AZ News from the Street 2015

Sorry, you're not a lawyer and you don't have a chance. If a doctor prescribes a beta blocker when a beta blocker is indicated it doesn't really matter which beta blocker unless it is contraindicated. The FDA does not judge superiority, only safety and efficacy.

But of course a lawyer can file suit, literally, because the doctor was wearing a white coat and there is a known white coat syndrome.

Hell a lawyer sued an RV company for failing to warn the driver that it is unsafe to get up out of the driver's seat while on the highway traveling at 50MPH. This driver left the wheel, the RV crashed, and the plaintiff WON.

So in your opinion, does that mean the RV manufacturer was negligent?

 

Oh, and I'm sure you're a lawyer, NOT.

In your cited case, YES, the RV manufacturer WAS found negligent, like it or not.

You have no idea what you are talking about. For potentially deadly effects like clots and bleeds, someone sure could be held liable for negligence. There is often partial liability assigned in many cases, and the deep pockets end up paying up.

 

I asked a direct question, here it is again:

"So in your opinion, does that mean the RV manufacturer was negligent?"

and your answer was:

"In your cited case, YES, the RV manufacturer WAS found negligent, like it or not."


What are you, running for office? You can't understand a simple question?
Based on the notion that it is a waste of time to argue with an idiot, I am resigning from the conversation.

 

Do you always call people idiots when you lose an argument?

 

Drug makers receive mysterious invites to White House

Meg Tirrell

The heads of research at several large drugmakers have received mysterious invitations to the White House for a meeting Friday morning, where more details are expected to be shared on President Barack Obama's plans for the "precision medicine" initiative he mentioned in his State of the Union address.

Vertex, Regeneron and Merck have all received invitations from the Office of Science and Technology Policy, asking for their top researchers to attend the event.

The White House didn't immediately respond to a request for more information.

The president briefly mentioned the "precision medicine" initiative in his Jan. 20 address, prompting questions about what it will entail and how much funding it could bring to medical research and drug development.

"Tonight, I'm launching a new precision medicine initiative to bring us closer to curing diseases like cancer and diabetes—and to give all of us access to the personalized information we need to keep ourselves and our families healthier," Obama said in his address.

"21st century businesses will rely on American science, technology, research and development," he said. "I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable."

 

New competitor diabetes drug is now available in the US:



Sanofi and MannKind Announce Afrezza®, the Only Inhaled Insulin, Now Available in the U.S.

PR Newswire
Sanofi and MannKind Corporation 4 hours ago

PARIS and VALENCIA, Calif., Feb. 3, 2015 /PRNewswire/ -- Sanofi and MannKind Corporation announced today that Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in U.S. retail pharmacies nationwide. Afrezza is approved by the U.S. Food and Drug Administration to control high blood sugar in adults with type 1 and type 2 diabetes.

"Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now they have another option to administer insulin that is not an injection," said Dr. Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine in St. Louis and Afrezza clinical trial investigator. "This delivery option may help change the dialogue between health care professionals and people living with diabetes about initiating or intensifying insulin therapy."

Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal.

Afrezza can help control high blood sugar as part of a diabetes management plan that may include diet, exercise and other diabetes medications. Afrezza should not be used in patients with chronic lung disease such as asthma or COPD. Afrezza cannot be used to treat diabetic ketoacidosis. Afrezza is not recommended in patients who smoke or who have recently stopped smoking.

"Afrezza is an important addition to Sanofi's growing diabetes portfolio of integrated, personalized offerings, and it is one that highlights our dedication to bringing innovative therapies to people with this disease," said Pierre Chancel, Senior Vice President Diabetes Division, Sanofi. "There is a recognized need for an insulin that doesn't require an injection, and our organization is committed to making this new treatment option available to patients."

"We are extremely proud to see the many years of work that went into developing Afrezza culminate in the day when it is now available to help people manage their diabetes," stated Alfred Mann, Executive Chairman, MannKind Corporation.

