AZ News from the Street 2015

AstraZeneca wins U.S. approval for longer use of blood thinner
By Bill Berkrot and Ben Hirschler

In practice, while the new label will certainly help, long-duration therapy may be reserved for patients with particularly high heart risks and little danger of bleeding complications, said Deutsche Bank analyst Richard Parkes.

The FDA approved Brilinta at a new 60 milligram (mg) dose to be taken with aspirin beyond a year after a heart attack. The drug, used to prevent blood clots that can cause heart attacks, strokes and deaths, had previously been approved at a higher dose just for use during the 12 months after a heart attack.

The FDA move comes a week after European heart experts endorsed the potential use of Brilinta and similar blood clot preventers beyond a year.

The expanded approval suggests patients could be taking Brilinta for considerably longer than now and the FDA did not set any limit on the duration of treatment.

Tom Keith-Roach, vice president for Brilinta at AstraZeneca, told Reuters the FDA endorsement would shift thinking among heart doctors and expand the market, as clinical practice moves increasingly towards longer-term drug use.

Only about a quarter of acute coronary patients in the United States who start on Brilinta, or rival blood-thinners, remain on treatment for 12 months. In Europe, more patients do receive therapy for a year but very few are treated beyond that.

"We're not going to see fireworks but this will support really strong and consistent growth over time. I've got a nice straight line that goes from our current reported sales to my $3.5 billion," Keith-Roach said.

Selling more Brilinta is a high priority for the British drugmaker. During a takeover battle with Pfizer last year, it forecast annual sales of the drug could reach $3.5 billion by 2023.

Consensus forecasts currently point to sales of $1.7 billion by 2020, according to Thomson Reuters Cortellis, suggesting considerable upside if AstraZeneca hits its target. Brilinta sales rose 23 percent to $144 million in the second quarter.

Under the new FDA recommendations, patients with a history of heart attacks can be treated with 60 mg of Brilinta twice daily along with a daily maintenance dose of aspirin of 75 to 100 mg, beyond the first year's treatment.

AstraZeneca also has clinical trial programmes under way to expand the use of Brilinta in stroke, peripheral arterial disease and diabetes.

 

AstraZeneca announced updated data on AZD9291 in first-line patients with epidermal growth factor receptor mutation positive advanced non-small cell lung cancer and previously-treated patients with EGFRm T790M mutation-positive NSCLC (AZN) : Data demonstrated that in 60 patients who received AZD9291 once daily in the first-line setting, 72% (95% confidence interval 58% to 82%) were progression free (PFS) at 12 months. Confirmed overall response rate was 75% (95% CI 62% to 85%). The longest duration of response (DoR) was ongoing at 18 months. Data on two AURA Phase II studies (AURA extension and AURA2) in previously treated patients with EGFRm T790M were also presented. While still preliminary, these studies showed an efficacy and tolerability profile for AZD9291 consistent with previously-reported data. In AURA extension (n=201), ORR was 61% (95% CI 54% to 68%); median DoR and median PFS were not calculable. Consistent results were observed in AURA2 (n=210); ORR was 71% (95% CI 64% to 77%), median DoR was 7.8 months (95% CI 7.1 months to NC) and median PFS was 8.6 months (95% CI 8.3 months to 9.7 months).2-3

 

Motley Fools analysis of Big Pharma:

AZ is a real outlier among the others big ones financially:

http://www.fool.com/investing/general/2015/09/20/are-big-pharma-stocks-grossly-overvalued.aspx?source=eogyholnk0000001

 

Thanks, Turing. Your 5000% price hike puts pharma in the election hot seat
September 21, 2015 | By Tracy Staton


Martin Shkreli
The spotlight on rising drug prices just keeps getting brighter: Lawmakers filing bills and holding hearings, presidential candidates devising anti-price-hike plans, doctors campaigning on social media, think tanks devising cost-benefit measures. The controversies are doing pharma no favors with consumers, either; most Americans blame drugmakers for their own rising pharmacy bills.

The last thing pharma needs right now is a scandalous price hike to turn up the heat even further.

But that's just what Turing Pharma and its CEO, Martin Shkreli, have on offer. The company bought a standard-of-care drug for toxoplasmosis infections, Daraprim, and promptly jacked up the price by 5000%. The pill, whose users tend to be AIDS sufferers and cancer patients, cost $13.50 per pill just weeks ago. Now, it's $750.

