LONDON (Reuters) – International drugmakers are working with European authorities on emergency plans to keep medicines flowing into Greece if the country crashes out of the euro.

Discussions have intensified in recent days, according to industry sources, and manufacturers are looking closely at the experience of Argentina’s collapse in 2002, when some firms agreed to continue to supply medicines without payment for a period of time.

Executives at leading drug companies – particularly those with European headquarters – are under pressure to avert a health catastrophe, which could occur if Greek imports are halted by a massive devaluation of newly issued drachma.

“There’s a moral obligation to continue to supply,” said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.

“Greece is not a big market, so most drug companies can absorb it … the reputational damage would, I think, more than outweigh the economic cost.”

Although plans are still in flux, the idea is to have a scheme ready for implementation at short notice that could bridge the gap by supplying critical medicines for a few months, according to one person familiar with the situation.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, confirmed his group was discussing the Greek situation but declined to go into details.

“We obviously are on alert and talking to people about it,” he said. “We are in very close contact with the European Commission and the Greece task force and we are monitoring developments.”

The European Union set up the task force last year under Horst Reichenbach to help Athens tackle its debt crisis.

Greece imports nearly all its medicines and is particularly reliant on branded drugs, as opposed to cheaper generics, which means it spends a relatively large amount per capita on medicines.

Any short-term initiative might be limited to certain categories of essential medicines and would probably not be a panacea, reflecting the need of companies to protect the interests of shareholders as well as patients.

Certain parts of the Greek healthcare system have already experienced drug shortages in recent months and drug manufacturers – owed 1.21 billion euros in unpaid bills from Greek state hospitals, according to the Hellenic Association of Pharmaceutical Companies – have adopted a range of strategies to limit exposure to an uncertain market.

Some, like Denmark’s Novo Nordisk, the world’s largest supplier of insulin for diabetics, have long demanded payment on delivery. Others, including Britain’s GlaxoSmithKline, say they have not changed the terms of business and are not demanding immediate cash settlement.

Swiss-based Roche, the world’s largest maker of cancer drugs, has a nuanced approach. It switched last year to a system of payment on delivery for hospitals with a history of bad payments but spokesman Daniel Grotzky said this policy did not apply to critical products like HIV drugs and CellCept, a medicine given to organ transplantation patients.

Drugmakers know from experience that turning off the supply tap may simply not be an option. Two years, Novo Nordisk was hit by storm of protest when it halted deliveries of certain insulins for around a month after Greece cut the price by more than a quarter. The cut-off ended when Athens agreed to somewhat smaller price cuts.

Greece represents just under 1 percent of the world drugs market but it has a potentially wider impact because the country is embedded in the European Union.

As a result, price cuts in Greece can trigger automatic cuts in richer countries through the practice of “reference pricing” to other countries – something industry is keen to avoid if Greece leaves the euro and prices in euro terms fall heavily.

Drug price cuts over the past two years have also helped suck medicines out of the country as wholesalers sell supplies to countries – like Germany – where drug prices are higher, although recently introduced quotas limiting exports of some drugs have tried to address this.

Such parallel trade is allowed under European free trade rules and can help keep costs down for European healthcare systems, according to the European Association of Euro-Pharmaceutical Companies, representing wholesalers involved in the practice.

Drug manufacturers, however, see it as a thorn in their side and any short-term emergency supply plan for Greece is likely to include a demand for assurances that drug deliveries will actually get to Greek patients. Fraud over medicine reimbursement in Greece is another concern.

On the ground, meanwhile, many patients are already struggling to get the prescription medicines they need, according to Apostolos Veizis, head of programs for Medecins Sans Frontieres in Greece.

One reason is a liquidity crunch among pharmacists, who face delays in payments from public insurers and, as a result, are unable to pay their suppliers.

But even when drugs are available, more and more Greeks have trouble paying the 10-25 percent of the prescription cost not covered by the public healthcare system.

“We’re seeing a massive decrease in patient access because of the economic crisis,” Veizis said.

(editing by Janet McBride)

(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging:; ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/reutersBenHir)

LONDON (Reuters) – International drugmakers are working with European authorities on emergency plans to keep medicines flowing into Greece if the country crashes out of the euro.