About Afrezza
Afrezza is a rapid-acting, inhaled insulin used to control high blood sugar in adults with type 1 and type 2 diabetes. The product consists of a dry formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12–15 minutes of administration. Afrezza is available in 4-unit and 8-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 8 units, patients may use a combination of 4 unit and 8 unit cartridges. Other sizes of cartridges are being considered. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.

 

Pfizer is definitely off the table for an AZ merger deal now. Biosimilar drugs is the deal driver.



Pfizer to Buy Hospira in Deal Valued at About $17 Billion

(Bloomberg) -- Pfizer Inc. agreed to buy Hospira Inc., the biggest provider of injectable drugs, in a transaction valued at about $17 billion, adding an array of medicines and boosting its efforts to develop copies of biological drugs.

Pfizer will pay $90 a share in cash, the New York-based drugmaker said today in a statement, a 39 percent premium to Lake Forest, Illinois-based Hospira’s closing price Feb. 4.

Pfizer has been looking to make an acquisition after a failed $120 billion bid for AstraZeneca Plc last year in what would have been the industry’s biggest-ever takeover. Buying Hospira will add a broad range of generic sterile injectable medicines to Pfizer’s portfolio and assist the company’s strategy to offer more biosimilar drugs.

“It’s all about fattening up the established pharma business,” said Sam Fazeli, an analyst at Bloomberg Intelligence in London. “This way they can get the established products into a much larger organization and potentially spin that off.”

Hospira and South Korean partner Celltrion Inc. developed a biosimilar copy of Johnson & Johnson’s Remicade, a $7-billion arthritis therapy, that was approved by European regulators in June 2013. Remicade is losing patent protection in several European markets this year.

Pfizer has been seeking its next blockbuster after a series of patent expirations. The company’s sales have been falling from a $67.1 billion peak in 2010, the year after the drugmaker acquired Wyeth in a transaction valued at more than $60 billion.
Enhanced Portfolio

Pfizer “will benefit from a significantly enhanced product portfolio in growing markets,” Ian Read, the company’s chairman and chief executive officer, said in the statement.

The global market for generic sterile injectables is expected to reach $70 billion in 2020, Pfizer said, while the market for biosimilars may be $20 billion by that time.

The transaction will be financed two-thirds in cash, and one-third from new debt, Pfizer said. It should deliver $800 million in annual cost savings by 2018, according to the company.

The purchase will immediately add to Pfizer’s earnings, with a gain of 10 cents to 12 cents predicted in the first full year after completion, Pfizer said. The deal is expected to close in the second half of the year.

 

AstraZeneca to buy Actavis lung drugs as earnings fall short
Reuters
5 hours ago

By Ben Hirschler

LONDON, Feb 5 (Reuters) - AstraZeneca said on Thursday it would buy Actavis' branded respiratory drug business in the United States and Canada for an initial $600 million as it reported disappointing fourth-quarter earnings.

AstraZeneca, which is seeking such deals to drive growth, will also pay another $100 million after Actavis agreed to changes in ongoing collaborations between the two firms.

Britain's second-biggest drugmaker said 2015 sales would decline by a mid single-digit percent at constant exchange rates.

But adjusted or "core" earnings per share (EPS) are forecast to increase by a low single-digit percent this year, due to lower spending and plans to find partners on certain projects.

"We'll behave as a biotech company would when it comes to products that are not core," Chief Executive Pascal Soriot told reporters, citing a recent Alzheimer's deal with Eli Lilly as a model for future cost-sharing.

The weak quarterly results knocked the shares back 1.9 percent by 1110 GMT.

Citi analyst Andrew Baum said AstraZeneca appeared to have "kitchen-sinked" the quarter, or taken a deliberate hit to earnings by bringing forward some drug development costs. Deutsche's Mark Clark said this should help secure 2015 profits.

The group, which fended off a $118 billion bid by Pfizer last year, saw sales in the fourth quarter fall 2 percent to $6.68 billion, generating core earnings down 38 percent at 76 cents a share.

