AZ News from the Street 2015

Do you think they will adjust our Farxiga and Onglya goals? hahahah

 

meanwhile: the new investments are being made in Sweden not at the Medimmune site.

AstraZeneca to invest $285 million in Swedish biotech drug factory
Reuters
4 hours ago

LONDON (Reuters) - AstraZeneca (AZN.L) is investing $285 million to expand biotech drug manufacturing in Sweden as the company bets on the future of high-tech medicine for future growth.

The new facility for biological medicines in Sodertalje will supply medicines for clinical trial programs from the end of 2018 and will deliver finished products for commercial use once fully operational by 2019.

The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019, the Anglo-Swedish company said in a statement on Monday.

The new plant will be focused on filling and packaging of protein therapeutics.

Sodertalje is already AstraZeneca’s biggest global manufacturing facility for traditional tablets and capsules.

The decision to add the new biotech capability reflects the changing nature of the company's portfolio as it focuses more on injectable biotech medicines, which now make up around half of the new drug pipeline.

Biotech drugs are increasingly being used to treat cancer, which AstraZeneca sees as a major commercial opportunity, as well as for a variety of other diseases, including asthma.

(Reporting by Ben Hirschler, editing by Louise Heavens)

 

Down and down she goes and where it stops only heaven knows. Stock nearing a 52 week low and $20 below the Pfizer offer. How long will our stockholders put up with this current leadership team? The financial experts who manage billions in assets have AZ as a definite sell. Not good.

 

apparently the new Swedish site will be toilet shaped so our shareholders can see exactly where their money goes

 

Put-etre, mais je dis no.

The swedish are the best drug development people in the world. it's dark there most of the day, all day.

 

Clearly not the lowest cost option, plus the Swedes only work about half of the year. They make the Brits look industrious.

Near Cambridge or Gaithersburg would make a lot more sense. Lots of jaunts overseas for the Swedes to the UK and US should be baked into the travel budget too. Oh, and you better build some more time into the Gant charts for the development and manufacturing timeline delivery schedules too.

 

but the Swedes still look good compared to the French!!

 

The stock market continues to set record highs almost daily while AZ stock continues toward a record low. This trend is not sustainable.

 

Pfizer likely to be coming soon for someone:


All Eyes on Pfizer as Shareholders Await the Mega-Deal: Real M&A
5:35 PM EDT
May 21, 2015
by Tara Lachapelle

Pfizer Inc. built itself into a $212 billion behemoth by spending more money on acquisitions than any other drugmaker in the world. Still, Pfizer’s next purchase is what will really leave its mark as a dealmaker.

The company may be plotting its biggest purchase yet to solve its biggest gripe: taxes. It pays a higher rate than most of its rivals, and Chief Executive Officer Ian Read has made it no secret that he wants to change that. It made a failed run at AstraZeneca Plc last year in what would have been a $120 billion tax-inversion deal.

As speculation about a deal mounts again, analysts this week began picking their top takeover candidates. They centered on GlaxoSmithKline Plc, AstraZeneca and Shire Plc. And if you ask Mylan NV, it’s also on the list. The executive chairman was said to have told shareholders last week that Pfizer could buy his company after Mylan buys Perrigo Co.

Any one of those deals may enable Pfizer to move its legal address to a place such as the U.K., where corporations have a lower tax burden. Some of its rivals have already done this and it’s led to a greater ability to access their overseas cash stockpiles and eke out more profits for future investments or shareholder payouts.

“Subject to price, there are a lot of merits to a deal like that,” Colin McWey, a fund manager for Heartland Advisors Inc., said in a phone interview. The Milwaukee-based based firm owns shares of Pfizer among the $4 billion it oversees.
Right Time

In addition to the tax benefits, a deal would give Pfizer more lucrative products and a way to cut costs. And now may be the time to do it before borrowing rates climb and the best targets get picked off. The pharmaceutical industry has been on a merger and acquisition spree for more than a year now, so targets are getting more and more expensive, especially as some draw bidding wars.

Many transactions were structured as tax-inversion deals, which have drawn increasing scrutiny from the U.S. Treasury Department since Pfizer bid for AstraZeneca a year ago. In September, the Treasury Department announced new rules to clamp down on inversions. While the changes do reduce some of the benefits of such transactions, they don’t eliminate those advantages altogether or make doing them impossible.

