AZ News from the Street 2015

These are not good numbers:


AstraZeneca's Onglyza Briefing Documents Raise Concern
By Zacks Equity Research
19 hours ago

AstraZeneca plc AZN received disappointing news with the FDA raising concerns related to the company’s diabetes drug, Onglyza (saxagliptin), in its briefing documents ahead of the review by its Endocrinologic and Metabolic Drugs Advisory Committee meeting. The FDA panel is scheduled to review the supplemental new drug application for Onglyza and Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets on Apr 14.

In its briefing documents, the FDA noted that patients when treated with Onglyza experienced a 27% increase in the risk of hospitalization due to heart failure as compared to placebo. Moreover, patients demonstrated a significant or near-significant increase in the risk of death from all causes.

AstraZeneca is looking to seek cardiovascular (CV) superiority to determine if treatment with Onglyza compared to placebo when added to current background therapy would result in a reduction in the composite endpoint of CV death, nonfatal myocardial infarction or non-fatal ischemic stroke. As per the briefing documents, Onglyza failed to achieve CV benefit compared to placebo.

These results were observed from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study, conducted in type II diabetes patients with established CV disease or at a high risk of CV disease.

Onglyza was approved by the FDA in 2009 as an adjunct to diet and exercise to improve glycemic control in adults suffering from type II diabetes. The drug generated global sales of $820 million in 2014, reflecting an increase of 119% at constant exchange rate.

We remind investors that AstraZeneca boosted its diabetes portfolio by acquiring Bristol-Myers Squibb’s BMY global diabetes business in Feb 2014 thereby gaining rights to major diabetes products including Onglyza and Kombiglyze XR/Komboglyze among others.

The latest news is a disappointment considering that Onglyza is the company’s main diabetes product. Among currently prescribed treatments for type II diabetes is Merck’s MRK Januvia.

 

FDA now wants a label change on Onglyza:


Tue, Apr 14, 2015, 4:02pm EDT
FDA panel wants heart failure risk on AstraZeneca drugs

FDA advisers say AstraZeneca diabetes drug label should bear warning of heart failure risk
Associated Press
By Matthew Perrone, AP Health Writer
56 minutes ago

WASHINGTON (AP) -- Federal health advisers say AstraZeneca's Onglyza and a related diabetes drug should carry new information about a possible association with heart failure and death.

The Food and Drug Administration's panel of diabetes experts voiced concern about data suggesting Onglyza and Kombiglyze can increase hospitalization due to heart failure and overall mortality. The panel voted 14-1 that that information should appear on the drugs' prescribing labeling. Yet the panelists also said complicating factors make it difficult to tell whether the risk is real or a statistical fluke.

Considering the drug's overall benefits for treating diabetes, the panel voted 13-1, with one abstention, that the drugs' heart safety profile was acceptable.

The FDA convened Tuesday's meeting to review data from a 16,000-patient study looking at Onglyza and Kombiglyze's heart safety. The agency began requiring such studies in 2008 after several high-profile safety controversies involving diabetes medications and links to heart attack. But pinpointing the heart impacts of diabetes drugs is difficult, because people with the disease are already predisposed to heart problems and other risks.

AstraZeneca's study did not show links to heart attack, but did show a higher rate of heart failure, in which the heart doesn't pump enough blood to maintain blood flow. Six percent of patients taking AstraZeneca's drugs were hospitalized for heart failure or died of heart-related complications, compared with 5.3 percent of patients taking a placebo. And when FDA scientists analyzed the company data, they found patients taking the drugs had a slightly higher overall chance of dying during the study.

However, panelists had difficulty interpreting the seriousness of the findings. AstraZeneca's study was not especially designed to measure heart failure, instead focusing on heart attack and stroke. And patients enrolled in the study were already predisposed to have heart problems, raising questions about the applicability of the findings to all patients taking AstraZeneca's diabetes drugs.

Some panelists said further studies are needed.

"I don't feel we have resolved concerns about cardiovascular risk," said Dr. Robert Smith, a professor at Brown University, who chaired the FDA panel.

