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Jan
3
Sandeep Singh Dhillon
New drug approvals hit 21-year high in 2017 – Reuters
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Ben Hirschler

LONDON (Reuters) – U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world’s second biggest market behind the United States.

Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies.

Consultancy Deloitte said last month that projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. (tmsnrt.rs/2hGom21)

Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has hailed these products as “a whole new scientific paradigm for the treatment of serious diseases”. However, there is debate as to how cash-strapped healthcare systems will pay for them.

Under Gottlieb, the FDA has taken advantage of policy changes implemented in recent years to accelerate the drug approval process.

Procedures such as the agency’s “breakthrough therapy” designation have cut review times and helped to stimulate competition by adding multiple new drugs that often work in a similar way.

A wide choice of medicines with the same mechanism of action can be a double-edged sword for manufacturers, since it gives insurers and governments ammunition to drive down prices.

Pfizer and Merck’s new diabetes drug Steglatro, for example, was the fourth product of its kind to win a green light in the United States, while Novo Nordisk’s Ozempic was the sixth of its type. Both were approved in December.

In cancer, AstraZeneca’s Imfinzi was the fifth medicine to target a key protein found on the body’s immune cells when it won approval last May.

For the current year, companies have more new products waiting in the wings, although the pace of FDA approvals may be tempered by the fact that several drugs that had been expected to be cleared in the first quarter of 2018 were actually approved in 2017.

In Europe, meanwhile, the focus will be on any disruption or delays to the approval process as the European Medicines Agency prepares to relocate from London to Amsterdam as a result of Britain’s decision to leave the European Union.

Reporting by Ben Hirschler; Editing by Keith Weir

This article originally appeared in https://www.reuters.com/article/us-pharmaceuticals-approvals/new-drug-approvals-hit-21-year-high-in-2017-idUSKBN1ER0P7

Dec
13
Sandeep Singh Dhillon
Chemotherapy-Free Cancer Treatments Move Closer To Reality – Forbes
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By Victoria Forster, CONTRIBUTOR

CAR T-cells first hit the headlines in 2012 after saving the life of a young girl in Philadelphia, Emily Whitehead, who was running out of options to treat her aggressive, relapsed leukemia. Doctors removed some of her T-cells, genetically modified them to attack a protein called CD19 on her leukemia cells and injected them into her bloodstream. Just three weeks later, she was in remission.

Although rare, it is not unheard-of for new treatments to achieve substantial early successes in one or two patients only to experience significant, sobering setbacks in larger-scale trials. This often at the very least dampens the media hype, but CAR T-cells have made consistent progress in garnering both considerable investments from pharmaceutical companies and strong results from clinical trials. Further promising results for the therapy were reported at the American Society of Hematology (ASH) conference this week for a host of blood cancers, including practically incurable multiple myeloma.

Blood cancers are often the experimental template for pioneering new cancer treatments, such as Gleevec for chronic myeloid leukemia, the first-ever FDA approved cancer therapy to target a specific protein found on cancer cells. Gleevec achieved spectacular clinical trial results before its approval in 2001 and went on to transform cancer medicine, changing a disease with a 30% five-year survival rate to one where over 80% of people survive for 10 years or more. This success is partly due to the ease of taking blood samples to monitor the effects of therapies compared to invasive biopsies and costly scans for solid tumor patients, but researchers are optimistic about the wider prospects of CAR T-cells.

“It’s an exciting time. Based on these results and recent FDA approvals in this field, there is reason to be confident that cell therapies, such as CAR T, may one day be the standard of care for hematologic malignancies as well as solid tumors,” said Reiner J. Brentjens, MD, Director of cellular therapeutics at Memorial Sloan Kettering Cancer Centre at the ASH meeting.

For tumors with currently dismal outcomes with conventional chemotherapy, this hopeful prediction can’t come true soon enough, and with almost 100 CAR T-cell clinical trials currently ongoing in the U.S. alone, including for pancreatic and brain cancers, options for patients with hard-to-treat cancers are increasing.

Many conventional chemotherapy agents kill cancer cells in a way which can crudely, but regrettably and truthfully, be described as carpet-bombing, indiscriminately affecting any cell which is dividing. CAR T-cells are the exact opposite, being engineered to target normally one very specific protein on whichever cells are in the crosshairs. In the case of many leukemias and lymphomas, this protein is CD19, present on B-cells, a type of white blood cell normally involved in the immune response when functioning correctly.

More specific therapies generally mean less toxicity for healthy tissues and fewer side-effects for patients. However, just as bacteria generate resistance to antibiotics, cancer cells are constantly evolving to evade the effects of chemotherapy. Many of the old chemotherapy drugs, for their many flaws, work in ways which make it difficult for cancer cells to evolve complete resistance as they affect processes key for survival such as DNA replication. However, the specificity of CAR T-cell therapies is, in this case, an Achilles heel. In one of the trials reported at ASH this week on refractory Non-Hodgkins Lymphoma, in a third of patients who relapsed after treatment, their cancer had evolved to simply not have the CD19 protein targeted by the CAR T-cells, rendering the therapy useless.

