AZ News From The Street 2016

AstraZeneca wins FDA breakthrough status for key cancer drug
9 hours ago

• LONDON, Feb 17 (Reuters) - The U.S. Food and Drug Administration has granted breakthrough therapy designation to AstraZeneca's biggest new drug hope durvalumab as a treatment in bladder cancer, the drugmaker said on Wednesday.
  
  The experimental medicine is a so-called PD-L1 therapy that fights cancer by boosting the immune system.
  
  Breakthrough therapy designation expedites the development and review of medicines intended to treat serious or life-threatening diseases.
  
  Durvalumab is also being developed as a treatment for lung, head and neck, gastric, pancreatic, liver and blood cancers. It faces competition from rival products made by Bristol-Myers Squibb, Merck and Roche.

 

AstraZeneca won a breakthrough designation for durvalumab, an immuno-oncology therapy designed to expose cancer to the body's natural defenses by blocking a protein called PD-L1. The FDA's move is based on early-stage data showing durvalumab can make a difference in advanced, drug-resistant urothelial bladder cancer, a devastating disease with 5-year survival rates under 15%, according to AstraZeneca. The company is pressing through a wide range of studies to establish durvalumab's efficacy in a host of cancers, hoping to compete with similar therapies from Bristol-Myers Squibb, Merck and Roche.
The FDA's breakthrough program promises drugmakers preferred access to top agency officials throughout the development process, an effort to speed up the journey for promising medicines that might change the standard of care in serious diseases.
AstraZeneca may face a rockier path with its high-profile therapy. In December, the company disclosed that an ongoing study pitting durvalumab against lung cancer--the treatment's lead indication--was unlikely to generate the data necessary to support FDA approval as a monotherapy. AstraZeneca has projected peak sales of $6.5 billion for durvalumab, but the changing landscape for so-called checkpoint inhibitors could put that goal out of reach.

 

AstraZeneca Gets European Approval for Heart Attack, Gout Treatments
By Trey Thoelcke 3 hours ago

• 
  Shares of pharmaceutical giant AstraZeneca PLC (AZN) ticked down in Friday’s premarket trading in New York after the company announced that the European Commission (EC) had granted marketing authorization for two of its treatments: Zurampic for gout and Brilique for heart attack patients.
  
  Both treatments were approved by the U.S. Food and Drug Administration (FDA) last year.
  
  The EC has granted marketing authorization for Zurampic (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of an XOI alone. As part of the approval, AstraZeneca will conduct a Non-Interventional Post-Authorisation Safety Study (PASS) to investigate the cardiovascular safety profile (mainly in patients with history of cardiovascular disorder) exposed to Zurampic.
  
  Brilique (ticagrelor) was approved at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti-platelet therapy.
  
  Earlier this week, AstraZeneca announced that the FDA had granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.
  
  The designation is intended to expedite the development of new drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, that demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.
  
  AstraZeneca shares were recently downgraded to Hold from Buy at HSBC, but also raised to Equal Weight from Underweight at Barclays.
  
  Shares of AstraZeneca were down 1.2% at $29.70 in Friday’s premarket, within a 52-week trading range of $28.29 to $36.69.

 

EC granted approval for a new dose (60 mg) of Brilique.

The new 60 mg dose of Brilique is approved for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.

Brilique sales should benefit from the label expansion due to increasing awareness and confidence at the physician level as well as longer treatment duration. Brilique has currently posted full year sales of $619 million in 2015, up 44% (at CER) and has performed well in all the key markets. The 60 mg dose is already available in the U.S. where it was approved in Sep 2015.

 

one more year of growth like this and Brilique/Brilinta will actually be a real blockbuster ($1 billion/anum sales). It didn't look like it would ever get there, but it looks like it will now.

 

Hilarious. Net profit was only $200 million in 2015. Just think what can be accomplished when they double the hospital division!!

 

Is that so bad on $640 million in sales? However, net profits are always lower during the early high promotional period, due to the added promotional expenses. The same was true for every other successful blockbuster in AZ history. You have to invest in the franchise early to get to the high profit regime later.

 

Why doesn;t anyone see that this is not a hospital drug. People are in the hospital for 4 days with an AMI and we focus all our efforts on inpatient? Who gives a shit. We could win every single dose but who cares.

