AZ News From The Street 2016

AZ hits another stock market low. An all time low now in the $25 per share range. That is almost a 50% drop below Pfizer's bid. So shareholders should hold Frenchie and his merry band of idiots accountable for losing half of their share value and all of this in a rally up market.

 

Dance band on the Titanic
Please put this miserable dying company out of its misery

 

AZ is the #1 worst performing Pharma stock on the NYSE in 2016. Yep, dead last. Well at least we are #1 in something.

 

Indeed, the future is dim.
Half the sales force could and should be gone. That's an easy way to add to the share price somehow.
Just can't see a big chance for our current portfolio to support the number of reps. we now have and we'll never get to the big growth numbers Pasquale promised.

 

in the relative rank world we live in, they should get a 1 for yr end review and face demotion like we now do!!!

 

Early Data Demonstrate Clinical Activity of Acalabrutinib in Difficult-to-Treat Chronic Lymphocytic Leukemia
Business WireDecember 5, 2016
WILMINGTON, Del.--(BUSINESS WIRE)--

AstraZeneca and its hematology Center of Excellence, Acerta Pharma, today announced preliminary results from the Phase I/II ACE-CL-001 clinical trial of acalabrutinib in subsets of patients with two difficult-to-treat forms of chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults.1 The trial includes data from individuals with intolerance to ibrutinib and those with Richter transformation, when CLL transforms into a more aggressive lymphoma.2 Findings were shared with the medical community during two oral presentations at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California.

Acerta Pharma Chief Executive Officer, Flavia Borellini, PhD, said: “The data at ASH further validate previous clinical trial findings and continue to demonstrate the potential of acalabrutinib in the treatment of B-cell malignancies.”

Investigator Jennifer R. Brown, MD, PhD and, Director, Chronic Lymphocytic Leukemia Center, Dana-Farber Cancer Institute, said: “The acalabrutinib data in patients in difficult-to-manage settings support the continued exploration of acalabrutinib’s potential for the treatment of CLL.”

Acalabrutinib is an investigational, highly selective, potent Bruton tyrosine kinase (BTK) inhibitor shown to minimize off-target activity in pre-clinical studies.3,4,5 The Phase I/II findings presented at ASH are part of an extensive and ongoing clinical development program for acalabrutinib in B-cell cancers including CLL, mantle cell lymphoma (MCL), Waldenström macroglobulinemia, follicular lymphoma and diffuse large B-cell lymphoma.

Results for acalabrutinib in patients intolerant to ibrutinib

The ibrutinib-intolerant cohort included 33 patients with relapsed or refractory CLL intolerant to ibrutinib. In this population with difficult-to-treat disease and limited treatment options, a 79% overall response rate was achieved with acalabrutinib.6 The median progression free survival has not yet been reached, with 81% of responding patients achieving a duration of response ≥12 months on acalabrutinib treatment,6 which may allow for continuation of BTK inhibitor therapy.

In this cohort of patients, the most common adverse events included diarrhea (52% overall; 0% ≥ Grade 3), headache (39% overall; 0% ≥ Grade 3), cough (24% overall; 0% ≥ Grade 3), increased weight (24% overall; 0% ≥ Grade 3) and nausea (21% overall; 0% ≥ Grade 3).6 Serious adverse events occurred in 33% of patients.6 Thirty six percent of patients had a recurrence of an adverse event they had experienced during previous treatment with ibrutinib, most of which were of decreased or the same severity.6 No patients discontinued acalabrutinib due to a recurrent adverse event.6

Results for acalabrutinib in patients with aggressive transformation of CLL

In a separate presentation, preliminary data showed the clinical activity of acalabrutinib monotherapy in a cohort of 29 patients with Richter transformation, or other transformations—aggressive B-cell malignancies associated with an aggressive clinical course and poor prognosis.7 Of the 21 Richter transformation patients evaluable for efficacy measures, the overall response rate was 38% and the median progression-free survival was 2.1 months (95% CI, 1.8 to 3.7).7 The median duration of response on acalabrutinib treatment was 5.2 months (range 0.3 – 6.5+).7

In this cohort of patients, the most common adverse events were headache (41% overall; 0% ≥ Grade 3), diarrhea (35% overall; 0% ≥ Grade 3), anemia (31% overall; 14% ≥ Grade 3), fatigue (24% overall; 7% ≥ Grade 3), arthralgia (joint pain) (17% overall; 3% ≥ Grade 3) and back pain (17% overall; 10% ≥ Grade 3).7 Serious adverse events occurred in 55% of patients. No patients discontinued acalabrutinib treatment due to adverse events.7

NOTES TO EDITORS

About chronic lymphocytic leukemia and Richter transformation

Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults and accounts for approximately one in four cases of leukemia.1,8 The average age at the time of diagnosis is approximately 71 years of age.8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.9 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.9 This could result in anaemia, infection and uncontrolled bleeding.9 Approximately 2% to 10% of CLL patients develop Richter transformation, where CLL transforms into an aggressive lymphoma, most often diffuse large B-cell lymphoma.10 Prognosis for patients with Richter transformation is poor, with median overall survival of approximately eight months.11 B-cell receptor signaling through Bruton tyrosine kinase (BTK) is one of the essential growth pathways for CLL.

