AZ News from the Street 2015

FDA lays out the roadmap for Symbicort generics:



Bad news for AstraZeneca: FDA lays out roadmap for would-be Symbicort copycats
July 1, 2015 | By Carly Helfand

The FDA has issued AstraZeneca's ($AZN) least favorite form of draft guidance--the kind that helps other drugmakers develop copies of a blockbuster seller.

Regulators have published bioequivalence guidelines for AstraZeneca's respiratory heavyweight Symbicort, giving generics makers a lift in their quest to bag a piece of the med's revenues. UBS analyst Alexandra Hauber says the prospect of knockoffs hitting this decade is now more likely, jeopardizing 2020 sales estimates of $1.8 billion for the drug, Reuters reports.

The way Hauber sees it, the worst-case scenario involves a mid-2018 generic launch, which would cut down valuation by about £3 ($4.69) per share, or about 5%. The drug brought in $3.8 billion for AstraZeneca last year.

AstraZeneca isn't the first maker of respiratory drugs to see its competitors helped by the FDA. In September 2013, the agency did the same with GlaxoSmithKline's ($GSK) hard-to-copy Advair, whose Diskus inhaler technology had been confounding would-be copycats for years.

With the British drugmakers already in a respiratory pricing war--negotiating discounts that have helped them take turns knocking each another off preferred formularies at the country's largest pharmacy benefits managers--stateside generics are the last things either company needs. Advair's U.S. sales are currently in a tailspin because of the payer tactics, plunging 22% in the first quarter of this year.

But with copies of Advair--sold as Seretide outside the U.S.--and Symbicort already floating around in Europe, their emergence in the U.S. is inevitable. Mylan's ($MYL) Sirdupla earlier this month joined a growing list of Advair copycats, including Novartis' ($NVS) AirFluSal Forspiro and a version from India's Cipla. And Teva ($TEVA) is busy rolling out its DuoResp Spiromax, a Symbicort stand-in, market by market on the continent.

AstraZeneca isn't ready to cede its leadership position in respiratory, though. CEO Pascal Soriot has tagged the field as one of 6 key growth areas that'll help the company deliver on its ambitious revenue goals. To that end, AZ recently inked a couple deals: In February, it agreed to fork over $600 million for a pair of Actavis lung meds, after picking up Almirall's respiratory portfolio a few months prior.

 

No way in hell Symbicort will sell $1.8 billion in 2020, even without a generic Symbicort. The damn patent goes early 2017 anyway!!

 

agreed, generic advair will be all over the world well before even generic symbicort anyway. Even the symbicort that is sold, will be sold at a lower price, so that number is not very realistic.

 

Of course at any time there are dozens of people on this board. What a toxic culture. Made up of a lot of whining cry babies and gossip queens like in the sunshine state who would die if they actually had to work for a living

 

and obviously some people who are totally obsessed with them too.

 

Seems like we're seeing the last of the $60 prices, soon. Wonder what the pressure will get like if we slide back through the $50's? Last May's $80 price driven by the $92.50 Pfizer offer, is nothing but a fond memory...

 

If the stock price breaks back into the fifties they will then have to consider taking serious measures to raise the share price by making substantial investments back into the business.

Is it time for a dividend increase and to reinstate the share buyback program?

 

No. More like a massive layoff.

 

That goes without saying, Wall Street always loves that!!

 

The French Fuck, aka Pascal, should be immediately fired by our sorry ass Board of Directors! He has cost investors hundreds of millions of dollars, and more likely, billions of dollars! Why is this fool still here? What will it take to get rid of his sorry ass!

 

Pascal can say "Science First" that's worth billions - you know he invented DNA before Pascal we didn't have a genome !! How can you fire the man who created humanity ????

