Taste Movie

Taste Movie 2015

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Endo, others to pay $270.8 mln to resolve Lidoderm U.S. antitrust cases

(Reuters) – Endo International Plc and two other companies have agreed to pay $ 270.8 million to resolve class action lawsuits alleging Endo paid a generic drug manufacturer to delay launching a cheaper version of its Lidoderm painkiller patch.

The accords were disclosed in papers filed in federal court in San Francisco on Tuesday and resolve claims centered on a deal Endo reached in 2012 to settle a patent infringement case it filed against generic drugmaker Watson Pharmaceuticals.

The case is among several in recent years targeting “pay-for-delay” settlements, in which brand-name drugmakers resolve patent lawsuits by paying generic manufacturers to keep their products off the market for a longer period.

Endo has agreed to pay a combined $ 100 million to resolve claims brought by separates classes of direct purchasers of Lidoderm like retailers and so-called end payors for the medication like consumers and insurers.

Teva Pharmaceutical Industries Ltd, which owns Watsons’ generics business, has agreed to pay $ 112 million, a sum that is part of the $ 157 million the Israeli company in February disclosed it would pay to settle the litigation.

Teikoku Seiyaku Co, a Japanese drugmaker that manufactures Lidoderm for Endo to sell in the United States, will pay $ 58.75 million, according to court papers.

The settlements are subject to court approval. Matthew Maletta, Endo’s chief legal officer, in a statement called the settlement “a significant milestone in Endo’s multi-year turnaround plan.”

Teva in a statement said it was “in the company’s best interest to resolve this matter and to focus on our mission of providing innovative and affordable medicines to people around the globe.”

Representatives for Teikoku and the plaintiffs did not respond to requests for comment.

The litigation centered on a settlement that was reached in 2012 after Endo and Teikoku sued Watson for patent infringement after it had applied to the Food and Drug Administration to market a generic version of the patch.

As part of the May 2012 settlement, Watson agreed to delay launching its generic Lidoderm until September 2013, about two years before the patent expired, the lawsuit said.

In exchange, Watson received $ 96 million in free product and the promise that Endo would not release an authorized generic version of the drug until nearly eight months after Watson began selling its version, the plaintiffs said.

They claimed the deal violated antitrust laws and prevented them from being able to purchase cheaper, generic versions of Lidoderm.

The case is In re Lidoderm Antitrust Litigation, U.S. District Court, Northern District of California, No. 14-md-2521.

Reporting by Nate Raymond in Boston; Editing by Lisa Shumaker

Longtime U.S. AIDS researcher picked to run CDC

CHICAGO (Reuters) – Longtime AIDS researcher Dr. Robert Redfield will be the new director of the Centers for Disease Control and Prevention in Atlanta, the administration of U.S. President Donald Trump announced on Wednesday.

FILE PHOTO: A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia September 30, 2014. REUTERS/Tami Chappell

Redfield, 66, a professor at the University of Maryland School of Medicine in Baltimore and a co-founder of the Institute for Human Virology, succeeds Dr. Brenda Fitzgerald, a former commissioner of the Georgia Department of Public Health who resigned in January because of financial conflicts of interest. The position does not require Congressional approval.

In a statement announcing the appointment, Health and Human Services Secretary Alex Azar noted Redfield’s long career in promoting public health, and his significant achievements in early work linking the HIV virus to AIDS. He also touted Redfield’s more recent work running a treatment network for HIV and hepatitis C patients in Baltimore.

“We are proud to welcome him as director of the world’s premier epidemiological agency,” he said.

Azar praised Redfield’s two-decade stint at Walter Reed Army Institute of Research, where he helped advance the understanding of HIV/AIDS and demonstrate how the virus is transmitted in heterosexuals. Redfield is the founding director of the Department of Retroviral Research within the U.S. Military’s HIV Research Program.

Dr. Robert Gallo, co-founder of the Institute of Human Virology with Redfield in 1996, said Redfield has “served his country well, and demonstrates strong public health instincts that are grounded in science and clinical medicine.”

Redfield’s appointment won praise from leading researchers and several U.S. lawmakers, including Democratic U.S. Representative Elijah Cummings.

