2 billion doses of Covid-19 vaccine by AstraZeneca

AstraZeneca lays out plan for producing 2 billion doses 
of Covid-19 vaccine, if it works

By MATTHEW HERPER @matthewherper

JUNE 4, 2020

Reprints

RAPHAEL LAFARGUE/ABACA/SIPA USA VIA AP

The drug giant AstraZeneca said Thursday that it has found partners to manufacture and distribute 2 billion doses of the experimental Covid-19 vaccine created by Oxford University, inking a series of deals with non-government organizations and another manufacturer.

AstraZeneca said that CEPI and Gavi, public-private partnerships aimed at developing and distributing vaccines, would spend $750 million to manufacture and make available 300 million doses of the vaccine to distribute by the end of the year — assuming the vaccine is shown to be safe and effective. It also reached a licensing agreement with SII, previously known as the Serum Institute of India, to supply 1 billion doses of the vaccine to low- and middle-income countries. SII committed to provide 400 million doses before the end of 2020.

AstraZeneca had previously said that it plans to ship 100 million doses to the United Kingdom and 300 million to the U.S.

“We believe we can get the vaccine to hundreds of millions of people around the world, importantly including those in the countries with the lowest income,” Pascal Soriot, AstraZeneca’s CEO, told a group of reporters on a webcast. “So our goal is really to not leave anybody behind.”

Related: 

Covid-19 Drugs and Vaccines Tracker

AstraZeneca signed on to develop and distribute the Oxford University vaccine on April 30. But efficacy data are not expected before August, after large trials of tens of thousands of patients are run to show if the vaccine prevents infections.

When asked if he was “bullish” on the vaccine’s prospects, Soriot said that was not the right word. “When you have something like this, with this pandemic and the tremendous impact it has on people, the economy, et cetera, you can’t second-guess what’s going to happen, you can’t spend your time figuring out if it will work or not work,” he said. “You just have to commit.”

Soriot declined to give specific odds on whether this vaccine would work, though he said it was promising, and said that he hoped the world would have multiple vaccines against Covid-19, noting the ongoing efforts from Moderna, Pfizer, and Johnson & Johnson.

If the vaccine were to fail to be effective, Soriot said, it is possible that the manufacturing capacity that is being built might be used to make another, similar Covid-19 vaccine.

The current effort is the first commitment made by the Access to Covid-19 Tools (ACT) Accelerator, a global mechanism created by the Bill and Melinda Gates Foundation, the World Health Organization, and other groups. The Gates Foundation also gives substantial funding to both CEPI, which is short for the Coalition for Epidemic Preparedness Innovations, and Gavi.

Proving a vaccine is effective and manufacturing enough of it will only be the first challenges in making it widely available.

Related: 

Moderna released scant Covid-19 data to prevent a leak, CEO says

“Just solving the problem of having a vaccine doesn’t result in it being delivered,” said Richard Hatchett, CEPI’s CEO. “And I think that the challenge of contemplating vaccinating hundreds of millions or billions of people globally over the next one to two to three years, however long it takes, is going to be a massive challenge.”

Different vaccines will require different amounts of refrigeration. There is, Hatchett noted, a global glass shortage that means that vaccines will be distributed in multi-dose, not single-dose, vials. The goal of beginning manufacturing now, he said, is to work out some of those problems ahead of time, Hatchett said.

Correction: A previous version said incorrectly listed the chairs of the Access to Covid-19 Tools Accelerator based on an AstraZeneca press release.

About the AuthorReprints

Matthew Herper

Senior Writer, Medicine

Matthew covers medical innovation — both its promise and its perils.

 matthew.herper@statnews.com

 @matthewherper

https://www.statnews.com/2020/06/04/astrazeneca-lays-out-plan-for-producing-2-billion-doses-of-covid-19-vaccine-if-it-works/

Heartburn Medicines Cause Cancer… FDA Does Nothing

People who take Zantac or similar drugs to combat heartburn may be unknowingly giving themselves cancer. Last week, the FDA announced that it had detected a cancer-causing contaminant called N-nitrosodimethylamine, or NDMA, in ranitidine heartburn medications.

By Ty Bollinger
September 19, 2019

But the FDA fell short of ordering a recall, and it wasn’t until a week later that distributors began to pull the drugs off the shelves. In response to the discovery, Sanofi spokeswoman Ashleigh Koss said,

Sanofi takes patient safety seriously, and we are committed to working with the F.D.A.”