The FDA is not required to follow the guidance of its panelists, though it often does.

Onglyza and Kombiglyze are part of a recently-developed class of diabetes drugs called DPP-4 inhibitors, which also includes Merck & Co.'s Januvia and Tradjenta, made by Eli Lilly & Co. and Boehringer Ingelheim.

The drugs work by making the body produce more insulin after meals, to reduce levels of glucose in the blood, and by limiting the amount of glucose made by the liver.

Merck is expected to release results from its own large study of Januvia's heart risks in coming months.

Leerink Swann analyst Seamus Fernandez said in a recent investment note that if Merck's drug is clear of heart risks it could cut sales of AstraZeneca's diabetes drugs by 50 percent. Fernandez estimates peak sales for Onglyza and Kombiglyze of $1.8 billion.

Those drugs had U.S. sales of $265 million in 2013, according to London-based AstraZeneca's most recent annual report.

 

The PR machine in action?


AstraZeneca science is on the move, one year on from Pfizer bid
Reuters
1 hour ago

By Ben Hirschler

LONDON, April 15 (Reuters) - Having seen off a hostile $118 billion bid launched a year ago by U.S. rival Pfizer, Anglo-Swedish company AstraZeneca is on the move -- quite literally.

As of last month, a four-days-a-week service set up by the drugmaker with Sun Air is connecting staff in its new Cambridge science and operations hub with those in Gothenburg, the group's other major European centre.

Chief Executive Pascal Soriot is making AstraZeneca more nimble as hopes build for its cancer pipeline, but he still has his work cut out to keep 2015 earnings above the floor needed to protect his bonus.

Investors must balance the short-term challenges posed by a massive "cliff" of patent expiries for older drugs against AstraZeneca's long-term promise that sales can reach $45 billion in 2023 from $26 billion last year.

So far, Frenchman Soriot has played his hand well, given the inevitable disappointment among some shareholders at the rejection of Pfizer's final 55 pound-a-share offer last year. Even though many analysts view the $45 billion sales target as a stretch, the stock is now back above 48 pounds.

Stephen Lamacraft, fund manager at Woodford Investment Management, thinks the price rise is fully justified given the pipeline progress in the last 12 months, especially in cancer.

"The merits of its immuno-oncology assets are well known but still undervalued, while there are still some relatively unknown drugs such as roxadustat - an oral product to treat anaemia - that could provide material upside," he said.

Woodford, a staunch opponent of Pfizer's bid, has made a big bet on Soriot delivering, since AstraZeneca makes up an outsized 7.5 percent of its Equity Income fund.

AstraZeneca faces tough competition in the market for hot new cancer treatments that boost the immune system, and it is behind Bristol-Myers Squibb and Merck & Co, which already have drugs on the market.

Yet Jefferies analysts argue it is effectively ahead of rivals when it comes to the big commercial opportunity of combining immuno-oncology drugs in lung cancer.

Its cancer progress was underscored this week, with news that it will present a bumper 62 pieces of scientific research at the April 18-22 American Association for Cancer Research annual meeting, while its tremelimumab drug won "orphan" drug status in the United States. The designation aims to encourage drug development for rare conditions.

Outside cancer, heart drug Brilinta has shown potential for wider use and its diabetes medicine Onglyza dodged a bullet on Tuesday when a U.S. advisory panel advised against recommending prescribing restrictions.

INDEPENDENT STRATEGY

"The quality of the transformation we are seeing across our organisation further underpins our confidence in AstraZeneca's longer-term prospects," a company spokeswoman said.

"We are on track to return to growth by 2017 and are well positioned to deliver our long-term goals through our independent strategy."

Quarterly results on April 24 are unlikely to be pretty, however. Sales of stomach acid pill Nexium are now eroding fast, following the arrival of U.S. generics in February, and its top-selling cholesterol drug Crestor is also in decline.