Already, the news has gone viral on Twitter, where debate raged Sunday and Monday. And just before FiercePharma press time, presidential candidate Hillary Clinton tweeted about it as a choice example of pharma price-gouging.

"Price gouging like this in the specialty drug market is outrageous," the tweet stated. "Tomorrow I'll lay out a plan to take it on. -H " Apparently, the "H" signature indicates an actual Hillary sentiment, rather than a statement from the campaign in general, not a good sign.

It's not the first example of a company buying in a drug and hiking the price by a big margin. Valeant Pharmaceuticals ($VRX) is under Congressional investigation for doing the same thing on CV meds Isuprel ($215 per vial to $1,346 per) and Nitropress ($257.90 per vial to $805.61). Horizon Pharma ($HZNP) jacked up its price on the pain pill Vimovo by almost sixfold, soon after buying the drug from AstraZeneca.

And Retrophin ($RTRX), where Shkreli served as CEO till he was tossed out by the board earlier this year, did the same thing to Thiola, used to treat a rare disease that causes kidney stones. The company took its monthly cost from $135 to upward of $2,700.

But those price increases--quite large at 525%, 212%, 597% and yes, even 2000%--are just a fraction of Daraprim's massive increase.


Sen. Bernie Sanders
So now, Clinton and her Democratic rival Bernie Sanders--who introduced drug-pricing legislation last week, and has been leading the charge in investigating price hikes in Congress--have a prime example to point to when pushing their own plans. Turing, Martin Shrkeli and Daraprim will serve as a big red flag for the candidates to carry--and that big red flag is likely to spill some blood onto the rest of the drug business.

Pharma can remind the public that the Daraprim example is particularly egregious, not representative of the usual price increases. But drugmakers can't argue that they're blameless. Price hikes are a widespread strategy for growing sales--just take a look at the increases in diabetes drug prices; Eli Lilly's ($LLY) Humulin went up by 325%, for instance, over the past five years. Or any number of brand price increases, topped by Jazz Pharmaceuticals ($JAZZ) and Xyrem (841% over 5 years ending in 2013).

​

And using R&D expenses as justification for rising prices just doesn't cut it anymore. Not when hep C activists can point to Gilead Sciences ($GILD), which has already raked in at least enough to pay for developing its hep C drugs Sovaldi and Harvoni, less than two years into their marketing lives.

That's Shkreli's apparent defense for the Daraprim increase; he told The New York Times that Turing needs the dough to invest in developing improved treatments for toxoplasmosis. But doctors told the paper that there's no pressing need for a new med in that field.

One big question is why an older drug like Daraprim has no generic competition. The NYT points out that the brand's distribution is tightly controlled, which could make it tough for generics makers to get the supplies they need in order to develop their own versions. But even without generics, Turing could find that its sales strategy backfires. Buyers might decide to stock cheaper rival drugs instead, despite the fact that Daraprim is currently the generally accepted leader in the field.

 

An executive from another biotech company said this:

"Sept. 23—Seeking to tamp down the outrage, industry leaders sought to further explain what innovative pharma companies do. Alnylam Pharmaceuticals CEO John Marganore went on CNBC and said ‘This is not what we do” and that industry isn’t about “re-pricing drugs from the 1950s.""

False. Combinations, XLs, and isomer versions of existing drugs have been all big pharma has really produced in the last 20 years. When something new comes along it is an accidental discovery. Because (as you will read in virtually every package insert) we don't understand how Rx drugs work. The mechanism of action is either "unknown" or "thought to be."

 

Here's what you do:

Go to the gym or at least walk around some.
Stop eating fast food. Stop eating any food that is tan in color (french fries, chicken nuggets, pizza dough, breaded fried food, etc.) Eat food that has bright colors like blueberries, strawberries, lettuce, bananas.
If you're overweight then lose weight.

That will improve your life personally big time, cut America's healthcare bill BIG TIME, and decrease the need for a pill to do what you should be doing for yourself. Easy but it takes work. Go to Europe and check out how obvious it is that the English and the Americans are the fat slobs in the crowd. Take a walk for a change instead of a drive.

 

So then its OK to gouge everyone because deep down the disease is all their fault? You have a very twisted way of rationalizing your greed.

 

No, doing as I recommend will make it so that you don't need medicine. And you call me twisted?