“Although I seldom agree with the Trump administration, I am in complete agreement that Dr. Bob Redfield is the best choice to lead the CDC,” Cummings said in a statement, noting Redfield’s public service, his scientific achievements and his work helping patients with HIV and hepatitis C.

Dr. Carlos del Rio, an infectious disease expert at Emory University School of Medicine in Atlanta, praised Redfield’s efforts in early HIV research, his more recent efforts working to address the opioid crisis and his expertise in addressing global health issues.

“His work to save lives in Africa and Haiti gives him a deep understanding of CDC’s global health mission, and it will serve him well as he works to address health issues nationally as well as around the globe as director of the CDC,” del Rio said in a statement.

Redfield takes over for acting CDC Director Dr. Anne Schuchat.

Reporting by Julie Steenhuysen; additional reporting by Yasmeen Abutaleb in Washington; Editing by Lisa Shumaker

Germany confirms H5N6 bird flu case on island farm

HAMBURG (Reuters) – German authorities have confirmed outbreak of the highly pathogenic H5N6 bird flu type at a farm on an island off the German North Sea coast, the Schleswig-Holstein state agriculture ministry said on Wednesday.

The virus was found on a farm of with 57 chickens, turkeys, ducks and geese on the island of Hallig Suederoog. All the birds on the farm have been culled.

It is said to be the first case on a farm in Germany, the ministry said.

A case of H5N6 bird flu was also reported by a farm in the Netherlands in February and in southern England in January.

The Schleswig-Holstein state agriculture ministry said there is no record of the strain of the disease spreading to humans.

Some past outbreaks of bird flu have required expensive slaughtering campaigns and costly orders to farmers to keep poultry indoors.

Reporting by Michael Hogan, editing by Louise Heavens

Gluten-free diet may still allow harmful levels of exposure

(Reuters Health) – Carefully following a gluten-free diet might not protect people with celiac disease from exposure to potentially harmful amounts of gluten, new findings suggest.

“Individuals who are on a gluten free diet are consuming more gluten than we actually imagined. It’s not uncommon for them to be consuming on average a couple of hundred milligrams a day,” Dr. Jack A. Syage, CEO of ImmunogenX in Newport Beach, California, and the study’s lead author, told Reuters Health in a telephone interview.

In people with celiac disease, consuming even microscopic amounts of the gluten protein in wheat, rye or barley triggers an autoimmune response that harms the lining of the small intestine. Left untreated, celiac disease can lead to a host of long-term ill effects including anemia, osteoporosis and fertility problems.

Hidden gluten is ubiquitous in medications, food additives, seasonings, sauces, lipsticks and lip balms, fried foods and many other sources.

Dr. Syage and his team quantified gluten exposure by analyzing amounts of gluten excreted in stool and urine in people with celiac disease who were following a gluten-free diet but still experiencing moderate to severe symptoms.

As reported in the American Journal of Clinical Nutrition, they estimated that these adults were still being exposed to an average of 150 to 400 milligrams (or less than two one-hundredths of an ounce) of gluten a day.

Up to 10 mg of gluten per day is generally considered safe for people with celiac disease, according to the University of Chicago Celiac Disease Center.

The study wasn’t designed to identify the sources of accidental gluten exposure.

Estimates of gluten exposure in the new study are indirect, and based on several unproven assumptions, said Dr. Carlo Catassi, head of pediatrics at the Universita Politecnica Delle Marche in Ancona, Italy, who studies celiac disease but did not participate in the new research.

“The risk of gluten contamination in the diet of treated celiacs is very well known,” Dr. Catassi said, adding that the new study’s estimate was surprisingly high. “Should these data be confirmed by direct evidence of a frequent high gluten contamination, further treatments beyond the gluten-free diet would certainly be an option.”

He added: “The data of this study suggest a ‘pessimistic’ view about the possibility to maintain a correct gluten-free diet that is not justified in my opinion, until further studies directly measuring the amount of gluten contamination will be available.”

Still, the authors conclude, the data suggest “that individuals on a gluten-free diet cannot avoid accidental gluten intrusions and these small amounts are sufficient to trigger severe symptomatic responses.”

