AZ News from the Street 2017

Yet more "efficiencies" are promised by the CEO:

AstraZeneca was able to offset falling sales by cutting costs, vowing to slash more than $1.1 billion from its budget before 2017 started. The company divested some non-core assets, including the sale of its small-molecule antibiotics business, which it sold in August to Pfizer for $1.6 billion.

However, AstraZeneca has also trimmed expenses by reducing jobs, impacting more than 100 workers in Delaware. In December, the company laid off 120 of its Delaware employees. The layoffs were part of cuts that eliminated 700 positions across the country. In addition, the small-molecule antibiotic business was said to have impacted a "small number of workers," but the company declined to say if they had been laid off.

AstraZeneca said at the time the layoffs were part of its return to growth strategy. The drugmaker in May reduced its worldwide sales force by 1,600.

AstraZeneca has also put its massive 30-acre Fairfax campus on the sales block. Some have said the company is seeking to get out of owning the property and, instead, lease the space back from an owner who will cover maintenance and other expenses, reducing AstraZeneca's overhead. AstraZeneca has not ruled out moving to a new location in Delaware, however.

 

"New" AstraZeneca:

So in summary, we had a good start to 2017. Total revenue declined in the quarter primarily reflecting the tail of the last of US exclusivity for Crestor. New AstraZeneca which we define as the three main priority areas and the established medicines in the emerging market grew by 6% in the first quarter. The emerging markets were really a highlight and they were up 9% and they're now the biggest sales region in AstraZeneca.

 

FDA Approval for an AZ biological drug.

AstraZeneca immunotherapy wins first approval in bladder cancer
Reuters
May 2, 2017

* Bladder cancer marks first approval for AZ's durvalumab

* Big market is in lung cancer, where data due mid-year

* AstraZeneca sets durvalumab price at $15,000/month (Adds analyst reaction, sales forecast, latest shares)

By Ben Hirschler and Divya Grover

May 2 (Reuters) - U.S. regulators have approved AstraZeneca's key immunotherapy drug durvalumab as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars.

The approval, while expected, marks a milestone for the British company, which expects new cancer drugs to help revive its fortunes following patent losses on older blockbuster products like cholesterol pill Crestor and Nexium for heartburn.

Bladder cancer itself is a relatively small initial market, where AstraZeneca is lagging behind rivals Bristol-Myers Squibb and Roche whose immunotherapies are already approved for the condition.

Durvalumab's big commercial opportunity lies in previously untreated lung cancer, where key clinical trial results, including with combination therapy, are due in June or July.

Leerink analyst Seamus Fernandez sees durvalumab capturing a modest 10 percent of the estimated $2.3 billion global bladder cancer market, while AstraZeneca in 2014 put the drug's peak sales in all cancers at $6.5 billion, including combination use.

The U.S. Food and Drug Administration (FDA) said late on Monday it granted accelerated approval to AstraZeneca's drug to treat advanced bladder cancer in patients whose disease had progressed despite chemotherapy.

The drug, which will have the brand name Imfinzi, works by helping the body's immune cells kill cancer, offering an alternative to toxic chemotherapy. While not without side effects, such immuno-oncology treatment has the potential of longer-lasting efficacy, although it comes at a high price.

AstraZeneca said the average wholesale acquisition cost of durvalumab would be around $15,000 a month.

"This first approval for Imfinzi is an important milestone in our return to growth," said AstraZeneca Chief Executive Pascal Soriot.

The drug belongs to a new class of medicines called PD-L1 inhibitors that block a mechanism tumours use to evade detection from the immune system.

It was approved by the FDA for use in patients with locally advanced or metastatic urothelial carcinoma, by far the most common form of bladder cancer, regardless of their status for the amount of PD-L1 protein on their cancer cells.

Durvalumab won accelerated approval, which enables the use of therapies for serious conditions to fill an unmet medical need based on data the FDA believes is likely to predict a clinical benefit. AstraZeneca is required to conduct trials to confirm actual benefit to patients.

The FDA also approved a complementary diagnostic from Roche that can be used with the drug to assess PD-L1 levels. Studies have shown patients with high PD-L1 are more likely to do well on durvalumab, although such a test is not required for its use.