She went on to say that Zantac “has been around for over a decade and meets all the specified safety requirements for use in the O.T.C. market.” –

At the time, Koss stated that Sanofi had no plans to recall the drug. But as evidence and consumer outrage grew over the following week, pharmaceutical company Novartis decided to stop the distribution of its generic Zantac drugs in all markets. At the time of publishing, Sanofi and the FDA had still failed to issue a recall.

NDMA in Drugs a Major Cancer Risk

This is not the first time that NDMA has been found in popular drugs. Last year, blood pressure medication valsartan, sold under the brand name Diovan, was also found to be contaminated. In that case, the FDA issued a voluntary recall of the drug, citing the risk of developing cancer.

Millions of people take ranitidine to relieve symptoms of heartburn and other gastrointestinal issues. But the potentially life-threatening drugs can still be found in pharmacies across the United States. In Canada, health officials have requested a stop to all distribution of the drug, making the only country in which Sanofi has ceased distribution.

NDMA is an industrial byproduct that can often be found in cured meats like bacon. The FDA says that it is “reasonably safe” to ingest up to one microgram a day. But safety testing has found levels significantly higher. In last year’s valsartan recall, the FDA found up to 17 micrograms of NDMA per dose. Valisure, a pharmacy that tests all drugs it distributes, found that Zantac had NDMA levels reaching 3,000 micrograms.

Valisure petitioned the FDA to recall all forms of ranitidine, though the agency has yet to take any such measures. They claim that NDMA may be “inherent” in the ranitidine molecule and have urged regulators to recall the drug until its safety can be guaranteed. But the FDA, as usual, seems apathetic about consumer safety.

FDA spokesman Jeremy Kahn said in a statement,

The FDA will take appropriate measures based on the results of the ongoing investigation.”

But they failed to recommend that people using the drug stop taking it. Instead, they simply suggested that alternative medicines are available.

This is the same “profits over patients” approach that we’ve seen repeatedly with our regulatory bodies. Safety testing – especially for generic drugs – is significantly lacking. Dinesh Thakur is a drug-safety advocate and whistleblower who exposed corruption and faulty quality control as an executive at Ranbaxy Laboratories. He says the FDA is not doing enough to protect consumers.

I think this is another good example of how our regulations need to change. Things like this will never get caught, unless somebody is actually actively looking for stuff.”

Meanwhile, a lack of oversight and testing standards has resulted in pharmacy shelves filled with drugs that can literally kill you. The FDA knows that Zantac has been contaminated with a carcinogen. Sanofi knows that something has gone terribly wrong with one of their flagship drugs. But the money is too good to recall them now.

Is Money Running Regulation?

Zantac was the first drug to total $1 billion in sales. In 2018, the drug generated nearly $130 million dollars for Sanofi. But a new class-action lawsuit filed earlier this week claims that the French drug makers have known the risks all along, hiding them from regulators and consumers in order to maintain profits.

The suit claims that each 150mg tablet of Zantac contains 26,000 times the FDA-approved daily limit of NDMA. Steve Berman, the lead attorney for the case, believes that consumers have been intentionally put in harm’s way.

Millions of people in the U.S. suffer from heartburn, and for years, Zantac has been sold to the masses as a safe and easy-to-find remedy for that common ailment. We’re certain that if those millions of consumers knew that the Zantac they take contains known carcinogens, they would be rightfully outraged.”

“Sanofi knew that Zantac contains a carcinogen, yet it chose to conceal these risks to the public to line its own pockets,” the suit claims.

Had defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac.”

But all statements from the FDA and Sanofi say basically the same thing:

“We care about consumer safety. We’re looking into it.”

This isn’t the first time that drug manufacturers have hidden risks and lied to the public in order to line their own pockets.

Johnson & Johnson knew that there was asbestos in their talcum powder but did nothing. Juul Labs marketed their e-cigarettes to children, only to destroy the evidence when confronted. Opioid manufacturers bribed doctors and lied about safety, causing an epidemic that has claimed tens of thousands of American lives each year.

We could call the FDA lapdogs for Big Pharma. We could say that the whole system is corrupt, with patents, approvals, and leadership bought and paid for with blood money from the industry. But we don’t need to. All we have to do is show you the numbers.

