AZ News From The Street 2016

AstraZeneca licenses inflammatory disease candidate to Allergan

October 3, 2016
LONDON, Oct 3 (Reuters) - Britain's AstraZeneca said it had licensed a potential medicine for inflammatory diseases to Allergan for an upfront payment of $250 million and potential additional payments of up to $1.27 billion.

AstraZeneca said the drug developed by its global biologics research and development arm MedImmune was being testing as a treatment for moderate-to-severe Crohn's disease and was ready to start trials for ulcerative colitis.

Amgen Inc, which has been collaborating with MedImmune on developing the medicine, will receive a third of all payments and royalties received from Allergan, AstraZeneca said on Monday.

 

Amgen bailed on this and then dumped it on AZ, now we have dumped it on Allergan. They probably figured out that it would never be a big player in the market, so they'll just let somebody else sell it.

 

AstraZeneca's Brilinta drug fails in big arterial disease trial

Oct 4, 2016, 3:12 AM

* Brilinta fails to show benefit over clopidogrel in PAD

* Follows failure of heart drug in stroke trial in March

* Drugmaker sells rights to Toprol-XL for up to $223 mln (Adds sales forecasts, detail on Toprol-XL deal with Aralez)

By Ben Hirschler

LONDON, Oct 4 (Reuters) - AstraZeneca's heart drug Brilinta has failed to help patients with serious circulatory problems in their legs, dealing a blow to a medicine that the company has tipped as a potential $3.5 billion-a-year seller by 2023.

AstraZeneca said on Tuesday that Brilinta failed to show a benefit over the older blood thinner clopidogrel in treating peripheral artery disease (PAD) in a large-scale clinical trial. PAD usually affects the legs.

Clopidogrel is the generic name of Sanofi's former blockbuster drug Plavix, which is now off patent.

The setback follows similar disappointing results in March with the same AstraZeneca pill in another big trial in stroke patients. Both studies were designed to open up new markets for Brilinta beyond its current use in heart attack patients.

Sean Bohen, AstraZeneca's head of global medicines development and chief medical officer, said he was disappointed that the so-called EUCLID trial had failed but added: "The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction (heart attack) patients are established and remain unchanged."

Full results from the EUCLID trial, which involved 13,885 patients, are expected to be presented at the American Heart Association annual meeting in New Orleans in November.

A positive result could have boosted consensus forecasts for Brilinta, which currently stand at an annual $2.1 billion for 2021, according to Thomson Reuters data.

During its defence against a takeover bid from Pfizer in 2014, AstraZeneca gave a projection of Brilinta sales reaching $3.5 billion by 2023, making it an important part of a $45 billion revenue target announced by the company at the time.

Brilinta's sales in 2015 were $619 million.

Separately, AstraZeneca also announced it had agreed to sell the U.S. rights its old beta-blocker heart drug Toprol-XL to Aralez Pharmaceuticals, marking the latest move by the British company to divest non-core businesses as it focuses on bringing out newer medicines, especially for cancer.

Aralez will pay AstraZeneca $175 million upfront to acquire the rights to Toprol-XL tablets in the United States, and the authorised generic medicine marketed by Par Pharmaceuticals. It will also pay up to $48 million in milestone and sales-related payments, as well as mid-teen percentage royalties on sales.

 

The 175M should almost cover Pascal's bonus. What a dick. He only came in to snag the big money the dumb ass BOD offered this jerk and never intended to do anything but dismantle the whole company. It's been his MO for years. AZ BOD is a disgrace. Glad I left with my millions when I did.

 

AstraZeneca's Brilinta fails drug trial

Published: Oct 4, 2016 6:57 a.m. ET
By DeniseRoland

AstraZeneca PLC cut its sales target for prescription blood-thinning medicine Brilinta after it failed to show a benefit over standard treatment in peripheral artery disease in a large clinical trial.

The U.K.-based drugmaker said Tuesday that Brilinta was no better than generic blood-thinner clopidogrel at reducing heart problems in people with peripheral artery disease, a condition in which a buildup of fatty deposits in the arteries restricts blood flow to the leg muscles.

