AZ News from the Street 2017

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Mystic study possible outcomes analyzed:

AstraZeneca's Cancer Trial Could Help Out A Rival, Analyst Says

ALLISON GATLIN
6/29/2017

AstraZeneca's (AZN) advanced lung cancer trial could benefit rival Bristol-Myers Squibb (BMY), leaving Dow component Merck (MRK) to twirl in the wind, an analyst said Thursday ahead of a key data readout.

But Leerink analyst Seamus Fernandez only gives AstraZeneca's trial a 15% chance of hitting a "grand slam." Instead, it's 25% likely the trial will result in a "strikeout," he said in a report before AstraZeneca reveals the results of its trial dubbed Mystic later this year.

Wall Street reactions to Fernandez's assessment were fairly muted on the stock market today. Merck stock fell 1.3% to close at 64.34. AstraZeneca and Bristol stocks slipped marginally to 34.12 and 55.82, respectively.

The Mystic trial is evaluating a combination of AstraZeneca's drugs Imfinzi and tremelimumab vs. chemotherapy in patients with advanced lung cancer. The trial is testing a long-standing theory that coupling immuno-oncology drugs could offer a better cancer defense.

Imfinzi is what's known as a PD-L1 inhibitor. It works by blocking an interaction involving the PD-L1 protein in the immune system. Tremelimumab is called an anti-CTLA-4 inhibitor. It works to block a different interaction in the body.

AstraZeneca is testing whether patients with more of that PD-L1 protein will have a stronger reaction to the combination drug. Fernandez sees just a 15% chance the combo will work in all patients regardless of how many PD-L1 proteins their bodies have.

However if it fails, the trial will have implications for Bristol, he said. In a separate trial, Bristol is testing its drugs Opdivo and Yervoy in advanced lung cancer. Yervoy is similar to tremelimumab. Opdivo is known as a PD-1 inhibitor, which has a slightly different mechanism from Imfinzi.

"Mystic is a clear binary event for AstraZeneca and — to some degree — Bristol as well," he said. Bristol's trial is also testing its immuno-oncology combination vs. chemotherapy in patients with advanced lung cancer. Data are expected later this year.

Though a "grand slam" is the least likely scenario, in that instance Fernandez says AstraZeneca and Bristol could expect to split the advanced lung cancer market in immuno-oncology combos, leaving Merck to lead the monotherapy market with its Keytruda.

Merck is testing Keytruda in combination with chemotherapy. It's also looking at a combination of Keytruda with Incyte's epacadostat, which is known as an IDO inhibitor. Keytruda is similar to Opdivo in that it's also a PD-1 inhibitor.

Roche (RHHBY), meanwhile, is looking at a combination of its drugs Tecentriq and Avastin with chemo. Tecentriq is also a PD-L1 inhibitor like AstraZeneca's Imfinzi. Top-line results from that trial are expected in the third quarter.

"We assume a modest peak share for Roche with an as-yet-to-be-determined combo," Fernandez said. "Among immuno-oncology plus chemo regimens, we anticipate Merck to dominate followed by Roche and Bristol."

He noted, however, a win in the Mystic trial would "negatively influence the potential for Merck and Roche's immuno-oncology plus chemo combos."

If the Mystic trial isn't successful, Fernandez sees a 13% downside for AstraZeneca. He sees a 16% upside, though, is the trial succeeds. In the slim chance AstraZeneca's combo works in all patients regardless of protein expression, it would set a high competitive bar for Bristol's combo.
 








Some competitor potentially very bad news in oncology. The question is, is this a compound specific problem or is it a class effect? If it is the former, then that could be a positive for AZ, whose compound is behind Merck's compound in testing. If it is the later, then that would be devastating to the AZ oncology program as well.



Dow's Merck Stumbles After FDA Puts Keytruda Trials On Hold

ALLISON GATLIN
7/05/2017

Dow component Merck (MRK) stock toppled late Wednesday after the Food and Drug Administration put three clinical trials on hold involving the drugmaker's immuno-oncology med, Keytruda, in a blood cancer known as multiple myeloma.

Trials of Keytruda and low-dose Dexamethasone combined with either Pomalyst or Revlimid, from Celgene (CELG), were placed on full clinical holds. Another similar combination study was placed on a partial clinical hold.