• In the last 40 years, only one FDA commissioner has failed to secure a high-paying job in the pharmaceutical industry. The most recent departure, Scott Gottlieb, took a lucrative job on the board of Pfizer.
• A study published earlier this year found that 17% of the cancer drugs approved by the FDA used “suboptimal control arms,” leading to the approval of expensive cancer therapies that don’t show any real benefit to patients.
• Sonny Perdue, the U.S. Secretary of Agriculture, seems to be the only regulatory authority in the world who still claims that glyphosate is safe, despite hundreds of studies to the contrary and evidence presented in court shows that Bayer/Monsanto executives actively tried to hide the cancer/Roundup connection. Perhaps it’s a coincidence that Perdue is a former fertilizer salesman who has received hundreds of thousands of dollars from the agricultural industry.
• A new expose has shown that many of the top-selling smartphones exceed federal radiation limits. FCC commissioner Ajit Pai worked in the telecommunications industry before his appointment. Former FCC heads have literally won awards for their efforts lobbying for the industry.

Doctors are literally incentivized to prescribe chemotherapy drugs to cancer patients, making more money with each dose of the toxic chemical. But maybe that doesn’t affect their judgement when it comes to patient care.

Maybe it’s all a coincidence. Maybe there’s no conflict of interest within the FDA. Maybe Sanofi is a great company that’s just trying to help patients. Maybe it’s the result of an innocent mistake that our shelves are filled with deadly drugs that cause cancer. Maybe the people who are calling foul are just crazy conspiracy theorists. Maybe a little bit of cancer isn’t a big deal so long as you get heartburn relief.

But I don’t buy it for a second…

https://thetruthaboutcancer.com/does-zantac-cause-cancer/

Big Pharma CEO: “My Primary Responsibility is to Shareholders” - MUST READ

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines..."

Published

 16 hours ago 

on

 October 1, 2019

By

 Arjun Walia

IN BRIEF

• The Facts:
  A recent interview with Michael Pearson, the CEO of Valeant Pharmaceuticals, outlined the importance of keeping shareholders happy.
• Reflect On:
  Are pharmaceutical companies in the business of health care, or sick care? Is their priority profit or helping to cure and treat people?

The truth, as explained by Dr. Marcia Angell, a physician and longtime Editor-in-Chief of the New England Medical Journal (NEMJ), one of the most prestigious peer-reviewed medical journals in the world alongside The Lancet, is that “it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”  (source)

Arnold Symour Relman, a Harvard professor of medicine and also a former Editor-in-Chief of The New England Medical Journal also made it quite clear that “The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.”  (source)(source)

At the end of the day, when it comes to medicine, it’s not really about healthcare, it’s more so about making money. This is why prescription drug use is one of the leading causes of death in the United States. It’s also why substances that can’t be patented like cannabis, for example, never really get funding for clinical trials because pharmaceutical companies can’t make money off them.

Pharmaceutical companies are not in the business of healthcare, which is why doctors don’t know much about nutrition and are simply trained to use and prescribe drugs, while at the same time being convinced that these medicines are completely safe and effective and the best way to go about treating, healing and curing diseases.

A recent interview with Michael Pearson, the CEO of Valeant Pharmaceuticals, outlined the importance of keeping the shareholders happy. The interview was with regards to raising drug prices, and really sheds light on the importance of making money and how it always seems to be the main focus of pharmaceutical companies.

The main reason we take so many drugs is that drug companies don’t sell drugs, they sell lies about drugs. This is what makes drugs so different from anything else in life… Virtually everything we know about drugs is what the companies have chosen to tell us and our doctors… the reason patients trust their medicine is that they extrapolate the trust they have in their doctors into the medicines they prescribe.

The patients don’t realize that, although their doctors may know a lot about diseases and human physiology and psychology, they know very, very little about drugs that’ve been carefully concocted and dressed up by the drug industry… If you don’t think the system is out of control, please email me and explain why drugs are the third leading cause of death… If such a hugely lethal epidemic had been caused by a new bacterium or a virus, or even one-hundredth of it, we would have done everything we could to get it under control.”  – Dr. Peter Gotzsche, co-founder of the Cochrane Collaboration (source)

The statement above reveals the truth. It’s also important to note the corruption that plagues our medical industry. The medical industry has been completely compromised by big corporations. There are several great examples that illustrate this point, in fact there are decades worth of examples. One of the best would be the SPIDER papers. A group called the CDC Scientists Preserving Integrity, Diligence and Ethics in Research, or CDC SPIDER, put a list of complaints in a letter to the CDC Chief of Staff and provided a copy of the letter to the public watchdog organization U.S. Right to Know (USRTK).