The failure cuts off a source of significant growth for Brilinta: peripheral artery disease affects around 8.5 million people in the U.S. according to the Centers for Disease Control and Prevention. Success could have boosted the drugs' sales by around $2 billion at peak, according to an estimate by UBS.

Ludovic Helfgott, head of the Brilinta franchise, said the company wouldn't now attain its target of raising sales of Brilinta to $3.5 billion by 2023. That goal was an important part of its overall target to nearly double revenue to $45 billion in the same period, unveiled to fend off an unwanted takeover approach from Pfizer Inc. nearly two years ago.

Mr. Helfgott said he nonetheless expected Brilinta to be a "key pillar of growth" and that the result didn't affect the company's overall growth targets, thanks to positive news on its new cancer and respiratory drugs.

The drugmaker is plowing significant investment into a huge clinical trial program for Brilinta, aimed at expanding its use. The drug is already marketed as a treatment for people who have suffered a heart attack, to lower their risk of having a second one. Sales of Brilinta were $619 million in 2015.

Those efforts have met with mixed results. Earlier this year, another large trial failed to show that Brilinta was any better than aspirin at preventing major heart problems in stroke patients. A final trial testing whether Brilinta reduces the risk of cardiovascular problems in people with type two diabetes is still under way, with results expected in early 2018.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said he was disappointed with the results but said they didn't effect the "proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients," referring to those who have suffered a heart attack.

Shares in AstraZeneca were down 0.1% at GBP50.34 in midmorning trade.

 

and another one down and another one down
another one bites the dust

 

yet another one licensed out:


AstraZeneca licenses respiratory drug to Insmed
October 5, 2016

Oct 5 (Reuters) - Drugmaker Insmed Inc said on Wednesday it had bought the rights to an experimental early-stage respiratory drug from Britain's AstraZeneca Plc in a deal worth $150 million.

AstraZeneca will get $30 million in upfront fees and $120 million in various milestone payments, Insmed said.

The deal adds AstraZeneca's AZD7986 compound to Insmed's pipeline. AZD7986 is designed to stop an enzyme that regulates inflammation in the respiratory system.

The British drugmaker has been trimming its pipeline by licensing its experimental drugs to other companies as it focuses on its cancer treatments.

The licensing deal with Insmed comes two days after AstraZeneca sold the rights to a treatment for inflammatory disease to Allergan Plc.

AstraZeneca, which has a long history of developing successful respiratory medicines, is focusing its resources on benralizumab, an experimental drug for severe asthma.

Insmed, which focuses on developing treatments for respiratory diseases, said it would start a mid-stage study of the drug in non-cystic fibrosis bronchiectasis, a disease in which the airways in the lungs become permanently dilated due to chronic inflammation and infection.

Insmed is also testing Arikayce in late-stage studies to treat chronic lung infections.

According to deal terms, AstraZeneca has the option to negotiate a deal to develop AZD7986 in chronic obstructive pulmonary disease or asthma.

 

What is going on? Respiratory is a growth area? Why sell it?!?

 

its not cancer

 

You can feel Pascal's desperation as he dismantles this company, one piece at a time.

 

As long as they keep on paying the high dividend the stock will hang in there, eventually the cash flow won't support it as the products fall off, but you can always borrow at 0% to pay it, at least for now. This is just a cost slashing, dividend paying enterprise now. Use the inflated stock as currency to buy products, then sell them off while keeping some royalties. This is not really a pharma company anymore, it is a financial instrument.

 

precisely

 

didn't they just float a big bond issue for general corporate purposes not too long back?

 

Notice that there has been NO mention of the dividend that typically occurs in Sept/Oct? No announcement, nothing. Looks like they are trying like hell to reduce costs for a prettier year end picture. Lipstick on a pig? Maybe.

And remember when PS discussed how important it was to keep the dividends going? Something must make that not so important anymore. Wonder what that could be?

 

In the British style, remember that AZN is only an ADR and that AZN.L is the main stock issue on the London Exchange, dividends are paid only at year end and at the half year point, so no dividend pay out is due again until late January or early February.

