AZ News from the Street 2018

Yet another attempt at the Amyloid hypothesis in Alzheimer's disease by Biogen:

Biogen;(NASDAQ:BIIB) shares soared on news that one of its Alzheimer’s drug trials was showing tremendous promise. Specifically, BIIB stock jumped nearly 20% after an update on BAN-2401, a phase 2 drug that showed a statistically significant slowdown in the memory loss associated with Alzheimer’s.

No, BAN-2401 isn’t the only Alzheimer’s drug in the works. There are, in fact, five drugs already on the market approved as a treatment for the disease. BAN-2401 is a very promising prospect though, taking aim at a market that’s in desperate need of a better solution than what’s currently available.

BAN-2401 Works! (so far)
It was almost a bust, given the 12-month results posted in December.
As it turns out though, the drug just needed another six more months to achieve measurable efficacy.

RealMoney’s Bret Jensen explains, “It is important to remember that this is only Phase 2 data and while encouraging, it is not the first time an Alzheimer’s drug that gotten past this hurdle. Every other company has blown up in Phase 3 development.”" Much work still needs to be done. Specifically, a much bigger phase 3 trial still needs to take place … a stage that’s proven brutal to the biopharma industry in the recent past. As RealMoney’s Bret Jensen explains, “It is important to remember that this is only Phase 2 data and while encouraging, it is not the first time an Alzheimer’s drug that gotten past this hurdle. Every other company has blown up in Phase 3 development.”

Eli Lilly;(NYSE:LLY) and AstraZeneca (NYSE:AZN). The former’s solanezumab failed in phase 3 testing back in 2016, while the latter’s lanabecestat also failed to meet its late-stage endpoints, forcing the end of that trial last month.

If there was any company in a position to do what’s been tough to do though, it’s Biogen, but not necessarily with BAN-2401.

Aducanumab Validated
In and of itself, the encouraging news regarding BAN-2401 may not have moved BIIB stock the way it did on Friday. When coupled with similarly convincing results from another, similar Biogen-made Alzheimer’s drug called Aducanumab, however, the trial’s success thus far says Biogen is on the right track.

Aducanumab, like BAN-2401, is an antibody that binds with amyloid beta plaque, preventing it from clogging up brain synapses.

While amyloid beta has long been thought to be the cause of Alzheimer’s, it has never been proven. And, regardless, reducing and/or removing it from the brain has proven enormously difficult.
 




Brexit precautions:

AstraZeneca to stockpile drugs as Brexit 'safety net'
Reuters
July 18, 2018

LONDON (Reuters) - AstraZeneca (AZN.L) is increasing stockpiles of those medicines in Britain and Europe that could be affected by Brexit by around 20 percent, in preparation for potential disruption if the UK crashes out of the EU without a deal.

The move affects drugs made in Britain that could be exported to Europe and supplies in the European Union that may be headed the other way.

A company spokesman said on Wednesday that AstraZeneca currently held several months of supplies of such medicines and this was being increased for products on both sides of the Channel.

AstraZeneca's global external manufacturing head Juliette White told BBC's Newsnight programme on Tuesday that the move was a "safety net" that would increase the amount of finished medicines available to pharmacies and hospitals.

"We always have an additional amount of medicines available. We are increasing that by about 20 percent," she said.

Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU, forcing manufacturers to prepare for duplicate product testing and authorisation to ensure their drugs stay on the market.

More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.

Brexit threatens the free flow of these goods, given stringent medicine regulations that will require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.


AstraZeneca and other drugmakers have long been vocal in their concerns about Brexit and the need for the pharmaceuticals sector to stay within the European regulatory system.

Lawmakers agreed on Tuesday that ministers should seek to secure an agreement that allows Britain to have continued participation in the European medicines regulatory framework, but it remains unclear how this will play out in the broader EU negotiations.
 