Last month, Merck paused enrollment in two of those trials after more patients receiving Keytruda died. On Wednesday, the FDA said the risks of those combinations outweighed the potential benefits.

In after-hours trading on the stock market today, Merck stock was off an additional 1%, near 63.50. It ended the regular trading session down a fraction, to 64.16. Shares have been forming a flat base since early March. Merck is one of three biopharmaceutical companies on the Dow Jones industrial average.
 




AZ oncology deal with Celgene discussed:


Deal May Help Celgene Rival Dow's Merck, Bristol In Cancer Drugs

ALLISON GATLIN
11:41 AM ET

Celgene (CELG) could rival Dow component Merck (MRK) and Bristol-Myers Squibb (BMY) in cancer-fighting drugs, an analyst said after the No. 2 biotech announced a $413 million deal, giving it access to a key immuno-oncology treatment.

Under the terms of the deal, Celgene will pay BeiGene (BGNE) $263 million in upfront license fees and make a $150 million equity investment to acquire the rights to develop the drug known as BGB-A317 in solid tumors across the globe.

BGB-A317 belongs to a class of immuno-oncology drugs called PD-1 inhibitors. These drugs, including Merck's Keytruda and Bristol's Opdivo, work to block a specific interaction involving the PD-1 protein in body that would prevent an immune response to cancer cells.

The deals allows Celgene to develop and commercialize BGB-A317 to treat solid tumors in the U.S., Europe, Japan and the rest of the world outside of Asia. BeiGene keeps the rights to its drug for blood cancers worldwide and for solid tumors in Asia.

Celgene already has an immuno-oncology play in blood cancers with its acquisition of the rights to AstraZeneca's (AZN) Imfinzi in hematological tumors in 2015, Evercore analyst Umer Raffat said. He called the deal a small upfront cost to get access to a PD-1 inhibitor beginning trials next year.

Also within the deal, BeiGene will acquire Celgene's commercial operations in China and an exclusive license to commercialize cancer drugs Abraxane, Revlimid and Vidaza in China, Celgene said in a news release early Thursday.

The deal comes a day after the Food and Drug Administration put three of Merck's Keytruda trials on hold after several patient deaths. Celgene was partnered in those trials. Still, questions linger regarding how much Celgene is willing to put in to finish development of BGB-A317, Raffat said.

"From Celgene's perspective, (it's) very important to understand how big a (research and development) undertaking this will be and how many additional immuno-oncology targets it will look to bring in for potential combos," he wrote in a note to clients.

A number of companies, Merck and Bristol included, are working to combine their immuno-oncology drugs with others to boost their potency. BeiGene, though, says its PD-1 inhibitor is more efficient because it's been engineered to minimize interactions with other targets outside the PD-1 protein.

Celgene is working on a number of immuno-oncology targets outside of PD-1. But Raffat expects it will need to add more, including an IDO inhibitor like Incyte's (INCY) epacadostat or a CTLA-4 inhibitor like Bristol's Yervoy.

In morning trading on the stock market today, Celgene stock dipped less than 1%, near 132.10. Shares of Merck fell 1.1%, near 63.40, as Bristol-Myers stock toppled 1.5%, near 55.50. BeiGene stock, though, rocketed 24.5%, near 65.10, touching a record high after its February 2016 initial public offering.
 




Diabetes Market for AZ analysis, Farziga is doing well anyway:

Farxiga Expected to Drive AstraZeneca’s Performance in Diabetes Segment
By Margaret Patrick | Jul 7, 2017 7:24 pm EDT

Diabetes franchise
In 1Q17, AstraZeneca (AZN) witnessed a 1% year-over-year (or YoY) drop in revenues earned by its diabetes portfolio. Intense pricing and competitive pressures resulted in a 7% YoY drop in the company’s diabetes franchise sales in the US market in 1Q17.

In Europe, the company witnessed ~1% growth in diabetes product sales despite declining demand for Onglyza. This is mainly attributed to the increasing adoption of Farxiga in Europe.

Farxiga’s growth trends
In 1Q17, AstraZeneca’s leading sodium-glucose co-transporter 2 (or SGLT2) therapy for type-2 diabetes, Farxiga, reported revenues close to $270 million, which is YoY growth of ~25% on a constant currency basis.