Celiac disease patients who are still having symptoms should re-evaluate their diets under the guidance of a clinician or dietician, they suggest.

SOURCE: bit.ly/2G8B2M9 American Journal of Clinical Nutrition, online February 26, 2018.

Shoe inserts may not help plantar heel pain

(Reuters Health) – Mass-produced shoe inserts available on drugstore shelves and customized orthotics may not work for plantar heel pain, a research review suggests.

Plantar heel pain is one of the most common foot ailments, accounting for about 15 percent of foot symptoms requiring medical attention and 10 percent of running injuries, researchers note in the British Journal of Sports Medicine. Many doctors recommend shoe inserts to ease this pain by supporting the arches and taking pressure off the heel, but research to date has been inconclusive about the effectiveness of this approach.

For the current study, researchers examined data from 20 previously conducted experiments that randomly assigned some participants to wear shoe inserts and other participants to join a control group receiving no treatment, a sham insert or a different intervention.

Altogether they tested eight different custom or mass-produced shoe inserts.

Short-term pain relief was similar with and without shoe inserts, and there wasn’t any difference between pre-fabricated models and custom versions, the study found.

“A patient might still prefer to try an orthotic and based on this study, could try a cheaper orthotic first as opposed to a more expensive one, which is custom made,” said lead author Nadine Rasenberg of Erasmus Medical Centre Rotterdam in the Netherlands.

While shoe inserts might be better than nothing, the current study wasn’t designed to answer this question, Rasenberg said by email.

“Most patients prefer to try an intervention as opposed to a `wait and see’ approach,” Rasenberg added. “It remains unknown, whether orthotics are better than doing nothing.”

Orthotics did appear slightly better than sham inserts in the current study, but the difference was too small to rule out the possibility that it was due to chance.

This suggests that orthotics might work for some people, but not others, said Glen Whittaker, a podiatry researcher at La Trobe University in Victoria, Australia, who wasn’t involved in the study. More research is still needed to determine who might benefit, and under what circumstances, Whittaker said by email.

“Appropriately contoured foot orthoses may reduce plantar heel pain by redistributing pressure away from the bottom of the heel to the arch, and may also prevent the arch from dropping, which may reduce tension in the plantar fascia,” Whittaker said.

One limitation of the current study is that it examined results from many small experiments with different methods for testing the effectiveness of orthotics. The small studies also differed in duration and how they assessed pain relief.

Even though they’re widely used, orthotics aren’t the only option for plantar heel pain, said Dr. Selene Parekh, a researcher at Duke University in Durham, North Carolina and partner in the North Carolina Orthopedic Clinic.

Patients can also try night splints or stretching exercises done at home or as part of a supervised physical therapy program, Parekh, who wasn’t involved in the study, said by email. Modified exercise and activity habits may also help avoid irritating the tissues around the heel that cause pain.

If they choose orthotics, patients should look for the cheapest option.

“It seems that patients can attempt to provide some relief to their plantar heel pain using cheaper, readily available orthotics found in grocery stores, online, and stores in their community,” Parekh added. “Based on this study, it appears that the cost of a custom orthotic, which can reach hundreds of dollars, is not medically necessary.”

SOURCE: bit.ly/2puzUbm British Journal of Sports Medicine, online March 19, 2018.

U.S. infant mortality high even for full-term babies

(Reuters Health) – Infant mortality rates for full-term babies vary across the U.S., but all states are worse than many European countries, a new study suggests.

Previous research has found babies more likely to die in the U.S. than in other developed and affluent nations, but the current study offers fresh evidence that this is true even for infants born at the very end of pregnancy when they should have excellent survival odds.

Across the U.S., infant mortality rates for full-term babies were 50 percent to 200 percent higher than in Austria, Denmark, Finland, Norway, Sweden and Switzerland, the study found.

The two main reasons for the higher U.S. mortality were “congenital malformations, which patients cannot really do much about other than ensuring adequate screening during pregnancy, and high risk of sudden unexpected deaths in infancy, which should largely be preventable through appropriate sleeping arrangements,” said study co-author Neha Bairoliya of the Harvard Center for Population and Development Studies in Cambridge, Massachusetts.