Industry analysts had on average forecast sales of $6.79 billion and earnings of 82 cents, according to Thomson Reuters.

Buying the Actavis respiratory drugs builds on AstraZeneca's acquisition of Almirall's lung drugs last July and gives it global rights to inhaled medicines containing aclidinium, which helps open airways. Actavis had owned North American rights under an earlier agreement with Almirall.

Respiratory is a key therapeutic area for AstraZeneca, which has predicted a 75 percent jump in annual sales to $45 billion by 2023.

"We are on track to return to growth by 2017 and are well positioned to deliver our long-term goals," Soriot said.

AstraZeneca's promising cancer drugs have won over many investors but it faces near-term profit pressure from loss of exclusivity on older drugs, with the arrival of generic copies of heartburn and ulcer medicine Nexium in the United States a big challenge in 2015.

After reporting core 2014 EPS of $4.28, Soriot and his team have good reason to ensure earnings hold up this year, since management incentives only vest fully if earnings remain at or above $4.20.

(Editing by David Holmes, Jane Merriman and Susan Thomas)

 

Last updated: February 5, 2015 6:42 pm
AstraZeneca / Sanofi: inversion
Given their numbers, the groups’ valuations look puzzling

It looks upside down. Two big European pharma groups reported 2014 results on Thursday. AstraZeneca clocked in with a 3 per cent rise in sales for the year but — even excluding a pile of one-off costs — net profit was down 8 per cent. It told investors to expect falling sales, and modest earnings growth, in 2015. This excludes the impact of currency which, at the pound’s current level, will probably worsen the sales decline and wipe out the earnings growth.

Then there is Sanofi, which expanded sales by 5 per cent and earnings by 7 per cent, and also sees modest earnings growth this year — but, at the current level of the euro, will receive a currency boost. Analysts expect Sanofi’s growth to accelerate in 2016 and 2017; it has a diverse portfolio with slow, consistent growers such as insulin; hard to copy treatments for rare diseases; and vaccines. Analysts expect declines in revenues and profits in those years at AstraZeneca, which will face generic competition for US Nexium (7 per cent of total sales) imminently, and for US Crestor (11 per cent of sales) next year.

Which company trades at a higher valuation? The one that is set to shrink. AstraZeneca trades at 17 times this year’s expected earnings; Sanofi at 16. For several years the difference in valuation went the other way — Sanofi has been outgrowing Astra for some time. The relationship inverted at the beginning of last year.

Perhaps there is some expectation, following Pfizer’s bid last year, that AstraZeneca will be bought. Thursday’s news that Pfizer has bought Hospira for $17bn, and that AstraZeneca has spent $600m on respiratory drugs, should put an end to these hopes.
Lex

The other explanation is that AstraZeneca’s growth will be strong a few years further out. This depends on the immuno-oncology drugs in its pipeline selling as well as it hopes. No drug class creates more excitement. Roche, Bristol-Myers Squibb and Merck are also active in the space.

Investors at ease making guesses about cancer treatment may feel at ease paying up for AstraZeneca. Those who like their pharma stocks defensive will stick with Sanofi

 

You can always buy puts.

 

AstraZeneca Lags Q4 Earnings, to Boost Respiratory Portfolio
By Zacks Equity Research 1 hour ago

AstraZeneca (AZN) reported fourth-quarter 2014 core earnings of 76 cents per American Depositary Share (ADS) that missed the Zacks Consensus Estimate by 8 cents. Earnings were down 28% (at constant exchange rates or CER) year over year due to higher expenses.

AstraZeneca’s fourth-quarter revenues increased 2% (at CER) year over year to $6.7 billion. Revenues were in line with the Zacks Consensus Estimate. Strong performance at key growth platforms (Brilinta, diabetes, respiratory and Emerging Markets) benefited revenues.

