca's Frederick, Maryland, facility related to this business.

“This agreement reinforces our strategic focus to invest in our three main therapy areas where we can make the greatest difference to patients’ lives," Luke Miels, head of the antibiotics business unit at AstraZeneca, said in a statement about the deal.

MedImmune’s portfolio of biologics, on-market products such as FluMist and Synagis, as well as AstraZeneca spinoff Entasis Therapeutics, which is focused on the development of small-molecule "anti-infectives," are not included as part of the agreement.

What is MedImmune doing in the infectious disease space?

The company is largely entrenched in cancer immunotherapy research as well as research for respiratory and autoimmune diseases, with more than 120 drugs in its pipeline. But its pipeline includes multiple infectious disease prophylaxis candidates aimed at preventing illnesses like respiratory syncytial virus, influenza and pneumonia. Among these candidates, two in the pipeline are aimed at curbing antibiotic-resistant bacterial infections.

AstraZeneca acquired MedImmune in 2007 for $15.6 billion. AstraZeneca's Frederick manufacturing center is its largest biologics facility. The site currently produces commercialized pediatric medication, as well as other investigational biologic products.