With AstraZeneca also facing headwinds from the strong dollar, consensus forecasts now point to 2015 earnings per share of $4.21, just one cent above the level needed to hit bonus targets.

Soriot and his team are required to ensure the dividend cover ratio does not fall below 1.5 times "core" earnings, which excludes certain items, implying an EPS target of $4.20.

Achieving the 2015 earnings goal will require tight control on costs and more cash-generating "externalisation" deals, like the ones Soriot has already struck with Eli Lilly in Alzheimer's and with Daiichi Sankyo for a new constipation drug.

Given the uncertainties about a sales target stretching out to 2023, some investors have argued management incentives should be nailed to firm milestones in achieving this goal.

But Charles Luke, senior investment manager at Aberdeen Asset Management, a top ten investor in AstraZeneca, is relaxed about the current set-up of tying incentives to pipeline sales growth, total shareholder return and maintaining the dividend.

"If they get all those right, it leads to a situation where the company will be doing pretty well in five or 10 years time, and having a tight focus on one particular number is not necessarily helpful," he said

 

Surprise, Surprise!! The DPP-4 news is all positive, especially for Merck's Januvia franchise apparently!!

Even worse label restrictions had been anticipated prior to the recent FDA panel decision.



SunTrust's Latest Comments On Merck
By Jayson Derrick
1 hour ago

In a report published Tuesday, SunTrust Robinson Humphrey analyst John Boris discussed the FDA AdCom's vote to add safety warnings to AstraZeneca plc (NYSE: AZN)'s Onglyza and Takeda's Nesina, which is a positive for Merck & Co., Inc. (NYSE: MRK)'s Januvia franchise.

The FDA AdCom voted that Onglyza has an acceptable CV risk profile (13 Yes, 1 No, 1 Abstain) and for safety label changes (14 Yes, 1 No). The voting outcome was similar on CV risk for Nesina (16 Yes, 0 No) and safety label changes (13 Yes and 3 No).

"The votes are a positive for the DPP-4 class as there was risk of a more restricted label due to potential heart failure (HF) signals," Boris wrote. "In general, panelists voiced more concern that the signal of increased hospitalizations for heart failure may be real; however, the concern centered on high risk patients (eGFR

Boris said the votes "provide relief" for the class and benefits of Merck's Januvia as well as Eli Lilly and Co (NYSE: LLY)'s Tradjenta franchises contingent on limited HF risk being seen in their respective TECOS (results in June) and CARMELINA (results in 2018) CV outcomes trials.

The analyst also added that Merck's ongoing restructuring combined with asset divestures and a rising pipeline will drive its share performance. In addition, the company could realize cost savings earlier than the Street is expecting with material cuts to its R&D organization and sales force.

 

5:56 am AstraZeneca's MedImmune and Immunocore announce that they have entered into a second collaboration (AZN) : Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune's investigational checkpoint inhibitors MEDI4736 (anti-PD-L1) and/or tremelimumab (anti-CTLA-4) with IMCgp100, Immunocore's lead T-cell receptor based investigational therapeutic, for the potential treatment of patients with metastatic melanoma. MedImmune has an exclusive relationship with Immunocore for the development of IMCgp100 in combination with MEDI4736 and/or tremelimumab, and will have first right of negotiation for the future commercial development of these combinations for tumours expressing gp100. Immunocore and MedImmune will collaborate to establish a dosing regimen for IMCgp100 combined with MEDI4736 and/or tremelimumab, as part of the Phase Ib study.

 

AstraZeneca lung cancer drug delays disease by more than a year
Reuters
7 hours ago

LONDON, April 17 (Reuters) - An experimental lung cancer pill from AstraZeneca delays disease progression by more than a year, according to new data presented at a medical meeting on Friday.

AZD9291, which the company expects to file for U.S. approval in the second quarter of 2015, is one of a number of cancer medicines AstraZeneca is hoping will rebuild its sales following patent losses on older drugs.

An analysis presented at the European Lung Cancer Conference in Geneva demonstrated a median progression-free survival for patients on the drug of 13.5 months.