The company reported 2014 core earnings of $4.28 per ADS, down 8% year over year at CER. Earnings also missed the Zacks Consensus Estimate of $4.34. Revenues in 2014 were up 3% year over year at CER to $26.1 billion. Revenues were below the Zacks Consensus Estimate of $26.2 billion.

Along with its financial results for the fourth quarter of 2014, the company also announced that it will be acquiring the U.S. and Canadian rights to Actavis’ (ACT) branded respiratory business for $600 million. AstraZeneca will also be paying low single-digit royalties above a certain revenue target. The deal is expected to close in the first quarter of 2015.

All growth rates mentioned below are on a year-on-year basis and at CER.

The Quarter in Detail

U.S. revenues remained flat year over year in the fourth quarter at $2.6 billion. The company’s key growth platforms performed well in this area however the increase was offset by the impact of completion of the acquisition of Bristol-Myers Squibb Company’s (BMY) share of the global diabetes alliance.

European markets sales were also flat year over year, with generic erosion (loss of exclusivity of Seroquel XR and Atacand) completely offsetting the impact of the inclusion of diabetes revenues and Brilinta (EU trade name: Brilique). Established RoW revenues were down 8%. Revenues were hurt by generic competition of oncology products and inventory depletion of Seroquel IR in Japan. Revenues in Japan decreased 9%.

Nexium, which generated 14% of AstraZeneca’s total revenues in 2014, is expected to face generic competition soon.

We are impressed with the performance of drugs such as Onglyza (up 122% to $200 million), Symbicort (up 5% to $978 million), Bydureon (up 153% to $123 million), Byetta (up 31% to $69 million), Pulmicort (up 15% to $269 million) and FluMist (up 170% to $134 million).

Sales from Brilinta, a key area of focus, were $133 million in the reported quarter, up 52% year over year. Brilinta performed well in Europe and Emerging Markets.

Other Details

AstraZeneca’s core gross margin was down 0.6 percentage points to 79.7% in the fourth quarter of 2014. Core selling, general and administrative (SG&A) expenses increased 23% to $2.9 billion, primarily due to investments in the company’s growth platforms.

During the quarter, core research and development expenses increased 17% to $1.4 billion, reflecting higher investments in pipeline.

2015 Outlook

AstraZeneca expects revenues to increase in the mid single-digit percentage range in 2015. The 2015 Zacks Consensus Estimate currently stands at $24.6 billion. The company’s guidance assumes the launch of Nexium generics in the U.S. soon.

The company expects core earnings to increase in the low single-digit percentage range in 2015. The 2015 Zacks Consensus Estimate is at $4.20 per share.

Our Take

We are encouraged by the company’s plans to boost it respiratory business. AstraZeneca’s respiratory portfolio is one of the key growth platforms at the company. The segment has performed encouragingly in 2014. The addition of Actavis’ branded respiratory business will drive growth further.

Meanwhile, AstraZeneca’s fourth-quarter results were disappointing with earnings missing our expectation. The company’s near-term threat is that of Nexium going generic. Generic competition has adversely impacted AstraZeneca’s revenues over the past few quarters and is expected to do so in the coming quarters too. This has put significant pressure on the company.

We are nonetheless encouraged by the recent approvals at AstraZeneca. The EU approvals of Duaklir Genuair (chronic obstructive pulmonary disease), Lynparza (ovarian cancer) and Movantik (opioid-induced constipation) were major milestones for the company. Lynparza was also approved in the U.S. These new product approvals will boost the top line, thereby driving growth.

AstraZeneca is also working on its pipeline to boost its product portfolio. The company currently has 133 programs in its pipeline, of which 118 are in the clinic.

 

This is all kool aid. The financial experts who invest $billions in biotech and pharma are dumping their AZ shares faster than shit through a goose. So they aren't buying this bullshit propaganda.

 

AstraZeneca agrees to pay $7.9M to settle kickback allegations
Feb 11, 2015, 4:07pm EST

AstraZeneca has agreed to pay $7.9 million to the government to settle allegations the company violated anti-kickback rules.