Discussions have intensified in recent days, according to industry sources, and manufacturers are looking closely at the experience of Argentina’s collapse in 2002, when some firms agreed to continue to supply medicines without payment for a period of time.

Executives at leading drug companies – particularly those with European headquarters – are under pressure to avert a health catastrophe, which could occur if Greek imports are halted by a massive devaluation of newly issued drachma.

“There’s a moral obligation to continue to supply,” said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.

“Greece is not a big market, so most drug companies can absorb it … the reputational damage would, I think, more than outweigh the economic cost.”

Although plans are still in flux, the idea is to have a scheme ready for implementation at short notice that could bridge the gap by supplying critical medicines for a few months, according to one person familiar with the situation.

Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, confirmed his group was discussing the Greek situation but declined to go into details.

“We obviously are on alert and talking to people about it,” he said. “We are in very close contact with the European Commission and the Greece task force and we are monitoring developments.”

The European Union set up the task force last year under Horst Reichenbach to help Athens tackle its debt crisis.

Greece imports nearly all its medicines and is particularly reliant on branded drugs, as opposed to cheaper generics, which means it spends a relatively large amount per capita on medicines.

Any short-term initiative might be limited to certain categories of essential medicines and would probably not be a panacea, reflecting the need of companies to protect the interests of shareholders as well as patients.

Certain parts of the Greek healthcare system have already experienced drug shortages in recent months and drug manufacturers – owed 1.21 billion euros in unpaid bills from Greek state hospitals, according to the Hellenic Association of Pharmaceutical Companies – have adopted a range of strategies to limit exposure to an uncertain market.

Some, like Denmark’s Novo Nordisk, the world’s largest supplier of insulin for diabetics, have long demanded payment on delivery. Others, including Britain’s GlaxoSmithKline, say they have not changed the terms of business and are not demanding immediate cash settlement.

Swiss-based Roche, the world’s largest maker of cancer drugs, has a nuanced approach. It switched last year to a system of payment on delivery for hospitals with a history of bad payments but spokesman Daniel Grotzky said this policy did not apply to critical products like HIV drugs and CellCept, a medicine given to organ transplantation patients.

Drugmakers know from experience that turning off the supply tap may simply not be an option. Two years, Novo Nordisk was hit by storm of protest when it halted deliveries of certain insulins for around a month after Greece cut the price by more than a quarter. The cut-off ended when Athens agreed to somewhat smaller price cuts.

Greece represents just under 1 percent of the world drugs market but it has a potentially wider impact because the country is embedded in the European Union.

As a result, price cuts in Greece can trigger automatic cuts in richer countries through the practice of “reference pricing” to other countries – something industry is keen to avoid if Greece leaves the euro and prices in euro terms fall heavily.

Drug price cuts over the past two years have also helped suck medicines out of the country as wholesalers sell supplies to countries – like Germany – where drug prices are higher, although recently introduced quotas limiting exports of some drugs have tried to address this.

Such parallel trade is allowed under European free trade rules and can help keep costs down for European healthcare systems, according to the European Association of Euro-Pharmaceutical Companies, representing wholesalers involved in the practice.

Drug manufacturers, however, see it as a thorn in their side and any short-term emergency supply plan for Greece is likely to include a demand for assurances that drug deliveries will actually get to Greek patients. Fraud over medicine reimbursement in Greece is another concern.

On the ground, meanwhile, many patients are already struggling to get the prescription medicines they need, according to Apostolos Veizis, head of programs for Medecins Sans Frontieres in Greece.

One reason is a liquidity crunch among pharmacists, who face delays in payments from public insurers and, as a result, are unable to pay their suppliers.

But even when drugs are available, more and more Greeks have trouble paying the 10-25 percent of the prescription cost not covered by the public healthcare system.

“We’re seeing a massive decrease in patient access because of the economic crisis,” Veizis said.

(editing by Janet McBride)

(ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging:; ben.hirschler.thomsonreuters.com@reuters.net)(www.twitter.com/reutersBenHir)

NEW YORK (Reuters Health) – Babies who are fed milk from their mothers’ breasts gain less weight over their first year compared to babies fed milk — breast or formula — from a bottle, suggests a new study.

The lead author said the difference may come down to how much of a role babies play in deciding when to stop feeding, instead of mothers or fathers forcing them to finish a bottle.