AZD9291, like a rival product in development at Clovis Oncology, targets a genetic mutation that helps tumours evade current lung cancer pills, including AstraZeneca's own established product Iressa.

During its defence against a $118 billion takeover attempt by Pfizer last year, AstraZeneca said it believed AZD9291 could sell as much as $3 billion a year.

 

AstraZeneca's '$3B' lung cancer drug impresses in a Phase II race with Clovis
April 17, 2015 | By Damian Garde

AstraZeneca's ($AZN) in-development lung cancer pill extended survival by more than a year in new Phase II data, a positive sign for a drug the company believes can bring in $3 billion in annual sales at its peak.

The treatment, AZD9291, charted a median progression-free survival of 13.5 months in patients with non-small cell lung cancer and EGFR mutations. The updated data come from AstraZeneca's ongoing Phase II study on nearly 300 patients, besting the 9.6-month PFS rate the company reported last fall. The drug also clocked a 54% overall response rate and a median duration of response of 12.4 months, AstraZeneca said.

AstraZeneca is raising with rival Clovis Oncology ($CLVS), whose lung cancer-treating CO-1686 also works by targeting EGFR. In November, Clovis reported a Phase II PFS rate of 10.4 months, disappointing analysts hoping for something closer to a year. The two companies are expected to reach the market around the same time and contend for dominance, and AZD9291's latest results sent Clovis' shares down about 4% on Friday morning.

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For AstraZeneca, the positive data affirm the company's plan to submit regulatory applications for AZD9291 next quarter, and the company is pressing on with additional studies testing the drug in early-stage lung cancer and in combination with other oncology assets. The FDA has bestowed its breakthrough-therapy designation on AZD9291, promising a speedy review once the drug is filed.

The treatment is a major cog in AstraZeneca's promise to deliver annual revenue above $45 billion by 2023, a number bandied about when the company was fighting off an advance from Pfizer ($PFE) last year. AstraZeneca has affixed a $3 billion figure to AZD9291, a $6.5 billion peak expectation for the PD-L1-blocking immunotherapy MEDI4736 and a $2 billion tag on the PARP inhibitor olaparib, approved last year as Lynparza.

 

AstraZeneca drug Lynparza shows promise in prostate cancer trial
Reuters
14 minutes ago

LONDON, April 21 (Reuters) - AstraZeneca's recently approved ovarian cancer drug Lynparza, or olaparib, can also help men with prostate cancer, according to new clinical trial results on Tuesday.

The news is the latest boost to the British company's cancer drug pipeline, which formed a central plank of its defence against a $118 billion takeover attempt by Pfizer last year.

AstraZeneca has flagged olaparib as a potential $2-billion-a-year seller, based on ongoing Phase III studies in ovarian, breast, gastric and pancreatic cancers. The latest Phase II prostate findings would represent further upside.

Olaparib works by blocking an enzyme involved in cell repair and is approved for women with ovarian cancer and hereditary BRCA gene mutations. The new research suggests it could also benefit men with genomic faults within their prostate tumours.

"This opens up the exciting possibility of delivering precise treatment for advanced prostate cancer, guided by genomic testing and based on the particular molecular characteristics of patients' tumours," said chief investigator Johann de Bono of Britain's Institute of Cancer Research.

De Bono presented data to the American Association of Cancer Research conference showing that 16 out of 49 men with treatment-resistant, advanced prostate cancer responded to olaparib. Among the responders, 14 of the men had detectable DNA repair mutations.

On the back of the results, the researchers plan to start a second part of the trial in which only men with detectable DNA repair mutations will receive olaparib, in the expectation that the response rate in this group will be much higher.

 

Celgene deal defended:


AstraZeneca insists Celgene deal about strategy, not cash
Reuters
47 minutes ago
By Ben Hirschler

LONDON, April 24 (Reuters) - AstraZeneca is getting a $450 million windfall by letting Celgene develop a prized immunotherapy drug for blood cancers but its chief executive insists the deal is about strategy, not cash.