Durvalumab is being tested on its own and also in combination with another immune system-boosting therapy called tremelimumab in various cancers.

The medicine is the latest immunotherapy to be approved by the FDA, after nods for treatments developed against various cancers by Bristol-Myers Squibb, Merck & Co, Roche, and a collaboration between Germany's Merck KGaA and Pfizer.

AstraZeneca shares were up 0.3 percent in early London trading on Tuesday.

 

New respiratory deal:


Pieris Pharma stock soars 54% on news of $57.5 mln AstraZeneca deal

Published: May 3, 2017 8:14 a.m. ET
By Emma Court, Market Watch Reporter

Pieris Pharmaceuticals Inc. PIRS, +52.55% shares surged as much as 54% in premarket trade Wednesday on news of the company's $57.5 million deal with AstraZeneca AZN, -0.18% to develop drugs for respiratory diseases. The deal includes $45 million upfront and $12.5 million in a milestone payment once Pieris begins a phase 1 trial this year for its lead preclinical drug, PRS-060, which is intended for patients with moderate to severe asthma. AstraZeneca will fund all clinical development and commercialization for PRS-060, with Pieris having the option of U.S. co-development and co-commercialization starting in phase 2a clinical trials. The agreement covers four additional therapeutic programs, with Pieris having the option for U.S. co-development and co-commercialization for two of them. Pieris is eligible for up to $2.1 billion in development dependent milestone payments and eventual commercial payments, according to the release. Pieris shares have surged 11.1% over the last three months, compared with a 4.1% rise in the S&P 500 SPX, -0.33%

 

AZ vs. Clovis and Tesaro in oncology. The eventual winner is still undecided.


How Clovis Might Still Quash AstraZeneca, Tesaro In Cancer
Clovis' losses were wider than expected, but the company's ovarian cancer drug could be promising.

ALLISON GATLIN
5/04/2017

Clovis Oncology (CLVS) stock toppled to a four-month low Thursday after the firm reported wider-than-expected losses, but analysts remained bullish on its ovarian cancer drug Rubraca, which topped views by $2 million.

By the closing bell on the stock market today, Clovis finished the session down 3.6% to 51.36 after earlier falling as much as 5.6%, touching a low last seen in January. Still, Clovis stock is up 20% for the year following Rubraca's launch in December.

The first quarter was Rubraca's first on the market. Rubraca sales crushed Wall Street's model, bringing in $7 million vs. the $5 million view. Rubraca is Clovis' first commercial product, and is being tested for treatment of prostate, breast and gastroesophageal cancers.

Overall sales of $7.04 million beat the consensus view for $5.1 million, Janney analyst Debjit Chattopadhyay wrote in a note to clients. But adjusted losses of $1.33 per share missed his view for a 95-cent loss.

Chattopadhyay raised his expectations for Rubraca sales in 2017 and 2018. He models $70.1 million for Rubraca in 2017, up from $57 million. For 2018, he boosted his outlook to $148 million from $142 million in revenue.

Estimates for 2019 will depend on Clovis' ongoing trial, dubbed Ariel-3, and other front-line stories in the PARP inhibitor world. Poly ADP ribose polymerase (PARP) are enzymes used to repair damaged DNA. These drugs aim to inhibit those enzymes to treat ovarian cancer.

AstraZeneca's (AZN) Lynparza was the first PARP inhibitor approved. Clovis' Rubraca followed in December and Tesaro's (TSRO) Zejula was approved in March. PARP inhibitors could potentially be used to treat breast cancer based on genetic mutations common to both breast and ovarian cancers.

Chattopadhyay is looking to compare the results of the Ariel-3 trial in patients with tumors that have the BRCA genetic mutation with Tesaro's trial, called Nova, of Zejula in patients with ovarian cancer. AstraZeneca's Solo-2 trial looked at Lynparza in BRCA-mutated ovarian cancer.

"Our lack of conviction in the story hinges on the comparability of Ariel-3 vs. Nova," he wrote. "Ariel-3 enrollment reflects a 'real-world population' and the data in the (BRCA mutation segments) are likely to be similar to Solo-2."