In the US, the drug reported sales close to $96 million, which is YoY growth of only 2%, due to the negative impact of restricted managed care access, ongoing affordability programs, and changing inventory levels. To learn more about Farxiga, please read What to Expect from AstraZeneca’s Farxiga in 2017.

AstraZeneca, however, is confident that the SGLT2 class of drugs could gradually capture the market of other type-2 diabetes class of drugs, specifically Dipeptidyl peptidase-4 (or DPP4) inhibitors such as Merck’s (MRK) Januvia and Janumet.

As physicians are becoming more confident prescribing SGLT2 drugs, they are being prescribed at an earlier stage of the disease, just after metformin and prior to DPP-4 inhibitors. Physicians are also combining SGLT2 inhibitors with other type-2 diabetes therapies at earlier stages of diabetes.

SGLT-2 inhibitors such as Farxiga, Johnson & Johnson’s (JNJ) Invokana, Boehringer Ingelheim and Eli Lilly’s (LLY) Jardiance, and others are expected to benefit from positive results of CVD-REAL, the first large study based on real-world evidence.

This study has demonstrated that type-2 diabetes patients treated with SGLT2 inhibitors witnessed a 51% reduction in mortality and a 39% drop in hospitalizations due to heart failure compared to patients treated with other classes of drugs.

This ongoing study, comprising more than 300,000 patients around the world, is expected to boost the uptake of Farxiga in 2017.
 








Lots of competition in that class so they need to practically give it away. While its free to the patient they still get some $ from insurance companies I think. Anyway, it isn't replacing any of the big off patent drugs so it isn't that of a big deal in the big picture. It is the current best seller in the entire diabetes portfolio though surprisingly.
 




anonymous said:
Lots of competition in that class so they need to practically give it away. While its free to the patient they still get some $ from insurance companies I think. Anyway, it isn't replacing any of the big off patent drugs so it isn't that of a big deal in the big picture. It is the current best seller in the entire diabetes portfolio though surprisingly.
Click to expand...
Our sales team gave it away on day one. We don't sell we give coupon cards away. Sad but true
 




Brilinta growing:

AstraZeneca Expects Brilinta to Become a Blockbuster Therapy in 2017
By Margaret Patrick | Jul 7, 2017 7:24 pm EDT

Brilinta revenue growth
In 1Q17, AstraZeneca’s (AZN) Brilinta reported total revenues of ~$224 million, which equals 27% growth year-over-year (or YoY) on a constant currency basis. This is mainly attributed to the increasing adoption of this cardiovascular drug in the US, China, and other emerging markets.

The drug witnessed 24% YoY growth in sales in the US, while revenues from emerging markets rose 54% YoY and reached $60 million. Brilinta also witnessed robust 68% YoY revenue growth in the Chinese market in 1Q17.

In Europe, the drug witnessed 12% YoY revenue growth in 1Q17. Based on its solid revenue growth trends, AstraZeneca expects Brilinta to cross the $1.0 billion revenue mark in 2017.

The continued adoption of Brilinta is expected to boost AstraZeneca’s stock price.

The chart above shows the growth trends for Brilinta in 1Q17. The drug has enabled AstraZeneca to pose solid competition to other cardiovascular players such as Sanofi (SNY), Eli Lilly & Co. (LLY), and Bristol-Myers Squibb (BMY).

Growth drivers
Brilinta has become a leading player in the oral antiplatelet (or OAP) market, mainly due to restrictions imposed on its competitor’s label as well as positive changes in guidelines issued by American College of Cardiology and the American Heart Association.

Despite not being included in China’s National Reimbursement Drug List (or NRDL), Brilinta earned ~58% of its emerging market revenues from this market in 1Q17. AstraZeneca is currently involved in negotiating favorable reimbursement for the drug in China.
 








Au Revoir

Shares in AstraZeneca took a hammering after word spread that its CEO, Pascal Soriot, is set to take the reins at Israel-based Teva.

early trial clinical readout? One has to wonder.
 




anonymous said:
Au Revoir

Shares in AstraZeneca took a hammering after word spread that its CEO, Pascal Soriot, is set to take the reins at Israel-based Teva.

early trial clinical readout? One has to wonder.
Click to expand...