We are a group of scientists at CDC that are very concerned about the current state of ethics at our agency.  It appears that our mission is being influenced and shaped by outside parties and rogue interests. It seems that our mission and Congressional intent for our agency is being circumvented by some of our leaders. What concerns us most, is that it is becoming the norm and not the rare exception. Some senior management officials at CDC are clearly aware and even condone these behaviors.

This is no secret, yet it never really gets any media attention. Everybody should know by now that pharmaceutical companies are extremely unethical, and that they have a very tight stranglehold over government health regulatory agencies like the Centers For Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA). According to Robert F. Kennedy Jr., pharmaceutical companies have more lobbyists in Washington D.C. than there are congressmen and senators combined. They are even more powerful than big oil and gas, so you can just imagine the power they exercise over politicians and our federal health regulatory agencies. It’s also important to point out the revolving door that exists between big pharma and federal health regulatory agencies. Julie Gerberding, the Healthcare Businesswomen’s Association ‘Woman of the Year,’ is a prime example of someone who has gone through the revolving door between government regulatory agencies and the corporations they are supposed to be regulating. She was once the Director of the CDC before moving over to an executive position at Merck.

The Takeaway

This article sheds only a small tidbit of light on the corruption that plagues the pharmaceutical industry. When it’s clear that the medical industry is not concerned about our health like it should be, it’s understandable why more people are choosing to take their health into their own hands. This does not mean that the medical industry does not have it’s positives, but when it comes to drugs and treatment specifically, a big problem exists.

https://www.collective-evolution.com/2019/10/01/big-pharma-ceo-my-primary-responsibility-to-shareholders/

AstraZeneca's immunotherapy drug wins key lung cancer approval

LONDON (Reuters) - AstraZeneca’s immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, opening up a multibillion-dollar market for a medicine that has so far lagged behind competitors.

FEBRUARY 17, 2018

The U.S. Food and Drug Administration said late on Friday it 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.

Imfinzi is the first immunotherapy to be approved in this setting.

The green light - which had been expected following 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.

Analysts believe using Imfinzi in so-called stage III lung cancer, where cancer has only spread locally, opens up an annual sales opportunity worth around $2 billion. Importantly, AstraZeneca has a lead of two to three years over other drug companies in this particular area.

The approval was based on a trial involving 713 patients, showing patients survived on average 16.8 months without their disease worsening when given Imfinzi, against just 5.6 months for those on placebo.

Globally, approximately 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, Roche and Merck 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.

AstraZeneca still hopes to catch up in the advanced lung cancer market, too, by combining Imfinzi with another immunotherapy drug called tremelimumab.

Initial results from a clinical trial testing this combination proved disappointing last July but the company has a second chance to prove the case for its cocktail when overall survival data are released later this year.

Some analysts forecast potential sales of all immunotherapy drugs at as much as $50 billion a year. Still, significant challenges remain, including deciding on optimal treatment regimens for using infused medicines with typical list prices near $150,000 a year.

https://www.reuters.com/article/us-astrazeneca-fda/astrazenecas-immunotherapy-drug-wins-key-lung-cancer-approval-idUSKCN1G02IA

Indian drug factories erode US generic prices

MUMBAI: The most recent earnings reports across the generic drug industry have read like dispatches from the front lines of a price war.

Downtrend: A logo of Sun Pharmaceutical Industries Ltd is pictured at its research and development centre in Mumbai, India. In August, the world’s largest copycat drugmaker, Israel’s Teva Pharmaceutical Industries Ltd, slashed its dividend; US giant Mylan NV lowered its profit target; and Sun Pharmaceutical reported its first quarterly loss in at least 12 years. — Reuters

Friday, 1 September 2017

Family-owned drugmakers driving price war

This month, the world’s largest copycat drugmaker, Israel’s Teva Pharmaceutical Industries Ltd, slashed its dividend; US giant Mylan NV lowered its profit target; and India’s Sun Pharmaceutical Industries Ltd reported its first quarterly loss in at least 12 years.

The source of the pain?

At least some of it can be traced to the global ambitions of a growing constellation of family-owned drug factories in India. Their expansion is boosting competition in the US, where mergers among pharmacy chains and pricing wars between drugmakers had already been driving down the cost of generics.

“The assumption was there would be a step-down, but nobody expected it would be this bad,” said Ronny Gal, an analyst at Sanford C Bernstein & Co.

As the smaller Indian manufacturers are growing stronger, the US Food and Drug Administration is working to boost competition by handing out approvals at a record pace. The agency has said it will specifically favor generic drug applications for products that have few competitors as a way to drive down prices further.