But the outcome for patients with different or no genetic mutations is unknown. Chattopadhyay kept his neutral rating on Clovis stock. Credit Suisse analyst Alethia Young, on the other hand, is outperform rated with a 74 price target on Clovis stock.

She is more bullish than Chattopadhyay, and raised her 2017 estimates for Rubraca sales to $78.5 million from $71.4 million. She assumes an 80% chance of success in the Ariel-3 trial.

"If the data are positive, we expect investors may give further credit to first-line therapy and other indications like prostate," she said

 

Couldn't be happening to a more ethical company...

NEW YORK, May 8, 2017 /PRNewswire/ -- The nationwide law firm of Bernstein Liebhard LLP is monitoring the growing litigation involving Onglyza and Kombiglyze XR, Type 2 diabetes medications allegedly associated with an increased risk of heart failure. According to recent report from The National Law Journal, between 150 and 200 product liability lawsuits have been filed against the manufacturers of these drugs nationwide, with more filings expected in the future.

Plaintiffs pursuing Onglyza and Kombiglyze XR lawsuits claim that AstraZeneca Pharmaceuticals and Bristol-Myers Squib knew that saxagliptin could raise an individual's risk of heart failure, but failed to provide doctors and patients with adequate warnings regarding this potential danger. They seek to recover compensation for medical bills, lost wages, pain and suffering, emotional distress and more.


"Our Firm has been contacted by many individuals who claim that their heart failure diagnosis was the result of treatment with Onglyza or Kombiglyze XR. We are not surprised that this litigation is growing at such a significant pace," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is offering free legal reviews to individuals who were diagnosed with heart failure while being treated with Onglyza or Kombiglyze XR.

FDA Warnings for Onglyza and Kombiglyze XR

Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in July 2009 and is used in conjunction with diet and exercise to lower blood sugar in people with Type 2 diabetes. Kombiglyze XR (saxagliptin and metformin) was approved by the agency in November 2010.

The FDA began a safety review of saxagliptin in April 2014, after a clinical trial known as SAVOR suggested that the medication was associated with a 27% increase in hospitalizations for heart failure, as well as a higher risk of all-cause mortality. On April 14, 2015, the agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-1 to recommend that new information regarding a potential association with heart failure be added to the labels of all saxagliptin-containing drugs.

A year later, the "Warnings and Precautions" sections of the Onglyza and Kombiglyze XR labels were modified to note their possible association with an increased risk of heart failure, particularly in patients with a history of heart and kidney disease. Individuals using these drugs should contact their doctor if they experience any signs or symptoms of heart failure, including:

• Unusual shortness of breath during daily activities
• Difficulty breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach

Type 2 diabetes patients who were diagnosed with heart failure while using Onglyza or Kombiglyze XR could be entitled to compensation from their manufacturers. To find out more about filing a Kombiglyze XR or Onglyza lawsuit, please visit Bernstein Liebhard LLP's website, or call the Firm directly at 800-511-5092.

 

This class of drugs improves glucose metrics, but does not seem to improve actual health outcomes, now we may know why.

 

tralokinumab fails phase 3. Biologics looking sketchy.

http://www.fiercebiotech.com/biotech/astrazeneca-asthma-drug-misses-endpoint-phase-3

 

Oncology competition is a step ahead again:

Merck (MRK) shares have risen $1.81% to $65.10 after winning U.S. approval Wednesday to use its immunotherapy Keytruda in combination with chemotherapy to treat patients newly diagnosed with non-small cell lung cancer. The approval marks the first time that an immunotherapy has been combined with another drug to kill cancer cells more effectively. Keytruda is now the only PD-1 or PD-L1 checkpoint inhibitor approved to treat first-line lung cancer either as monotherapy or as part of a combination therapy.

 

Merck has a 1 to 2 year lead in oncology:

ALLISON GATLIN
4:34 PM ET

Dow component Merck (MRK) now has a one- to two-year lead on its rivals in treating advanced lung cancer, an analyst said Thursday after the FDA approved the drug giant's Keytruda-chemo combo.