Read, the Pfizer CEO, said in October that he saw “no reason” why the company wouldn’t be able to do an inversion if it found an attractive enough opportunity.

Joan Campion, a spokeswoman for Pfizer, said the New York-based company doesn’t comment on speculation. When asked about M&A and inversion plans on an earnings call last month, Read stressed that creating shareholder value is what guides his dealmaking.
Not Done

In February, the company announced a takeover of Hospira Inc. for $16.8 billion, including net debt. Through that deal, it gains generic injectable drugs and devices to deliver them, bolstering its established-products division. That part of Pfizer, which comprises drugs that have lost or are going off patent protection, may eventually be spun off.

“We believe that other significant acquisitions are possible, though more likely to be aimed at” Pfizer’s innovative-pharma side of the company, Jeffrey Holford, a New York-based analyst for Jefferies Group, wrote in a report Thursday. He cited Shire as that type of candidate.

Shire, valued at $52 billion, makes treatments for neurological disorders such as attention deficit hyperactivity and rare diseases such as Hunter syndrome. Perrigo, the maker of over-the-counter medicines that received an unsolicited bid from Mylan, could also be attractive to Pfizer, Holford wrote. Both companies’ tax jurisdictions are in Dublin.
Glaxo Argument

Deutsche Bank’s Gregg Gilbert highlighted Glaxo in a report May 20 that said Pfizer may feel a sense of urgency to boost shareholder value by leveraging its balance sheet and doing a “needle-moving” transaction. Brentford, England-based Glaxo would be the largest of the likely targets at $111 billion. It would diversify Pfizer’s vaccine and consumer portfolios while doubling and quadrupling each of those revenue bases, respectively, Gilbert wrote.

Pfizer could always make another attempt at buying AstraZeneca. The London-based company’s stock has risen just 2.2 percent since it spurned Pfizer last May, underperforming most of its competitors.

Any deal may be a precursor to an eventual breakup. Pfizer’s stock is currently one of the cheapest in its peer group, which many analysts attribute to its conglomerate structure. The company has said it may explore a split in which its established-drugs unit gets spun off or sold.

That means multiple deals may be in Pfizer’s future. Or as Holford of Jefferies called it, “a rich seam of corporate optionality.”

 

Not my thread and it is a good thread, but I saw this an was taken:

http://seekingalpha.com/news/2542156-amgen-terminates-brodalumab-co-development-deal-with-astrazeneca

The company Amgen is getting out of this deal and leaving it to AZ because when people are involved with it they want to kill themselves.

Ironic.

 

AZ has completed a health economic analysis and will continue development of the antiIL17 program that Amgen has dropped. Since the patients either kill themselves or think about killing themselves, AZ has found that this can result in substantial savings to the healthcare system.

 

AstraZeneca hit after psoriasis drug linked to suicide fears

http://www.reuters.com/article/2015/05/26/us-astrazeneca-amgen-psoriasis-idUSKBN0OB0LW20150526?feedType=RSS&feedName=businessNews

 

Amgen is out of the deal:

AstraZeneca’s Prospects Weaken as Amgen Exits Drug Partnership
by Oliver Staley
6:58 AM EDT
May 26, 2015

AstraZeneca Plc may lose as much as 9 percent of projected earnings after a key drug was put into jeopardy last week when Amgen Inc. ended a partnership to develop a treatment for psoriasis and psoriatic arthritis.

Brodalumab was a “critical asset” for AstraZeneca, Alexandra Hauber, an analyst at UBS AG, wrote in a note to clients. She had previously estimated that the drug would start contributing to the London-based company’s earnings in 2017, and would generate core operating profit of $930 million in 2020.

Shares of AstraZeneca slumped in London trading. The drugmaker would face tough competition from Novartis AG and Eli Lilly & Co., which are developing similar treatments, if it opts to pursue development of brodalumab on its own, said Simon Mather, an analyst at Barclays Plc. Analysts had estimated a year ago that the drug would generate peak-year sales of between $500 million and $1.5 billion, according to AstraZeneca.

