AZ News from the Street 2018

It's going a lot lower this year. The free money ride is over. YOu will see it drop below the mean and then bounce back to it. Could see Dow at 15,000 by October. BUT, it will only last for a brief time. Back up the truck if this happens. FED will be forced to go back to easing interest rates which will keep the party going.

 

Dow tumbles 450 points again today in a late session collapse. No government shutdown, but a huge Omnibus spending bill passed and was signed into law. The combination of huge tax cuts and huge deficit spending will force the Fed to continue in raising interest rates. Geopolitical tensions are being purposely stoked about Iran are driving oil prices higher too. Higher oil prices, as has been proven in previous episodes, permeate all through the economy in forming inflationary price hikes for goods and services. Geopolitical tension is now the only way to drive oil prices higher as their is actually a glut on the market as new supplies are coming on line from fracking and as oil usage steadily declines globally. A little artificial oil scarcity does an oil company good. Uncle Putty likes it too, oil is pretty much all that they are able to sell on the world market.
It will be interesting to see what the market does in the next few weeks.

 

JERUSALEM, April 2 (Reuters) - Israeli drugmaker Compugen Ltd said it had agreed an exclusive licensing deal with a unit of AstraZeneca to develop antibody products to treat cancer, which could be worth more than $200 million.

Under the terms of the deal announced on Monday, MedImmune - the research and development arm of AstraZeneca - will develop genetically engineered antibody products derived from Compugen's oncology drug pipeline and pay royalties to the Israeli firm.

Compugen will receive a $10 million upfront payment and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as tiered royalties on future product sales, Compugen said in a statement.

If additional products are developed, additional milestones and royalties would be due to Compugen, which would retain all other rights to its entire pipeline of products, it said.

"This licensing deal allows us to monetize specific scientific advances in our programmes, while we continue to advance our lead programmes into clinical trials," Compugen CEO said Anat Cohen-Dayag said in a statement.

MedImmune said the deal will advance its "goal of delivering treatments to meaningfully improve the lives of cancer patients."

 

Interesting.... Funny how good old AZ has us do required compliance and ethic BS training every year because of the misdeeds of high level people. I guess the old song and dance continues. Do as I say, not as I do, right folks?

https://www.thetimes.co.uk/article/20m-secret-payments-to-plug-drugs-by-astrazeneca-and-shire-ns2qrf7m2

 

Lung Cancer is a tough disease to treat. They can't all be big winners:

LONDON, April 24 (Reuters) - A combination of AstraZeneca immunotherapy drugs in lung cancer patients who have already received at least two previous treatments has failed to show a benefit in slowing disease progression or helping patients live longer.

The disappointing results from the so-called ARCTIC study, announced on Tuesday, are a fresh setback for the idea of using two immunotherapy drugs together. The Phase III ARCTIC study was testing a combination of Imfinzi and tremelimumab.

A sub-study that was not powered for statistical significance did, however, find that Imfinzi monotherapy showed a clinically meaningful reduction in the risk of death compared to chemotherapy

 

EMA approval:


Today, Merck and AstraZeneca announced that the European Medicines Agency (or EMA) approved Lynparza tablets (300 mg twice daily) as a maintenance therapy for platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer.



About Lynparza
Lynparza is a PARP inhibitor presently approved for the following indications:

• as a maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in patients who are in complete or partial response to the platinum-containing chemotherapy.
• as a treatment for deleterious germline BRCA mutated advanced ovarian cancer in patients who have undergone at least three prior lines of chemotherapy
• as a treatment for deleterious germline BRCA mutated HER2-negative metastatic breast cancer in patients previously treated with chemotherapy

Lynparza approval
The approval was based on the two studies, SOLO-2 and Study 19, both of which show the reduced risk of disease progression and death with Lynparza for patients with platinum-sensitive relapsed ovarian cancer compared to placebo.

 

Will it get approved??

 

COPD drug trial dissappointment:


AstraZeneca, plc’s AZN new asthma drug, Fasenra (benralizumab) did not meet the primary endpoint in a late-stage study evaluating the respiratory biologic medicine for an expanded indication - chronic obstructive pulmonary disease (COPD)." AstraZeneca, plc’s AZN new asthma drug, Fasenra (benralizumab) did not meet the primary endpoint in a late-stage study evaluating the respiratory biologic medicine for an expanded indication - chronic obstructive pulmonary disease (COPD).

Fasenra was approved in the EU in January and in the United States in November last year as an add-on maintenance treatment in patients with severe eosinophilic asthma. Fasenra is given as a fixed-dose subcutaneous injection via a prefilled syringe, once in every eight weeks, making it the first respiratory biologic medicine to be approved in the United States and the EU with the convenient 8-week maintenance dosing schedule. GlaxoSmithKline’s GSK Nucala (subcutaneous administration) and Teva Pharmaceutical Industries' TEVA Cinqair (intravenous infusion) are presently marketed for the same indication but administered once every four weeks.