Late Wednesday, the FDA had granted accelerated approval to Keytruda plus Eli Lilly's (LLY) chemotherapy Alimta and carboplatin, another chemo drug. The combination is approved for all patients regardless of whether their tumors have a lot of what is known as a PD-L1 protein, which exists on cancer cells.

Keytruda works by blocking the interaction between a PD-L1 protein on the surface of a cancer cell and the PD-1 protein on an immune system cell. Doing so helps the immune system identify the camouflaged cancer.

UBS analyst Marc Goodman sees Merck as having a one- to two-year lead in lung cancer over the likes of Bristol-Myers Squibb (BMY), AstraZeneca (AZN) and Roche (RHHBY). But other combo therapies from the likes of Bristol-Myers and AstraZeneca are on the horizon for 2017 and 2018. He has a buy rating and 70 price target on Merck stock.

Merck's accelerated approval for Keytruda plus chemotherapy is contingent on a study confirming the strength of the treatment. Results from the confirmatory study, dubbed Keynote-189, are expected in September.

"However, we believe this accelerated approval may be a tacit admission that the agency took an early peek at this study and the interim data were compelling," Leerink analyst Seamus Fernandez said in a note.

Credit Suisse analyst Vamil Divan expects the approval to expand Keytruda's market to 100,000 patients in the U.S. from 35,000. Keytruda is also approved as a first treatment and following chemo to treat lung cancer patients whose tumors have a lot of the PD-L1 protein.

Studies have shown that patients whose tumors have a lot of the PD-L1 protein respond better to the type of therapy offered by Keytruda as well as Bristol's Opdivo. But in a study presented in October, Keytruda plus chemo improved overall survival rate by 55% in all patients regardless PD-L1 status.

Adam Schechter, executive vice president and president of Merck's Global Human Health unit, expects physicians to think about the Keytruda-chemo combination differently in younger patients vs. older patients.

"In addition to that, we believe that since we've studied the drug with Alimta, that early adoption will probably used where physicians would use Alimta," he said on Merck's first-quarter earnings conference call on May 2.

But "it's not a pent-up demand," he said. "I would look at it as a build as new patients come into the market and I think that it really is (an) exciting opportunity for lung cancer patients, but also to establish Keytruda further as a real preferred treatment therapy."

Keytruda's approval with chemo regardless of PD-L1 status doesn't bode well for Bristol which is struggling amid increased competition. In lung cancer, Bristol's Opdivo is approved as a second-line treatment, meaning it's only prescribed after patients have undergone a round of chemo.

Bristol is looking at Opdivo plus Yervoy in advanced lung cancer. Yervoy targets the CTLA-4 interaction between an immune cell and a cancer cell. AstraZeneca's Mystic study is looking at its Imfinzi, a PD-L1 antibody, with tremelimumab, a CTLA-4 antibody, in lung cancer.

"Data readouts could change investor sentiment this year," UBS' Goodman wrote in a note. He assumes $2 billion and $3 billion in first-line lung cancer sales in the U.S. for Keytruda in 2018 and 2019, respectively. First-line means Keytruda can be prescribed before chemo.

 

Tesaro leads in Ovarian Cancer for now:

ALLISON GATLIN
5/10/2017

Wall Street forgave Tesaro (TSRO) its wider-than-expected first-quarter losses Wednesday, as the drugmaker's stock popped on news that 500 prescriptions were written for ovarian cancer drug Zejula in the month following its approval.

On the stock market today, Tesaro shares were up 1.1% to 139.45. Still, Tesaro stock has traded well below its 50-day moving average since March 14 when shares crashed 10.6% on strong trial results from competitor AstraZeneca (AZN).

For the first quarter, Tesaro reported Tuesday adjusted losses of $2.55 a share, lagging the consensus for a $2.25 per-share loss and widening from a $2.22 loss last year. Total sales came in at $3.07 million vs. $300,000 in the year-earlier period.

Product revenue came in at $2.1 million, up from $276,000 in the year-earlier quarter.

Janney analyst Debjit Chattopadhyay warns investors to "get your popcorn ready" because rivalries are starting to mount in the ovarian cancer world.