AstraZeneca agreed to pay the government $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act.

The settlement with the Justice Department resolves allegations that AstraZeneca (NYSE: AZN) agreed to provide unspecified "renumerations" to Medco Health Solutions, a pharmacy benefit manager, in exchange for Medco maintaining Nexium's "sole and exclusive" status on certain Medco formularies. ( Formularies are lists of prescription drugs covered by a particular drug benefit plans.)

Nexium is AstraZeneca's branded medicine use to treat gastroesophageal reflux disease (GERD) and other stomach conditions. Nexium generated sales of just under $3.9 billion for AstraZeneca in 2013. Sales figures for 2014 are not yet available.

AstraZeneca, which is based in London and has its U.S. headquarters in Wilmington, Del., admitted to no wrongdoing under the terms of the settlement.

"It is in the best interest of the company to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation," the company said in a statement.

The United States alleged that AstraZeneca provided some or all of the remuneration to Medco through price concessions on drugs other than Nexium, namely on its GERD drug Prilosec and its high blood pressure medicines Toprol XL and Plendil. The United States contended that this kickback arrangement between AstraZeneca and Medco violated the federal Anti-Kickback Statute.

This civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. The lawsuit was filed by former AstraZeneca employees Paul DiMattia and F. Folger Tuggle, who will collectively receive $1,422,000

 

AstraZeneca's patent on asthma drug invalidated by U.S. court
Reuters
19 hours ago

NEW YORK, Feb 15 (Reuters) - A U.S. federal judge ruled late on Friday that AstraZeneca PLC's patent on its Pulmicort Repsules treatment for asthma was invalid, opening up the market to a second, cheaper generic version.

Actavis Plc said that the U.S. District Court for the District of New Jersey ruling prompted it to release a generic version of the lung drug. Another generic version of Pulmicort Respules from Teva Pharmaceutical Industries, under a previous agreement with AstraZeneca, has been on the market for some time.

Total branded and generic sales of Pulmicort over the twelve months ended June 30, 2014 were approximately $1.1 billion, according to Actavis.

Paul Hudson, president of AstraZeneca's U.S. operations, said that the company strongly disagreed with the court's decision and that it is considering legal options, including an appeal.

In April 2013, the U.S. District Court for the District of New Jersey invalidated AstraZeneca's patent on its Pulmicort treatment, but that ruling was reversed and remanded in October 2013 by the U.S. Court of Appeals for the Federal Circuit.

AstraZeneca said the decision would not have an impact on its 2015 guidance of a mid single-digits percent decline in sales revenue and a low single-digit percent gain in core earnings per share, assuming currency exchange rates remain constant.

 

Did AZ miss the boat?


Rigel Pharma CEO pulls back the curtain on drug deal with Bristol-Myers
Feb 26, 2015, 6:34am PST Updated: Feb 26, 2015, 9:44am PST

Rigel Pharmaceuticals Inc. has fallen short of the finish line in a couple of highly spectacular instances.

First, there was the drug fostamatinib, which in 2012 failed in a late-stage trial by AstraZeneca plc (NYSE: AZN) as a potential rheumatoid arthritis treatment. Then an experimental treatment for lupus patients failed a mid-stage trial and the company killed an asthma program after another failed Phase II trial.

But while the South San Francisco company (NASDAQ: RIGL) refocuses fostamatinib in a blood platelet-destroying bleeding disorder known as immune thrombocytic purpura, or ITP, on Monday it snagged a potential $339 million partnership with Bristol-Myers Squibb Co. (NYSE: BMY).

The deal was a surprise to many because Rigel had said nothing about the deal's centerpiece, small molecules that block a protein known as TGF beta, or transforming growth factor. TGF beta is believed to play a role in a variety of conditions, but BMS zeroed in quickly on the potential role Rigel's molecules could have in the emerging field of immuno-oncology.