Atacand rights sold off in Europe:

AstraZeneca Plc AZN announced that it has sold its European rights to Atacand and Atacand Plus to Cheplapharm Arzneimittel for $210 million. Per the terms of the agreement, AstraZeneca will receive $200 million upon completion of the deal. The company is also eligible to receive another $10 million as time-bound/sales-based milestone payments. However, AstraZeneca will retain all the rights to Atacand and Atacand Plus in the rest of the world." AstraZeneca Plc AZN announced that it has sold its European rights to Atacand and Atacand Plus to Cheplapharm Arzneimittel for $210 million. Per the terms of the agreement, AstraZeneca will receive $200 million upon completion of the deal. The company is also eligible to receive another $10 million as time-bound/sales-based milestone payments. However, AstraZeneca will retain all the rights to Atacand and Atacand Plus in the rest of the world.

The deal is expected to be completed in the third quarter of 2018.

Atacand, a selective, AT1 subtype angiotensin II receptor antagonist blocker (ARB), is prescribed for the treatment of hypertension and heart failure. Atacand Plus, a combination therapy is administered when the monotherapy (Atacand) fails to deliver.

Notably, Atacand was developed in collaboration with Takeda Pharmaceutical Company.

Global product sales for Atacand and Atacand Plus were $300 million in 2017 including $86 million in Europe. However, in the first quarter of 2018, Atacand sales were down 9% to $71 million.

We like to remind investors that lately, AstraZeneca is facing a significant generic competition. Core products like Nexium, Seroquel XR and Crestor are fighting generic rivalry, which is hurting near-term earnings growth. Atacand, Toprol-XL and Merrem are also struggling with the same issue in the United States. The genericization of key products will make it challenging enough for the company to drive its top line.
 




Not so NICE news:

It hasn’t been an easy couple of months for AstraZeneca when it comes to challenging GlaxoSmithKline’s Nucala (mepolizumab) with newcomer Fasenra (benralizumab). And in England, that ambition just took another hit.

The National Institute for Health and Care Excellence (NICE) said in draft guidance that it would recommend the AZ med only under certain conditions—and only in patients who can’t use Nacala.


Why the preference for the GSK drug? It’s simple: price. The cost watchdog acknowledged that there hasn’t been a head-to-head between the two drugs and that an “indirect comparison” of the drugs showed “no difference” in asthma exacerbations. But “compared with mepolizumab, when this is a treatment option, benralizumab is not cost effective and cannot be recommended as an alternative to mepolizumab,” NICE said.
 








Some good oncology news!!

(Reuters) - AstraZeneca's (AZN.L) cancer drug Imfinzi has won a key recommendation from a European Medicines Agency (EMA) panel less than six months after the first global approvals in Western markets.

EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Imfinzi, an immunotherapy drug already boosting sales for the British drugmaker, for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.

While final approvals are up to the European Commission, it generally follows the CHMP's recommendation and endorses them within a couple of months.

The U.S. Food and Drug Administration (FDA) in February granted approval for expanded use of Imfinzi to treat non-small cell lung cancer (NSCLC) patients with inoperable mid-stage disease that has not spread widely around the body.

Japan also approved the drug earlier this month.

The latest green light - which had been expected after positive clinical data last year - gives AstraZeneca a chance to intervene earlier in lung cancer, distinguishing it from rivals that have approval for tackling advanced or metastatic disease.

Globally, about 30 percent of patients with NSCLC present with stage III disease. These individuals typically receive a combination of chemotherapy and radiotherapy, but only around 15 percent of them are still alive after five years.

Imfinzi, chemically known as durvalumab, belongs to a new class of immuno-oncology drugs that block a mechanism tumours use to evade detection from the immune system.

AstraZeneca's drug already had approval for treating certain patients with bladder cancer. However, this market is relatively small.

The really big opportunity for all companies seeking to exploit the power of modern immuno-oncology drugs is lung cancer, since it is the leading cause of cancer deaths.

Bristol-Myers Squibb (BMY.N), Roche (ROG.S) and Merck (MRK.N) all have approved products for treating certain patients with advanced lung cancer - but AstraZeneca is now in a position to carve out a niche in treating earlier stage III patients.
 




Cost of doing business?

AstraZeneca Plc agreed to pay $110 million to settle a Texas claim alleging that the company cheated the state’s Medicaid program by fraudulently marketing two medications, according to the state’s attorney general office.

