AZ News from The Street 2014

Some real competition for Medi coming?


Tue, Sep 30, 2014, 9:25AM EDT
Johnson & Johnson to buy private drug developer for $1.75 bln

Sept 30 (Reuters) - Johnson & Johnson said it would buy privately held drug developer Alios BioPharma Inc for $1.75 billion in cash, to access a portfolio of drugs targeting viral infections.

Johnson & Johnson said the deal includes Alios's experimental drug for infants with respiratory syncytial virus.

In the United States, respiratory syncytial virus is the most common cause of an inflammation of the small airways in the lung and pneumonia in infants under the age of 1, according to the U.S. Centers for Disease Control and Prevention.

 

Brilinta:

AstraZeneca heart drug gets preferred status in U.S.
Reuters
4 hours ago

LONDON, Oct 6 (Reuters) - AstraZeneca's blood-thinning drug Brilinta has won preferred status in the United States, where two medical groups have recommended it over the older drug Plavix, also known as clopidogrel.

The endorsement comes in an updated guideline from the American Heart Association and American College of Cardiology on the management of so-called non-ST-elevation acute coronary syndromes, or acute chest pain without certain electrocardiogram changes.

AstraZeneca said on Monday it was the first time the cardiology organisations had recommended one drug of this type over another in the treatment of acute coronary syndromes.

Brilinta has struggled so far to gain traction in a competitive market, where Plavix -- developed by Sanofi and Bristol-Myers Squibb -- is now available as a cheap generic.

However, prospects for the drug brightened in August when the U.S. Department of Justice dropped an investigation into the original clinical trial used to win marketing approval, lifting a shadow hanging over the product.

AstraZeneca flagged up the promise of Brilinta in its defence against an abortive $118 billion takeover bid by Pfizer earlier this year, forecasting annual sales of $3.5 billion for the drug by 2023.

That number assumes it works in a variety of other settings beyond its current indication for acute coronary syndromes, and a series of large trials are now under way to prove the case.

AstraZeneca hopes to report headline results from one of these trials, known as PEGASUS, in December.

Commenting on the new U.S. guideline, Brilinta global vice president Tom Keith Roach said: "This is just another example of the growing momentum behind the brand, particularly in the U.S., but there is still much to do as we anticipate PEGASUS top line results at the end of the year."

 

This so-called "endorsement", along with $2 will get you a cup of coffee at Starbucks. Generic Plavix works, simple as that. The question is, whom did we pay off to get their vote of confidence??

 

I don’t drink a lot of Kool-aid, but have spent enough time in a cath lab to know you haven’t. Firstly, you would have called it clopidogrel, secondly, you would never personally take it or suggest it for a family member over Brilinta.

 

What a moron! Firstly, I have never heard a doc refer to Plavix as clopidogrel, ever! Secondly, Plavix has worked on millions of patients. Brilinta is better. Plavix is generic. Nuff said.

 

While this endorsement won't immediately get all the docs to switch to Brilinta, going against clinical recommendations can get a doc sued if anything happens to go wrong. I would bet that this will start the switching cascade from the generic to Brilinta to gain momentum. How fast? I don't know.

 

OMG, here goes the ole sue threat again by AstraZeneca. Used to hear the same thing about other drugs like Seroquel vs other atypicals. If they're not using your drug, frighten them.

 

No, not by AZ, but by the patient's own ambulance chaser lawyer!!

 

Yeah, by hints from the reps.

 

Well, its only fair to warn them!!

 

AstraZeneca's Benralizumab Encourages in Phase II Study
By Zacks Equity Research October 10, 2014 4:52 PM

AstraZeneca (AZN) announced that data on its respiratory disease candidate, benralizumab, was published in The Lancet Respiratory Medicine. The data was from a phase IIb study which evaluated the use of benralizumab in patients suffering from severe eosinophilic asthma that remained uncontrolled despite the use of medium or high dose inhaled corticosteroids and long-acting beta agonists for at least one year, and who had experienced at least two exacerbations in the past year.

The study met the primary endpoint. A statistically significant reduction in the asthma exacerbation rate was observed in the benralizumab arm as compared to placebo over a one-year period. Additionally, benralizumab showed improvements in lung function and asthma control.

The study found that benralizumab reduced asthma exacerbations by approximately 40%–70% based on dose and baseline blood eosinophil levels. The candidate was found to be effective in reducing the blood eosinophil count to low levels after the first dose.

We note that benralizumab is currently in phase III development for both chronic obstructive pulmonary disease COPD) and severe and uncontrolled asthma. AstraZeneca has in-licensed the drug from Kyowa Hakko Kirin Co., Ltd. in all countries except Japan and certain other Asian countries.