Tesaro's Zejula was approved in March as a treatment after chemotherapy puts an ovarian cancer patient into partial or complete remission. This treatment, following an initial round of chemo is referred to as a second-line treatment. AstraZeneca's Lynparza and Clovis' Rubraca are only approved for patients who've already undergone two or more rounds of chemotherapy. They are what's known as third-line treatments.

Zejula's label is much broader than Lynparza's and Rubraca's. The drug can be prescribed to patients regardless whether they have the mutated BRCA gene that has been linked to ovarian and breast cancers, unlike some of its rivals.

"The competition in the second-line maintenance segment will heat up in 2018," Chattopadhyay predicted in a research note. He estimates the total addressable market to be between 10,000-12,000 patients in the U.S.

AstraZeneca's Lynparza grabbed accelerated approval in 2014 — contingent on ongoing clinical trials — in ovarian cancer patients with BRCA mutations after three or more prior rounds of chemotherapy. But Lynparza could get approval in the third quarter as a maintenance treatment.

Further, Clovis Oncology (CLVS) is likely to have data from its trial dubbed Ariel-3 in the second quarter. Ariel-3 is looking at Clovis' drug Rubraca as a maintenance treatment in certain ovarian cancer patients with a mutated BRCA gene and other biomarkers.

"If Rubraca's numbers look similar to Zejula, then safety and tolerability could come into play during 2018," Chattopadhyay wrote.

 

market moving, surprisingly good, oncology drug news, stock up 6% so far in Europe:

Key AstraZeneca drug shown to reduce risk of death from lung cancer
Reuters
May 12, 2017

* Positive trial results put AstraZeneca ahead of rivals

* Seen helping patients who can't be operated on

* AstraZeneca seeking to mitigate loss of patents (Adds details, share reaction, analyst comment)

By Alistair Smout

LONDON, May 12 (Reuters) - A trial of AstraZeneca's key immunotherapy drug durvalumab showed it reduced the risk of death from advanced lung cancer, giving it a lead over rivals as it seeks to transform its oncology business.

The trial results are an unexpectedly early boost for the product, known commercially as Imfinzi, which the company hopes will become a blockbuster drug with sales in the billions of dollars.

Shares in AstraZeneca were up 4.7 percent by 1000 GMT, the top FTSE 100 riser, and the company said it was in talks with the authorities over plans for regulatory approval.

"These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option," Sean Bohen, Executive Vice President, Global Medicines Development at AstraZeneca, said in a statement.

Analysts said the results of the trial, known as PACIFIC, showed AstraZeneca was ahead of competitors as there was a gap in the market for such treatment. It also augured well for another trial due in mid-2017 which could mean the drug could be used in combination in newly diagnosed cases.

"The surprise early positive readout of the PACIFIC trial of... durvalumab (Imfinzi) in locally advanced lung cancer is a major inflection point for AstraZeneca's immuno-oncology," analysts at Deutsche Bank said in a note.

"In theory, this could open a market opportunity of $1.75bn to $3.5bn (or more) for the drug, which is not included in our current forecasts."

AstraZeneca is looking to sales of recently launched and experimental cancer medicines to help offset the impact of a loss of patents on blockbusters such as cholesterol pill Crestor.

The drug works by helping the body's immune cells kill cancer, offering an alternative to chemotherapy.

The trial found that durvalumab "significantly reduces risk of disease worsening or death" in forms of lung cancer which are difficult to operate on but have not spread. In this trial it was used after chemotherapy or radiation therapy.

Analysts at Berenberg said that trial results, which were earlier than expected, put AstraZeneca ahead of rivals Roche and Merck, whose trials for similar treatments aren't expected until September 2019.

They also said the efficacy of durvalumab in PACIFIC augured well for the results of a trial of the drug in a combination therapy, called MYSTIC. That is used used on more advanced cancers, but before or instead of chemotherapy, and results are expected in June or July.

"While MYSTIC is still very important, PACIFIC clearly lessens its importance, and provides more reassurance that Imfinzi is an active drug and therefore must have a chance of working in MYSTIC," analysts at Berenberg said.