One of the current theories as to why this happens is that the CD19 negative cells may have been already present in the patient, just in tiny numbers. When the cells with CD19 were massacred by the CAR T-cell therapy, the cells without it no longer had any competition and thrived. So what is the solution? Make the therapy just a little bit less specific again. New studies are trialing CAR T-cells which go after two targets on B-cells, a protein named CD22 as well as CD19. It is hoped that the B-cells can’t survive if they lose both CD19 and CD22 and even if they evolve to lose one protein, they will still be susceptible to the therapy via the other.

Most CAR T-cell trials have currently been done in patients with few other options but the hope is that they will eventually be able to reduce, or even replace chemotherapy currently needed to achieve a cure, even in cancers with an excellent prognosis. For example, over 85% of children now survive leukemia long-term, but the cocktail of chemotherapies they receive come with considerable side effects, with many survivors experiencing serious health conditions later in life as a result of the treatment.

Although scientists are beginning to understand the short-term toxicities of CAR T-cells, their long-term side effects are largely an unknown and will remain so for several years. However, scientists are hopeful that CAR T-cell therapy will have fewer and less severe long-term side effects than conventional, old chemotherapies. A big ethical and moral question is how to justify replacing treatments which are undeniably very good at achieving the main goal of saving lives, with something which is currently less certain. For parents of children with leukemia who have failed conventional treatments already, the decision to try CAR T-cells is easy. For the first parents that consent to the inevitable chemotherapy-free CAR T-cell only trial, it will be a leap of faith. If all goes well, their children will be the first ever to survive leukemia without any chemotherapy treatment.

In May this year Emily, the first patient to get CAR T-cells celebrated the milestone of being five years cancer-free. Undoubtedly there are still numerous challenges to overcome before CAR T-cells become a mainstream therapy for multiple cancer types, but in five years from now, hundreds if not thousands of others will be joining Emily in this currently unique club.

The original article first appeared at https://www.forbes.com/sites/victoriaforster/2017/12/12/chemotherapy-free-cancer-treatments-move-closer-to-reality/?ss=pharma-healthcare#1486f28e6676

Dec
4
Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
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By Bill Wilson
Business reporter, BBC News

Brexit may affect the cost of medicines and hit UK pharmaceutical investment, a Commons committee head has warned.
Rachel Reeves, who chairs the Business, Energy and Industrial Strategy (BEIS) committee, says access to new medical products may also be at risk.
She said the uncertainty around Brexit was “very concerning”, as MPs prepare to examine its effects on the industry.
They include the sector’s access to highly skilled workers after the UK leaves the European Union.
Ms Reeves said the evidence MPs had received suggested Brexit could threaten “the cost of medicines, investment in the UK and access to new and innovative research and products”.
“There are serious concerns raised around the future regulation of pharmaceuticals, mutual recognition of medicines, and the prospect of damaging disruption to cross-EU drug supply chains,” she said.
“This is very concerning, with uncertainty risking the UK becoming a less desirable place for investment and development in a growing, productive industry.
“We are keen to examine the detail of these concerns and to hear from the industry what it wants from the government to ensure the smoothest possible transition as we leave the EU.”
Brexit will mean the relocation of the European Medicines Agency from London to Amsterdam.
The MPs’ inquiry comes despite the announcement last week of two big deals in the UK’s pharma sector.
The government said then that the decisions by MSD, known as Merck in North America, and Germany’s Qiagen illustrated confidence in its recently announced industrial strategy for when the UK leaves the EU.
The industrial strategy white paper outlines the government’s plans to support more research and development, encourage firms to embrace new technology and boost the economy.
A report in the Sunday Times said more major investment for the sector is due to be announced soon, with GlaxoSmithKline expected to reveal a new research partnership.
The Business committee has been seeking views from across the sector and has received written submissions from big pharmaceutical companies, trade unions, industry bodies and the government.
The submissions have been published ahead of a public evidence session on Tuesday when the committee will question witnesses from the industry on the impact of Brexit.
It will consider different outcomes relating to future cross-border customs and trading arrangements, and consider what the government should aim to achieve in negotiations.
Those appearing before the committee will include the Association of the British Pharmaceutical Industry (APBI) and Belgian-headquartered Janssen Pharmaceutical, part of US giant Johnson & Johnson.
The ABPI said the inquiry was important.
“The written evidence received by the committee highlights how regulatory cooperation, a frictionless system for trade and access to research funding, collaboration and talent, underpin the successful development and delivery of medicines,” a spokesperson said.
“Evidence also shows that 45 million packs of medicines go from Britain to the EU every month and 37 million come the other way. With this whole system at stake, clarity on medicines regulation and trade is urgently required for all patients across Europe.”