Remember that the captain went down with the Titanic but the CEO took a seat in one of the first lifeboats.
These corporate raiders and crooks don't care about anything but lining their own pockets. I guess he stole as much as he could here and needs to move on to the next piggy bank. Mother fucker.
 




AstraZeneca shares fall for a second day over CEO uncertainty
Shares in AstraZeneca fell for a second day on Friday as uncertainty over the future of Chief Executive Pascal Soriot weighed on the Anglo-Swedish company ahead of a crucial period. Shares in Astra closed down 3.5 percent on Thursday and were trading down a further 2.5 percent on Friday, at a two-month low, following an Israeli report late on Wednesday that Soriot was in talks to join Teva Pharmaceutical Industries. Moving to a generics drugmaker, albeit the world's largest, would be a big change in direction for French-born Soriot, 58, who had made research-based pharma his whole aim at AstraZeneca.
U.K. stocks inch lower on Friday, kept under pressure by further gains for the pound and continued losses for drug giant AstraZeneca.

Mystery at AstraZeneca: Is CEO Pascal Soriot Staying or Going?
Shares in the U.K. drug giant fell sharply after a news outlet reported he was moving to lead Teva Pharmaceuticals, an Israeli generics drugmaker that has been looking for a new chief for months.
 




Potential AstraZeneca C-Suite Shuffle Rekindles Takeover Chatter
Michael Brown
Jul 14, 2017 12:07 PM EDT
https://secure2.thestreet.com/cap/prm.do?OID=033365&ticker=AZN
AstraZeneca plc (AZN) shares are down after rumors began swirling that its CEO Pascal Soriot is on his way to Israel's Teva Pharmaceutical Industries Ltd. (TEVA) ahead of key drug information release.

But amid the rumors of his departure, which comes as AstraZeneca is ready to release key data for its Mystic oncology program, there is a murmur that if Soriot jumps ship the company could be susceptible to a takeover.

"His exit would leave [AstraZeneca] rudderless in the wake of several other recent departures," wrote Seamus Fernandez of Leerink Partners in a note Thursday, echoing the sentiment of several other analysts. "In a best case scenario, we could see a change in management as an opening to a potential merger."

According to Calcalist, an Israeli business website, Soriot met with Teva's search committee and chairman and agreed to take the position, which comes with a salary nearly double Teva's last CEO's, which was $5.7 million, plus a signing bonus of $15 million to $20 million. The companies have refused to comment on the rumors.

Teva stock traded up almost 4% and AstraZeneca stock fell 1.6% by Thursday's close. AstraZeneca stock was up 2.9% on Friday, and Teva's was down 1%.

The rumors come after Martin Mackay, president of research and development, and Tony Zook, global commercial executive vice president, had their roles eliminated on Jan. 31 and as AstraZeneca's one-time hostile bidder, Pfizer plc (PFE) , as well as other big pharma companies, may soon have access to large overseas cash hoards to fuel M&A. A management shake-up of this proportion could also make the company susceptible to an activist investor, especially as the company could be sitting on potentially valuable assets with a management team in flux.

"If true, the optics around his departure would be terrible ahead of the Mystic readout," Fernandez said, adding that the results are expected "any day now."

"Realistically it would leave the company in a state of flux ahead of both this important IO catalyst as well as upcoming data readouts from several other key pipeline assets," Fernandez added, referencing Lynparza, an ovarian cancer treatment, and roxadustat, which addresses chronic kidney disease and anemia, among other assets.

Pfizer, which made a $110 billion bid to acquire AstraZeneca in 2014, has left the door open for large-scale M&A as well.

"We will continue to evaluate deals," Pfizer CEO Ian Read said on a conference call with investors in May. "We never say never, but I believe the current environment needs to stabilize in order to be an advantageous market for big deals."

To be sure, there is no promise that Pfizer or any other large-cap pharma company is in a position to actually acquire an $80 billion-plus-market cap company like AstraZeneca. Or that anything in the way of corporate tax cuts like those that could help Pfizer get a deal done for AstraZeneca will actually come to fruition. However, if the company does indeed watch its CEO walk, anything is possible.
 