U.S. regulators earlier this month approved durvalumab as a treatment for bladder cancer, marking the first commercial green light for the product. (Reporting by Alistair Smout; Editing by Keith Weir)

 

more market analysis:

AstraZeneca Has Opportunity In Lung Cancer Treatment Vs. Dow's Merck

ALLISON GATLIN
5/15/2017
Expert opinion indicates AstraZeneca (AZN) will have a "sizable market opportunity" in treating advanced lung cancer including some potential off-label use in patients in earlier stages of the disease, an analyst says.

The suggestion followed strong results from AstraZeneca's drug Imfinzi in Stage 3 lung cancer patients, announced Friday. In patients who had already undergone chemotherapy or radiation and weren't eligible for surgery, Imfinzi cut down on the risk of death or advancement of cancer.

But the market won't just be limited to that subset of patients, Leerink analyst Seamus Fernandez said in a note to clients, citing comments he received from an unidentified expert. There could be some off-label use in patients with lung cancer whose tumors could be removed through surgery and are undergoing chemo or radiation to cure the cancer.

"Overall, (the expert) viewed the top-line results as a positive surprise and expects broad uptake among eligible patients assuming the (progression-free survival benefit) seen in the full data presentation is clinically meaningful," Fernandez wrote in a research report.

AstraZeneca is set to unveil full results of the trial at an upcoming medical conference. The strong top-line results follow the Food and Drug Administration's approval of Merck's (MRK) Keytruda with chemotherapy in lung cancer. Merck, member of the Dow Jones industrial average competes most directly against Bristol-Myers Squibb (BMY).
Earlier last week, Roche's (RHHBY) Tecentriq failed in a late-stage bladder cancer trial.

Patients whose lung cancer can't be removed through surgery and have already undergone chemo or radiation are likely to have a longer treatment duration than those with metastatic lung cancer, Fernandez said. Metastatic cancer can spread via the blood or lymph system.

"In all, we believe this bodes well for Imfinzi's opportunity in this currently untapped non-small cell lung cancer setting and represents a true market expansion for AstraZeneca as well as the overall immuno-oncology space," he wrote.

 

Competition from Clovis could also be strong in ovarian cancer:

AstraZeneca PLC's (NYSE: AZN) shares had a modest close in the red down 0.70% on Wednesday as traders learned that one of the company's rivals may have a blockbuster drug in its hands. According to JPMorgan analyst Cory Kasimov, he says that ovarian cancer drugs from Clovis Oncology as well as Tesaro, are "more similar than different" compared to ones AstraZeneca has. He upgraded Clovis ahead of a key Phase 3 study called Ariel-3. Kasimov expects the Clovis trial to bring similar results like Tesaro's Nova trial for Zejulu. Regardless of their biomarkers, Tesaro's Zejulu has seen significant improvement in progression-free survival for all ovarian cancer patients. The analyst thinks Clovis shares could skyrocket as much as 50% if the Ariel-3 data is similar to Nova.

 

Mixed results in diabetes clinical study:

AstraZeneca (AZN) shares edged higher Tuesday as investors shrugged off a mixed set of phase-3 results for the Anglo Swedish drug maker's Bydureon Exscel type II diabetes treatment.

The drug maker said that patients taking Bydureon Exscel saw a reduction in cardiovascular risk during the trial but that this was not statistically significant.

Reduced cardiovascular risk means that Bydureon Exscel has met its primary safety objective under Food & Drug Administration rules, which dictate that type II diabetes treatments must not increase cardiovascular risk. However, the drug did not meet its efficacy objective, which was to demonstrate a superior reduction in major adverse cardiovascular events (MACE).

 

Very positive oncology news announced today. The stock didn't go up very much today for such big news so the news must have already been fully priced in. Had the news already been leaked?



AstraZeneca's Big Bet on Oncology May Finally Pay Off
James Skinner
Jun 5, 2017 7:18 AM EDT


AstraZeneca plc (AZN) said Monday that one of its new drugs has proven more effective than chemotherapy in treating a certain type of breast cancer.

The Anglo-Swedish firm said Lynparza showed a statistically significant and clinically meaningful improvement in progression-free survival, when compares with a physician's choice of standard chemotherapy, during its phase III OlympiAD trial.