The company has high hopes on benralizumab and expects the drug to generate peak sales of $2 billion. We believe AstraZeneca’s experience in marketing products like Symbicort and Pulmicort in this area should prove beneficial if and when benralizumab receives approval.

Currently, the asthma market is heavily crowded with the presence of several companies including GlaxoSmithKline (GSK).

 

another big lawsuit coming:

Texas AG Lawsuit Claims AstraZeneca Improperly Marketed Seroquel
By Ed Silverman, WSJ

The Texas Attorney General has filed a lawsuit against AstraZeneca AZN.LN +1.37% that alleges the drug maker illegally marketed its Seroquel antipsychotic pill for unapproved uses, paid kickbacks to physician and state health officials, and subsequently caused the state Medicaid program to overpay for the medicine.

The lawsuit, which was filed this week in a state court in Texas, builds on claims in lawsuits that were filed by two former AstraZeneca sales reps, who alleged the drug maker used various tactics to induce physicians to prescribe different versions of the Seroquel pill.

As an example, the drug maker allegedly paid $465,000 to a pair of unidentified state mental health officials “with the power to influence formulary decisions within the state hospital system,” according to the lawsuit. A formulary is a list of drugs for which an insurer offers reimbursement.

An AstraZeneca spokeswoman sent us this note: “We are in the process of reviewing the allegations and considering appropriate next steps. However, we believe that the company’s actions in Texas have been lawful and ethical.”

The lawsuit notes that people with schizophrenia or bipolar disorder were more likely to be uninsured and not able to afford Seroquel, therefore relying on state health programs. As a result, AstraZeneca anticipated a “significant portion” of its revenue would come from “public sector” payers.

“Understanding the need to obtain significant government buy-in to achieve their financial goals for Seroquel, [the drug maker] set their sights on Texas Medicaid, declaring it ‘low hanging fruit’ and ‘an absolute must win’ that would fuel brand growth,” the lawsuit states.

“…As a result of [AstraZeneca’s] conduct, the Texas Medicaid program was prevented from making fully informed and appropriate policy decisions,” the suit states. This “resulted in millions of dollars in excessive reimbursements” for Seroquel by the state.

In his lawsuit, the Texas Attorney General also repeats various allegations in the lawsuit filed by former AstraZeneca sales rep Tracy Miksell-Branch, who alleged the drug maker established quotas to force reps to market Seroquel for unapproved uses, minimized safety risks and touted unsubstantiated superiority claims.

The allegations mirror charges of off-label marketing that led AstraZeneca to pay $520 million five years ago as part of a settlement with the U.S. Department of Justice. The feds charged the drug maker with promoting the pill toward patients – notably, children – for whom the drug was not yet approved. AstraZeneca denied wrongdoing.

As part of that 2010 settlement, AstraZeneca signed a five-year corporate integrity agreement, which required the drug maker to establish an internal compliance program and report violations, among other things. The feds regularly require drug makers to sign such agreements as part of settlements.

Interestingly, a spokeswoman for Texas Attorney General Greg Abbott writes us that “we do believe the alleged [illegal marketing] behavior went beyond 2010.” That would have to be determined by the feds, however, since the Texas Attorney General does not have legal standing to enforce the CIA.

The Texas Attorney General, by the way, also pursued Janssen Pharmaceuticals, a unit of Johnson & Johnson, for illegal marketing of the Rispersal antipsychotic. After a brief and embarrassing trial began, the drug maker two years ago reached a $181 million settlement.

An attorney for the other former AstraZeneca sales rep raised another issue by noting that antipsychotics have been associated with cardiovascular risk. “In this case, AstraZeneca’s illegal conduct not only cost Texas Medicaid tremendous amounts of money but also placed Medicaid beneficiaries at grave risk for sudden cardiac death and cardiac arrest,” says James Pepper, who represents Allison Zayas, in a statement.

The lawsuit notes Seroquel poses a cardiovascular risk and that such side effects “can be particularly dangerous in the vulnerable pediatric and elderly populations.” The product labeling cites a cardiovascular risk for people with cardiovascular disease. The attorney pointed to a study published last year by the Aritmo Project, which is funded by the European Commission, that four of all newer-generation antipsychotics, Seroquel may cause a greater risk of an irregular heart rhythm.

 

We regularly hired speakers just to pay them.my manager couldn't have cared less that NO ONE showed up. We got the speaker paid!

 

I'm sure that got them writing!

 

Management Incentives Could Be Bonus For AstraZeneca
Overheard, By Helen Thomas


When in doubt, bet on executives’ ability to defend their own pay-outs.

That seems to be the message from Jefferies, which Monday upgraded AstraZeneca AZN.LN +0.57% to a ‘Buy’ rating. Astra may not be getting enough credit for its pipeline of immunotherapy assets. But the broker has another reason to stay positive. With Astra’s sales forecast to shrink as drugs lose patent protection, earnings per share will come under pressure.