India was already the world’s largest exporter of generic drugs, with US$16.4bil sold abroad last year. In the first half of 2017, Indian firms got about 40% of new US approvals for generics, up from 35% just a year earlier, and with a wider base of companies than ever before taking part, according to FDA data analysed by Bloomberg News.

“With more and more companies in the fray, the competition has intensified,” Pankaj Patel, chairman of Ahmedabad-based Cadila Healthcare Ltd, said in an email.

The company’s main US subsidiary has received 27 approvals this year through July, compared with eight last year. “The pure generics sphere has seen price erosion.”

India is home to about 6,000 drugmakers, according to its government’s estimates, members of a cutthroat market characterized by price controls, limited insurance levels and low patient incomes.

That makes the US look like easy pickings, according to Surajit Pal, an analyst at Prabhudas Lilladher Pvt Ltd in Mumbai.

Instead of introducing a generic product and then lowering the price when forced to, many of the Indian companies will play a far more brutal game, Pal said.

“The US business is basically icing on the cake, so they don’t mind giving you a 90% discount on the very first day,” Pal said. “The US will get cheaper products going forward.

“The US will get more competition from Indian guys.”

Thirty-two different Indian firms received US approvals to sell new generics in the first half of this year - almost double the number from two years ago.

The approvals came as India’s top 10 drugmakers grew their share of the US generics market from 14% in 2010 to about 24% today, according to Bernstein’s Gal.

Among the leaders in approvals were Hyderabad-based Aurobindo Pharma Ltd and Cadila, two of India’s biggest drugmakers who have only turned their attention to the US more recently. The companies, controlled by their founding families, are worth US$6.8bil and US$8.2bil respectively on the local stock exchange.

Smaller Indian firms that previously had little presence in the US are also seeing approvals surge.

Mumbai-based Macleods Pharmaceuticals Ltd, a closely held company that came onto the US scene in 2012 with 12 approvals, has been one of India’s most prolific filers every year since. It’s gained approvals for eight new drugs this year to treat conditions including pain, high blood pressure and depression. Ajanta Pharma Ltd, a US$1.6bil public firm that’s been operating in India since 1973, only had two US approvals to its name until 2014.

Last year, it had nine new approvals.

Or Alkem Laboratories Ltd, also operating in India for nearly fifty years.

Alkem had been chugging along with about two or three US approvals a year since 2009, but this year it’s received six.

Aurobindo, Macleods, Ajanta and Alkem didn’t respond to requests for comment.

With so many rivals in the generics space, Cadila’s pipeline needs to broader, said Patel, whose father founded the company.

“It will be crucial to look beyond pure generics at specialty products if we need to stay ahead of competition,” said Patel.

“We have a large pipeline of products which are under approval, and the attempt has been to create a judicious mix of generics, specialty and niche products.”

Successful drug makers will be ones who can develop complex technologies to deliver drugs and new formulations to create a specialty niche portfolio with less competition, he said.

Shares of Sun Pharmaceutical declined 0.9% as of 10:02 am in Mumbai. Cadila Healthcare fell 0.4%, Cipla Ltd dropped by 0.7%, Alkem Laboratories dropped 0.8% and Ajanta Pharma advanced 0.6%. The benchmark S&P BSE Sensex Index fell 0.2%.

In the US, falling prices are sweeping across the industry.

Mylan’s revenue growth has slowed in part by pressure on generic-drug prices, prompting the company to try to stave off the damage through acquisitions and new products.

Teva said it was in danger of breaching covenants on its debt amid a drop in cash flow that’s forcing it to cut jobs and exit markets. When Swiss giant Novartis AG reported earnings results in July, it said US generics sales were down 15%, driven largely by price pressure.

Overall, US generic drug prices fell 8% last quarter compared with a 4% increase in sales volume, according to Bloomberg Intelligence.

It’s not just the drugmakers that have been suffering. McKesson Corp and other major wholesalers that distribute about US$400bil worth of drugs each year cited generic pricing as a reason for their shrinking margins.

McKesson and Mylan declined to comment.

While prices of some specialty medicines have surged in recent years, such increases are harder to pull off amid greater political scrutiny and a wide-ranging US Justice Department investigation that is looking into possible price collusion in the US generics industry.

The deep discounts offered by the new Indian players to gain market share force the incumbent players to match them.