 

Sanofi have started due diligence for their inhalations business at the Holmes Chapel site in the UK. The site produces an inhalations product, Bevespi, on contract for AZ. Anyone heard any rumors?

 

AZ announces some cuts in the UK

in the back office at the Alderley Park site. They will eventually close that site completely in the future most likely.

AstraZeneca PLC (ADR) (AZN) Relocating Jobs At U.K. Division
Market Exclusive
Insider Monkey
December 6, 2016

AstraZeneca plc (ADR) (NYSE:AZN) plans to cut some back office jobs in the U.K. as the company works toward cost-cutting and operation consolidation. The latest job cut by the company in the U.K. will be at its finance division located in Alderley Park, England. Some 280 employees work at the company’s finance office in Alderley Park. The jobs will be moved to regional centers or transferred to the company’s headquarters in Cambridge. The headcount adjustment at the finance operation is part of measures by the company to eliminate about $1.1 billion in annual costs. But it remains unclear at this juncture how many workers in Alderley Park will be affected. “Employees globally have been briefed

 

I don't know; I'm not qualified to make these assessments really, but as I see it the "market capitalization" of AZ is based on shares outstanding X share price. There are 1.26 billion shares outstanding. Today each share is worth $25.85. Pfizer offered 55 pounds (about 69.00) per share. So 69.00 - 25.00 = 44.00. But there was a 2:1 split too; hmmmm, lose math, say the loss was 22.00 per share -- 1/2 of the $44.00.

22 X 1.26 billion, what's that? 27.72? Billion? And the jackass still has a job?

 

Maybe with the split I should cut the result in half, again. 27.72 / 2 = 13.86, billion US dollars. So again, I ask, why does the jackass still have a job? Can you imagine if you fucked up by 1/10,000,000 th of this fuck up? Right, it's fair. Performance is what counts.

 

120 Wilmington job cuts announced and some sales cuts too

AstraZeneca cuts about 700 jobs, including 120 in Delaware
RANDALL CHASE
Associated PressDecember 8, 2016
DOVER, Del. (AP) — British-based pharmaceutical company AstraZeneca says it is eliminating about 700 jobs in its U.S. commercial business, including about 120 at its North American headquarters in Wilmington.

The company said Thursday that the cuts also affect sales and non-sales positions across the United States, and include roughly 80 vacant positions.

The job cuts will leave AstraZeneca with about 1,500 employees in Delaware.

AstraZeneca, which once employed close to 5,000 workers in Delaware, announced in 2013 that it was cutting 1,200 jobs at its Wilmington headquarters.

In persuading AstraZeneca to select Wilmington over Pennsylvania as the site of its U.S. headquarters in 1999, then-Gov. Tom Carper offered the company about $50 million in state incentives, including 86 acres of state-owned land and tens of millions of dollars in tax credits.

 

Medi and Lilly deal:

MEDI1814 Clinical Development Program

On Friday, AstraZeneca and Eli Lilly and Co (NYSE:LLY) have entered into a global agreement to collaboratively develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42) that is currently being evaluated for the treatment of Alzheimer’s disease (AD) under Phase 1 clinical trials. The agreement builds on the companies’ existing agreement to develop AZD3293, a BACE inhibitor being evaluated under two Phase 3 clinical trials.

Both AstraZeneca and Eli Lilly and Co (NYSE:LLY) are excited to work on yet another valuable collaboration that can result in a substantial breakthrough.

Generally, MEDI1814 can potentially lead to significant AD progression decline. Consequently, the companies believe that it can provide a unique treatment option for AD, significantly improving the lives of AD patients and the patient care they get.

This new partnership on a clinical development program will also play a vital role in the growth strategy of AstraZeneca as it seeks to build up a competitive product portfolio and avert further losses.

 

David Brennan finally found new work:

Alexion Tanks After CEO, CFO Unexpectedly Resign Amid Sales Probe.

• ALLISON GATLIN
• 10:57 AM ET

Alexion Pharmaceuticals (ALXN) stock crashed to a three-year low Monday after its CEO and CFO unexpectedly resigned amid the company's monthlong accounting probe into sales of immunosuppressant Soliris.

In early trading on the stock market today, Alexion stock toppled 17%, near 110. Shares already had plunged 11% in the two days following Alexion's Nov. 9 announcement of the probe into whether an employee engaged in sales practices inconsistent with company policies.