Coming back to the latest news, the phase III study, GALATHEA, evaluated the safety and efficacy of Fasenra in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Top-line results from the study showed that treatment with Fasenra, as an add-on to dual or triple inhaled therapy in COPD patients with a history of exacerbations across a range of baseline blood eosinophils, did not result in a statistically-significant reduction of exacerbations compared to placebo.

Full data from the pivotal GALATHEA study is expected to be presented at a future medical meeting. Another pivotal study, TERRANOVA, is also evaluating Fasenra for a similar indication. AstraZeneca will determine the next steps for Fasenra in COPD after it gets results from the TERRANOVA study and full data from the GALATHEA study.

 

This was taken from a business article in 2013. Pascal states:

"Based on our focused investment in key growth platforms and our pipeline, we believe we can significantly exceed current market consensus for 2018 revenues of $21.5 billion."...

Currently, at 5.3 billion for Q1, AZ better pick up the pace or he's not going to be fulfilling this promise. What would happen if I fall flat on my goals for five years. Think i could get a hefty raise like our fearless leader?

 

Lokelma, ZS-9, FDA approved:

AstraZeneca, AZN announced that the FDA has approved Lokelma (sodium zirconium cyclosilicate), formerly known as ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood and Lokelma is a highly selective, oral potassium-removing agent. AstraZeneca, AZN announced that the FDA has approved Lokelma (sodium zirconium cyclosilicate) formerly known as ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood and Lokelma is a highly selective, oral potassium-removing agent.

The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials. The drug has demonstrated in the trials that it can lower potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking renin-angiotensin-aldosterone system (RAAS) inhibitors.

The drug was approved in the EU in March this year.

We remind investors that the company had received two Complete Response Letter (CRL) for Lokelma from the FDA, thus delaying the drug’s entry to the market. The company received the first CRL in May 2016 while the second was received in Mar 2017. The first CRL had cited observations from a pre-approval manufacturing inspection and the receipt of new data, which was yet to be reviewed. AstraZeneca re-submitted the NDA in Oct 2016. The second CRL, however, did not require new clinical data generation but an inspection of the manufacturing facility by the FDA was needed.

Lokelma became part of AstraZeneca’s pipeline following the Dec 2015 acquisition of ZS Pharma.

 

Oh yeah, ZS9 approved and $45 stock price just around the corner!

 

Absolutely......But just wait the jokers will come out and start announcing layoffs in the later part of this year.....Let the trolls begin!!!!

 

Fasenra full readout for second clinical trial failure to achieve main endpoint for the COPD indication:

AstraZeneca drug Fasenra fails to achieve main goal in COPD trial
Reuters
May 30, 2018

(Reuters) - AstraZeneca's (AZN.L) first respiratory biological medicine Fasenra failed to meet its main target in a second clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The drug is currently approved as an add-on treatment for severe eosinophilic asthma in the United States, the European Union, Japan and several other countries.

Fasenra failed to meet its target in the final-stage trial, named Galathea, this month

 

Its hard to keep a "good" drug down. Seeing lots of TV commercials for Fasenra already for eosin cell based asthma disease.

 

Some good news in oncology:

LYNPARZA® (olaparib) in Combination With Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer (mCRPC). Olaparib is being jointly developed and commercialized by AstraZeneca and Merck.

The Lancet Oncology. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death (PFS2), overall survival (OS) and health-related quality of life." The results of Study 08, a randomized, double-blinded, multi-center Phase II trial, comparing olaparib in combination with abiraterone (n=71) to abiraterone monotherapy (n=71) in patients with previously-treated mCRPC, regardless of homologous recombination repair (HRR) mutation status, were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, June 1-5, 2018, as a “Best of ASCO presentation” and were published online today in The Lancet Oncology. The primary endpoint was rPFS. Secondary endpoints included time to second progression or death (PFS2), overall survival (OS) and health-related quality of life.

Olaparib is not FDA-approved for prostate cancer.

Noel Clarke, Professor of Urological Oncology, Christie NHS Foundation Trust, Manchester, UK, said: “This is the first time we have seen an improvement with the use of a PARP inhibitor in combination with abiraterone in patients with metastatic castration-resistant prostate cancer and this effect may be independent of HRR status. The data suggest this therapeutic combination may be a promising new treatment approach for this aggressive disease.”