Full article at http://www.bbc.com/news/business-42213937

Nov
27
Sandeep Singh Dhillon
Roche Cancer Drug Rises To Challenge Merck, Bristol-Myers – Forbes
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By Matthew Herper

Tecentriq, a cancer immunotherapy developed by the Swiss drug giant Roche, slowed the progression of previously untreated lung cancer in a large clinical trial when combined with a chemotherapy regimen, the drug giant said.

“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer said in a press release

The news represents the latest upset among a class of new medicines that unlock the body’s ability to fight tumors. These medicines, called PD-1 inhibitors, are already big sellers for Bristol-Myers Squibb and Merck. In the third quarter of 2017, Bristol’s Opdivo generated $1.3 billion in sales; Merck’s Keytruda generated $1 billion. Financial analysts at Wall Street banks forecast that by 2022, these drugs will generate annual global sales of $25 billion a year, with the bulk of sales going to Bristol and Merck.

Merck has pulled ahead of Bristol, the pioneer in developing these drugs, because an early Merck trial in first-line lung cancer succeeded, while a similar study from Bristol failed, baffling investors and researchers. Keytruda is approved in advanced non-small lung cancer in patients whose tumors express a protein called PD-L1 above a certain level, or in combination with the chemotherapy drugs Alimta and carboplatin. Today’s Roche result complicates things further, because Roche used a different combination of drugs

Roche’s study had three arms. All patients received carboplatin and paclitaxel, the cancer drug once sold as Taxol. The control group also received Avastin, one of Roche’s best-selling cancer drugs. Then two groups got Tecentriq, one with Avastin and one without. What Roche has announced today is that the Avastin-Tecentriq-chemotherapy combination did better than Avastin and chemotherapy alone, and that the survival results so far are “encouraging.” That leaves a big question: how are the patients who got Tecentriq, but not Avastin, doing?

It’s impossible to know exactly what this will mean until the full results of the study are presented. (Companies release early results by press release because they are considered too important to investors to keep secret.) In morning trading, Roche shares are up as much as 5.6%, and Merck shares are down 2%. But two analysts, Umer Raffat of Evercore/ISI and Timothy Anderson at Bernstein Research. commented that the results could actually be seen as a validation of the general Merck approach of combining PD-1 drugs with chemotherapy. Rivals, including Bristol and AstraZeneca, have favored combining them with another type of immunotherapy drug, called a CTLA4 inhibitor, such as Bristol’s Yervoy.

One big question will be how the chemotherapy regimens stack up against the CTLA4 combinations. Another will be how they stack up against each other. How will doctors compare the Merck and Roche drug regimens? How will insurance companies decide which ones to cover? Anderson, the Bernstein analyst, said that investors are likely to not view Roche as a big threat because it is entering the market late. But he also wrote that the trial is “one important piece of a complex, still largely incomplete, puzzle.” Bernstein forecasts 2022 Tecentriq sales of $3.7 billion, less than half as much as for Opdivo or Keytruda.

Nov
24
Sandeep Singh Dhillon
Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. – Reuters
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Teva Pharmaceutical is expected to cut up to a quarter of its 6,860-strong workforce in Israel, and a few thousand more staff in the United States, media reported Thursday, though a minister said the figures may not be accurate.

The world’s largest generic drugmaker will send termination letters to “tens of percent” of its 10,000 employees in the United States in coming weeks, Israeli financial news website Calcalist said, citing people familiar with the matter.

The debt-laden company’s stock closed up 4.6 percent in Tel Aviv on the report. A spokesman for Teva, which was seen as one of Israel’s great corporate success stories, declined to comment.

Teva had been widely expected to cut costs after warning this month it would miss 2017 profit forecasts due to falling prices of generics in the U.S. and weakening sales of its multiple sclerosis drug Copaxone.

Teva has also been saddled with nearly $35 billion in debt due to its $40.5-billion acquisition of Allergan’s generic drug business Actavis last year. Investors have been pushing for clarity on its future.

Teva has already been selling off assets to help meet its debt payments.

Teva’s new Chief Executive Kare Schultz was working out the details of the job cuts with regional management in Israel and the United States, Calcalist reported.

It said between 20-25 percent of the staff in Israel could go, including Michael Hayden, Teva’s chief scientific officer and president of research and development.

Israeli Economy Minister Eli Cohen told Reuters he had spoken with officials at Teva and was told that the numbers leaked to the media were off.

“I spoke to them this morning, they said the figures are not accurate,” Cohen said.

The Histadrut labour federation said it would not accept any unilateral moves by Teva’s management.

“Any efficiency measures, if and when they arise, will be done through negotiations and with the agreement of the Histadrut and the labour unions,” Histadrut spokesman Yaniv Levi said. “Lay-offs are the last resort.”