Bairoliya and colleagues studied more than 10 million U.S. infants born between 2010 and 2012 at full-term, that is, between 37 and 42 weeks gestation.

Out of every 5,000 full-term births, 11 babies died before age 1, researchers report in PLoS Medicine.

Overall, more than 7,000 full-term babies die each year in the U.S., and researchers estimate that infant mortality could be reduced by about 4,000 deaths if all states achieved the mortality levels of the best-performing state for each cause of death.

At the state level, infant mortality rates ranged from 6.45 deaths for every 5,000 full-term births in Connecticut to nearly 19 deaths for every 5,000 in Mississippi.

Every state was worse than the six European countries in the analysis, which had an infant mortality rate of slightly over 6 deaths for every 5,000 full-term births.

Birth defects, or congenital malformations, accounted for 31 percent of U.S. infant deaths during the study. So-called perinatal complications, or medical problems babies developed shortly before or after birth, accounted for another 13 percent of fatalities.

The biggest cause was sudden unexpected death in infancy (SUID), which includes sleep-related fatalities and accounted for 43 percent of infant mortality cases.

“While we do not have data on actual sleeping arrangements from our study, other data sources suggest that a substantial number of babies continue to sleep on their tummy,” Bairoliya said by email. “We also found a shockingly large number of babies dying from suffocation, which suggests that parents either use covers that are not safe, or let children sleep in their own beds.”

Babies are safest sleeping on their backs in their own cribs without any pillows, toys, blankets or other loose bedding, according to the American Academy of Pediatrics. If babies do sleep in parents’ beds, parents should have a firm mattress, remove soft objects such as pillows, and move the bed away from the wall.

The study wasn’t a controlled experiment designed to prove whether or how infant sleep practices or other parenting behaviors in the U.S. might explain higher infant mortality rates here. Researchers also used death certificates, which don’t provide a complete picture of any medical conditions that might have contributed to babies’ deaths.

It’s also hard to say exactly why infant mortality rates are so much lower in Connecticut than in Mississippi, although researchers say this may be more due to mothers’ education and income levels rather than disparities in health care after birth.

Different approaches to parental leave and infant sleep in the U.S. and Europe may help explain why babies have better survival odds elsewhere, said Michael Gradisar, a psychology researcher at Flinders University in Adelaide, Australia, who wasn’t involved in the study.

“Once a baby is born in the U.S., the odds of that baby dying in its first year from poor sleeping arrangements (sleeping position, co-sleeping) is higher than the best European countries, especially in Scandinavia,” Gradisar said by email. “There are also clear links between paid parental leave, which is higher in Scandinavian countries, and lower infant mortality risk in the first year of life.”

SOURCE: bit.ly/2ptFCuR PLoS Medicine, online March 20, 2018.

Scientists develop brain scanner in a helmet

(Reuters) – British scientists have developed a lightweight and highly sensitive brain imaging device that can be worn as a helmet, allowing the patient to move about naturally.

Results from tests of the scanner showed that patients were able to stretch, nod and even drink tea or play table tennis while their brain activity was being recorded, millisecond by millisecond, by the magnetoencephalography (MEG) system.

Researchers who developed the device and published their results in the journal Nature said they hoped the new scanner would improve research and treatment for patients who can’t use traditional fixed MEG scanners, such as children with epilepsy, babies, or patients with disorders like Parkinson’s disease.

“This has the potential to revolutionize the brain imaging field, and transform the scientific and clinical questions that can be addressed with human brain imaging,” said Gareth Barnes, a professor at the Wellcome Trust Centre for Human Neuroimaging at University College London, who co-led the work.

Current MEG scanners are cumbersome and weigh as much as half a tonne, partly because the sensors they use to measure the brain’s magnetic field need to be kept very cold – at minus 269 degrees Celsius, Barnes’ team explained.

They also run into difficulties when patients are unable to stay very still – very young children or patients with movement disorders for example – since even a 5-millimeter movement can mean the images are unusable.