The deal resolves the suits, which both date to 2013, at a fraction of the $5 billion the state sought. Texas claimed the drugmaker had targeted the state’s Medicaid program by urging doctors to prescribe its antipsychotic drug Seroquel for unapproved treatments, and that it had misrepresented Crestor, a cholesterol fighter, as superior to other statins.

Texas claimed AstraZeneca promoted Seroquel to Medicaid providers who primarily treated children and adolescents when it wasn’t approved as safe or effective for that population. These allegations “are especially disturbing because the well-being of children and the state hospital system were jeopardized,” Texas Attorney General Ken Paxton said in a statement Tuesday.

AstraZeneca is paying $90 million over Seroquel and the rest over Crestor.

“AstraZeneca makes no concessions or admissions of fault in the settlement agreements,’’ the Cambridge, U.K.-based company said in a statement. “While AstraZeneca denies the allegations, it is in the best interests of the company to resolve these matters and to move forward.’’
 




















Cost of doing business?

AstraZeneca Plc agreed to pay $110 million to settle a Texas claim alleging that the company cheated the state’s Medicaid program by fraudulently marketing two medications, according to the state’s attorney general office.

The deal resolves the suits, which both date to 2013, at a fraction of the $5 billion the state sought. Texas claimed the drugmaker had targeted the state’s Medicaid program by urging doctors to prescribe its antipsychotic drug Seroquel for unapproved treatments, and that it had misrepresented Crestor, a cholesterol fighter, as superior to other statins.

Texas claimed AstraZeneca promoted Seroquel to Medicaid providers who primarily treated children and adolescents when it wasn’t approved as safe or effective for that population. These allegations “are especially disturbing because the well-being of children and the state hospital system were jeopardized,” Texas Attorney General Ken Paxton said in a statement Tuesday.

AstraZeneca is paying $90 million over Seroquel and the rest over Crestor.

“AstraZeneca makes no concessions or admissions of fault in the settlement agreements,’’ the Cambridge, U.K.-based company said in a statement. “While AstraZeneca denies the allegations, it is in the best interests of the company to resolve these matters and to move forward.’’

It would be interesting to see an audit of all the millions AZ has paid to ex employees over the years because of faulty terminations, discrimination, or primarily fuck ups by human resource employees in handling investigations or termination proceedings.
 




A good downgrade?

Jefferies Downgrades AstraZeneca, Sees Limited Additional Upside


Wayne Duggan
Benzinga
August 16, 2018

AstraZeneca plc (ADR) (NYSE: AZN) was hit with just such a downgrade."The best kind of analyst downgrade for investors is the one that comes because a stock has performed so well that it has exceeded expectations. On Thursday, AstraZeneca plc (ADR) (NYSE: AZN) was hit with just such a downgrade.

The Thesis

With AstraZeneca stock up 12.5 percent in the past six months, Hilliker said the stock is fairly valued at this point.

Jefferies had upgraded the stock to Buy back in March based on expectations that the company would be able to grow CORE EPS by 20 percent annually from 2020 to 2022 due to new product growth and expanding margins, the analyst said. With the stock up about 22 percent since his Buy call, Hilliker said additional near-term upside is likely limited.

There’s no reason for long-term investors not to like the stock, but without double-digit upside in the near-term, there’s simply no way to justify the Buy rating, he said.

Looking ahead, Hilliker said there are still a number of potential positive catalysts coming in the second half of the year.

“Further catalysts still expected over [the second half of 2018] include: Farxiga PIII DECLARE CV outcomes data, Anifrolumab PIII SLE data and Imfinzi /Treme PIII (KESTREL & EAGLE) data in head & neck cancer."

Price Action

AstraZeneca shares were trading down 0.31 percent at the time of publication Thursday but remain up 31.8 percent overall in the past year.
 




Faslodex coming under generic pressure, will they get an injunction?


British pharma giant AstraZeneca (NYSE: AZN) has filed a second suit last week against a generic drug seller with a big Triangle presence, alleging patent infringement over a treatment targeting breast cancer.

The dispute, according to the complaint, starts with regulatory paperwork filed by Accord Healthcare, an Indian pharma with its U.S. headquarters in Durham.