Fitch Ratings downgraded Teva’s debt to junk this month. (Editing by Andrew Heavens)

Read more: Teva Pharmaceutical Set for Major Layoffs in Israel, U.S. -Report | Investopedia https://www.investopedia.com/partner/reuters/teva-pharmaceutical-set-major-layoffs-israel-us-report/#ixzz4zMQtBcMy
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Oct
23
Sandeep Singh Dhillon
Amazon Is About To Disrupt The Drug Industry, But Not The Way Most Think – Forbes
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By Steve Brozak, CONTRIBUTOR

It’s now a foregone conclusion that Amazon.com will enter the healthcare sector. Every day there is another article on how Amazon is planning to dominate some new corner of the American economy. One day Amazon is taking down Grainger and Home Depot. The next it’s single-handedly taking down not only FedEx, but also UPS and the United States Postal Service. No sector seems safe as Amazon sails its ship into new waters. But those expecting Amazon to cannon ball into healthcare may need to bide their time.

Two years ago I wrote in Forbes about how Amazon’s entry into healthcare could decimate CVS and Walgreens. I think it’s still possible, but not in the way the markets and media are anticipating today. Amazon’s entry into healthcare will not be sudden. It is likely to be similar to the acquisition of Whole Foods which developed over years as Amazon evolved its strategy in home grocery delivery, one part of the incredibly valuable consumables market. It was accomplished through trial, error and recognition that Amazon needed a bricks and mortar approach to the segment that led to the Whole Foods acquisition. Sudden and complete immersion into the healthcare system as it currently exists could taint the Amazon brand and will make the company vulnerable to regulatory risk. But there are segments of the healthcare market that offer an opportunity for Amazon’s unique capabilities, and there is evidence that Amazon has been making those slow and steady moves toward healthcare.

Becoming A PBM Could Be Amazon’s Healthcare Market Entry

Pharmacy Benefit Managers are the gate-keeping middlemen of the healthcare system. PBMs administer health plans for insurance companies and employers. They manage benefits and treatment costs for these organizations. The more organizations a PBM services, the greater number of patients (or lives, in insurance lingo) under its umbrella. With more lives comes more leverage when a PBM negotiates with pharmaceutical manufacturers for drug prices.

The three largest PBMs are Express Scripts, CVS and OptumRx, covering more than 80% of insured Americans. A PBM that manages tens of millions of lives has greater purchasing and negotiating power than a standalone company with 3,000 employees, or a pension plan with 20,000 lives, or even an independent insurance plan with just a few million lives. Among a slew of other services, PBMs primarily work with their clients to construct and administer a pharmacy benefit program, which is often referred to as a drug formulary. Formularies are just the lists of drugs that are approved or that have preferred pricing for the insurance company through a PBM’s negotiations with the drug’s maker. In exchange for placing its drug on formulary, a PBM receives a preferred price and a cash rebate from the drug’s manufacturer for every prescription it processes. Your insurance plan’s formulary is a major reason why your doctor prescribes you one drug company’s medicine over a competitor’s. Being the preferred drug is the goal. PBMs share a portion of the rebate it receives with their clients (the health plans) and patients receive the benefit of a drug at a preferred price. PBMs also collect fees for transactions and services it processes for its clients.

Target and Walmart learned that merely selling pharmacies in their bricks and mortar operations or through the mail doesn’t equal profits, although a case can be made that it certainly increases foot traffic and store loyalty. Margins are incredibly thin for the kinds of drugs they sell most routinely. In fact, Target sold its in-store pharmacy business to CVS, a pharmacy and a PBM, and Walmart has partnered with McKesson to source its drugs. Becoming a full service PBM would have allowed Target and Walmart to have greater control over margin, but it wasn’t in the cards for either company. While becoming a PBM could be the key to unlocking profits for Amazon, the current political and social environment is unfriendly toward PBMs and drug makers and comes with its own risks.

Despite this, a gamble in healthcare has to happen sooner rather than later. Amazon’s primary customer is between 30 and 45 years old, and that’s a demographic that will soon be looking to fill more and more prescriptions. And if you don’t think their customers’ life cycle milestones are part of retailers’ strategic plans, just look at the pace of acquisitions around baby startups just under a decade ago. Amazon bought diapers.com while Bed Bath & Beyond acquired Buy Buy Baby. Finding an algorithm that figures out when you’re going to have a child before you even think of having one yourself is the holy grail of E-commerce. The birth of a child is a significant milestone around which there is a burst of spending to capture. Likewise, as its consumers age and continue to change their habits through online shopping, healthcare has become the next frontier. Amazon has already made an entry and is setting prices for over the counter medications (OTC). On average, its OTC products, like Tylenol, are cheaper on its website than most bricks and mortar stores. There are several theories circulating around Amazon’s entry into healthcare. Here are my thoughts on three of the most common scenarios being discussed.