By blocking TGF beta, the companies believe, a door can be opened that allows the immune system to more-easily seek out and destroy cancer cells. That process could boost the power of BMS's immunotherapy drugs, including those picked up in a $1.2 billion acquisition Monday for San Carlos' Flexus Biosciences Inc.

Rigel will receive $30 million upfront from BMS and be eligible to get milestone payments totaling more than $309 million

The news led to a breakout day for Rigel's stock, which climbed 53 percent from Friday's close to $3.91. Although the stock eventually settled back to $3.23 (under its $3.66 opening price), it traded at more than 20 times its average daily three-month volume and returned the South San Francisco company to their radars.

That interest, of course, can be a double-edge sword, but Rigel CEO Raul Rodriguez said the deal gives the company an opportunity to tell investors more about its story during a year of transition.

Rodriguez, a triathlete who was promoted in November from president and COO, gives his thoughts on the 140-employee company's new deal, its high-profile sublease tenant and drug development's long run.

How'd this deal with BMS come together?

At the BIO [Biotechnology Industry Organization] meeting in June — that was the first time. Then it went slowly in the next three months and kicked into a higher gear in the last quarter of last year. We've been talking in earnest since October.

We see you companies disappear behind the curtains of those one-on-one sessions at conferences. How did that work here? Do you lay out the whole portfolio to BMS and they picked what was relevant?

We knew where the areas of interest were and that they were working in immuno-oncology.

The temptation is to talk about five different programs, but you have 30 minutes behind the confessionals and you may have eight, 10, 15 meetings a day in a row, so if you focus on one thing, that actually helps a great deal.

It also helps if you have a company on the other side actually interested in immuno-oncology, in this case, and interested in new programs.

What's exciting about these small molecules?

TGF is an older target. People have looked at it in a variety of different areas. Lilly pursued it as a molecule in oncology and worked it into the clinic and had good clinical results at the last ASCO [American Society of Clinical Oncology] meeting.

We had been working on this as part of a broader family of (the protein) GDF-8 — a muscle target — but we also had been working on TGF beta and had many hundreds of compounds. When we saw the Lilly results, we decided it was a good time to focus on pour molecules to show that our molecules had potential as immuno-oncology assets.

We felt we had taken this as far as we can. … We talked to a number of potential partners, but BMS is really the best partner for this asset.

BMS takes it through the clinic with Rigel. That should take close to two years. They will move everything from preclinical to into the clinic. They have all the antibodies and potential combination products. With Flexus, they have additional target assets for combination.

So what's the role of TGF-beta in immune-oncology?

TGF-beta is the mechanism by which the immune system, or the T cell approaches, are down-regulated in the cancer microenvironment. When you inhibit TGF beta signaling, you allow the immune system to more-readily detect tumor cells and destroy them.

In mouse studies, we've been able to show that we can improve tumor outcomes in those animals.

Cancer immunotherapy is hot. Did you initially see this as an immuno-oncology drug or shift it into that silo?

We had been working on the muscle side. We knew Lilly was in the clinic and we saw the potential utility. When we saw (Lilly's ASCO presentation), we needed to do the studies in animals, but you could actually run parallel studies.

You have to know which assets you have and the potential of those assets. Overall, Rigel has a lot of focus on immunology and that helps and we've done six, seven — maybe eight — deals in oncology, counting this one.

There are very strong immunology and oncology applications. The mechanisms are very much overlapping. We're very well attuned to this. Luck favors the prepared mind.

What does having a $30 million check in the mail mean for Rigel today?

It actually helps a great deal. It's a sign that a company that knows this (cancer) area very well values the program.

We've been working on this program for a while.

Financially, this puts Rigel on a cash position well into 2017. That's very comfortable. We are expecting ITP Phase III results (with fostamatinib) in the first quarter 2016, so that gives us more than 12 months of cash after the first ITP Phase III readout.

So where does fostamatinib sit in the portfolio now?