Payer Pangs over PARP Pricing:


Cancer-fighting PARP drugs from AstraZeneca, Clovis and Tesaro largely overpriced, watchdog says
by Eric Sagonowsky
Jul 13, 2017 10:01am

With three PARP inhibitors battling it out in ovarian cancer, competition is heating up between AstraZeneca, which reached the market first, and smaller players Tesaro and Clovis Oncology as new approvals and new indications upend the field. But U.S. cost watchdog ICER has drawn some conclusions about the class—mostly that they're too expensive.

In a new draft evidence report (PDF), the Institute for Clinical and Economic Review found that AstraZeneca’s Lynparza meets common cost-effectiveness thresholds to treat recurrent BRCA-mutated ovarian cancer, but that the medication would need discounts of 50% to 80% to be cost-effective as a maintenance therapy.

The FDA granted a priority review in March for that indication, which would expand Lynparza's market considerably, with an action date set for the third quarter. Patients on maintenance therapy—used after a patient responds to initial treatment—stay on their treatments for longer periods of time.

Boston-based ICER says Tesaro's Zejula, already approved as a maintenance therapy, would have to be discounted 60% to 90% to achieve common cost-effectiveness thresholds in ovarian cancer patients with a germline BRCA mutation, "while there is no price that would achieve the thresholds in women without the mutation." Zejula won FDA approval for all patients regardless of mutation.

And for Clovis’ Rubraca in BRCA-mutated ovarian cancer? ICER says that med would have to be discounted 50% to 75% to achieve common cost-effectiveness thresholds. The group noted that Rubraca “provides substantial clinical benefit” at a high cost. All of the findings are open to public comment until Aug. 9.

ICER’s model incorporates total payer costs, progression-free survival time, life years, quality-adjusted life years, incremental cost-effectiveness ratios and other factors, according to the report. Since the group started reviewing cost-effectiveness back in 2015, it’s frequently earned the ire of the drug industry, which has claimed the calculations are biased.

When Rubraca won U.S. approval in December, Clovis announced a price of $6,870 for a 15-day supply, or $13,740 for a month. Tesaro’s list price for Zejula, which won approval in March, is $9,833 monthy, while AstraZeneca’s Lynparza retail cost is $12,450 per month. Lynparza won U.S. approval in 2014. All of these prices are before rebates offered to payers.

A spokesperson for Tesaro said “we appreciate the efforts that ICER has made to seek and incorporate input from stakeholders,” but added the company has “significant concerns” with the draft report.

“PARP inhibitors are a new, paradigm-shifting class of medicines for a disease with limited treatment options,” she said in a statement. “ … The ICER preliminary report, based on assumptions that are not supported by sound evidence, should not be used to restrict access to this valuable new therapy for women living with ovarian cancer.”

AstraZeneca's spokesperson said the company continues to "have concerns with how ICER evaluates products from both a clinical and economic perspective."

She said AZ "supports patient-centric value assessments that comprehensively measure available data, costs, and budget impact, taking into consideration personalized approaches to care delivery. However, we believe these tools need to be carefully constructed to ensure they do not restrict patient access to appropriate therapies and support continued innovation to address unmet medical needs."

Rubraca is "priced appropriately," according to a Clovis representative. She added that the ICER report "does not fully account for the investment made in Rubraca or other, approved PARP inhibitors, nor the true cost benefits of these precision-medicine therapies and their potential, long-term value to women with ovarian cancer, their families and physicians."

Speaking with FiercePharma, ICER chief scientific officer Dan Ollendorf said his group has always been “open and transparent about the assumptions that we are making.

“We invite comment and concerns about those assumptions,” he said. “Those are out there for anyone to make comment on and to understand.”

While ICER received the request to delay the report so it could include more data, the group decided to go ahead and publish its draft findings because the PARP drugs are on the market and stakeholders need to make decisions on the meds, Ollendorf said. As more data become available, ICER plans to “update the report accordingly."

Since winning a $5 million grant from the Laura and John Arnold Foundation to look into U.S. drug pricing, ICER has sparked anger from drug industry players on a number of occasions for its cost-effectiveness reviews. The group recently said osteoporosis meds from Radius and Eli Lilly are far too expensive. Before that, it concluded most multiple sclerosis drugs on the market are overpriced. It’s also hit at pharma’s pricing for PCSK9 cholesterol meds, immuno-oncology therapies and other drug classes. Pharma has hit back by blasting the nonprofit's review methods.