 

Sure sure sure.

Another blockbuster for AZ.

 

Of course, in all their wisdom, AZ closed the site that gave them this new blockbuster, so they could keep others open that produce nothing.

 

AstraZeneca's $4 bln Acerta deal endorsed by orphan drug status

• London9:37AM EST
  
  LONDON, Feb 25 (Reuters) - AstraZeneca's bold move to buy 55 percent of privately held biotech firm Acerta Pharma for $4 billion in December has been vindicated, at least in part, by the award of special "orphan" status to the key drug involved.
  
  The drugmaker said on Thursday that the European Medicines Agency had recommended acalabrutinib as an orphan product for chronic lymphocytic leukaemia or small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma.
  
  Orphan status is awarded to medicines promising significant benefit in the treatment of rare, life-threatening diseases and the designation provides companies with special development and market exclusivity incentives.
  
  AstraZeneca bought control of Acerta to get its hands on acalabrutinib, which it believes could generate sales of more than $5 billion a year.
  
  Acalabrutinib works in a similar way to AbbVie and Johnson & Johnson's Imbruvica. But AstraZeneca reckons it has fewer side effects than Imbruvica and potentially better efficacy. Rival drugs are further behind in development.
  
  The new medicine is a so-called Burton's tyrosine kinase inhibitor that targets an array of blood cancers and potentially some solid tumours. It may also help in autoimmune diseases such as rheumatoid arthritis and lupus.

 

AstraZeneca cancer drug fails in mesothelioma trial
1 hour ago

• 
  
  LONDON, Feb 29 (Reuters) - AstraZeneca said a closely watched experimental cancer drug failed in a clinical trial when used on its own to treat mesothelioma, a rare lung and abdominal cancer, but it remained confident the drug had a role to play in combination treatments.
  
  Tremelimumab failed to meet the primary endpoint of improving overall survival in hard-to-treat mesothelioma patients, the drugmaker said on Monday.
  
  Tremelimumab is also being tested in combination with another of AstraZeneca's immune-boosting drugs called durvalumab in multiple tumour types, including non-small cell lung cancer.

 

AZ is unloading its OIC drug:

AstraZeneca sells drug for $70 mln as divestment drive continues
8 hours ago

• 
  LONDON, March 1 (Reuters) - AstraZeneca has sold rights to a non-core drug to a unit of Kyowa Hakko Kirin for an upfront payment of $70 million, a day after getting $500 million for two ageing heart medicines.
  
  The British-based drugmaker has been divesting peripheral products to help pay the bills as it invests in new medicines, while taking a profit hit from the loss of patent protection on a raft of former blockbusters.
  
  Such divestments, or "externalisation" deals, contributed $1.1 billion to revenue last year and the company has said the figure is likely to be higher in 2016.
  
  Under the latest deal, Kyowa's subsidiary ProStrakan is acquiring European rights to Moventig, which is used to treat opioid-induced constipation, AstraZeneca said on Tuesday.
  
  In addition to the initial payment, ProStrakan will also pay AstraZeneca tiered double-digit royalties and milestones related to sales and the roll-out of Moventig in certain markets.

 

Can't believe that AZ was able to dump Movantik on some half-ass pharma company for marketing in Europe. What happened Frenchie, lost faith in Movantik as a "blockbuster". What a fucking moron!

 

AstraZeneca Continues to Sell Off Its Drug Portfolio
by Sy Mukherjee
March 1, 2016, 12:17 PM EST
The latest sale is for $70 million.


British drugmaker AstraZeneca has sold the European marketing rights for the opioid-induced constipation drug Moventig to ProStrakan, a unit of Japanese biopharma firm Kyowa Hakko Kirin. It is the second big sale of a non-core drug that the company has made in the last two days.

AstraZeneca will receive $70 million in upfront payments as well as future tiered royalties on net sales as part of the arrangement, which will allow ProStrakan to sell the medication in the EU, Iceland, Norway, Switzerland, and Liechtenstein. AstraZeneca also received $500 million in a separate deal from selling two older heart medications on Monday, according to Reuters.