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “A previous trial demonstrated improvements in response rates with olaparib monotherapy in metastatic castration-resistant patients with HRR mutations. The Study 08 combination data suggests that, regardless of their mutation status, men with metastatic castration-resistant prostate cancer may potentially benefit from olaparib in combination with abiraterone.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: “There is a significant unmet medical need for patients with metastatic castration-resistant prostate cancer as they are a high-risk group with limited treatment options. Olaparib is the first PARP inhibitor to demonstrate activity in combination with standard-of-care treatment in prostate cancer. These data from Study 08 represent another important milestone in the clinical development of olaparib.”

 

Alzheimer's Disease remains a very difficult puzzle to solve. So many failures by many companies in various different attempts to block beta-amyloid buildup begins to call into question the validity of the amyloid hypothesis as a cause itself.

Eli Lilly, AstraZeneca Shares Fall After Halting Alzheimer's Drug Test
The Street.com
Alexander Nicoll
June 12, 2018

Eli Lilly and AstraZeneca have discontinued late-stage trials of their experimental Alzheimer's disease drug Lanabecestat, (Lanabecestat is an oral beta-secretase 1 cleaving enzyme inhibitor. A BACE inhibitor in theory would prevent the buildup of beta-amyloid and may help slow or stop the progression of Alzheimer's disease) sending both companies' stock prices down in early morning trading Tuesday. AstraZeneca's stock was off 16 cents to $36.20 a share at market open, while Lilly saw its stock drop 17 cents to $85.69 a share. A committee from Internal Displacement Monitoring Center, a third-party data-monitoring group, recommended to officials to halt the trials because it found that lanabecestat didn't work in two trials set up to help patients with early onset and mild dementia, according to the two companies.

 

Oh ok Sedulo Group!

 

AZ Lilly negative results in Alzheimer's disease, as well as all the other failures by all of pharma in this area, are prompting new discussion of the amyloid hypothesis validity as the cause of the disease. Is it an effect and not a cause?

AP Top News
By LAURAN NEERGAARD
Yesterday

New evidence that viruses may play a role in Alzheimer’s

WASHINGTON (AP) — Viruses that sneak into the brain just might play a role in Alzheimer’s, scientists reported Thursday in a provocative study that promises to re-ignite some long-debated theories about what triggers the mind-robbing disease.

The findings don’t prove viruses cause Alzheimer’s, nor do they suggest it’s contagious.

But a team led by researchers at New York’s Mount Sinai Health System found that certain viruses — including two extremely common herpes viruses — affect the behavior of genes involved in Alzheimer’s.

The idea that infections earlier in life might somehow set the stage for Alzheimer’s decades later has simmered at the edge of mainstream medicine for years. It’s been overshadowed by the prevailing theory that Alzheimer’s stems from sticky plaques that clog the brain.

Thursday’s study has even some specialists who never embraced the infection connection saying it’s time for a closer look, especially as attempts to block those so-called beta-amyloid plaques have failed.

“With an illness this terrible, we cannot afford to dismiss all scientific possibilities,” said Dr. John Morris, who directs the Alzheimer’s research center at Washington University School of Medicine in St. Louis. He wasn’t involved in the new research but called it impressive.

The study also fits with mounting evidence that how aggressively the brain’s immune system defends itself against viruses or other germs may be riskier than an actual infection, said Alzheimer’s specialist Dr. Rudolph Tanzi of Massachusetts General Hospital. With Harvard colleague Dr. Robert Moir, Tanzi has performed experiments showing that sticky beta-amyloid captures invading germs by engulfing them — and that’s why the plaque starts forming in the first place.

“The question remained, OK, in the Alzheimer brain what are the microbes that matter, what are the microbes that trigger the plaque?” explained Tanzi, who also had no role in the new research.

The team from Mount Sinai and Arizona State University came up with some viral suspects — by accident. The study, funded by the National Institutes of Health, wasn’t hunting viruses but was looking for new drug targets for Alzheimer’s. The researchers were using complex genetic data from hundreds of brains at several brain banks to compare differences between people who’d died with Alzheimer’s and the cognitively normal.

The first clues that viruses were around “came screaming out at us,” said Mount Sinai geneticist Joel Dudley, a senior author of the research published Thursday in the journal Neuron.

The team found viral genetic material at far higher levels in Alzheimer’s-affected brains than in normal ones. Most abundant were two human herpes viruses, known as HHV6a and HHV7, that infect most people during childhood, often with no symptoms, and then lie dormant in the body.

That wasn’t unusual. Since 1980, other researchers have linked a variety of bacteria and viruses, including another type of herpes that causes cold sores, to an increased risk of Alzheimer’s. But it was never clear if germs were merely bystanders, or actively spurring Alzheimer’s.

The new study went farther: Researchers used computer models to check how the viral genes interacted with human genes, proteins and amyloid buildup, almost like the viruses’ social media connections, Dudley explained.

“We’re able to see if viral genes are friending some of the host genes and if they tweet, who tweets back,” Dudley said.