Scenario 1: Amazon Acquires Or Partners With A Large PBM

One of the more popular scenarios bandied about is that Amazon may acquire a large PBM player. This is unlikely for a few reasons. Foremost, while it would allow Amazon to quickly enter the healthcare market, integrating the processes and services from a large operation into Amazon would be complicated and chaotic. As the drug pricing debate continues in the mainstream, PBMs have been painted with a big target on their backs as more light is thrown on their opaque and very misunderstood segment of the healthcare system. Just this week, Senator Lamar Alexander (R-TN) wondered out loud why PBMs even need rebates, which is the lifeblood of the industry.

It will be very difficult to recreate the frustration-free consumer experience Amazon currently offers and replicate it through healthcare services as healthcare currently exists. Therefore Amazon will want to separate any healthcare services it offers from its main brand and ease into the business. You could argue that Amazon is already easing in by selling prescription drugs on their Japanese website, perhaps a test case for an American entry (supporting the case for Scenario 3). If you think Amazon can do no wrong, remember this is the company that thought it would be a good idea to emblazon Amazon.com on the back of its Fire Phone, a complete flop. Amazon can’t afford a flameout in healthcare, and making another transformative purchase that could easily eclipse the purchase of Whole Foods so soon, while entirely possible for a company the size of Amazon, would be wholly inadvisable.

As far as partnering goes, sure, Amazon could attempt to partner with a Prime Therapeutics or an Express Scripts. As others have pointed out, Amazon has a strong history of partnering with companies, leveraging its consumer reach and logistical magic to tap into and offer lifelines to companies like Circuit City and Toys R Us. But then what happened? The companies Amazon partners with tend to go out of business as Amazon upends the market.

Scenario 2: Amazon Re-engineers The Wheel With A Smaller PBM

It’s clear that Amazon needs to either re-engineer the PBM wheel or partner with a creative player who already is. While a partnership with a conventional middle market PBM will give Amazon a good entry point in healthcare, a better route would be to partner with an even smaller PBM to really learn the business, gain valuable insights on the industry and bring the PBM model into the 21st century. There are already reports that Amazon, with its 350,000 employees, is trying to administer its own health plan internally as its own PBM. While hiring executives from industry to construct its own virtual PBM is a good way for Amazon to start, it’s still just virtual. An even better path forward would be to acquire or partner with a smaller PBM that already manages millions of lives, self adjudicates (processes its own claims) and can easily manage an additional 350,000 Amazon employees. Through the smart acquisition of a creative PBM, Amazon would learn the business model and incorporate a PBM-like service into an expanding slate of healthcare programs and service offerings.

Scenario 3: Amazon Becomes A Bricks And Mortar Pharmacy In Order To Become A Mail Order Pharmacy

Amazon is well positioned to enter the mail order pharmacy business. Most mail order services are contracted out to a handful of other pharmacies that specialize in mail order delivery. For a while, insurance companies preferred their patients to enlist in a mail order pharmacy because the pricing was competitive compared to going to CVS or Rite Aid. Over the last several years that gap has narrowed. But mail delivery is what Amazon does very well, and combining a mail delivery strategy with a bricks and mortar strategy makes an incredible amount of sense for the company, especially now that it has acquired Whole Foods.

Before acquiring Whole Foods, it never made sense for Amazon to build or to acquire a network of independent pharmacies. Since none of the Whole Foods stores have a pharmacy, Amazon has an opportunity to establish in-store pharmacies that are powered by mail order fulfillment centers. A bricks and mortar strategy should be based around having an in store pharmacist fill as few prescriptions as possible. Rather, a regional prescription fulfillment center could fill and deliver the majority of prescriptions to both the store and to the patient’s doorstep. This is not unlike the current pharmacy model whereby local bricks and mortar pharmacists fill immediately needed prescriptions in the store, while chronically needed medications are filled and delivered to the store by a regional fulfillment center for monthly pickup by the patient. A model in which Amazon combines its mail delivery capabilities with its Whole Foods bricks and mortar would begin to draw two-way traffic from the stores and onto Amazon’s website. As patients sign up and manage their medications, they would create an essential link between the virtual and bricks and mortar Amazon. Shopping for eggs at Whole Foods isn’t going to compel me to go to Amazon.com no matter how many signs Whole Foods hangs in its stores to remind me that they’re now owned by Amazon. But managing my pick up/drop off of medications at my local Whole Foods through my Amazon health portal would draw me into both. Amazon seems to understand this and has already begun to blend its online business in Whole Foods by placing its innovative pick up/return locker system in Whole Foods lobbies.

Of course, while a current generation of Americans prefer to have the personal touch of interacting with and picking up their prescriptions, the trend will soon be to have most drugs delivered by mail. I have even evaluated companies that are working on fill-on-demand drug dispensing vending machines, which may also one day make their way into Whole Foods stores (let’s call them Locker 2.0). To date the one area of true weakness for mail order pharmacy services has been providing essential prescriptions immediately, say, on the day a patient is discharged from the hospital. That’s a weakness Amazon could easily topple with its tests of Prime Now, its same-day two-hour delivery service, another incremental step as Amazon inches toward the healthcare market.