Some investors are worried about the drugmaker's reliance on such "externalisation" deals to fill a short-term revenue gap. Deutsche Bank analyst Richard Parkers said income from these agreements was of "questionable sustainability".

Chief Executive Pascal Soriot, however, said he had been looking for a partner in blood cancers since last year and by teaming up with U.S.-based Celgene, a leader in haematology, AstraZeneca would accelerate its drug's path to market.

AstraZeneca will effectively give away around half the sales of its drug MEDI4736 in blood cancers under the Celgene agreement, but Soriot said the deal would unlock value that the British company could not have achieved on its own.

"We could do it ourselves but with a partner in haematology we will do much, much better," he told reporters in a conference call. "It's more strategically driven than financially driven, though of course the financial aspects also help."

AstraZeneca believes blood cancers could represent 40 percent of the total cancer market, yet Soriot said it did not include this in a $45 billion 2023 sales forecast issued last year as it was not clear then how it would tap the market.

AstraZeneca has extensive experience in solid tumours, but not blood cancers, which is a highly specialised field involving different groups of doctors.

Citi analyst Andrew Baum said the Celgene collaboration made sense given AstraZeneca's absence of expertise and Celgene's desire to expand its presence in immuno-oncology (I-O).

AstraZeneca is up against several I-O rivals, such as Bristol-Myers Squibb, Merck and Roche, and Soriot argued that by getting into bed with Celgene it would be at a competitive advantage in the blood cancer space.

Under the deal, AstraZeneca will book sales of MEDI4736 in blood cancers and will pay Celgene an initial royalty of 70 percent, which will decrease to approximately half of sales over a period of four years.

 

AstraZeneca Profit Falls as Top Drugs Lose Patent Protection
Bloomberg By Oliver Staley
6 hours ago

AstraZeneca Plc, the second-largest U.K. drugmaker, said earnings fell in the first quarter as sales of two of its biggest medicines continued to decline and currency fluctuations took a slice from revenue.

Profit excluding certain items slipped to $1.37 billion, or $1.08 a share, from $1.47 billion, or $1.17, a year ago, the company said in a statement. That matched the average estimate from 13 analysts surveyed by Bloomberg. Total revenue was $6.06 billion, down from $6.46 billion a year earlier.

Sales of two of AstraZeneca’s best-selling products -- acid reflux drug Nexium and cholesterol pill Crestor -- are falling as patents expire. At the same time, revenue from newer medicines isn’t growing as fast as analysts predict. Sales will slump this year and next before returning to growth in 2017 when new drugs propel earnings, AstraZeneca has said.

“We’re not fully comfortable with the underlying trend,” said Eric Le Berrigaud, an analyst at Bryan Garnier & Co. in Paris. “The older drugs are more resilient and new drugs like Brilinta and Symbicort are below estimates.”

Sales of Nexium fell 31 percent to $644 million in the quarter, though that exceeded the $589 million estimated by analysts. Among newer drugs, Brilinta, an anti-clotting medicine, rose 32 percent to $131 million, less than the $141 million estimate, while Symbicort, an asthma drug, fell 9 percent to $845 million, less than the $878 million estimate.
Share Performance

AstraZeneca shares fell 2.3 percent to 47.20 pounds as of 9:46 a.m. in London. The stock has returned 6.8 percent, including reinvested dividends, this year, while the 19-member Bloomberg Europe Pharmaceutical Index is up about 27 percent.

AstraZeneca faces pressure on near-term goals and on Chief Executive Officer Pascal Soriot’s pledge to boost annual revenue to $45 billion by 2023 from $26 billion last year.

“Our pipeline progressed well in each of our therapy areas,” Soriot said in the earnings statement. “We also continued to reinforce our oncology franchise.”

AstraZeneca now has 72 oncology trials under way, including 31 in immuno-oncology. It is aiming to submit AZD9291, a potential $3 billion lung cancer treatment, for regulatory submission before July.