"The OlympiAD results shared today mark the first time a targeted therapy shows benefit over the current standard of care for patients with HER2-negative gBRCA-mutated metastatic breast cancer," said chief medical officer Sean Bohen.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that attacks cancer cells by exploiting DNA damage response (DDR) pathway deficiencies. DNA damage response inhibition is a unique platform in oncology, pioneered by Astrazeneca.

The trial is a milestone for Lynparza, a key growth driver for Astra, as it marks the first time that a PARP has shown a significant benefit for patients outside of the field of ovarian cancer treatment.

Astrazeneca shares were little-changed in early London trading and changing hands at 5,364 pence each by 08:30 GMT after having gained around 21%.

The drug maker has bet the house on oncology in recent years as part of an attempt to move past a series of expired patents that have been a key source of concern for investors.

In May Astrazeneca called a halt to its PACIFIC clinical trial of Imfinzi (durvulamab) as a unresectable stage III non-small-cell lung cancer treatment after it showed "clear efficacy".

"We estimate a US sales opportunity of just over $2bn and assume that early access for AstraZeneca will enable it to capture 50% of these patients, making this a blockbuster opportunity alone for Imfinzi," said Alistair Campbell, an analyst at Berenberg, in a note.

 

Thanks for posting

 

Mixed competitive results in other oncology trials, still nothing too bad.

Tesaro Crashes Despite Beating AstraZeneca With 'Stronger' Data

ALLISON GATLIN
12:56 PM ET

Tesaro (TSRO) stock plunged Monday despite a Sunday presentation during the American Society for Clinical Oncology meeting that showed its Zejula could be stronger than drugs from AstraZeneca (AZN) in breast cancer.OffIn midday trading on the stock market today, Tesaro stock crashed 5%, near 143.50, as shares of rivals AstraZeneca and Pfizer tilted less than 1%. Clovis Oncology (CLVS) and Eli Lilly (LLY) stocks also lost more than 1%.

Tesaro and Dow component Merck (MRK) combined their drugs Zejula and Keytruda to treat ovarian and breast cancer patients. Zejula is what's known as a PARP inhibitor. Keytruda is a PD-1 inhibitor. Combining them is thought to offer a more potent response.

Half of ovarian cancer patients responded to treatment "which compares favorably to historical data from either PARP or PD-1 inhibitors alone in this patient population," Leerink analyst Seamus Fernandez wrote in a note to clients.

"While still early, this data appear stronger than the initial results seen with AstraZeneca's Lynparza plus Imfinzi in these tumor types," he wrote. Lynparza is a PARP inhibitor and Imfinzi is a PD-1 inhibitor.Three breast cancer patients had partial responses to the combo. All signs of cancer disappeared in one patient. And a patient with what is known as triple-negative breast cancer — a form that doesn't respond to normal treatments — achieved stability. The company also has seen promising, unconfirmed responses in other patients.

In other presentations, AstraZeneca said its Lynparza showed a 2.8-month improvement in progression-free survival over chemotherapy in patients with some forms of breast cancer. But Pfizer showed similar data for its drug talazoparib on Saturday, Fernandez said.

"Overall, Lynparza's less severe toxicity profile will likely drive use of the drug over chemotherapy," he said. "The main adverse events associated with Lynparza were nausea and anemia. Neutropenia was the most common adverse event in the chemotherapy arm."

Lilly also presented "incrementally positive but not groundbreaking" data for its drug abemaciclib in some forms of breast cancer. Death rates were broadly in line with that of Pfizer's Ibrance. Diarrhea as a side effect was "manageable," Lilly said.

Abemaciclib belongs to a class of drugs called CDK4/6 inhibitors. It competes with Novartis' already approved Kisqali. But Lilly says its continuous dosing method of treatment could do more to disrupt cancer cell cycles.

 

I'm starting to wonder who is posting this.

AZN as a stock has lost exclusivity on ALL of her primary revenue producers. AZN is overpaying its CEO to the point that shareholders are revolting. This company is a pink sheeter. This thread is a pump and dump. SELL.

 

If I am fos then post your name, OP.