In the helmet scanner, the researchers overcame these problems by using quantum sensors, which are lightweight, work at room temperature and can be placed directly onto scalp – increasing the amount of signal they are able to pick up.

Matt Brookes, who worked with Barnes and built the prototype at Nottingham university, said that as well as overcoming the challenge of some patients being unable to stay still, the wearable scanner offers new possibilities in measuring peoples’ brain function during real world tasks and social interactions.

“This has significant potential for impact on our understanding of not only healthy brain function but also on a range of neurological, neurodegenerative and mental health conditions.”

Editing by Mark Heinrich

Britain's use of copycat biotech drugs takes off while U.S. lags

LONDON (Reuters) – Cut-price copies of an expensive Roche biotech drug for blood cancer have taken 80 percent of the British market since launching last year, saving the healthcare system 80 million pounds ($ 113 million) a year, experts said on Wednesday.

FILE PHOTO: The logo of Celltrion is seen at the company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji/File Photo

The rapid adoption of two so-called biosimilar forms of rituximab from Celltrion and Novartis has been accompanied by discounts of 50-60 percent as the National Health Service (NHS) has used tenders to bring down costs.

The situation contrasts sharply with the United States, where regulators have lagged Europe in approving biosimilars while a complex system of rebates offered to insurers by original-brand drugmakers has created barriers to use.

The U.S. logjam prompted Food and Drug Administration (FDA) Commissioner Scott Gottlieb to complain of “rebating mischief” and a “rigged payment scheme” in a speech here on March 7.

Biological drugs such as Rituxan, a $ 7 billion-a-year seller, are complex molecules made inside living cells.

Copies of some biotech medicines have been on sale in Europe for more than a decade, but it is only now that patents are starting to expire on big-selling antibody treatments for cancer and other serious diseases, with the pace expected to accelerate.

Only this month Merck launched Europe’s first biosimilar copy of Roche’s breast cancer antibody drug Herceptin in Britain under a deal with Samsung Bioepis. More Herceptin copies are set to follow this year.

A biosimilar version of AbbVie’s rheumatoid arthritis drug Humira — the world’s biggest-selling medicine — is also expected later this year, with biosimilar Avastin, another Roche cancer drug, expected in 2019.

Britain’s NHS has estimated that biosimilars could save it up to 300 million pounds a year. Jatinder Harchowal, chief pharmacist at the Royal Marsden hospital and one of the coordinators of the UK’s push for biosimilar use, believes the scale of discounts achieved so far mean the savings could be even higher.

“These are large figures. Without compromising clinical effectiveness, this is a big saving that can be reinvested back into the NHS,” he told a news briefing.

The uptake of biosimilar rituximab has been significantly faster than with the first antibody biosimilar, a copy of Johnson & Johnson and Merck’s Remicade for arthritis, which Harchowal attributed to tendering and growing doctor confidence.


In the United States the key battleground is still over copycat Remicade, which has sparked a high-profile legal fight between J&J and Pfizer.

Pfizer, a major biosimilars player and supplier of innovative drugs, has sued J&J over its Remicade contracts with health insurers, arguing that they are anti-competitive and block sales of Pfizer’s new biosimilar.

Pfizer contends that J&J is offering discounts on Remicade in exchange for essentially excluding Pfizer’s drug from insurance coverage, keeping it out of the hands of doctors and patients. J&J says Pfizer’s suit is without merit.

Jenny Alltoft, Pfizer’s global head of biosimilars, told Reuters that a tilted playing-field against biosimilars was a threat not only to Pfizer but also to the wider U.S. healthcare system, which is struggling with spiraling costs.

“Pfizer wanted to shine a light on this with the lawsuit so that it doesn’t become common practice, because if it does, then the U.S. will never get the benefit that biosimilars could offer in terms of patient access and healthcare savings,” she said during a visit to London.

The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, such as South Korea’s Celltrion, and worries about the long-term sales threat to makers of original drugs, such as Roche and AbbVie.

Consensus forecasts from analysts suggest that combined sales of Roche’s Rituxan, Herceptin and Avastin will halve over the next five years, leaving a gap the Swiss group must fill with new drugs for cancer, multiple sclerosis and haemophilia.