Accord filed what’s called an Abbreviated New Drug Application (ANDA), part of the documentation required to get Food and Drug Administration approval for new treatments.

Accord filed an ANDA for a cheaper, generic version of an AstraZeneca breast cancer drug known as Faslodex, the suit notes.

But AstraZeneca says its patents on the drug – which it obtained in 2004 - haven’t yet expired.

The patents, according to the suit, expire in 2021.

Accord, according to the complaint, notified AstraZeneca in January that it had submitted an ANDA and that it believed the existing patent claims were invalid. That’s as instructions for the Accord treatment, according to the suit, “substantially copy the instructions for Faslodex.”

AstraZeneca claims Accord should be blocked from seeking FDA approval for its treatment, and that if Accord is allowed to move forward with the drug, AstraZeneca “will be substantially and irreparably harmed by the infringing activities.”

The drugmaker had already filed an amended suit over the same infringement in New Jersey July 25. But, on the chance that Accord “may assert that it is not subject to such jurisdiction,” AstraZeneca filed the identical case in the Middle District of North Carolina Aug. 24.

Attorneys for Accord Healthcare didn’t return a request to comment on the case.

Accord is a subsidiary of Intas Pharmaceuticals.
 




Diabetes news:

AstraZeneca PLC AZN announced that the European Commission has granted approval to Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of its GLP-1 receptor agonist Bydureon in an improved once-weekly, single-dose pre-filled BCise device for treating patients with type-II diabetes (T2D)." AstraZeneca PLC AZN announced that the European Commission has granted approval to Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of its GLP-1 receptor agonist Bydureon in an improved once-weekly, single-dose pre-filled BCise device for treating patients with type-II diabetes (T2D).

The nod was expected as earlier in June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion, recommending marketing approval for the new device. Bydureon BCise was approved in the United States in October last year.

The approval of this new formulation of once-weekly Bydureon will allow the use of the drug as an add-on therapy to basal insulin for treating type II diabetes in patients receiving one or more antidiabetic medicines in addition to diet and exercise and with inadequate glycemic control.

Shares of AstraZeneca have returned 11.9% so far this year, outperforming the industry’s increase of 5%.
 








Lupus trial had bad news:


AstraZeneca Plc’s experimental treatment for lupus failed to meet the goal of a late-stage trial, a blow to the drugmaker’s efforts to develop a therapy for a relatively uncommon disease.

Patients with moderate to severe cases of the disease who got the drug, called anifrolumab, didn’t see a statistically significant reduction in disease activity compared with those who received a placebo in the yearlong study, Cambridge, England-based AstraZeneca said Friday in a statement.

Lupus is a hard-to-treat, sometimes life-threatening condition in which the immune system can attack the kidneys, brain and other organs. Current therapies, such as oral steroids, can have harsh side effects when used over the long term. Astra’s treatment is a monoclonal antibody intended to block the activity of immune-linked inflammation in lupus patients.

“The result of this trial is disappointing for patients and the lupus community,” said Sean Bohen, Astra’s executive vice president for global medicines development, in the statement.

A full evaluation of the data from the trial, called Tulip 1, will be conducted later this year, Astra said.
 












Asthma news:

AstraZeneca AZN and partner Amgen AMGN announced that the FDA granted Breakthrough Therapy designation to their asthma candidate, tezepelumab. Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody being evaluated for the treatment of patients with severe, uncontrolled asthma without an eosinophilic phenotype.

The Breakthrough Therapy designation from the FDA is expected to speed up the development and review of drugs intended to treat serious or life-threatening diseases. AstraZeneca believes that tezepelumab has the potential to treat a broad population of severe asthma patients including those who cannot be treated with presently marketed biologic therapies.

The Breakthrough Therapy designation was supported by the data from the tezepelumab phase IIb PATHWAY study. The data showed that tezepelumab reduced the annual asthma exacerbation rate (“AAER”), a measure of deterioration of asthma,compared with placeboin patients with severe, uncontrolled asthma.

The PATHWAY study compared three doses of the candidate — 70 mg or 210 mg every four weeks or 280 mg every two weeks — to a placebo. Tezepelumab was administered as an add-on therapy in patients who have experienced asthma exacerbations
 




Similar threads