 

Here's a link:

http://www.streetreport.co/astrazeneca-plc-adr-nyseazn-purchased-us-biologics-manufacturing-facility/22669/

AZ buys a manufacturing facility and will take over a year getting it up to speed with renovations, yet AZ sells the Westborough plant. It is not fair of me to write this since it is a complicated matter (I'm ready for the lambasting), but it is simply my knee-jerk reaction that AZ is choosing to sell Westborough, and buy and renovate in Colorado big time (over a year's work), because some of the decision makers want to visit Colorado regularly on the shareholders' dime. Just a wild guess. No coincidence that life in Colorado is very different than life in Westborough. Lots of fun in Colorado. I do not know anything about this for a fact.

 

Aren't technical analysts great. Who cares about fundamentals anyway!!


AstraZeneca (AZN) Stock: Searching for a Bottom, Critical Level Is $34.50

By Bruce Kamich Follow | 09/28/15 - 10:06 AM EDT


NEW YORK (TheStreet) -- After a 50% correction, AstraZeneca (AZN - Get Report) appears to be searching for a bottom.

From its 2012 low of $20, AZN rallied to $40 in a blow-off move and heavy volume, see chart above. Prices have drifted lower for months, finally touching $30, marking a one-half or 50% retracement of the previous rally. The power of the 50% retracement dates back to around 1900-1902 when Charles Dow wrote about it in his editorials at the Wall Street Journal.

In this shorter-term chart, above, one can see how quickly AZN rebounded from $30, and it's easier to see the recent improvement in the On-Balance Volume line (OBV). The rising OBV line is a technical positive. Analysts like to see volume expand in the direction of the move.

Also, the trend-following Moving Average Convergence Divergence oscillator has crossed back above the zero (0) line, telling us the trend has improved. The overall pattern of lower highs and lower lows since November 2014 is still intact, but a rally above $34.50 for AZN will give us a new pattern of higher lows and higher highs.

We rate ASTRAZENECA PLC (AZN) a HOLD. The primary factors that have impacted our rating are mixed -- some indicating strength, some showing weaknesses, with little evidence to justify the expectation of either a positive or negative performance for this stock relative to most other stocks. The company's strengths can be seen in multiple areas, such as its largely solid financial position with reasonable debt levels by most measures and expanding profit margins. However, as a counter to these strengths, we also find weaknesses including a generally disappointing performance in the stock itself, disappointing return on equity and weak operating cash flow.

Highlights from the analysis by TheStreet Ratings Team goes as follows:

• The debt-to-equity ratio is somewhat low, currently at 0.60, and is less than that of the industry average, implying that there has been a relatively successful effort in the management of debt levels.
• The gross profit margin for ASTRAZENECA PLC is currently very high, coming in at 95.50%. It has increased from the same quarter the previous year. Regardless of the strong results of the gross profit margin, the net profit margin of 10.71% trails the industry average.
• Regardless of the drop in revenue, the company managed to outperform against the industry average of 6.7%. Since the same quarter one year prior, revenues slightly dropped by 5.4%. The declining revenue appears to have seeped down to the company's bottom line, decreasing earnings per share.
• Net operating cash flow has decreased to $1,080.00 million or 48.05% when compared to the same quarter last year. In addition, when comparing the cash generation rate to the industry average, the firm's growth is significantly lower.
• The company's current return on equity has slightly decreased from the same quarter one year prior. This implies a minor weakness in the organization. In comparison to the other companies in the Pharmaceuticals industry and the overall market, ASTRAZENECA PLC's return on equity is significantly below that of the industry average and is below that of the S&P 500.

 

New Dose of Brilinta Now Available in US Pharmacies

BRILINTA 60 mg available for long-term use in patients with a history of heart attack

• WILMINGTON, Del.--(BUSINESS WIRE)--
  
  
  AstraZeneca (AZN) announced today that BRILINTA® (ticagrelor) 60-mg tablets are now available in US pharmacies. On September 3, 2015, the US Food and Drug Administration (FDA) approved a new 60-mg dosage strength for BRILINTA to be used in patients with a history of heart attack beyond the first year. BRILINTA is approved to reduce the rate of cardiovascular (CV) death, myocardial infarction ([MI], also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, BRILINTA is superior to clopidogrel. BRILINTA is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel at 12 months.
  