AstraZeneca was primarily in rheumatoid arthritis and in a very large Phase III trial, the product worked very well — just not well enough to be competitive.

We have a large product safety database as a result, so when we got (fostamatinib) back, we looked at the range of opportunities with the molecule. When we looked at ITP, it's an attractive niche market. There's still a substantial medical need for new products. Fostamatinib has a very different mechanism of action. We thought it was an attractive market opportunity.

The Phase III program is 150 patents in total — very doable — looking at platelet counts, raising from 30,000 platelets to more than 50,000. It's a very objective endpoint, which we like. Basically, we could look at how other companies had done their trial and basically copy the trial protocol.

If we're successful, we could have a product that's actually very attractive and for a very small amount of infrastructure, commercialize it in the U.S. ourselves.

Our objective now is to get to the finish line. We believe we can do that. We are working on the NDA (new drug application for the Food and Drug Administration), and we are very much ready to slot in the clinical results when we get there and, hopefully, file our first NDA. That's an exciting milestone for the company because companies with commercial products are valued very differently.

At the J.P. Morgan Healthcare Conference last month, you called 2015 a "transition year." What kind of feedback have you gotten from shareholders who may be tired of waiting?

In general, the feedback has been very positive. The argument of having Phase III results in another year was very well received. They appreciate the significant step up in valuations at that point. Already there's a higher level of interest in the company.

There wasn't much pushback about this being a year away, because a year in this industry isn't very long. To get from an IND-stage company to a commercial-stage company and the potential for this opportunity, this was very well received.

We've already had a bit of discussion last year at our analyst day discussing ITP. For AstraZeneca, ITP is just not large enough; for a company like Rigel, a product like this is very attractive. The two competing products (Amgen Inc.'s Nplate and GlaxoSmithKline's Promacta) sell over $800 million a year.

 

AstraZeneca to carve out antibiotic R&D into separate firm
Reuters
7 hours ago

By Ben Hirschler

LONDON, Feb 27 (Reuters) - Drugmaker AstraZeneca has decided to carve out its early-stage antibiotic research by creating a stand-alone subsidiary company, as it sharpens its focus on other therapy areas.

Chief Executive Pascal Soriot said last year he was looking to partner or sell its anti-infective business, which is no longer viewed as a core area for the British drugmaker.

AstraZeneca said in an emailed statement it would invest $40 million in the new antibiotic company, which will include early-stage products such as a drug in Phase II for gonorrhoea. The move will impact approximately 95 employees based in Waltham, Massachusetts.

The new structure has no impact on anti-infective products already on the market, including Merrem, Zinforo, Fluenz/Flumist and Synagis. It also does not affect Avycaz, a new antibiotic approved this week from Actavis, which was co-developed with AstraZeneca.

Antibiotics have fallen out of favour in the past decade among many Big Pharma companies, because of their typically low margins. The industry has focused instead on more profitable areas, like cancer.

More recently some companies have started coming back to the space, given the demand for novel medicines that can fight drug-resistant superbugs, with Merck & Co agreeing to buy Cubist for $8.4 billion in December.

But AstraZeneca prefers to deploy its resources on its three priority areas of oncology; cardiovascular and metabolic diseases; and respiratory and inflammation.

The decision to carve-out early-stage antibiotics fits with Soriot's aim of doing more so-called "externalisation", involving the sale of non-core drugs, both to increase the company's focus and generate additional income to see it through a tough period of patient expiries on older drugs.

Last year it struck a partnership deal worth up to $500 million for Alzheimer's treatment with Eli Lilly, which could be a model for further transactions.

 

Business as usual for AZ--the most unethical pharma company on the planet.

 

AstraZeneca Heart Drug Proves Worthy, Elevating Sales Potential


(Bloomberg) -- AstraZeneca Plc’s Brilinta reduces the risk of death from heart attack or stroke long after an initial attack, according to research that may bring billions of dollars to the company as more people use the drug for extended periods.