But, notes Jefferies, Astra’s long-term bonus plan for management requires the company’s dividend to be at least 1.5 times covered by earnings per share. That implies a floor of $4.20 per share in earnings. The assumption that, by hook or by crook, Astra’s management will keep earnings above this threshold means Jefferies forecasts are up to 10% higher than consensus from 2015 to 2017. That would suggest additional cost cutting, or deals to add to revenues, before the pipeline comes to fruition beyond 2017.

Not exactly the long-term thinking such programs were designed to encourage.

 

Ruh-Roh. Kickbacks and Fraud making the news and pain the dues...

http://www.fiercepharma.com/story/texas-ag-astrazeneca-paid-465k-kickbacks-committed-fraud-seroquel-marketing/2014-10-13

 

Pipeline news:

AstraZeneca finally bails on troubled Targacept after years of failure
October 9, 2014 | By Damian Garde

After 9 years of fruitless work on treatments for Alzheimer's disease and depression, AstraZeneca ($AZN) is dissolving its partnership with Targacept ($TRGT), leaving the battered biotech to pick up the pieces of its dwindling pipeline.

Targacept disclosed its partner's impending departure in a terse SEC filing, saying that AstraZeneca exercised its termination clause on Wednesday, and, in 90 days, the pair's oft-amended agreement will be null. AstraZeneca will hand back any and all compounds it hasn't already surrendered, Targacept said, including AZD1446, a once-promsing treatment for Alzheimer's.

AstraZeneca's final exit comes as little surprise considering the pair's record of clinical failure. The antidepressant TC-5214, another pillar of their collaboration, endured four Phase III setbacks that forced Targacept to cut its payroll and refocus its R&D efforts in 2012, and TC-1734, another Alzheimer's treatment, failed to beat out placebo in a late-stage study of its own. AstraZeneca handed both of those drugs back to Targacept last year, and, in February, the company cut its ties with another slew of undisclosed early-stage candidates in a broad housecleaning effort.

And Targacept's efforts to find silver linings haven't fared any better. After AstraZeneca ditched TC-1734, the biotech pressed on with a Phase IIb trial to see whether the drug could beat Eisai and Pfizer's ($PFE) now-generic Aricept (donepezil) in Alzheimer's patients, an effort that ended in failure over the summer. And it's a similar story for TC-5214: Moving on from treating depression, Targacept tried it out in a Phase IIb against overactive bladder, recording another miss as the drug failed to meet its primary endpoint in July.

That leaves the Winston-Salem, NC, biotech with just one clinical candidate on its books: TC-6499, which is in a Phase I/II exploratory trial in& diabetic gastroparesis.

Now CEO Stephen Hill, intent on rebuilding Targacept's promise, is looking beyond the company's home base of nicotinic receptor treatments.

"Continuing our strategic planning and business development efforts of the last several months, we are focused on selectively fortifying our pipeline with non-nicotinic opportunities and intend to engage our major shareholders in this process," Hill said in a statement attached to the company's second-quarter results, released in August.

 

Cancer drug news:

Fri, Oct 24, 2014, 9:02AM EDT - US Markets open in 28 mins
AstraZeneca cancer drug pipeline gets boost from European green light
Reuters
1 hour ago
By Ben Hirschler

LONDON, Oct 24 (Reuters) - AstraZeneca's cancer drug pipeline received a boost on Friday, as European regulators recommended approval of an experimental medicine against ovarian cancer.

The green light from the European Medicines Agency (EMA) for olaparib, or Lynparza, is welcome news since the product hit a road bump in June when a U.S. panel voted against its accelerated approval.

AstraZeneca has flagged the medicine as a potential $2 billion-a-year seller.

Olaparib blocks an enzyme involved in cell repair and is designed for patients with certain hereditary gene mutations. It also has promise in treating other cancers, opening up a substantial market opportunity.

"We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumour types including breast and gastric cancer," said Briggs Morrison, AstraZeneca's chief medical officer.

The treatment is expected to be the first drug in the so-called PARP inhibitor class to reach the market in Europe.

The EMA said its committee of experts on new drugs also recommended approval of Pfizer's Duavive for oestrogen deficiency, Baxter International's Rixubis for haemophilia and Clinuvel's Scenesse for phototoxicity.

Recommendations for marketing approval by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

An AstraZeneca spokeswoman said a final decision on olaparib's approval was now expected in January 2015. The British company also hopes to hear back from regulators on the approvability of the medicine in the United States by Jan. 3.

Cancer medicine is central to AstraZeneca's claims that it has a strong independent future, after fending off a $118 billion takeover bid from Pfizer in May.