Amazon’s customer base may be young, averaging 35 years old, but they are aging and in the midst of the child-rearing cycle, which requires frequent trips to the pharmacy. Amazon’s customers will need more prescriptions for themselves and for their children. Soon an entire generation will be even more used to buying things online. Right now Amazon has announced it is preparing to make two very big decisions public. The first is whether or not it will get into healthcare, to be announced, supposedly, sometime around Thanksgiving. The second is where it will locate its second world headquarters. If Amazon wants to capture as much of the purchasing a customer can do, it will need to mature with its consumers and formally enter into the healthcare market.

And as for my prediction for Amazon HQ2: It’s Boston.

Oct
2
Sandeep Singh Dhillon
Malaysia’s healthcare budget below WHO recommendation – The Malaysian Insight
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By Noel Achariam

MALAYSIA’S budget for healthcare is 3% lower than the World Health Organisation (WHO) recommendation and needs to be raised, said a consultant.

InfoMed chief executive officer Mohan Manthiry said the nation’s current budget for healthcare was 4% of the gross domestic product, and the government must spend more to provide quality care especially in public hospitals.

“The general population, where a majority are hard-pressed by inflation, are now flocking to government hospitals.

“Malaysians can’t afford proper healthcare because of stagnant salaries, poor revenues and negative growth.

“The government needs to provide more services, improve facilities and reduce congestion.

“To do this effectively, the government needs to allocate more funds for healthcare,” he said after speaking at the Malaysian Insurance Institute on Medical Health and Insurance Seminar today.

It was reported that the Health Ministry would seek a bigger allocation under Budget 2018 due to increasing medical costs.

Its minister, Dr S. Subramaniam, said the RM23 billion allocated for this year was insufficient, which prompted the ministry’s request for an increased allocation.

He said the ministry was committed to providing the people with quality healthcare.

Budget 2018 will be unveiled in Parliament on October 27. In past budgets, the ministry had received between 10% and 15% more in the annual allocation.

Mohan said according to WHO, the recommended budget for healthcare in Malaysia should be 7%.

“Malaysia’s current budget (for healthcare) is 4% of GDP. Singapore, whose healthcare is among the best in the world, is only spending 5% of its GDP, and is still able to provide quality healthcare.

“This is because the funds have to be efficiently utilised. Otherwise, quality healthcare is not going to be felt by the public.”

Mohan said the healthcare sector should be geared towards prevention and enhancing the education system to reduce incidences of chronic diseases.

“There is a worrying trend in non-communicable diseases, such as diabetes and obesity. This is something we should focus on, which is consuming most of the resources in healthcare. ”

WHO had stated that almost 70% of the global mortality rate was due to such diseases, he said, adding that in Malaysia, the number of patients was on the rise, with the country being No. 1 in diabetes and obesity in the region.

“To manage this, we need to get individuals to take charge. We cannot leave it to the government, doctors and hospitals.

“This has got to do with lifestyle, and one of the major causes is the food we eat.

“We need to have a long-term plan, and I have been advocating the need for education in healthcare.”

Mohan said it was crucial for healthcare to be taught as a subject at the primary school level.

“It should be in the curriculum, where children are taught everything in healthcare and matters related to health, from food and the environment to exercising.

“Such education should start at home, but it’s not happening. So, it has to become part of formal education.

“It is good if this can be implemented in primary schools. Then, the government would not have to spend so much money (in its healthcare budget) because it’s part of the curriculum.”

The original article can be viewed at https://www.themalaysianinsight.com/s/16128/

Sep
26
Sandeep Singh Dhillon
Pfizer spends billions to develop new drugs. It’s not satisfied. So it’s launching a startup – Statnews.com
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By DAMIAN GARDE @damiangarde SEPTEMBER 25, 2017

There’s a popular theory about the limitations of global pharma companies: For all their skyscrapers and strategy reviews and private jets, they’re simply too knotted up in bureaucracy to realize how many great drugs are gathering dust in their vaults.

Now, the biggest of Big Pharma is out to do something about that. Pfizer, home to nearly 100,000 employees, on Monday announced the launch of a six-person startup to develop new drugs.

This may seem odd in that Pfizer spends literally billions of dollars a year advancing treatments of its own. But the company’s executives say they simply don’t have the resources to advance all the promising compounds that catch their eye — and they believe an independent company with the scrappy ethos of a startup will be in a better position to take on that task.

“The problem is very simple: There’s too much good science and not enough resources to advance it,” said Dr. Lara Sullivan, a former Pfizer vice president who is now leading the startup.

“If you want to see grown men cry, stop a program for budget reasons, not based on science,” Sullivan said.