 

You have to love Leif's reasons for not accepting Pfizer's offer of over $90 a share, including the fact that it didn't create enough shareholder value. Hard to believe the real owners of the company fell for management's pipe(line) dream. $36 Billion left on the table so far.

http://www.nytimes.com/video/business/100000002888664/astrazeneca-chairman-on-pfizers-bid.html

 

Refusing the Pfizer offer was pure politics, as is everything in Europe. Don't blame Pascal, it was Leif all the way killing the deal. Pfizer surely would have completely sacked Molndal and they just couldn't bear the thought of their idle there being even further idled.

 

The last of the "Zeneca" drugs to contribute.

"Personalized medicine" actually now has a real example too!



IRESSA® (gefitinib) Approved by the U.S. Food and Drug Administration for First-Line Treatment of Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer
2 hours ago
WILMINGTON, Del.--(BUSINESS WIRE)--

In the fifth paragraph and the second paragraph of the "Clinical Studies -- IPASS & IFUM" section of the release dated July 13, 2015, the last sentence should read: The Confidence Interval (CI) is 41, 59 (BICR) and 61, 78 (investigators).

The corrected release reads:

IRESSA® (GEFITINIB) APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION FOR FIRST-LINE TREATMENT OF ADVANCED EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved IRESSA® (gefitinib) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

IRESSA is a once daily oral EGFR-tyrosine kinase inhibitor (TKI), which inhibits the activity that contributes to intracellular signaling pathways implicated in the growth and survival of cancer cells. IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive advanced NSCLC.

“In 2003, IRESSA was the first EGFR-TKI for patients with non-small cell lung cancer. While some patients showed dramatic benefit, the research at that time did not enable us to identify those patients that would benefit the most from this treatment,” said Gregory Keenan, Vice President, Medical Affairs & U.S. Head Medical Officer. “Today, our understanding of molecular mutations and molecular targeting has enabled better decision making in the treatment of NSCLC.”

AstraZeneca has partnered with QIAGEN to provide the FDA-approved therascreen® EGFR companion diagnostic test for IRESSA in the U.S. The test uses a tumor tissue sample to rapidly identify EGFR exon 19 deletions or exon 21 (L858R) substitution mutations status of a lung cancer patient’s tumor. Patients whose tests are positive for the EGFR exon 19 deletions or exon 21 (L858R) substitution mutations may be eligible for treatment with IRESSA.

The FDA approval of IRESSA is based on data from the IFUM (IRESSA Follow-Up Measure) clinical trial which showed an Objective Response Rate (ORR) of 50 and 70% (BICR and investigators, respectively) with a median Duration of Response (DOR) of 6 and 8.3 months. The Confidence Interval (CI) is 41, 59 (BICR) and 61, 78 (investigators).

The IFUM results were supported by the IPASS (IRESSA Pan-ASia Study) study which assessed IRESSA vs. carboplatin/paclitaxel as a first-line treatment in these patients. The subset population consisted of 186 of 1217 patients (15%) determined to be EGFR positive by the same clinical trial assay as used in IFUM and had radiographic scans available for a retrospective assessment by BICR. IPASS showed an ORR of 67% with a median duration of response of 9.6 months in IRESSA-treated patients vs. 41% with a median duration of response of 5.5 months for the carboplatin/paclitaxel group. Progression Free Survival (PFS) was 10.9 months in the IRESSA group vs. 7.4 for the carboplatin/paclitaxel patients, as assessed by BICR. The hazard ratio for PFS favored the IRESSA-treated patients [HR of 0.54 (95% CI: 0.38, 0.79)] with a median PFS of 10.9 months for the IRESSA-treated patients and 7.4 months for the carboplatin/paclitaxel-treated patients as assessed by BICR. The safety profile of IRESSA is well established through a large, global clinical program and extensive real world evidence. The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea.

“We are very pleased with this new milestone in our partnership with AstraZeneca. The FDA approval of our therascreen® EGFR test to guide the use of IRESSA in NSCLC patients will offer U.S. physicians insights for decision-making based on a clinically proven companion diagnostic. We look forward to continued progress with our AstraZeneca partners,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area and a member of the Executive Committee of QIAGEN.

IRESSA is approved in 91 countries for the treatment of adult patients with metastatic EGFR mutation-positive NSCLC.