Astra is also seeking new revenue sources, including marketing partnerships. The company announced last month that Tokyo-based Daiichi Sankyo Co. will jointly sell Movantik, a drug for constipation resulting from opiates, in the U.S. in exchange for a $200 million upfront fee and sales-related payments of as much as $625 million.

The drugmaker said today it will collaborate with Celgene to develop an AstraZeneca immuno-oncology compound called MEDI4736 for blood cancers. Celgene will pay AstraZeneca $450 million upfront.

Such agreements may not be the best strategy, according to Alistair Campbell, an analyst at Berenberg.

“Earnings were improved by partially selling off a number of its drugs, including Movantik,” Campbell said. “This raises a concern that the company might be trading in long-term opportunities to protect short-term earnings.”

The strong U.S. dollar is also crimping AstraZeneca’s earnings, which the London-based company reports in that currency.

The company reiterated its forecast that revenue will decline by a mid single-digit percentage in 2015, at constant exchange rates, with core earnings per share rising by a low single-digit percentage on the same basis.

Soriot made his aggressive sales prediction last year as he successfully fought off a $117 billion takeover attempt by Pfizer Inc. Astra said last month that new medicines for cancer may generate a quarter of sales by 2023, up from 12 percent last year.

One new drug in Astra’s stable is Lynparza, an ovarian cancer treatment approved in the U.S. in December. Sales of the drug in the U.S. reached $4.5 million in March, almost double the amount in February, Bloomberg Intelligence analysts Michael Shah and Sam Fazeli reported yesterday, citing Symphony Health data.

Nexium and Crestor together accounted for a third of AstraZeneca’s 2014 revenue, or $9.2 billion. Analysts expect that to fall to $7.2 billion this year after a generic version of Nexium debuted in February. Crestor’s patent expires in 2016.

 

Januvia: later subgroup analyses may bring to light some information that is different than the message from the top line analysis, just like what happened with Onglyza and the others. Januvia is not very impressive even in the top line analysis. Just like all the other DPP-4 class members it shows no actual cardiovascular benefit.



4/27/2015 @ 6:58PM 2,876 views
Cardiovascular Outcomes With Merck's Januvia: No Better Or Worse Than Conventional Care

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin). The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.”

The FDA has been wrestling for a number of years now with the problem of the cardiovascular effects– whether positive or negative– of diabetes drugs. The first large outcomes trials with two other DPP-4 inhibitors, saxagliptin (Onglyza, AstraZeneca) and alogliptin (Nesina, Takeda Pharmaceuticals) were reported in 2013 and found no impact of the drugs on cardiovascular outcomes.

However, a troubling signal emerged suggesting a possible raised risk for heart failure, though the endpoint was not rigorously studied in the trials. Two weeks ago the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed the trials and rejected recommendations from critics for new restrictions on their use, but they did say that information from the two clinical trials should be added to the drugs’ labels.

In a research note Bernstein analyst Timothy Anderson wrote that the TECOS news removes “a psychological overhang” from the drug and leaves Januvia as “the best-positioned DPP4 in the category,” which may allow it to “pick up at least some market share from its direct competitors.”

At this point, however, some caution may be warranted. Even when the data do become available it bears remembering that without direct comparisons of the drugs any conclusions about differences between the drugs should be considered highly speculative. The only thing known for sure at this point is that all three drugs have been shown to have a neutral effect on cardiovascular outcomes.

Sanjay Kaul, a frequent FDA advisor, pointed out the paradox of the large commercial success of the diabetes drugs despite the absence of any proven clinical benefit:

“So, we have a drug that yields modest glycemic efficacy, is neutral with respect to cardiometabolic factors (lipids, weight, blood pressure), does not kill you or land you in a hospital, and yet is a blockbuster drug nearly 5 times over! What is the big news here? That it does not kill you or land you in a hospital? Or that it is a blockbuster drug nearly 5 times over without evidence of microvascular or macrovascular outcome benefit? Miracle of medicine or miracle of marketing?”