  “Patients continue to be at risk for a second heart attack, even if their first heart attack was more than a year ago and they continue on the recommended therapies prescribed to them,” said Tonous Silfani, PhD, Executive Director, CV Thrombosis, US Head of Marketing, AstraZeneca. “We wanted to make this new 60-mg dosage strength available as quickly as possible so that healthcare providers can consider adding BRILINTA 60 mg to the treatment regimen for patients with a history of heart attack beyond the first year.
  
  The dosing of BRILINTA in the management of ACS is 90 mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60 mg twice daily. BRILINTA must be used with a daily maintenance dose of aspirin of 75-100mg.

 

AstraZeneca announces the New England Journal of Medicine has published Brodalumab study results (AZN) :

The New England Journal of Medicine has published positive results from two pivotal, multi-centre, Phase III studies-AMAGINE-2 and AMAGINE-3-demonstrating that treatment with brodalumab resulted in significant clinical improvements in patients with moderate to severe psoriasis and was superior to both placebo and ustekinumab. The studies were funded by AstraZeneca and Amgen (AMGN), the former sponsor of the brodalumab programme.

• At week 12, the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo (86% and 67%, respectively, vs. 8% [AMAGINE-2] and 85% and 69%, respectively, vs. 6%; P
• The week 12 PASI 100 response rates were significantly higher with 210 mg of brodalumab than with ustekinumab Mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo.
• Through week 52, the rates of serious infectious episodes were 1.0 (AMAGINE-2) and 1.3 (AMAGINE-3) per 100 patient-years of exposure to brodalumab

 

Bristol-Myers' gets early approval of combo cancer treatment
Bristol-Myers takes lead with approval of first combo of immune system-boosting cancer drugs

By Linda a. Johnson, AP Business Writer 18 hours ago

TRENTON, N.J. (AP) -- The first combination of breakthrough drugs that boost the immune system to fight cancer has been approved, giving maker Bristol-Myers Squibb Co. an early lead over competitors testing other combos in a pharmaceutical gold rush of sorts.

The Food and Drug Administration gave accelerated approval to a regimen combining the New York-based drugmaker's already-approved immuno-oncology drugs, Opdivo and Yervoy, to treat the half of patients with advanced melanoma who have a genetic variation called "BRAF wild-type."

Together, the drugs slowed or temporarily stopped tumor progression in 60 percent of patients, versus 11 percent who only received Yervoy, in a key study of 140 previously untreated patients with melanoma, the deadliest skin cancer type. The combo increased the time until melanoma resumed progressing, to an average of about nine months, versus nearly five months for Yervoy alone.

The combination of Yervoy, which was approved in 2011, and Opdivo caused serious side effects in 62 percent of study participants, compared with 39 percent only getting Yervoy, and many of those patients had to stop or delay treatment. The worst side effects included colitis, kidney and liver damage, severe diarrhea, lung inflammation and fever.

With a wholesale price of $141,000 to $256,000 for the combination, depending on length of treatment, even many insured patients may not be able to afford their portion of the tab, though Bristol-Myers and some charities help many patients cover much of it.

Immuno-oncology drugs, also called immunotherapy, have brought the first significant advances in patient survival — though generally not cures — in many years for some cancer types, particularly lung cancer and melanoma. Now advances are coming more quickly.

Almost daily, Bristol-Myers or rivals including Merck & Co., AstraZeneca PLC, Roche Holding AG and Pfizer Inc. has been announcing the start of new patient testing of combinations of their own drugs or their drug with one being developed by a partner, or announcing new collaborations with other drugmakers in the hottest segment of cancer research.

Analyst Jeffrey Holford at Jefferies International Ltd. in August raised his peak sales forecast from $40 billion to $51 billion for immuno-oncology drugs from those five companies — just for the biggest subcategory, medicines called immune checkpoint inhibitors. These drugs, including Yervoy and Opdivo, work by blocking different pathways that tumor cells use to "cloak" themselves from the immune system so it can't spot and attack tumors.

Bristol-Myers posted combined sales of Yervoy and Opdivo, which was just approved last December, of $783 million in the first half of 2015.

Melanoma, in which pigment-producing skin cells grow at an uncontrolled rate, has been getting more common for at least three decades. Nearly 75,000 cases are forecast to be diagnosed this year in the U.S. While mostly curable when caught early, when melanoma is discovered in its late stages, only 10 percent to 15 percent of patients survive for 10 years, according to American Cancer Society data.