As part of its defence, the British drugmaker set out a bullish set of forecasts for its drug pipeline and predicted that group sales would climb 75 percent by 2023.

Most interest is focused on the company's rapidly developing line-up of experimental immunotherapy treatments, which boost the immune system's ability to fight cancer. Research presented at a cancer congress in Madrid last month suggests AstraZeneca is in a strong position in this field.

Shares in AstraZeneca pared losses by 1130 GMT to stand 0.6 percent down on the day, after falling as much as 2 percent earlier on news of an $11 billion share buyback plan by Pfizer.

Some investors saw the move as reducing the likelihood that Pfizer would renew its pursuit of AstraZeneca, although analysts cautioned against reading too much into the U.S. company's decision to continue its share repurchase plans.

 

Is AstraZeneca Getting Ready to Exit Antibiotics Research?
By Ed Silverman
Associated Press

For the past year, the fate of antibiotics R&D at AstraZeneca AZN.LN +0.83% has been uncertain. The drug maker, which possesses what is generally regarded as having the strongest antibiotics pipeline in the pharmaceutical industry, indicated that spending on this area would be reduced as part of a larger cutback and strategic refocusing. Ever since, speculation has grown that antibiotics may be abandoned altogether.

Now, an unconfirmed report suggests AstraZeneca may, in fact, be ready to walk away from the field.

Pharmaceutical industry consultant David Shlaes wrote on his Antibiotics blog earlier this week that the drug maker has told “its antibiotic researchers that they should make efforts to find other jobs in the near future. Even though there has been no official announcement yet that the antibiotics research group will be disbanded, their scientists are starting to head for the hills.”

When asked for a response, an AstraZeneca spokeswoman wrote us that “we saw the blog and it is highly speculative. We continue to be active in anti-infectives and have a strong pipeline of drugs in development.” She cited, as an example, an antibiotic for treating hospitalized adults with complicated stomach infections. Positive late-stage study results were recently reported showing the product was ‘non-inferior,’ or not statistically worse compared with an existing treatment.

“However, we have previously said on a number of occasions that we would take an opportunity-driven approach in our non-core therapeutic areas of infection and neuroscience,” she continues. “This means we would focus our resources on the core therapeutic areas and look for opportunities to maximize the value of our pipeline infection and neuroscience.”

This response was largely similar to one given to Nature, which then wrote that AstraZeneca neither confirmed nor denied plans to exit antibiotic R&D. So we asked for further clarification and the spokeswoman wrote us this: “When we have anything to announce, such as a partnership activity, we would do so. But at this time, there is no news or change to our position on anti-infectives.”

Any move by AstraZeneca will be closely watched because of the timing – public health officials, notably the World Health Organization, have been warning about the growing threat of resistance to existing antibiotics and the need to develop new products. Last month, for instance, the Obama administration released a game plan for combating antibiotic resistance. The pharmaceutical industry, however, has largely drifted away from research into this area.

 

AstraZeneca's Lynparza a Step Closer to European Approval
By Zacks Equity Research
18 hours ago

The European Medicines Agency’s (EMA.TO) advisory body, the Committee for Medicinal Products for Human Use (CHMP), gave a positive opinion in favour of approving AstraZeneca’s (AZN) Lynparza (olaparib).

AstraZeneca is looking get Lynparza, a poly ADP-ribose polymerase PARP) inhibitor, approved as a monotherapy for the maintenance treatment of adults suffering from platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. These adults are in complete or partial response to platinum-based chemotherapy.

We note that though the European Commission, which will be rendering a final decision on the approval status of Lynparza, is not bound to follow the CHMP's decision, it generally does so.

The CHMP’s decision comes on the basis of results from a phase II study evaluating the efficacy and safety of Lynparza in comparison to placebo. Results from the study revealed that progression free survival was prolonged in patients under Lynparza (11.2 months) compared to those under placebo (4.3 months).

We are encouraged by the CHMP’s positive opinion on the approval of Lynparza. The candidate’s fate was however not that good in the U.S. In Jun 2014, AstraZeneca announced that the FDA’s Oncologic Drugs Advisory Committee ODAC) voted against the approval of the oncology candidate (read more: AstraZeneca's Olaparib Fails to Impress FDA Panel).

A final decision on the approval status of the candidate in the U.S. is expected by Jan 3, 2015. On approval, Lynparza is expected to be the first PARP inhibitor to hit the EU, Iceland, Norway and Liechtenstein for the treatment of platinum sensitive relapsed BRCA-mutated high grade serous ovarian cancer.

We note that Clovis Oncology’s (CLVS) rucaparib is another PARP inhibitor being developed for the treatment of platinum-sensitive ovarian cancer patients.