“If the babies are fed by the breast, the baby plays a very active role, because they are the ones who decide when to suckle and when to stop,” said Dr. Ruowei Li, of the United States Centers for Disease Control and Prevention in Atlanta.

Li told Reuters Health some researchers believe that “if the babies are fed with the bottle, they will gradually lose their self-regulation of their energy intake and the internal cues of satiety and hunger.”

To look at the link between weight gain and feeding, Li and her fellow researchers followed about 1,900 babies from across the U.S. born in the mid-2000s.

Through a series of surveys sent to their mothers, the researchers asked for — among other things — babies’ weights at different ages and how often women breastfed, pumped their breast milk or used formula.

Babies who were only fed from a bottle — either with only breast milk or only formula — gained about three ounces more per month compared to those who were solely breastfed.

After that, the findings got a bit complicated.

When moms did a combination of breastfeeding and bottle feeding with human milk only, babies didn’t gain any extra weight — but if they both breastfed and bottle-fed with formula, their babies gained an additional two ounces each month, on average.

And when moms exclusively bottle-fed, but alternated between using human milk and formula, their babies grew similarly to solely-breastfed babies.

It’s not totally clear why babies fed a combination of bottled breast milk and formula may not have gained additional weight, the researchers wrote in the Archives of Pediatrics & Adolescent Medicine.

But, “The key message out of this study is that breastfeeding really is the first feeding choice for the babies,” said Li, who added that supplementing breastfeeding with breast milk from a bottle is a good second option.

MOUNTING EVIDENCE

The new study is only a piece of the growing evidence that breastfeeding appears to be the best choice for a newborn, and may protect against obesity later in life.

In the same journal, Tessa Crume and her colleagues published findings suggesting breastfeeding for at least six months may not only protect kids against being overweight later in childhood, but also against being underweight.

Simply put, overweight kids might have been even more overweight if they weren’t breastfed as babies, the researchers reported. At the opposite end of the weight spectrum, there was a suggestion that underweight kids might have weighed even less if their moms hadn’t breastfed them.

Those findings are based on weight and body fat measurements, as well as breastfeeding history, for 442 children between the ages of six and 13 years old.

“It is suggesting that breastfeeding has a growth-regulating effect — preventing extremes,” said Crume, from the Colorado School of Public Health at the University of Colorado in Denver.

IN AN IDEAL WORLD

Despite growing research in favor of breastfeeding, the authors of a linked commentary say the new findings may put too much pressure on new mothers.

“Pediatricians should deliver their expert advice with empathy, being mindful of the gap that always exists for parents between doing what is ideal for their children and doing what is possible,” according to the editorial.

Co-author Dr. Jeffrey Wright, a pediatrician from the University of Washington School of Medicine in Seattle, told Reuters Health there could be anatomical or economic reasons why mothers cannot breastfeed their children.

Some mothers have to return to work, fathers may want to help with feeding and the parents may want to know how much milk their baby is getting. Wright said all of these reasons may keep mothers from breastfeeding.

The American Academy of Pediatrics recommends mothers exclusively breastfeed for six months, and continue breastfeeding as foods are introduced until at least 12 months.

“There were millions of babies raised on formula well before the obesity epidemic started,” said Wright. “Each family should weigh the benefits they see against the hassles they take to get there, and the father should be involved with that discussion.”

As with any research, the new studies also have limitations — including that neither can prove breastfeeding directly protects kids from gaining too much weight.

But researchers agreed that employers need to do what they can to promote breastfeeding, such as having onsite child care and allowing new parents to work part-time.

“Breastfeeding is really the best feeding for the babies, and needs to be the first choice,” said Li.

If that’s not possible, she said it’s important to pay attention to the signals a baby sends out to prevent overfeeding with a bottle, such as keeping their mouth shut or not wanting to suckle.

SOURCE: bit.ly/Jjpti1> <bit.ly/J3i4PS and bit.ly/KwzHvx Archives of Pediatrics and Adolescent Medicine, online May 7, 2012.

BOSTON (Reuters) – Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD — those who have more or less failed all other therapies — Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

FDA SUBMISSION THIS YEAR

Osiris, which is based in Columbia, Maryland, plans to apply for marketing authorization with the U.S. Food and Drug Administration by the end of this year, including the newly-analyzed information. Mills said that if the FDA were to approve the drug, he would expect it to be on similarly conditional terms as outlined by the Canadian authorities.