That can cut the total value of the market by as much as half, said Kumar Saurabh, an analyst at Motilal Oswal Securities Ltd

While Indian companies have drawn scrutiny from US regulators over manufacturing quality in recent years, curtailing some of the biggest players’ ability to win approvals, other firms have stepped in.— Bloomberg

http://www.thestar.com.my/business/business-news/2017/09/01/indian-drug-factories-erode-us-generic-prices/

How Roche Tweaked an Aging Drug to Keep Profits Rolling In

 The pharma company reformulated a cancer drug to treat MS and jacked up the price.

August 23, 2017

By 

Naomi Kresge

 

PHOTOGRAPHER: SIMON DAWSON/BLOOMBERG

In the remote forests of northern Sweden, Anders Svenningsson’s multiple sclerosis patients have benefited from a drug he’s been prescribing for the past eight years. It doesn’t require weekly injections, doesn’t leave patients feeling achy and feverish; and most important, halts their disease. That drug, Rituxan—originally developed to treat cancer—has become Sweden’s most prescribed medicine for MS, in which the body attacks its own central nervous system. Swedish doctors have great freedom to prescribe treatments they believe are appropriate, but few MS patients elsewhere can get the drug. That’s because its maker, Roche Holding AG, has never tried to sell it for the disease. Instead, Roche this year introduced a nearly identical medication that it markets under a new name and at 10 times the cost.

The tale of the two drugs highlights how pharmaceutical companies tweak aging medications to keep the profits rolling in. With Rituxan facing the expiration of its patent starting in the middle of this decade and another drugmaker due a share of the profit from the medication, Roche didn’t pursue it as a treatment for MS despite studies indicating it probably works. Instead, Roche invested in the offshoot medicine, which would take years to reach the market but enjoy longer protection against generics. That strategy began paying off in July, when the new drug, Ocrevus, wildly outperformed expectations in its first quarter of sales. 



Stephen Hauser, a neurology professor at the University of California at San Francisco who led MS trials for both drugs, says the two have some minor differences. But doctors and patients must decide whether it’s worth buying Ocrevus, which he says is “10 percent more effective, 10 percent easier to administer, but 10 times more expensive.” Ocrevus runs $65,000 a year, while Rituxan costs about $2,400 annually in Sweden and $8,000 to $10,000 in the U.S. for patients who can get it prescribed for MS.

Roche argues that there are significant differences between Rituxan and Ocrevus. Because the newer formula is composed mostly of human genetic components, it has fewer side effects and patients won’t develop as much resistance to it, the company says. “Ocrevus was specifically engineered for long-term use in patients with chronic diseases,” says Daniel O’Day, head of Roche’s pharmaceutical unit.

When Roche decided to abandon Rituxan as a treatment for MS about a decade ago and focus on Ocrevus instead, “I felt it was immoral, because we had very good data” showing the older medication worked, says Timothy Vollmer, a neurology professor at the University of Colorado’s health sciences center. Vollmer says some insurers will pay for Rituxan, so he prescribes the one that will be cheaper for patients, because “I don’t have a reason to distinguish between them other than cost.”

It’s not uncommon for drugmakers to bolster their profits by reformulating medications and charging more for the new versions—though the companies always say they’re safer and more effective. Ocrevus is one of at least 10 MS drugs that have been revamped to boost their moneymaking potential, according to the Blizard Institute, a medical research center in London. Insulin producers have for decades made small improvements to keep prices high. Johnson & Johnsonin 2007 rejiggered an antipsychotic formula to extend its patent protection. And Roche a decade ago developed an eye drug similar to its cancer medicine Avastin but priced about 40 times higher.

In the U.S., where the Multiple Sclerosis Foundationestimates that more than 400,000 people have the disease, neurologists have embraced Ocrevus. Since it got U.S. Food and Drug Administration approval in March, Ocrevus has generated almost $200 million in sales, the best drug launch in Roche’s history. Approval in Europe is expected this year, and analysts predict it will top $3.5 billion annually by 2021. By contrast, Rituxan, which is widely prescribed for lymphoma, was never cleared for multiple sclerosis and probably never will be. A few thousand Americans with MS take the drug because their doctors prescribe it anyway.