On Monday, Alexion tapped former AstraZeneca (AZN) CEO David Brennan to temporarily replace CEO David Hallal, who resigned for personal reasons. Brennan has been on Alexion's board since July 2014 and previously led AstraZeneca from 2006 to 2012. Spencer Stuart will search for a permanent CEO.

Former Honeywell International (HON) CFO David Anderson will permanently succeed CFO Vikas Sinha, Alexion said in a press release. Anderson served as Honeywell's CFO from 2003 to 2014.

The resignations of Hallal and Sinha were effective immediately and come as Alexion preps to wrap an internal audit into its sales practices. Alexion postponed its Q3 filing on Nov. 9 amid the allegations by a former employee.

Alexion expects to file its delayed 10-Q form for the period ended Sept. 30 in January. At this point, the investigation hasn't found cause to require Alexion to update its previously-reported results, the company said.

 

Poor Dave, after all of this time and this is the best he could come up with? David Brennan must have been black listed by the club after what he did to to AZ. His reputation may now be being resurrected somewhat after what his successors did which was even worse.

 

Dave looks pretty good now compared to this crew.

 

Poor Dave, it turns out he's just a temp!!


On Monday, it (Alexion) said former AstraZeneca CEO David Brennan will replace Hallal on an interim basis


I guess he needs the work!

 

Antisense drug deal:

Ionis Earns $28 Million from AstraZeneca for a New Drug to Treat Cancer

PR Newswire
December 16, 2016

CARLSBAD, Calif., Dec. 16, 2016 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (IONS) announced today that it has earned $28 million from AstraZeneca (AZN) following AstraZeneca's completion of IND-supporting studies and license of IONIS-KRAS-2.5Rx, or AZD4785. IONIS-KRAS-2.5Rx is a Generation 2.5 antisense drug discovered by Ionis designed to directly target KRAS, one of the most frequently mutated genes in cancer. KRAS mutations are thought to underlie the pathogenesis of up to 30% of human tumors. The KRAS protein is involved in regulating cell division and tumor cell survival. However, developing therapeutics using traditional drug modalities to block KRAS activity has proven difficult. IONIS-KRAS-2.5Rx will be the first drug to enter clinical development that directly targets KRAS, regardless of mutation type. AstraZeneca will be responsible for further developing and commercializing IONIS-KRAS-2.5Rx.

Brett Monia, Ph.D., senior vice president of drug discovery at Ionis, said: "We and AstraZeneca are uniquely positioned to advance the first antisense drug in development to target KRAS as this is a very challenging target to engage with other therapeutic modalities. Our partner AstraZeneca has extensive experience in successfully developing and commercializing drugs to treat cancer and we look forward to working with them to advance this innovative cancer treatment through clinical development."

As IONIS-KRAS-2.5Rx advances in development, Ionis is eligible to receive up to $137 million for additional development and regulatory milestone payments. In addition, Ionis is eligible to receive up to low double-digit royalties from sales of the drug.

ABOUT IONIS AND ASTRAZENECAIonis and AstraZeneca are collaborating to discover and develop antisense drugs to treat cancer under a Collaboration, License and Development Agreement entered into in December 2012. The collaboration combines AstraZeneca's experience and expertise in developing anti-cancer agents with Ionis' antisense technology platform to broaden Ionis' cancer franchise. With the completion of the IND-supporting studies for IONIS-KRAS-2.5Rx, Ionis has received more than $85 million in upfront and milestone payments from its oncology collaboration with AstraZeneca and is eligible to earn additional milestone payments as the drug progresses in development as well as royalties on sales of IONIS-KRAS-2.5Rx if it is commercialized. AstraZeneca is also evaluating, as part of the oncology collaboration, another drug to treat cancer, AZD9150 (IONIS-STAT3-2.5Rx), in combination with durvalumab, AstraZeneca's investigational anti-PD-L1 antibody, in patients with head and neck cancer and in patients with diffuse large B-cell lymphoma. The two companies have also formed a strategic collaboration to discover and develop antisense therapies for treating cardiovascular, metabolic and renal diseases.

 

Quoting:

" The collaboration combines AstraZeneca's experience and expertise in developing anti-cancer agents with Ionis' antisense technology platform to broaden Ionis' cancer franchise. "

Huh? Has AZ ever developed an anti-cancer drug? Is Pascal's Mother running Ionis?

 

Chances are it will fail, and even if it makes thru the clinical trials, it's 10 years away!

 

Zeneca, pre-merger was a cancer drug powerhouse. Drugs such as Nolvadex, better know today as Tamoxifen, Casodex and Zoladex were all important cancer drugs. All are of course long off patent now, but that expertise did once exist in company. Not much has come out post merger, just like in every other therapy area.