“The commercial perspectives are clearly very challenging,” said Mather, who had projected peak sales of $880 million for the treatment. “Amgen’s decision to terminate the brodalumab collaboration does little to increase confidence in AZN’s pipeline aspirations.”

Mather removed brodalumab sales from his estimates for the drugmaker, while UBS’s Hauber cut her core EPS projections for AstraZeneca in a range of 3 percent to 9 percent for 2017-2020.

AstraZeneca shares were down 1 percent, the most in about 10 days, to 44.21 pounds at 11:25 a.m. in London. Astra said it will evaluate the data before making a decision about whether to proceed with developing the treatment.

AstraZeneca and Amgen have been working on the drug since 2012. In ending the partnership, Amgen said in a statement that the warning labels of suicide risk would limit the potential audience for the treatment.

The collaboration began three years ago, when the companies agreed to work together to develop five drugs in Amgen’s pipeline. AstraZeneca initially paid Amgen $50 million, and agreed to fund 65 percent of the cost of the drugs from 2012 to 2014. After that, they planned to split costs and profits, the companies said in a joint statement at the time.

 

How did AZ not get in on this new cholesterol treatment? Medimmune where are you??


Fight over hot new cholesterol drugs may be won in milligrams
Reuters
May 26, 2015 1:00 AM
By Deena Beasley

LOS ANGELES, May 26 (Reuters) - Two powerful and innovative cholesterol drugs likely to be approved this summer both target the same protein and have been shown to sharply lower LDL in high-risk patients. But there is at least one significant difference between the two offerings: the dosages in which they will be sold.

Assuming approval from the U.S. Food and Drug Administration, Amgen Inc. will offer its drug, Repatha, as a biweekly 140 mg injection or a monthly injection of 420 mg, while Praluent, from Regeneron Pharmaceuticals Inc and Sanofi, will be offered in biweekly injections of 75 mg or 150 mg.

The difference in dosages is likely to lead to very different sales strategies for the two drugs, in what could be a fierce competition for market share. Amgen's high-dose monthly injection could be seen as more convenient and might appeal to doctors because of its higher potency. Regeneron and Sanofi could enjoy a significant pricing advantage with their low-dose option.

Both drugs belong to a new class of antibodies that target PCSK9, a protein that maintains "bad" LDL cholesterol in the blood, and are aimed at the millions of people who don't benefit from statins. Statin pills, like Pfizer Inc's Lipitor, work very differently, blocking the liver's production of LDL cholesterol.

Neither Amgen nor Regeneron/Sanofi would talk about possible pricing of their new drugs, but some industry experts suggest that low-dose Praluent will be priced significantly below Repatha to make it more attractive to health insurers who have become increasingly aggressive about keeping medication costs down.

Dr Jennifer Robinson, a University of Iowa epidemiologist and lead researcher on clinical trials of Praluent, believes Sanofi and Regeneron "would be crazy not to" price its 75 mg dose below the 150 mg option.

"Sanofi will say you can start off at this cheaper, lower dose," Robinson said. "If you don't reach the LDL goal, you can move up" to a higher dose, at the higher price.

Sanford Bernstein analyst Geoffrey Porges predicts that lower-dose Praluent will cost $5,000 a year, with the higher dose at $10,000. He estimates Repatha's price at $10,000 per year for both the biweekly and monthly versions. Manufacturers do not necessarily charge less for lower doses of a medication.

Amgen's high-dose injections could be appealing in light of recent clinical data that has shown that keeping LDL very low can better protect against heart attack and stroke in high risk patients. Trial data has shown that both drugs produce greater LDL reductions in higher doses.

"It goes back to the patients we are trying to serve - patients with elevated, very high LDL cholesterol," said Scott Wasserman, Amgen's head of cardiovascular and metabolic therapies. "We didn't feel that a low dose option would serve those patients."

The FDA is due to decide on approval for Praluent by July 24 and on Repatha by Aug. 27. The agency, which has convened expert panels on June 9 and 10 to review both drugs, could also issue a joint decision.

The two PCSK9 drugs are each expected to generate about $2.5 billion in annual sales by 2020, according to Wall Street estimates compiled by Thomson Reuters Cortellis. Some predict total sales for the class rising to $20 billion by 2026.