The company has been on a divestment binge over the past several years as it attempts to clear out fading portions of its pipeline to fuel future R&D and concentrate on therapeutic spaces such as cardiovascular and cancer drugs. AstraZeneca reportedly hopes to top last year’s divestment-related revenues of $1.1 billion in 2016.

Moventig, which is marketed as Movantik in the U.S., has caused some controversy for AstraZeneca in the past month. The company and its marketing partner for the treatment in America, Daiichi Sankyo, came under fire from Democratic Vermont Governor Peter Shumlin for airing a Movantik ad during the Super Bowl in February despite the ongoing opioid addiction crisis in the U.S.

“Like many Americans, I was baffled by the commercial your companies paid an estimated $10 million to air during the Super Bowl,” wrote Shumlin in a letter to the companies demanding that the ads be taken down. “In the midst of America’s opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies’ profits.”

AstraZeneca later rebuffed Shumlin’s request, writing that the commercial’s message would encourage “a clinically important conversation about [opioid-induced constipation] between patients and their doctors.”

 

AZ should face the inevitable and become a generics manufacturer. Selling off her older drugs is another gargantuan mistake management is making in a long list of mistakes.

AZ cannot discover any new therapies. History for the last 20 years proves that. The money comes in from old school products and still does. AZ Gen. Because we care about patients' lives first!

 

Diabetes franchise news:


Novo Nordisk says Victoza helps lower heart risks
2 hours ago

• • COPENHAGEN (Reuters) - Novo Nordisk said on Friday the results from a trial showed that its Victoza diabetes drug significantly reduced the risks of major adverse cardiovascular events.
    
    "People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That's why we are very excited about the results from LEADER (trial), which showed that Victoza ... also reduces their risk of major adverse cardiovascular events," Novo's Chief Science Officer Mads Krogsgaard Thomsen said.
    
    Novo Nordisk's shares jumped as much as 7 percent in the minutes after the announcement.

 

From Motley Fool:

Pharma giant AstraZeneca (NYSE:AZN) has a big challenge coming this May, when its top-selling cholesterol-busting drug, Crestor, is slated to lose patent protection. That's a big deal, considering worldwide sales of Crestor topped $5 billion in 2015, which represents more than 20% of the company's total revenue. Losing exclusivity in the U.S. puts the company in a bind, since more than half of Crestor's total sales come from the United States.

To help prepare for the decline, AstraZeneca has been pumping money into R&D to bring new drugs to market, and the company has made a lot of progress. AstraZeneca scored six regulatory approvals in 2015, which included new drugs that hold blockbuster potential, such as Tagrisso, which treats lung cancer, and Lynparza, which treats ovarian cancer.

Beyond its recent approval, the company also boasts a handful of other drugs that are producing great growth. Farxiga/Forxiga, which treats type 2 diabetes, grew sales 137% globally in 2015, and Brilinta/Brilique, an antiplatelet drug that lowers the risk of having a heart attack, grew sales 44%.

These new medicines look like they should pay off big time for the company, which is expecting low- to mid-single-digit revenue and earnings-per-share growth in 2016. That's a heck of an accomplishment for a company that expects to lose patent protection for its most successful drug, and it speaks to its commitment to invest so heavily in new medicines.

 

Who's Winning the Battle to Treat the Diabetic Masses?
Innovative type 2 diabetes treatments are catching on, but which will come out on top?




It's difficult to overstate the size of the diabetes epidemic facing the developed world. In the U.S. alone, it affects more than 29 million people, although about 8 million are undiagnosed. Some people are born unable to produce insulin. Those are type 1 diabetics. But about 90% to 95% of diabetics are of the type 2 variety. Type 2 diabetics don't produce enough insulin, don't respond to insulin, or have some combination of both.

A type 2 diabetic's disease typically begins when his or her pancreas becomes unable, or unwilling, to produce enough insulin to keep blood sugar at a low enough level. Often, as the disease progresses, the person becomes less responsive to insulin either created in one's own pancreas or injected.

Type 2 diabetics who fail to respond properly to "old-fashioned" insulin injections have some relatively new options. The GLP-1 agonists such as Victoza from Novo Nordisk (NYSE:NVO) reduce glucagon -- the hormonal yin to insulin's yang -- and stimulate release of the patient's own insulin.