Meanwhile, on Thursday the Dana-Farber Cancer Institute in Boston said it was asking a federal court to declare one of its scientists a co-inventor on five patents for Opdivo that Bristol-Myers licensed from a drugmaker and a university in Japan. Depending on the case's outcome, Bristol-Myers could lose some future revenue or have to pay royalties on Opdivo.

 

AstraZeneca pauses two lung cancer drug combination trials
Fri, Oct 9, 2015, 11:50AM EDT
3 hours ago


LONDON, Oct 9 (Reuters) - AstraZeneca has temporarily halted two clinical trials combining experimental drugs to treat lung cancer, following reports of lung disease in some patients, the company said on Friday.

The trials involve giving its drug AZD9291, which is currently awaiting regulatory approval, alongside the immune system-boosting medicine durvalumab, also known as MEDI4736, to treat patients with advanced non-small cell lung cancer.

A spokeswoman said the tests had been paused due to an increase in the incidence of interstitial lung disease-like reports. No deaths have been reported as a result of the problem.

Patients in the trials will get updated consent forms before deciding whether to continue in the studies.

AZD9291 and durvalumab are two of AstraZeneca's most promising experimental cancer treatments, although their use together in lung disease is only one of many possible applications.

AZD9291, like a rival product in development at Clovis Oncology, targets a genetic mutation that helps tumours evade current lung cancer pills. AstraZeneca has said it could generate sales of as much as $3 billion a year.

Durvalumab belongs to the keenly anticipated class of immuno-oncology drugs known as anti-PD-L1 therapies, which work by stopping a tumour's ability to evade the body's defences. AstraZeneca has forecast it could sell $6.5 billion a year.

 

Wow! Yet another failure for this POS company! interstitial lung disease is a BIG problem! A friend of mine had to have both lungs replaced because of it! Time to flush this one!

Frenchie, we expected more from you than this! Time to go mon ami' !

 

I wonder if the Clovis agent has the same type of lung problem, (i.e. its a class effect). If not, then we have the clear winner in the AZ vs. Clovis horse race.

 

until Wall Street takes whatever number a drug company gives as an estimate and calls bulls**t, this will continue to happen. I look at drug estimates and cut by 75% to figure what they will really do. Morons.

 

Morons? You mean liars.

 

AstraZeneca diabetes drug combination faces delay after FDA rebuff

• * U.S. FDA issues complete response letter for saxa/dapa
  
  * Setback may mean delay of 1-2 years, analysts believe
  
  * AstraZeneca predicted $3 bln sales for combination (Adds analyst comments on likely length of delay)
  
  By Ben Hirschler
  
  LONDON, Oct 16 (Reuters) - U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca, delaying its launch and dealing a blow to an important plank of the drugmaker's business.
  
  AstraZeneca said on Friday it had received a so-called complete response letter from the Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.
  
  
  Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval and the move means AstraZeneca faces an unspecified wait in getting its potential blockbuster drug cocktail to market.
  
  Deutsche Bank analyst Richard Parkes said the FDA move probably reflected lack of data on the new formulation rather than safety or efficacy concerns and it seemed likely a launch would simply be delayed by between 12 and 24 months.
  
  Morgan Stanley analysts said a best-case scenario was an 8-10 months' delay but this could extend to a few years if new clinical trials were needed.
  
  Last year, during its defence against a $118 billion takeover attempt by Pfizer, AstraZeneca predicted the saxagliptin and dapagliflozin fixed-dose combination could generate peak annual sales of $3 billion, out of total diabetes revenue of $8 billion expected by 2023.
  
  Shares in the company were flat by late morning, underperforming a 1.5 percent rise in the European drugs sector .
  
  AstraZeneca said the FDA wanted to see more clinical trial data from ongoing or completed studies and it might also require information from new studies.
  
  The individual component drugs in the new mix are already approved and marketed for the treatment of type 2 diabetes, under the brand names Onglyza and Farxiga, and the FDA move is not expected to affect their status, the company added.
  
  Sales of Onglyza reached $391 million in the first half of 2015, with recently launched Farxiga selling $205 million.
  
  Onglyza is a type of diabetes medicine known as a DPP-IV inhibitor, similar to Merck's highly successful Januvia.
  
  Farxiga belongs to a newer drug class called SGLT2 inhibitors, which have created great excitement since a clinical trial last month showed that Eli Lilly's Jardiance slashed deaths in patients at risk of heart attack and stroke.