Rituxan was among the first therapies to fight cancer by attaching to a specific protein. Its target is found on a type of white blood cell called a B cell. After it was shown to help people with various autoimmune diseases, researchers surmised it might also prevent the immune systems of MS patients from attacking the brain, spinal cord, and nerves. It was a new theory—doctors had thought another type of white blood cell played a bigger role—but the medicine worked. In 2007, a decade after Rituxan was first approved for blood cancer, a Roche trial showed that MS patients who took the drug had about 90 percent less scarring in their brains than people who took a placebo. Although a second study a year later failed in the toughest-to-treat type of MS, the results were encouraging enough to spur hopes that it would be effective for some of those patients, too.

Annette Langer-Gould, a former assistant medical director at Genentech Inc., the Roche biotech affiliate where Rituxan and Ocrevus originated, helped create a development plan for the two drugs. “How the medications work is exactly the same,” says Langer-Gould, now a researcher at health giant Kaiser Permanente, which has about 1,000 MS patients taking Rituxan. While both use proteins from humans and mice, she says, Ocrevus is “a little less mouse.” Genentech decided to push forward with Ocrevus mostly because the company could charge a higher price, according to Langer-Gould. Rituxan and other treatments for lymphoma were significantly cheaper than MS drugs, she says, but Roche couldn’t arbitrarily increase the price for cancer patients. Roche says the decision “was based on scientific and medical considerations so people with MS could have the medicine with the highest potential benefit.”

Even as Roche was backing away from Rituxan for MS, neurologists began to embrace it on their own. While running an MS center in the Swedish city of Umea, Svenningsson was impressed by trial results. He started prescribing Rituxan and saw a notable improvement in patients’ day-to-day lives. Some 3,500 Swedish MS patients take Rituxan, which has proved more effective than many rival drugs designed for MS, according to the Karolinska Institutet, the Swedish research center where Svenningsson now works. Unlike older treatments that cause flu-like symptoms and sometimes must be administered every other day, Rituxan is given via injection once or twice a year. “As patients got to the end of the trial, they said, ‘Please don’t give me back that old stuff again,’ ” Svenningsson says. “ ‘Let me continue with this.’ ” —With Susan Decker

BOTTOM LINE - Roche declined to pursue research showing cancer drug Rituxan can treat MS, instead focusing on an offshoot the company says is more effective—but costs 10 times as much.

https://www.bloomberg.com/news/articles/2017-08-23/how-roche-tweaked-an-aging-drug-to-keep-profits-rolling-in

Behind big pharma's race to develop the next wave of cancer therapy

Pharmaceutical companies are betting big on a new wave of innovative cancer therapies they believe will be more effective than existing treatments and move them a big step closer to finding a cure for the disease.

•  Iain Withers 

25 JUNE 2017 • 9:14PM

Staff working in Astrazeneca's Medimmune biologic laboratory in Cambridge CREDIT: DAVID PARKER/ANL/REX/SHUTTERSTOCK

The fast-emerging branch of therapies – immuno-oncology (IO) – works by equipping the body’s immune system with the tools to kill cancer cells.

Britain’s FTSE 100 giant AstraZeneca and rival pharma conglomerates, including America’s Merck & Co and Bristol-Myers Squibb (BMS), Switzerland’s Roche and Germany’s Merck KGaA are in a race to develop the most effective IO therapies.

When they work, the body learns to fend off cancer as it would a virus, developing a long-term memory for killing off tumours in the process.

They are already transforming lives, with tens of thousands of patients around the world benefiting from first generation IO treatments, which can extend lives for months or years longer than chemotherapy and radiotherapy with fewer debilitating side effects.

It’s this “long-term benefit” and “curative potential” that excites Stuart Farrow, director of biology at Cancer Research UK’s commercial arm Cancer Research Technology, which is partnering with industry on developing IO treatments. “It is the biggest breakthrough in oncology R&D for 20 years, possibly even since chemo,” he says.

Immuno-oncology is a huge opportunity for UK plc. We have an incredibly vibrant science community here.

As well as providing potential life-changing medical benefits, effective IO treatments bring big commercial rewards. IO drugs sales hit $8bn (£6.3bn) last year, led by blockbuster forerunners Keytruda and Opdivo, produced by Merck & Co and BMS respectively.

But analysts say the potential prize is much larger – a $50bn a year market if the future pipeline of IO drugs realise their full potential. That’s because there are still substantial gaps to plug in the market, both for Merck and BMS and its international rivals playing catch-up, including AstraZeneca. Only around 25-30pc of patients have been responsive to the early IO treatments. They also haven’t been approved for every type of cancer, with lung cancer remaining the largest – and largely unmet – potential market opportunity, worth up to an estimated $10bn a year. It is also the biggest cancer killer, responsible for more than 1.6m deaths each year.