More recent is the SGLT2 class of drugs from Johnson & Johnson (NYSE:JNJ), AstraZeneca (NYSE:AZN), and partners Boehringer Ingelheim and Eli Lilly (NYSE:LLY). Taken as a pill, not an injection, this class of therapy inhibits the kidneys from keeping glucose in the bloodstream, allowing it to be excreted through the urinary tract. While some members of this class are performing better on the market than others, overall the uptake has been impressive.

Becoming the go-to-drug for a disease that affects hundreds of millions worldwide is a goal worth fighting for. Let's check in on these four to see who's winning.

Lousy sales; great data:

Eli Lilly's SGLT2 inhibitor, Jardiance, would have been last to market in the U.S. by a few months, but an FDA rejection in March 2014, citing manufacturing facility deficiencies on Boehringer's part, delayed it even further. As the third SGLT2 to enter the U.S. market after winning FDA approval in August 2014, it saw sales get off to a slow start. After its first full year of commercialization, Lilly still didn't even mention Jardiance sales in its 2015 annual report.

That could change, because last November the company announced terrific results for the drug from a cardiovascular outcomes trial, with over 3,000 patients taking either a placebo or Jardiance along with the standard of care for three years. Adding Jardiance reduced patients' risk of cardiovascular death by 38% and reduced hospitalizations for heart failure by 35%. That's the first time any therapy for the reduction of blood glucose has shown such a benefit.

Roughly half of all diabetics die from cardiovascular disease, so you might think that that would have led to an uptick of Jardiance sales in the fourth quarter, but it didn't. At about $15 million they were actually a bit lower than the third quarter, although its share of the new-to-brand SGLT2 market recently rose to 25% from 15%.

Perhaps adding cardiovascular benefit information to the drug's label will help, Lilly has already filed a supplementary application that would do just this on both sides of the Atlantic. However, going from last place in sales figures to first might not be that simple.

Better sales; data forthcomingGaining FDA approval in January 2014, AstraZeneca's SGLT2 inhibitor, Farxiga, was second of its class to reach pharmacy shelves in the U.S. -- J&J's Invokana was first. Farxiga is also the second most popular SGLT2 inhibitor, and it's growing sales nicely. Annual sales of Farxiga grew 119% to $492 million last year.

Perhaps the reason physicians haven't jumped for Lilly's Jardiance is that it might not be the only SGLT2 that can lower the risk of cardiovascular events. AstraZeneca is in the middle of a study that's similar to, but larger and longer than, Lilly's. The Declare study is following more than 17,000 patients receiving placebo or Farxiga in addition to standard care for a longer time frame.

Showing a similar or stronger benefit in this larger, longer trial might help Farxiga overtake the front-runner, but it might be too late: The outcome data isn't expected until 2019.

Even better sales; even more data forthcomingFirst to the U.S. market in spring 2013, Johnson & Johnson's SGLT2 inhibitor has left its class contenders in the dust. Part of its success has to do with the quick approval of Invokamet, a combination of common type 2 diabetes treatment metformin and Invokana in August 2014. Last year, annual sales of the Invokana franchise more than doubled to $1.3 billion.

The healthcare heavyweight is also running two outcome studies. The first, involving 4,400 patients, will measure time to cardiovascular events and should read out early next year. Results from another trial, with 4,200 patients assessing kidney damage, along with more cardiovascular info, is expected in 2019.

If I had to guess, I'd say the medical community is assuming Jardiance's cardiovascular, hospitalization, and mortality benefit isn't unique to Lilly's drug, but a classwide benefit. With J&J's Invokana the next to report outcome data, we'll know soon enough.

The best sales; "significant" dataWith diabetes products responsible for a whopping 79% of total sales, it's surprising that Novo Nordisk doesn't have an SGLT2 program. What it does have is the popular GLP-1 agonist, Victoza. Last year, sales of the drug grew by double digits to $2.7 billion.

Since Jardiance posted its impressive mortality benefit, Novo has good reason to be nervous. However, the company has results that show Victoza demonstrated a "statistically significant" reduction of these three things combined: first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke.

How significant? You'll need to wait until June to find out. If you find the lack of details in the announcement troubling, you're not alone. I'm not suggesting something's rotten in Denmark, but if the benefit is greater than that shown for Jardiance, I'll eat nothing but pickled herring for a week.