In response to the criticism, ICER last year convened a discussion with a broad group of players to change its assessment methods. Afterward, the group broadened its quality-adjusted life year threshold to $50,000 to $150,000 and committed to reviewing drugs at their price minus rebates, among other changes.
 




Soriot is Staying put for now.

AstraZeneca Stock Surges After Company Confirms Soriot Staying on as CEO
Kinsey Grant
Jul 14, 2017 3:36 PM EDT

Pascal Soriot will stay on as CEO of AstraZeneca (AZN) , the company said, following rumors Soriot would take a new position as CEO of Teva Pharmaceuticals (TEVA) , Bloomberg reported.

AstraZeneca stock surged almost 4%, while Teva stock fell more than 3% in late afternoon trading.

AstraZeneca said it never responded to the rumors of Soriot's departure, which were first reported by Israeli business news site Calcalist. AstraZeneca confirmed on Friday that Soriot will present the company's earnings July 27. Company insiders said things are business as usual at AstraZeneca.
 




Is the CEO going or not? He is staying until July 27 anyway. No clarity after that so far.

AstraZeneca says CEO Pascal Soriot will host earnings call
ReutersJuly 14, 2017
By Kate Holton and Paul Sandle

LONDON, July 14 (Reuters) - Anglo-Swedish pharmaceutical firm AstraZeneca said on Friday its chief executive, Pascal Soriot, would host a results call with reporters on July 27, after refusing to comment on speculation this week that he was leaving the firm.

A report on Wednesday on Israeli financial news website Calcalist said Soriot was in talks to join Israel's Teva Pharmaceutical Industries, the world's biggest generic drugmaker.

Shares in AstraZeneca, after falling on Thursday following the Israeli report, rose 4.6 percent on Friday to close at $33.87 on the New York Stock Exchange.

Before announcing the earnings call, AstraZeneca had cited a policy of not commenting on market rumour or speculation. The cost of the two days of silence in terms of the company's market capitalisation had been more than 3 billion pounds ($3.9 billion).

An invitation sent to reporters after Friday's market close in Europe said Soriot would be hosting the usual financial results call on July 27.

"You are invited to participate in a media teleconference hosted by Pascal Soriot, CEO, to discuss the results," it said.

In London, AstraZeneca shares lost 3.5 percent on Thursday and fell further on Friday to close at 48.75 pounds.

The timing of the news report alarmed investors, coming as the company waits for all-important data from a lung cancer drug trial which is seen as a game-changer for Astra.

The company is hoping to secure a substantial slice of a multibillion-dollar market by proving its combination of two immunotherapy drugs, durvalumab and tremelimumab, can help previously untreated patients with advanced lung cancer.

The results of the major trial, called MYSTIC, are due any day now.

One top 20 shareholder said there had been a "newsflow vacuum".

"It's hard because companies cannot be seen to be responding to every newspaper article because once you start you cannot stop. But as we all agree, if true, then timing is 'interesting'," the shareholder said, on condition of anonymity.

Moving to a generics drugmaker would be a big change in direction for French-born Soriot, 58, who made research-based pharmaceuticals his whole drive at AstraZeneca.

Analysts at Leerink, an investment bank that specialises in healthcare, said Soriot's exit would come as a major surprise, if true, and leave AstraZeneca rudderless at a key time.

"We spoke with the company, who simply stated that it does not comment on rumours; however it did not outright deny the report," they said. "If true, the optics around his departure would be terrible ahead of the MYSTIC readout."

AstraZeneca has already been shaken by the departure of the head of its European business, Luke Miels, who defected to rival GlaxoSmithKline, and there have been a number of other senior management departures.

During his five years at AstraZeneca, Soriot successfully defended the company against a $118 billion takeover approach from Pfizer.

He also rebuilt AstraZeneca's drugs pipeline through research and acquisitions to replace revenue lost from a wave of patent expiries on many of its blockbuster medicines.

The Calcalist report said Soriot had met Teva's search committee and its chairman to express his agreement to serve as its next CEO.

It said he was expected to earn twice as much as former boss Erez Vigodman and receive a signing bonus estimated at about $20 million. It said the financial terms were still being discussed. ($1 = 0.7717 pounds)
 




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