So the race is on, with pharma companies increasingly turning to trials of combinations of drugs to try to boost response rates.

For AstraZeneca, Mystic can go a long way to validating CEO Pascal Soriot’s decision to rebuff Pfizer’s £69bn takeover approach CREDIT: CHRIS RATCLIFFE/BLOOMBERG

Two such closely watched trials are due to report by the end of the year – AstraZeneca’s Mystic this summer and BMS’s CM-227, both of which are phase three lung cancer trials that will go some way to demonstrating the medical and commercial potential of IO treatments.

They are also likely to be big market-movers. AstraZeneca investors expect a positive result in Mystic would lead to a 17pc jump in the company’s share price, while a negative result would send them crashing 12pc, according to an average of responses to a Credit Suisse survey.

David Cook, analyst at Panmure, cautions: “Everyone is watching Mystic to see what happens. If it’s a failure the reaction will likely be severe. With clinical trials the market tends to punish you when it goes wrong.”

Meanwhile, BMS shareholders will be hoping the company’s combination of Keytruda and Opdivo will garner positive results, after a failed lung cancer trial last August sent shares nosediving. They are still more than 20pc down since the news, slashing its market capitalisation by more than $30bn to $92bn.

For AstraZeneca, Mystic can go a long way to validating CEO Pascal Soriot’s decision three years ago to rebuff American rival Pfizer’s £69bn takeover approach in order to focus on its drugs pipeline, and on oncology R&D in particular. Since then AstraZeneca has doubled its spending on oncology R&D to around $2.6bn, almost half its total $6bn spend. A group of 1,118 patients in 17 countries are taking part in the Mystic trial, which combines IO drug durvalumab, commercially known as Imfinzi, with antibody tremelimumab.

For its part AstraZeneca insists Mystic should not be seen as the “binary” market event some investors are making it out to be.

Robert Iannone, head of IO at AstraZeneca, stresses “there’s quite a bit of optionality” built into the Mystic trial, as it will capture data for a variety of types of patients, as well as produce further “more robust” overall survival data in 2018.

AstraZeneca has seven late stage cancer drug trials underway, and another seven outside the cancer space

Nor is AstraZeneca a one-horse stable when it comes to cancer drug development. Mystic is one of seven late stage cancer drug trials the firm is working on, while it has another seven outside the cancer space.

Imfinzi has already generated positive headlines for AstraZeneca this year, boosting investor confidence ahead of Mystic, by winning US approval for use by some bladder cancer patients and producing positive trial results in a separate group of lung cancer sufferers.

Elsewhere, fellow FTSE 100 firm GSK has largely vacated the oncology market after selling its cancer drugs portfolio to Novartis in 2015, but it retains an oncology R&D operation that investors will want to keep an eye on.

Yet the IO drugs space is not just the domain of massive conglomerates. A whole host of innovative start-ups are investing in developing IO therapies, including UK firms working in partnership with Britain’s world-leading bioscience universities.

If it’s a failure the reaction will likely be severe. With clinical trials the market tends to punish you when it goes wrong

Smaller firms working in IO include Crescendo Biologics, Cell Medica, e-Therapeutics, F-star, Targovax, ANGLE, IGEM and Scancell.

“IO is a huge opportunity for UK plc,” says Cancer Research’s Mr Farrow. “We have an incredibly vibrant science community here.” The fierce race among big pharma companies to become IO market leaders means even small firms with limited clinical data can be candidates for takeovers or successful IPOs, industry insiders say.

But companies working in this cutting-edge field still face big challenges. IO drugs are known to produce significant side-effects for some patients, including the immune system mistakenly attacking normal organs and gut problems such as severe diarrhoea.

Then there’s the cost, put at around £150,000 a year per patient for a typical IO treatment. Will the NHS and other country’s health services be willing to pay this?

Scientists in the field say the potential for side-effects and the high costs make it more crucial than ever to identify which patients stand to get the best outcomes from particular treatments, by identifying biomarkers that make them most suitable and through more targeted treatments.

IO nonetheless offers up huge potential, with scientists estimating the approach may be able to address 60pc of all cancers through combinations of drugs within five years.

Dr David Berman, head of oncology innovative medicines at MedImmune, part of AstraZeneca, is bullish for the future of his field: “This is a golden age for patients and an exciting time.”

http://www.telegraph.co.uk/business/2017/06/25/behind-big-pharmas-race-develop-next-wave-cancer-therapy/