They found a lot of interactions, suggesting the viruses could even switch on and off Alzheimer’s-related genes. To see if those interactions mattered, the researchers bred mice lacking one molecule that herpes seemed to deplete. Sure enough, the animals developed more of those amyloid plaques.

“I look at this paper and it makes me sit up and say, ’Wow,’” said Alzheimer’s Association scientific programs director Keith Fargo.

He said the research makes a viral connection much more plausible but cautioned that the study won’t affect how today’s patients are treated.

If the findings pan out, they could change how scientists look for new ways to treat or prevent Alzheimer’s, said Dr. Miroslaw Mackiewicz of NIH’s National Institute on Aging. Already, NIH is funding a first-step study to see if an antiviral drug benefits people who have both mild Alzheimer’s and different herpes viruses.

Just having a herpes virus “does not mean you’re going to get Alzheimer’s,” Mass General’s Tanzi stressed. It may not even have penetrated the brain.

But in another study soon to be published, Tanzi showed biologically how both HHV6 and a cold sore-causing herpes virus can trigger or “seed” amyloid plaque formation, supporting the Mount Sinai findings.

Still, he doesn’t think viruses are the only suspects.

“The Mount Sinai paper tells us the viral side of the story. We still have to work out the microbe side of the story,” said Tanzi, who is looking for bacteria and other bugs in what’s called the Brain Microbiome Project. “The brain was always thought to be a sterile place. It’s absolutely not true.”

 

Oncology making money:

LONDON (Reuters) - AstraZeneca's oncology business received a boost on Wednesday as results of a clinical trial showed its drug Lynparza helped women with ovarian cancer live longer without their disease worsening when given as a first-line treatment.

The result should pave the way for expanded use of the medicine, which is being developed and marketed with Merck & Co under a deal struck last year.

Analysts said first-line use could boost Lynparza sales by more than $1 billion a year, although experts will first want to see the scale of the clinical benefit when full results are presented at a medical meeting.

The two companies did not say where they planned to present the data but one obvious venue would be the ESMO cancer congress in Munich in October.

Lynparza is already approved for later use in patients with so-called BRCA genetic mutations. Its latest success could expand the number of women with newly diagnosed ovarian cancer who are suitable for the drug by 30-50 percent, AstraZeneca believes.

Lynparza - abandoned at one stage by AstraZeneca but revived by CEO Pascal Soriot when he took over in 2012 - became the first drug in a class known as PARP inhibitors to reach the market when it won U.S. approval at the end of 2014.

It now faces competition from rival products made by Tesaro and Clovis Oncology.

Based on the strong results seen in the latest Phase III study, known as SOLO-1, AstraZeneca and Merck said they would talk to regulators about approving the earlier use of the medicine in women with BRCA mutations, which can drive tumour growth.

"It is the first time that we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor," said Sean Bohen, chief medical officer at AstraZeneca.

Deutsche Bank analysts said this could represent around a $1 billion incremental sales opportunity for the drug, on top of its existing approved second- and third-line use, while Jefferies put it at $1.6 billion.

A spokeswoman said AstraZeneca viewed competitors as 18 months behind in generating similar clinical data. The closest rival is Tesaro, which is expected to report first-line ovarian cancer results next year.

 

more:

WILMINGTON, Del.--(BUSINESS WIRE)--

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced positive results from the randomized, double-blinded, placebo-controlled, Phase III SOLO-1 trial of LYNPARZA® (olaparib) tablets (300 mg twice daily).

BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with LYNPARZA maintenance therapy had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions." Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with LYNPARZA maintenance therapy had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.

BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all, the patients who took part in this trial, without whom medical advancements would not be possible.”" Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive LYNPARZA earlier. We would like to thank the investigators, hospitals and most of all, the patients who took part in this trial, without whom medical advancements would not be possible.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: “Building on the strong data we’ve seen with LYNPARZA to date, the data from SOLO-1 reinforces LYNPARZA’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring LYNPARZA to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible.”

BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA-mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see complete indications below." LYNPARZA is not currently FDA-approved for 1st-line ovarian maintenance treatment. LYNPARZA is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA-mutation previously treated with three or more lines of chemotherapy. Physicians should select advanced ovarian cancer patients for therapy based on a FDA-approved companion diagnostic. Please see complete indications below.

BRCA status. Results are expected in 2019." Additionally, the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1, sponsored by ENGOT/GCIG, is testing the effect of LYNPARZA in combination with bevacizumab as a 1st-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.

LYNPARZA is a first-in-class PARP inhibitor approved in the US for certain patients with recurrent ovarian and metastatic breast cancer and has treated nearly 5,500 patients since 2014. LYNPARZA has a broad clinical-development program and AstraZeneca and Merck are working together to deliver LYNPARZA as quickly as possible to more patients across multiple cancer types, including prostate and pancreatic cancers.