The new spinoff, SpringWorks Therapeutics, is getting started with $103 million from investors including Pfizer and Bain. It will focus at first on four Pfizer-invented therapies, for conditions including post-traumatic stress disorder and rare forms of cancer. All are already in clinical trials. The two most advanced therapies, targeting tumors found on connective tissue and nerves, will advance to the final stage of development in the coming year.

SpringWorks, which will be based in New York, also plans to scour the pipelines of other pharma companies for compounds that have been set aside for lack of resources, hoping to license some of them for further testing.

It’s a business idea that has been gaining steam of late.

Roivant Sciences, founded by an ex-hedge fund manager in 2014, has built a cottage industry on the same principle, licensing unwanted therapies from the likes of GlaxoSmithKline and Takeda and then launching small startups to test them.

BridgeBio Pharma, established in 2015, takes a similar approach, searching academia and pharma alike for early-stage projects in the field of inherited disease. “We have what we call a better-owner model,” CEO Neil Kumar said. “We try to advance things as far as possible until we’re clearly not the best owner for the asset.”

The concept of scavenging for waylaid gems is considered so promising that Roivant has raised more than $1 billion to widen its search. Its 32-year-old founder, Vivek Ramaswamy, landed on the cover of Forbes, and two Roivant spinoffs pulled off a pair of biotech’s largest-ever Wall Street debuts.

Neither Roivant nor BridgeBio, however, has yet brought a drug to market.

And they’re dogged by the same questions that will follow SpringWorks: If these discarded compounds are so promising, why were they discarded in the first place? And how can a startup push them along better than a multinational heavyweight?

“What I’d say is that from the ground up we’re different,” said Saqib Islam, SpringWorks’ chief financial officer and chief business officer.

The company doesn’t intend to push for quick-turnaround returns on investment, he said. And it plans to work alongside the companies that originally invented or discovered each compound — such as Pfizer — to take advantage of in-house expertise.

“We think that’s the distinction that will draw some attention from those looking to partner their assets going forward,” Islam said.

Pfizer’s decision to wade into the space follows years of navel-gazing at major pharma companies, which have long envied the agility and nothing-to-lose gusto of biotech startups.

Conscious of how the comforts of corporate largess can be counterproductive, companies including GlaxoSmithKline and AstraZeneca in the past sought to create mini startups within their own walls. But though they tried to replicate the feverish immediacy of startup culture, that proved almost impossible when the employees knew they were operating above the multibillion-dollar safety net of a huge pharma company.

Pfizer’s move to create an independent company — deliberately safety net-free — suggests the biggest wheels of the drug industry have learned an important lesson, said Bernard Munos, a former R&D executive at Eli Lilly who now consults for pharma companies.

“I think the industry has realized that they have not really been true to their words in terms of embracing innovation,” Munos said. “So this is very encouraging, frankly, especially coming from Pfizer.”

Read the original post here https://www.statnews.com/2017/09/25/pfizer-startup-new-drugs/

Sep
20
Sandeep Singh Dhillon
Malaysia moves forward to combat Hepatitis C; issuing compulsory license to produce generic treatment – MIMS Malaysia
Pharma News, Pharma Notables
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By Reshmin Kaur Cheema

With the rising costs of the Hepatitis C treatment, Malaysian authorities have decided to step up and take measures to ease patients’ burden. They will be following through on plans to allow for generic companies to produce a version of the expensive Sovaldi (Sofosbuvir) pill.

This sets Malaysia as the first country to initiate such move, amidst global headlines highlighting this distressing financial matter. In light of the difficulties governments are facing – especially in Malaysia – patient advocates have commended the move in widening access to treatments.

Putting things into perspective, MIMS previously reported that roughly 500,000 or 2.5% of the Malaysian population are said to be living with chronic liver conditions.

Different approach to tackling increased costs

Executive Director of South Centre, a non-governmental organisation based in Switzerland, Martin Khor wrote to The Star publication stating, “The government decision is the key to opening the door to affordable treatment. The government will have freedom to choose which drug to buy from which firm, at what prices, and with which other drugs to combine it.”

This latest update comes after the government initial plans to issue a supposed government-use license that was announced last month. Following this, Gilead Sciences went on to expand a 2014 licensing deal. This allows for seven larger generic drug makers, with operations in India, to sell copycat forms in middle-income countries like Malaysia, Ukraine, Belarus and Thailand.

The deal was originally thought up to increase access in 101 low-income nations and shut down criticism over the pricey drug status. However, Gilead still endured objections because some of those from middle-income countries cannot afford the Sovaldi drug. Thus, the Malaysian government has decided to roll out generic licensing to bypass the Gilead patent altogether.

Consumer activists say that Malaysia chose to pursue the license as a less restrictive option. They elaborated that Gilead’s ways would jeopardise an ongoing Malaysian project whereby the authorities are working hand in hand with Drugs for Neglected Diseases Initiative – a non-profit and an Egyptian company to produce a generic treatment.