While I'm making predictions, I don't expect much of an increase in Jardiance sales until -- and unless -- J&J's first outcome trial for Invokana throws off less impressive data early next year. If however, Invokana shows a similar, or stronger, benefit than Jardiance, J&J could end up with the most popular drug in one of the world's largest indications.

 

AstraZeneca Boss Shouldn't Forget Pfizer
by Chris Hughes
Bloomberg

Enduring muttering over Pascal Soriot's pay at AstraZeneca is a warning to other CEOs that they will be held accountable for pledges made during a bid defense.

In May 2014, AstraZeneca said it would deliver $45 billion of revenue in 2023. At the time, the British drugmaker was attempting to see off an unsolicited takeover approach from U.S. rival Pfizer. Just after the claim was made, AstraZeneca rejected a 55-pounds-a-share bid, which failed as it was conditional on the U.K. firm's recommendation.

Some shareholders have been asking -- rightly -- why nothing in Soriot's pay is linked directly to hitting that 2023 target. AstraZeneca says this idea has "some attraction," and is considering ways a "more transparent link" could be made between the controversial target and executive pay. It needs to get on with it.

AstraZeneca's rejection was based on the view that 58.85 pounds per share was the level at which to yield to Pfizer. The $45 billion revenue projection was doubtless central to this valuation. The difficulty is that such forecasts are hard for outsiders to assess, let alone police. Projections about cost-savings in a merger are subject to rules set by the U.K. Takeover Panel, to ensure they are credible. But auditing a nine-year sales target is near impossible.

Baking such targets into CEO pay is probably the least bad solution to achieve some accountability. Still, it would be odd to skew the bonus of any CEO directly to a 2023 revenue target. This could distort decision-making against the near-term needs of the business.

AstraZeneca stock tumbled on the day of the bid rejection and has fallen 5 percent since to about 40.60 pounds. Bloomberg's Europe 500 Pharmaceuticals Index is up 7 percent over the same period. Last year Soriot was paid 8.4 million pounds, up from 2014's 3.5 million pound thanks to 4.7 million pounds of long-term incentives vesting. It looks like shareholders have suffered all the pain while Soriot has done okay.

Soriot may not be running AstraZeneca in 2023, and it probably won't be possible to devise a perfect way to hold him to account. But that's no reason to shirk linking part of his pay to what he promised.

Enduring muttering over Pascal Soriot's pay at AstraZeneca is a warning to other CEOs that they will be held accountable for pledges made during a bid defense.

In May 2014, AstraZeneca said it would deliver $45 billion of revenue in 2023. At the time, the British drugmaker was attempting to see off an unsolicited takeover approach from U.S. rival Pfizer. Just after the claim was made, AstraZeneca rejected a 55-pounds-a-share bid, which failed as it was conditional on the U.K. firm's recommendation.

Some shareholders have been asking -- rightly -- why nothing in Soriot's pay is linked directly to hitting that 2023 target. AstraZeneca says this idea has "some attraction," and is considering ways a "more transparent link" could be made between the controversial target and executive pay. It needs to get on with it.

AstraZeneca's rejection was based on the view that 58.85 pounds per share was the level at which to yield to Pfizer. The $45 billion revenue projection was doubtless central to this valuation. The difficulty is that such forecasts are hard for outsiders to assess, let alone police. Projections about cost-savings in a merger are subject to rules set by the U.K. Takeover Panel, to ensure they are credible. But auditing a nine-year sales target is near impossible.

Baking such targets into CEO pay is probably the least bad solution to achieve some accountability. Still, it would be odd to skew the bonus of any CEO directly to a 2023 revenue target. This could distort decision-making against the near-term needs of the business.

AstraZeneca stock tumbled on the day of the bid rejection and has fallen 5 percent since to about 40.60 pounds. Bloomberg's Europe 500 Pharmaceuticals Index is up 7 percent over the same period. Last year Soriot was paid 8.4 million pounds, up from 2014's 3.5 million pound thanks to 4.7 million pounds of long-term incentives vesting. It looks like shareholders have suffered all the pain while Soriot has done okay.

Soriot may not be running AstraZeneca in 2023, and it probably won't be possible to devise a perfect way to hold him to account. But that's no reason to shirk linking part of his pay to what he promised.