In general, the FDA does not approve drugs based on subset analyses.

Prochymal is made up of bone marrow stem cells derived from an adult donor and is designed to control inflammation, promote tissue regeneration and prevent scar formation. It is not entirely clear how it works to help patients with GvHD, of which there are between 3,500 to 4,000 worldwide, Mills said.

Osiris said it will receive at least eight years of exclusivity in the Canadian market. But competition is heating up elsewhere.

Athersys Inc said last month it had met with the FDA to discuss the results of a recently completed clinical trial of its MultiStem stem cell treatment to prevent GvHD in patients being treated for leukemia or other conditions that place them at risk of the complication.

Dozens of adult stem cell therapies are moving through clinical trials, and Canada’s approval of Osiris’s drug will likely boost optimism in the sector. Stem cells derived from adult tissue such as fat or bone marrow circumvent the ethical concerns raised by the use of cells derived from embryos.

In 2008, Genzyme Corp, which is now owned by Sanofi SA, paid $130 million to Osiris and agreed to pay up to $1.25 billion more if Prochymal and another Osiris drug, Chondrogen, designed to repair tissue in damaged knees, reached the market and achieved certain sales levels.

In February, Sanofi said it had discontinued its project with Prochymal. Osiris said the statement was issued without its consultation and that it had not received notice from Sanofi regarding the discontinuation. However, the company said that the agreement between the two companies provides that in this instance all rights to Prochymal revert to Osiris without compensation to Sanofi.

(Reporting By Toni Clarke; Editing by Tim Dobbyn, Bernard Orr)

LONDON (Reuters) – An experimental cancer drug developed by Britain’s GlaxoSmithKline may add vital months to the lives of melanoma patients whose disease has spread to their brains, according to data from an early-stage trial published on Friday.

Results of Phase I trial published in The Lancet medical journal showed substantial shrinking of tumors in patients treated with the drug, dabrafenib, and showed promise against secondary melanoma tumors, or metastases, in the brain.

Dabrafenib blocks the activity of a cancer-causing mutated form of a gene known as BRAF, which is found in about half of melanoma cases.

Results released on Wednesday from a separate trial looking at dabrafenib in combination with another GSK drug, trametinib, were also positive.

Researchers said the results of the dabrafenib-only trial, although early-stage, represented an important step forward in the treatment of this deadly cancer.

Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months.

Georgina Long of the Melanoma Institute Australia and Westmead Hospital in Sydney, and Gerald Falchook from the University of Texas in the United States, treated 184 patients with dabrafenib in a Phase I trial — the earliest step of the drug development process in humans.

They said some of the most exciting results came from a subset of 10 patients whose tumors had spread to their brains.

None of these had previously received treatment for their brain tumors. However, the brain metastases disappeared in four of the patients when they were treated with 150 milligrams of dabrafenib twice daily.

Five patients saw their brain metastases shrink, and one had stable disease, where the tumors remained the same size.

“The results in the brain were remarkable,” Long said. “I don’t think there is a single other systemic agent that is as active in the brain.”

Experts not involved in the trial also said the drug showed promise.

In a commentary piece in The Lancet, Geoffrey Gibney and Vernon Sondak from the H Lee Moffit Cancer Center and Research Institute in the U.S. described the results as “impressive” and “encouraging”.

Long and Falchook said it was not clear why the drug was so effective in the brain where other drugs have failed, but further trials are under way to try to clarify the mechanism.

“The big message is that the brain, with this drug, is just like another organ,” Long said. “If you are going to respond in your lung and liver, you tend to respond in your brain as well.”

Unfortunately, for most of the patients with brain metastases, the response to the drug was limited to several months.

Long said, however, these few months of extension of life were very rare in patients with melanoma that has spread to the brain. Normally, such patients can only expect to survive for four months from the point of diagnosis, she said.

“With this drug, these patients had no progression of their disease for a median of 4.2 months. Without treatment, many of them might already have died at that point,” she said.

Two of the 10 brain metastasis patients who received the drug survived for more than 12 months. One was still alive and receiving the drug at 19 months.

(Editing by David Hulmes)