Varying responses – to commend or remain sceptical

Sangeeta Shashikant, a legal advisor to Third World Network (TWN), opined that with this move, Malaysia is projected to obtain combination Hepatitis C treatments for USD300 and perhaps less. The Gilead license, on the other hand, may not reflect the most affordable prices, as pricing relies on the level of generic competition in the country.

Consumers Association of Penang stated that “It is imperative that the government sticks to its decision to issue a government-use license. This is because there are strict limits to what Malaysia can do or cannot import or produce under the Gilead license, and other factors that restrict the freedom to choose the generic companies that it can work with.”

It continued, “…Therefore, it is best for Malaysian consumers and patients that the government have both the government-use license as well as the license scheme that Gilead will extend to Malaysia. Both can co-exist, providing Malaysia with maximum policy choice.”

However, The Galen Centre for Health and Social Policy said Putrajaya should deliberate negotiating the best possible deal with Gilead – including technical support, concessions and additional assistance.

Chief executive Azrul Mohd Khalib said, “This hard-won development would see increased access to a treatment which will improve the quality of life for patients and most importantly, save lives. It represents a moral victory for the government which has worked hard to enhance access for Malaysians to innovative drugs and treatment to treat emerging health challenges.”

However, “implementing a government-use license would be outside that framework. It could represent a pyrrhic approach to a long-term problem with possible consequences and complications,” cautioned Azrul. MIMS

Full article at http://today.mims.com/my-moves-forward-to-combat-hepatitis-c-issuing-compulsory-license-to-produce-generic-treatment?elq_mid=35178&elq_cid=26983

Sep
12
Sandeep Singh Dhillon
Why The Omega-3s In Walnuts Are Not The Same As The Ones In Fish And Algae – Forbes
Pharma Notables
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By Alice G Walton,

There seem to be an awful lot of articles suggesting that people have a handful of walnuts or seeds to get their omega-3 fatty acids. While this isn’t wholly bad advice, it’s not exactly the most accurate. The problem is it assumes all omega-3s are interchangeable, when in fact they’re not. There are actually several different iterations of the fats, and unfortunately the ones that come from plants are not as healthy as the ones that come from fatty fish (and happily for vegetarians, algae).

Here’s a brief rundown: The variety of omega-3s in plants is α‐linolenic acid (ALA). The omega-3s in fish are eicosapentaenoic acid (EPA) and docosapentaenoic acid (DHA). Humans aren’t able to make EPA or DHA from scratch; we need either to eat them or to form them from shorter fatty acids (like ALA). The body is able to convert ALA into EPA and DHA through a chain of chemical reactions that generally take place in the liver. In this sequence of events, DHA is the final product, arriving a couple of steps after EPA. (For a detailed breakdown of all the reactions needed to take ALA to DHA, see this.)

The problem is that the conversion isn’t very efficient, with only a small percentage of ALA making it all the way to DHA. This is partly due to competition from omega-6 fatty acids, which people tend to eat in higher quantities than omega-3s in general.

“The human body can convert the plant omega-3s into the fish omega-3s but in many people this process does not seem to work very well,” says Philip C. Calder, a professor of Nutritional Immunology at the University of Southampton who studies omega fats. ”One reason for that might be the high amount of omega-6s that people eat – these stop the body’s conversion of plant omega-3s.”

So people who rely on the omega-3s from plants may still be low on DHA and EPA, since the conversion isn’t so efficient. In other words, eating walnuts to get your omega-3s may not be enough. “It is very important for consumers to be aware that some omega-3s come from plants and some come from fish,” says Calder. “These omega-3s are not the same thing.”

The larger issue—and the reason any of this matters at all—is that the different omega-3s have different effects on our health. The long-chain fatty acids, EPA and DHA, are well known to reduce inflammation in the body, and are particularly good for the cardiovascular system, reducing heart disease risk, and for the brain, reducing the risk of dementia. They are also important to the developing brain—pregnant women should take special care to take in enough. The bulk of ALA, which isn’t converted to EPA and DHA, still plays important roles in the body, from the structure of cell membranes to use as energy or energy storage. And omega-6s, though essential in low levels, are linked to inflammation at higher levels. Most people eat many more omega-6s, which are found in a number of foods including poultry, eggs, grains, and nuts, than omega-3s of any type.

So keep in mind the difference in the omega fats, and most importantly, the fact that while DHA, EPA, and ALA all fall under the omega-3 umbrella, they’re not interchangeable. Lumping all omega-3s together may not be wise. Lumping omega-3s and omega-6s together is probably even less wise.

“There is a role in human health for both the plant and fish omega-3s,” says Calder, “but the fish omega-3s are more active in the body. Ideally people will get their omega-3s from foods like fish.” If you don’t eat much fish, you may want to supplement with fish oil supplements. And for those who don’t eat any fish, algae oil supplements will do just fine, since algae contains DHA. In any case, remember that omega-3s from the land are ok, but the ones from the sea are much better.

Opinions expressed by Forbes Contributors are their own.