 

Another AZ fails clinical trials!!!
http://finance.yahoo.com/news/astrazeneca-drug-selumetinib-fails-uveal-062717807.html

 

Oh no!! It can't be true that an AZ drug fails in clinical trials!!! I CAN'T BELIEVE IT! Stupid idiots that run this POS company should all be fired! Start with the French Fool known as Pascal!

 

Banana peels are closely linked to slips that can cause injury.

Pharmaceutical companies are closely linked to hiding relevant medical data that injures innocent people. Over and over and over again.

Do the banana companies buy insurance to cover the risk?

 

You really do have to wonder how long the Board can keep Pascal around. The 2nd qtr. earnings report comes out next week, and I would be willing to bet it will suck like all the rest. Just think how bad things will look once we start losing revs from the big boys going generic next year and 2017!

 

AstraZeneca Earnings Beat Estimates as New Drugs Take Hold
by Oliver Staley
July 30, 2015 — 2:12 AM EDT Updated on July 30, 2015 — 3:04 AM EDT

AstraZeneca Plc, the U.K.’s second-largest drugmaker, reported earnings that beat analysts’ estimates as sales of diabetes treatments and the blood thinner Brilinta helped offset declines in older medicines.

Core operating profit, a measure used by the company that excludes some costs, fell to $1.81 billion, or $1.21 a share, in the second quarter from $2.03 billion, or $1.30 a share, a year earlier, the London-based company said in a statement. Analysts had predicted $1.06 a share, according to the average of estimates compiled by Bloomberg.

AstraZeneca raised its full-year sales forecast, saying that revenue will decline by a low single-digit percentage at constant exchange rates. It had previously predicted a mid-single-digit drop. The company maintained its earnings forecast.

Revenue is falling as Astra faces the loss of patents for some of its biggest-selling drugs, including Nexium, Crestor and Seroquel. Chief Executive Officer Pascal Soriot has promised investors that the company will return to growth in 2017 when new cancer treatments reach the market.

“Astra has one of the most impressive pipelines in the European industry,” Emmanuel Papadakis, an analyst at MainFirst Bank AG, said before earnings were announced. “The company is clearly in a transition phase. It needs to deliver on the clinical data and commercial execution to return to growth in 2017.”

Astra shares rose 2.2 percent to 42.83 pounds at 8:03 a.m. in London. That pared the decline this year to 6 percent.

Soriot successfully fended off a $117 billion bid by Pfizer Inc. last year in part by pledging that Astra would reach $45 billion in revenue by 2023. Analysts estimate 2015 sales of $24 billion.

Licensing Deals
To fill the gap, the drugmaker is striking deals to license or sell medicines, a strategy it calls “externalization.” It received $450 million from Celgene Corp. in the quarter for the rights to develop treatments for blood cancer with MEDI4736, AstraZeneca’s experimental immune therapy drug.

Sales in the quarter were $6.31 billion, down from $6.45 billion or a restated $6.76 billion a year ago. Analysts estimated $6.09 billion on average.

Revenue from Brilinta was $144 million for the quarter, up 23 percent, while Bydureon, a diabetes medicine, recorded $140 million in sales, a 25 percent increase. Some older drugs did better than analysts expected, with cholesterol drug Crestor raking in $1.31 billion versus the average analyst prediction for $1.28 billion. Nexium revenue declined 33 percent, though the acid reflux pill beat estimates.

The company announced that it submitted lung cancer drug AZD9291 to regulators in the U.S. and Europe for approval. The company last year estimated peak annual sales of $3 billion for the drug.

Nexium, Crestor and Seroquel, for bipolar disorder, combined for $10.6 billion in sales last year, or 41 percent of AstraZeneca’s revenue. Analysts expect that sum to decline to about $4.5 billion in 2017.

 

Nexium and Crestor are falling. XR goes generic next year, along with Crestor. Symbicort in 2017 or maybe sooner. Nexium will continue to fall like a rock. If you think the new cancer drugs will make up for these loses, you are delusional !