PRICE MATTERS

In March, new clinical trial data showed that both Repatha and Praluent, combined with statins, reduced LDL levels dramatically, cutting in half the risk for heart attack, stroke, and other major cardiovascular problems. Sanofi/Regeneron and Amgen are conducting larger trials to confirm the benefits of PCSK9 drugs in reducing cardiovascular risks.

Industry experts note that there are many unanswered questions about the market for the drugs, including how widely the FDA will allow them to be used, how aggressively cardiologists will seek to lower LDL and whether other differences between them will emerge from the larger trials that will yield results in 2017.

Some see Sanofi having an advantage purely due to its larger marketing force among heart doctors. Another possible factor in which drug will dominate the market is the success or failure of a lawsuit Amgen has brought against Sanofi and Regeneron for alleged patent infringement.

But in the meantime, with the main merits of the two drugs appearing nearly equal, their comparative dose and price will become much more important differentiators.

Health insurers "are likely to view this as a class, one is the same as the other," said Les Funtleyder healthcare portfolio manager for ESquared Asset Management, which does not own shares in any of the three drugmakers. "You could have a case where if payers pay, they'll only pay for one rather than the other."

Express Scripts Holding Co is the largest U.S. manager of pharmacy benefit plans and successfully pressed for price reductions on novel hepatitis C drugs earlier this year.

Its chief medical officer, Dr. Steve Miller, said in an interview that $10,000 per year for a new cholesterol drug is "an extraordinarily high price." As many as 15 million Americans are estimated to have high cholesterol that cannot be controlled by statins.

"We are bullish on the health benefits, but they have to bring value," Miller said, adding that pricing would be a major factor in recommending either Praluent or Repatha for coverage.

Dr Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said he is most concerned about effectiveness: "What counts is how much you can lower LDL cholesterol," he said.

But he acknowledges that if the lower dose also had a lower price, "there might be some people who find that appealing," Nissen said.

 

Will Pfizer be back?

Why Pfizer's Pursuit Of AstraZeneca Continues To Shape The Outlook Of Both Companies
Simon King
Forbes
5/28/2015, 8:35AM

A year on from Pfizer PFE +0.32% abandoning its bid to acquire AstraZeneca and the UK drugmaker has received a timely reminder that touting an impressive R&D pipeline is a far cry from delivering innovative new products to the market.

There is a certain irony that although Pfizer’s pursuit was largely motivated by an opportunity to lower its corporate tax rate, it provided the UK drugmaker a suitable canvas on which to paint a picture of rapid pipeline momentum; one framed with an ambitious top-line revenue target of $45 billion by 2023.

Amgen's AMGN -1.7% decision to return development rights for the experimental psoriasis treatment brodalumab to AstraZeneca – prompted by concerns that the drug increases the risk of suicidal thoughts – has helped to shape a neatly packaged narrative; that the UK company will struggle to meet its sales targets given likely termination of the product.

This equation appears to be something of a misnomer. The majority of analyst revenue forecasts fall short of the targets projected by CEO Pascal Soriot, while the breadth of pipeline expansion overseen by the Frenchman during the past 2.5 years should, in theory, limit the impact of individual product setbacks on broader company performance.

In turn, one suspects that many investors have been willing to take management’s revenue aspirations with at least a pinch of salt, while accepting that Soriot was forced to map out tangible (if over ambitious) targets in the heat of Pfizer’s pursuit, as long as the company is demonstrating forward momentum. The reality, therefore, is that the brodalumab setback is likely more damaging to sentiment than sales projections.

In contrast to rigid expectations for AstraZeneca, the strategic narrative at Pfizer is one of fluidity – centered on management’s ‘will they, won’t they’ rhetoric towards another large-scale deal and potential dismantling of the company in a few years’ time, as a means to unlock shareholder value.

Pfizer has made progress both on the regulatory front, with the ongoing and reportedly successful launch of Ibrance for breast cancer, and the development front, albeit with an expensive looking deal with Merck KGaA to bolster its presence in immuno-oncology.

Front-line strategic discussion remains locked, however, on future capital deployment choices; a card that CEO Ian Read has played strongly for some time and which has supported a 16% share price increase for Pfizer over the past 12 months versus a 6% rise for AstraZeneca.