($ 1 = 0.7109 pounds)

Reporting by Ben Hirschler; Editing by David Goodman

Childhood `toxic stress’ leads to parenting challenges later on

Reuters Health – Parents who endured “toxic stress” during childhood may be more likely to have kids with developmental delays and have a harder time coping with their children’s health issues, new research suggests.

Adverse childhood experiences, commonly called ACEs, can include witnessing parents fight or go through a divorce, having a parent with a mental illness or substance abuse problem, or suffering from sexual, physical or emotional abuse.

Previous research has linked these experiences to what’s known as toxic stress, or wear and tear on the body that leads to physical and mental health problems that often continue from one generation to the next.

“What we didn’t know is how these risks are “inherited,” or specifically what is the chain of events from a parent experiencing adversity in childhood to their own children experiencing adversity early in development,” Sheri Madigan of the University of Calgary and Alberta Children’s Hospital Research Institute in Canada said by email.

One reason may be that mothers who experience more adversity in childhood have more health risks during pregnancy and, in turn, have babies with a greater risk of developmental problems, Madigan and colleagues report in one of three papers on the topic published this week in Pediatrics.

Madigan’s team studied 1,994 mothers and their infants. They focused on mothers’ ACEs and physical and mental health issues during and soon after pregnancy, and their babies’ development.

Maternal ACEs explained about 12 percent of infants’ developmental delays in communication, motor skills, problem solving and social skills by age 1, the study found.

A second study in Pediatrics followed children through age 2 and looked at exposure to 10 different types of ACEs for 311 mothers and 122 fathers.

For each additional ACE mothers experienced, children were 18 percent more likely to have a suspected developmental delay. Kids had a 34 percent higher risk of delays for each ACE fathers experienced.

When mothers reported exposure to at least three ACEs, kids were significantly more likely to have multiple developmental delays, the study also found.

These delays may limit school readiness and emotional health, said study leader Alonzo Folger of Cincinnati Children’s Hospital Medical Center.

“Childhood exposure to abuse, neglect and other forms of household dysfunction can have psychobiological effects that are toxic to the brain during sensitive time points of development,” Folger said by email.

“Accumulating over the life course, these effects may undermine parenting and relatedly attachment, making it more difficult to handle normal behaviors of infants and toddlers,” Folger added. “We increasingly recognize the disruptive nature of toxic stress caused by early life adversity and the importance of early intervention.”

A third study in Pediatrics looked at the link between ACEs and coping skills in 671 parents after they took sick kids home from the hospital. Overall, 64 percent of parents reported at least one ACE, and 19 percent reported at least four ACEs.

Parents who experienced more adversity and trauma during childhood displayed less resilience and more difficulty coping and caring for their sick children, researchers found.

The three studies weren’t designed to prove whether or how parents’ traumatic childhood experiences might directly impact physical or mental health outcomes for their kids.

Still, the results suggest that providing extra support for parents with ACEs might help improve outcomes for their children, said Anita Shah of Cincinnati Children’s Hospital Medical Center, lead author of the third study.

“The effect of a stable, nurturing relationship for a child is incredibly important to mitigating the effects of adversity, or ACEs,” Shah said by email. “For a parent with high ACEs, this may mean reaching out to someone to help them learn how to cope with daily stressors as well as making sure their children can find ways to cope with toxic stressors.”

SOURCE: bit.ly/2FWveSt, bit.ly/2FZxEjb and bit.ly/2pt3rSs Pediatrics, online March 20 and 21, 2018.

GlaxoSmithKline prescribes commercial reboot for pharma division

LONDON (Reuters) – In January, GlaxoSmithKline’s (GSK.L) new head of pharmaceuticals Luke Miels issued a blunt challenge to his managers: find budget savings of 20 percent.

The plan was to pool the savings and reallocate the money to priority medicines and markets for Britain’s biggest drugmaker, according to people familiar with the meeting.

The tough demand startled some GSK veterans who are used to a more consultative approach, said the sources. But it is a sign of the harder commercial edge new Chief Executive Emma Walmsley – almost 12 months into the job – is bringing to a company whose shares have moved sideways for years.