 

Brilinta fast tracked by FDA for new use:



AstraZeneca heart drug in regulatory fast lane for wider use
Reuters
7 hours ago

LONDON, April 29 (Reuters) - U.S. regulators are to fast-track the review of a new use of AstraZeneca's heart drug Brilinta, meaning it could get the green light in the third quarter to be given to patients with a history of heart attacks.

The drugmaker said on Wednesday the decision by the Food and Drug Administration (FDA) reflected the potential of Brilinta to address an unmet medical need by reducing risks for patients who had a heart attack one to three years previously.

The FDA grants a priority review when a medicine has scope to provide significant improvements in the treatment.

AstraZeneca is relying on Brilinta, which it believes can sell $3.5 billion annually by 2023, to help offset a wave of patent losses on older drugs. The product was a central plank in its defence against a takeover bid by Pfizer last year.

 

How the hell does that Frog hang onto his job? He'd better start doing some fast tap dancing. This company is going down.

 

AstraZeneca drug combination on track to fight lung cancer
16 hours ago
By Ben Hirschler

May 13 (Reuters) - A closely watched immune system-boosting drug cocktail from Britain's AstraZeneca shows promise in advanced lung cancer, despite adverse side effects in a number of patients.

Researchers said on Wednesday that the combination of the experimental drugs MEDI4736 and tremelimumab had "a manageable safety profile with evidence of clinical activity, including in PD-L1 negative disease".

The update was provided in a scientific summary, or abstract, released ahead of the annual meeting of the American Society of Clinical Oncology (ASCO) later this month.

MEDI4736 is an anti-PD-L1 therapy, which works by stopping a tumour's ability to evade the body's defences. Tremelimumab blocks a different molecule, CTLA-4, that also keeps the immune system from attacking cancer.

Such immunotherapy drugs are widely tipped to revolutionise cancer care and analysts predict they will generate tens of billions of dollars in annual sales.

Safety, however, may be an issue, especially after results a year ago from a small study with a similar Bristol-Myers Squibb cocktail showed about half of patients experienced serious side effects.

In the case of AstraZeneca's combination, 31 percent of 61 patients had adverse events rated as serious, or grade 3/4, and 18 percent had events that led to discontinuation of treatment, according to the summary of results as of Dec 4, 2014.

A total of 31 patients were assessed for efficacy, of whom 26 percent experienced tumour shrinkage and 35 percent had stable disease.

Because immunotherapy does not work for all patients, some experts have suggested focusing on people whose tumours test positive for a likely response. However, many of the patients assessed in the AstraZeneca study were PD-L1 negative and three of the 10 partial responses were reported in people with negative tumours.

Further data from the Phase Ib trial will be presented at the May 29 to June 2 ASCO conference in Chicago and AstraZeneca said it was increasingly confident MEDI4736's potential "as a cornerstone for combination treatments".

The company, which saw off a $118 billion takeover attempt by Pfizer last year, has already forecast that MEDI4736 could sell $6.5 billion a year, including its use in combinations.

It is eager to develop the two-drug cocktail as fast as possible and recently started final-stage Phase III clinical tests in non-small cell lung cancer patients who have received at least two previous different kinds of treatments.

 

U.S. FDA warns on newer class of type 2 diabetes drugs
Reuters
1 hour ago

May 15 (Reuters) - The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drug sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may a cause dangerously high levels of blood acids that could require hospitalization.

The drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer.

The FDA in a warning on its website said the medicines may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones.

(Reporting by Bill Berkrot; Editing by Jeffrey Benkoe)

 

Between the ketoacidosis and the 27% increase in hospitalization rates, I'm batting a thousand!

 

Oops!

 

Who gives a rat's ass! Means nothing! My bonus is ALL that counts, and nothing more.

 

Well, idiot, your bonus will be impacted by a warning on The FDA website about the drug you're trying to sell.

 

I doubt it. Frenchie can handle the FDA. He can handle anything, just like he showed Pfizer who was boss! They insulted Frenchie with a paltry $120,000,000,000 offer, and he told them where to stick it! He da man!