Many believe that Read took a risk in launching Pfizer’s bid for AstraZeneca a year ago by muddying a clear message of future separation and suggesting the company needed to get bigger before it could get smaller. Twelve months on and despite being forced to walk away without his prize, Read has put Pfizer back on course with investors. Soriot on the other hand may be facing stronger headwinds.

 

https://www.youtube.com/watch?v=jNHM4AL7LdU

 

http://www.forbes.com/sites/matthewherper/2015/05/28/with-a-1-2-billion-hammer-the-ftc-closes-loophole-to-prevent-generic-drugs/

That's billion with a b ladies and gentlemen, things will continue to change. Since big pharma R & D has not done her job, big pharma will be replaced. As ye reap.

 

Some ASCO data out:


Clovis Wins One ASCO '15 Battle, Loses Another, Against Rival AstraZeneca
By Adam Feuerstein


CHICAGO (The Street) -- It seems impossible to invest in, think about (or write on) Clovis Oncology (CLVS) without first considering the heated, multi-front competitive battle with AstraZeneca (AZN - Get Report). This weekend's ASCO annual meeting was no different.

Clovis' rucaparib made a strong claim Saturday to unseat AstraZeneca's Lynparza as the most effective PARP inhibitor treatment for a genetically defined segment of previously-treated ovarian cancer patients.

But AstraZeneca fought back Sunday when a highly anticipated presentation of Clovis' lung cancer drug rociletinib produced mediocre results. AstraZeneca's lung cancer drug AZD9291 appears superior.

Clovis shares closed Friday at $92.44, but the stock could fall Monday given lung cancer data at ASCO acknowledged as "disappointing" by one one sell-side analyst with a history of being very bullish about the company.

In a mid-stage study of patients with advanced ovarian cancer carrying the mutated BRCA gene, treatment with Clovis' rucaparib yielded a response rate of 82%. Ten percent of patients had complete resolution of their tumors. Median progression-free survival was 9.4 months.

Another 45% of ovarian cancer patients with "BRCA-like" mutations responded to rucaparib. Median progression-free survival in these patients was 7.1 months.

Mid-stage studies of rucaparib are still ongoing, but Clovis set plans to seek regulatory approval for rucaparib next year. The company estimates 25% of ovarian cancer patients carry the BRCA mutation, with another 35% of patients carrying "BRCA like" mutations also amenable to treatment with rucaparib.

AstraZeneca secured accelerated approval for Lynparza in the U.S. last December based on a 34% response rate and a median progression-free survival of 7.9 months in women with BRCA-mutated ovarian cancer. Both Lynparza and rucaparib work by blocking a protein, PARP, used by tumors to heal themselves, however Clovis believes rucaparib could be approved to treat the larger swath of patients with BRCA and BRCA-like mutations.

Clovis' targeted lung cancer drug rociletinib didn't fare as well during a Sunday presentation. Updated results from a mid-stage study showed a median progression-free survival of eight months, lower than the 10-month progression delay reported previously. Response rate to rociletinib was 60%.

Earlier this spring, AstraZeneca reported a median progression-free survival of 13.5 months in lung cancer patients treated with AZD9291.

Both drugs have safety concerns to tend with. Clovis' rociletinib causes a significant number of patients to suffer from high blood sugar, which in some cases must be controlled with oral diabetes drugs. AstraZeneca's AZD9291 is linked to serious cases of interstitial lung disease, including deaths.

Both Clovis' rociletinib and AstraZeneca's AZD9291 are designed to be effective against non-small cell lung cancer containing a genetic mutation known as T790M, which renders tumors resistant to treatment with drugs like Roche's Tarceva.

Clovis and AstraZeneca are each expected to seek regulatory approval for their respective lung cancers drugs later this year.

 

None of this shit matters. All you need to know is that AZ is in charge of its development and you know it will be a loser. AZ could fuck up a one person parade.

 

AZ's greed catches up with them with NICE effusing to cover AZ's amazingly expensive ovarian cancer drug!

http://www.pharmatimes.com/Article/15-06-01/NICE_says_AZ_ovarian_cancer_drug_is_too_expensive.aspx