 

PARP inhibitors news:

Tesaro Bolts On Ovarian Cancer Win Vs. AstraZeneca, AbbVie
ALLISON GATLIN
10/10/2016

Tesaro (TSRO) stock rocketed to an all-time high Monday on Phase 3 results showing its ovarian cancer drug could benefit 70% of all patients, making it "the PARP inhibitor to beat," according to RBC analyst Adnan Butt.

Tesaro stock flew as much as 24%, near 123, on the stock market today, and closed the day at 119.23, up 20%. Shares more than doubled in June thanks to earlier win for niraparib, its ovarian cancer drug.

In a late-stage trial, Tesaro said niraparib increased progression-free survival (PFS) in four subsets of patients with ovarian cancer regardless of whether they had the BRCA gene or homologous recombination deficient (HRD) tumors.

Those with the germline mutation of the BRCA gene (associated with breast cancer) topped the group with a median PFS that was 15 and a half months better than the control arm.

But all four groups benefited, meaning niraparib could potentially treat 70% of ovarian cancer patients vs. 50% if BRCA, HRD positive or biomarkers had been required, Butt wrote in a research report.

Tolerability also appeared manageable. Less than 15% of patients dropped out. Of those who experienced Grade 3 or 4 adverse effects (thrombocytopenia, anemia or neutropenia), all were resolved with dosing changes, Butt wrote.

Tesaro plans to complete the rolling new drug application in Q4 for patients with recurrent, platinum-sensitive ovarian cancer and will file with the U.S. Food and Drug Administration for broad appeal, Butt wrote.

Butt sees no near-term rivals for niraparib, a PARP inhibitor. According to BMC Medicine, a publisher of peer-reviewed journals, PARPs are enzymes used to repair damaged DNA. Companies like Tesaro are studying whether inhibiting those enzymes could be key to treating ovarian, breast and other cancers.

AstraZeneca's (AZN) PARP inhibitor, Lynparza, won conditional approval in 2014. Clovis Oncology (CLVS) stock lost 18% on Friday after data showed its ovarian cancer drug might be inferior to Lynparza, but Clovis shares rose 10% to 32.40 on Monday, on Tesaro's stock pull.

Medivation (MDVN) and AbbVie (ABBV), too, are testing PARP inhibitors. AbbVie stock rose a fraction Monday, while Medivation was basically flat.

Butt kept his outperform rating on Tesaro stock and boosted his price target to 128 from 122. At least three other analysts hiked their price targets Monday on Tesaro stock.

 

If the dividend is cut the stock price will fall sharply.

 

AstraZeneca Plc (ADR) (NYSE:AZN) has once again reiterated its intention to focus on core therapeutic areas with the signing of a new commercialization agreement with a subsidiary of 3SBio, in China. The exclusive licensing agreement is for the sale of the company’s two diabetes drugs Byetta and Bydureon.


Licensing Terms

AstraZeneca Plc (ADR) (NYSE:AZN) is to continue manufacturing and supplying the drugs for sale, under the terms of the agreement. The company can cancel the agreement should 3SBio fail to achieve the agreed sales targets.

The company is also entitled to a $50 million upfront payment that could be worth an additional $50 million on the Chinese firm winning import approval for two Bydureon formulations. The agreement provides the UK-based Pharma an opportunity to attract more sales on the drugs given that diabetes affects one in every 10 adults in China.

Inking deals with Chinese, company’s has turned out to be Astra’s main play as it continues to explore growth in the communist nation. Last year it entered a strategic alliance with WuXi AppTec for the production of biologic drugs.

AstraZeneca offloading commercial rights for the two diabetes drugs has however not gone well with some investors. Diabetes is one of the company’s core areas of focus. By issuing such rights the company will not be able to generate all the returns had it pursued sales on its own. The company on its defense insists such agreements allow it to expand its footprint in emerging markets.

Trimming Non-Core Areas

The giant pharmaceutical company has not enjoyed much success with the two diabetes drugs in China. Last year alone, it made less than $15 million on the two compared to $896 million generated from global sales of diabetes drugs.

Handing over the commercialization rights to a local entity could help the company focus its attention in other areas with greater opportunity for growth. Respiratory is one of the areas that have emerged as a soft spot when it comes to sales.