The anti-clotting medicine also was shown to work without causing an unacceptable level of bleeding, a key issue for blood thinners, the study team announced today at the American College of Cardiology’s annual meeting in San Diego.

Patients now receive drugs such as Brilinta, combined with aspirin, for about a year after a heart attack, then switch to aspirin alone. In the latest trial, patients who took Brilinta, also known as ticagrelor, and aspirin for an average of 33 months after their heart attack had a reduction in serious cardiovascular events of about 15 percent, without excess side effects.

“In my practice, I would start a patient when they came in with a heart attack and I would keep them on ticagrelor long-term as long as they are tolerating it,” Marc Sabatine, the lead investigator on the study, said in an interview. “These data support the notion you should continue ticagrelor indefinitely.”

The results bolster AstraZeneca’s claims for the drug, which it predicts will bring in annual sales of $3.5 billion by 2023, based on expanded use for heart attack patients as well as moving into additional disease areas such as stroke and diabetes. Brilinta, which is sold as Brilique in Europe, had sales of $476 million in 2014.
Unlocking Potential

“The study should be a major driver for treatment duration and thus finally unlock Brilinta’s multibillion-dollar potential,” Alexandra Hauber, an analyst at UBS AG, said in a note to investors before the trial results were announced. The expanded patient population created by the recent study could add $2.5 billion in sales, she said.

The risk of bleeding did increase, to about 2.5 percent for patients taking Brilinta compared to 1 percent for those taking a placebo, said Sabatine, a cardiologist at Brigham and Women’s Hospital in Boston.

“As expected with a blood thinner, we observed an increase of bleeding, but there was no excess of fatal bleeding or bleeding into the brain,” he said in a statement announcing the findings.

AstraZeneca, the U.K’s second-biggest drugmaker, reported preliminary results of the study in January.
Generic Competitor

The company has struggled to gain acceptance for Brilinta from cardiologists since the drug was introduced in 2011, in part because of the success of clopidogrel, an anti-platelet sold as Plavix and now available as a generic. Clopidogrel costs about $12 a month, compared to about $270 for Brilinta.

The new study only tested Brilinta for use beyond a year, so doctors don’t have evidence that clopidogrel provides the same benefit. But the rival medicine may get prescribed for the new indication anyway, which would dent Brilinta’s advantage, Tim Anderson, an analyst at Sanford C. Bernstein, said in a note.

A recent analysis showed that in the U.S., generic Plavix is already being prescribed for longer periods in 20 percent of patients similar to those in the Brilinta study, he said.

The Brilinta trial, dubbed Pegasus, involved more than 21,000 patients who had suffered a heart attack. Some were given the drug twice daily in a 90 milligram dose, while others got 60 milligrams twice a day or a placebo. All took low-dose aspirin.

For Additional News and Information: AstraZeneca Earnings Miss Estimates as Sales of Drugs Slip Stakes High for AstraZeneca Heart Drug Facing Tough Competition AstraZeneca’s Soriot Asks for Patience as Pfizer Return Looms

 

Another me too for respiratory franchise:

AstraZeneca two-in-one drug succeeds in lung disease test
Reuters
10 hours ago

LONDON, March 18 (Reuters) - AstraZeneca said on Wednesday its experimental lung drug PT003 for chronic lung disease had proved successful in two final-stage Phase III trials, boosting hopes for the company's respiratory pipeline.

The drug, which AstraZeneca acquired after buying Pearl Therapeutics two years ago, combines a long-acting beta-2 agonist (LABA) and a long-acting muscarine antagonist (LAMA). AstraZeneca plans to file PT003 for approval commencing in 2015.

Rival firms also have LAMA/LABA drugs that are more advanced than PT003, but AstraZeneca's drug is administered with a pressurised meter-dose inhaler instead of a dry-powder inhaler, which may suit elderly patients in particular.

 

This is going to improve patient's lives. I say it should cost at least $300.00 per month.