Miels – a long-time protege of AstraZeneca (AZN.L) CEO Pascal Soriot, whose departure sparked a legal spat between the rival drugmakers – is a key lieutenant for Walmsley as she tries to overhaul the core pharma business.

The unit has lagged rivals like Novartis (NOVN.S) and Merck & Co (MRK.N) in producing multibillion-dollar blockbusters, so Walmsley has prioritized plans to refocus both its research and marketing efforts in a drive for fewer but bigger new drugs.

Miels declined to comment in detail on his budget demand, including the savings figure of 20 percent, but confirmed the strategic goal of achieving a leaner, meaner commercial footprint to match a recently pared-down research and development (R&D) operation.

The aim is to concentrate sales and marketing resources on new products, particularly lung drug Trelegy and shingles vaccine Shingrix, in 10 big markets – ranging from the United States, major European countries and Japan to China, India and Russia, he told Reuters.

“In R&D, we’re trying to pick which assets are most productive and are going to add the most value to patients. Well, we need to do the same thing in the commercial organization,” Miels said.

“That is something that will become more visible over time and it is a process that we are going through now … the strategy is more advanced than is visible externally.”

One early casualty is the reversal of previous expansion in Africa.

GSK’s track record for bringing new drugs to market has actually been in the middle of its peer group since 2011, according to a recent Berenberg bank analysis, but its commercial performance has disappointed.


Miels and his colleague Hal Barron – a long-time Roche (ROG.S) scientist who joined in January as R&D head – know they have their work cut.

Even with a renewed sense of urgency, GSK’s new drug pipeline will not deliver its next batch of products before 2020 and, in the meantime, big challenges loom in two pivotal established disease areas.

A new drug from Gilead Sciences (GILD.O) is set to dent GSK’s HIV business, while U.S. generic competition to aging lung drug Advair is coming.

Adding to uncertainty is the possibility that Walmsley – a consumer products veteran who worked for 17 years at L’Oreal (OREP.PA) – might buy Pfizer’s (PFE.N) over-the-counter business for up to $ 20 billion. A deal may boost earnings but could prove a financial stretch.

GSK shares have underperformed the European healthcare sector by 16 percent since she took over on April 1, 2017, which has not been lost on skeptics like high-profile fund manager Neil Woodford, who sold out of GSK in May.


Walmsley announced plans last July to streamline pharma R&D by ditching more than 30 drug projects.

Still, Miels said he had the resources needed to build up the business in new focus areas like oncology and immunology, including potential funding for add-on biotech deals.

Significant cash is already being put to work, especially in the company’s cancer research labs.

Three years ago, GSK sold its established cancer medicines to Novartis. But it retained some early-stage projects that it now believes have the potential to leapfrog rivals and be at the forefront of treatment.

They include an antibody drug for multiple myeloma, which could be launched in 2020, as well as new kinds of immunotherapy and cell therapies designed to modify patients’ immune cells.

In cell therapy alone, GSK has spent “hundreds of millions of dollars” to build a large presence focused on T-cell receptors (TCRs), according to oncology R&D head Axel Hoos.

Its presence may be largely below the radar but GSK’s commitment is on a par with better-known cell therapy companies like Novartis, Gilead and Celgene (CELG.O), Hoos said in an interview.

Unlike CAR-T cells that recognize proteins on the cell surface, TCRs can find tumor-specific proteins on the inside of cells and, significantly, they appear to be able to fight solid tumors, rather than just the blood cancers hit by CAR-T treatments like Novartis’ Kymriah and Gilead’s Yescarta.

Just last week, GSK’s partner Adaptimmune (ADAP.O) reported a second solid tumor response to TCR therapy.

The research is early and the cancer field is highly competitive but successful oncology drugs can deliver quickly, as rival AstraZeneca is starting to demonstrate. Consensus forecasts point to its 2018-22 annual earnings growth averaging 15.3 percent compared with just 5.3 percent for GSK.

(GRAPHIC: GSK comparative total return – reut.rs/2FXTmEt)

Reporting by Ben Hirschler; Editing by Pravin Char