Novo Nordisk to invest up to $3.7 bln on diabetes pills


COPENHAGEN |
Mon Oct 7, 2013 8:55am EDT

COPENHAGEN Oct 7 (Reuters) – Novo Nordisk plans
to invest up to 20 billion Danish crowns ($3.65 billion) on
developing diabetes tablets intended to replace traditional
insulin injections, it said on Monday.

The Danish company said it planned to spend the money
through to 2020 on six diabetes pills it has under development
and that the sum included potential production facilities.

It estimates the global market for diabetes tablets could be
worth more than 100 billion crowns a year from the beginning of
the next decade, a spokesperson said, confirming a report in the
Danish business newspaper Borsen.

In the conventional treatment, insulin has to be injected
into the bloodstream, something that scares off many potential
users in the early stages of diabetes.

The challenge for the tablet technology is to get the
insulin through gastric acid and into the bloodstream.

Novo Nordisk, the world’s largest insulin producer, aims to
develop both an insulin and a so-called GLP-1 agonist in tablet
form. The company has around 500 employees working on the
development of the tablets, the spokesperson said.

It will spend around 1 billion crowns on the projects this
year, with investment increasing towards possible product
launches early next decade.

At 1235 GMT, Novo Nordisk shares were flat at 913.5 crowns.

(Reporting by Copenhagen Newsroom; Editing by Mark Potter)

Paula Deen Dumped By Home Depot And Diabetes Drug Company Novo …

Paula Deen takes her tearful apology tour to the Today Show on Wednesday.

As Wal-Mart goes, so goes the nation. Or, at least, so go two more lucrative Paula Deen business partnerships.

The world’s largest retail chain cut ties with Deen on Wednesday, as did casino giant Caesars Entertainment Caesars Entertainment, which operates four Deen-themed restaurants.

On Thursday, Home Depot Home Depot and pharmaceutical company Novo Nordisk Novo Nordisk joined the growing number of companies publicly ending their relationships with the disgraced chef, who recently admitted in a deposition for a workplace discrimination suit that she used racial slurs in the past and tolerated bigoted behavior in her restaurants.

Home Depot confirmed to NBC News that they’d stop carrying Deen-branded cookware hours after the 66-year-old made a tearful appearance on the network’s Today Show, telling Matt Lauer she doesn’t consider herself a racist.

Slightly more surprising is Novo Nordisk’s decision to dump Deen, since the pharma firm initially backed the Southern cook. The makers of diabetes drug Victoza partnered with Deen in 2012 following the announcement of her diagnosis with the disease. On Thursday, Novo changed its tune, issuing the following statement:

Novo Nordisk and Paula Deen have mutually agreed to suspend our patient education activities for now, while she takes time to focus her attention where it is needed.

Novo Nordisk would like to acknowledge Paula’s involvement in our Diabetes in a New Light™ campaign, where she has helped make many people aware of type 2 diabetes and the lifestyle changes needed to control this serious disease.

Novo Nordisk is the sixth company to end their Deen endorsement deal. A company spokesperson told Forbes they’d consider getting back into business with her once she’s regained the trust of her audience. “It does leave us with an option,” said Novo Nordisk’s Ken Inchausti, “but she needs to focus on rebuilding her relationship with the public.”

On Friday, the butter queen was fired from the Food Network, effectively ending her TV career. On Monday, she lost a deal promoting Smithfield Foods Smithfield Foods ham and pork products.

Target Target, Sears and QVC are said to be considering whether they’ll stand by Deen, who Forbes estimated as the fourth highest-earning celebrity chef last year. She pocketed around $17 million in 2012, mostly thanks to these lucrative endorsement deals.

Also on Forbes – Last year’s biggest career crashes:

15 Big Career Crashes of 2012

Forgotten Dimension of Diabetes Revealed in DAWN2 Study

Would you be surprised to know family members of people with diabetes share similar emotional difficulties as their loved ones? Many health care providers don’t acknowledge the self-blame and anxieties that keep diabetes patients away for years? Enough people report positive experiences with diabetes that it’s leading to a new field of research?

Below are highlights from my talk with Søren Skovlund, global director of patient research and engagement at Novo Nordisk and research director of the company’s DAWN2 (Diabetes Attitudes, Wishes and Needs) study. Above were some of the study’s surprising findings.

Novo Nordisk, the Danish pharmaceutical giant, is one of the world’s largest health care companies and manufacturers of insulin. Its 90-year history has been built on improving the everyday experience and care of people living with diabetes through its services as well as products.

The purpose of the DAWN studies (the first was conducted in 2001) is to help people with diabetes improve their self-management by looking at, and increasing understanding and awareness of, the unmet psycho-social needs of people with diabetes and caregivers. And subsequently, fostering initiatives, policy changes and education to help meet those needs.

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Over the weekend at the 73rd Scientific Conference of the American Diabetes Association (ADA), the company released results from their two-year long DAWN2 study.

As an advocate myself of emotional strength and support to self-manage diabetes, oddly, I see an increasing appetite for everything but — for quick and slick fixes.

We salivate over new technology and devices — meters with increasing bells, whistles and download capability, cool iPhone-like looking insulin pumps, greater functionality in mobile health devices, apps and games.

Yet just as in the Hans Christian Andersen tale “The Emperor’s New Clothes,” where no one in the kingdom told the emperor he wasn’t wearing any clothes but for one small child, few acknowledge the emotional component of managing diabetes. Why? It’s murky, messy, ill-defined and hard.

But study after study shows nearly half of the U.S. adult population with diabetes do not achieve the ADA’s recommendation of an A1C less than 7 percent and two-thirds of young people are not meeting their A1C target goal.

Study after study also shows that people do significantly better managing diabetes, and their quality of life improves, with support.

Do we need the best medicines and tools we can get to help us manage diabetes? Absolutely. My point is that you can have access to better medicines and tools and yet do little because you haven’t got the emotional strength, resilience and support to get up every day and manage this chronic condition; you may lack internal resources and/or family, friend, caregiver or peer-support.

Successful diabetes management in my book requires a “MUSE”: Meaningful reason to stay well, Understanding what diabetes is, Skills for lifestyle changes and Emotional strength/support, in addition to medicine and devices.

2013-06-24-ScreenShot20130624at10.44.22AM.png

Here follow highlights from my talk with Dr. Skovlund (pictured at left).

Key and surprising findings of DAWN2
RG: What are the key findings from both the original DAWN study in 2001 and the DAWN2 study?

Søren Skovlund: Both studies confirm the increased psychological burden that people with diabetes face and how significant that burden is in managing diabetes. Simply, you cannot deal with diabetes without also addressing how it affects your life.

We also learned the differences in perception health professionals and people with diabetes hold about what diabetes is and what the challenges are. And, I’m sure you won’t be surprised to know, there’s a communication gap between doctor and patient.

While health professionals report that they ask their patients regularly about how diabetes affects their life, few people with diabetes report that their care team asks them this question or involves them in any other ways, including planning their own treatment.

The good news, however, is we saw that the more people with diabetes feel that those helping them listen to them, the better they do with their diabetes.

One key finding in the first DAWN study that resonated particularly with clinical professionals was what keeps people with Type 2 diabetes from seeking and accepting treatment. Across all countries, fear and denial often keep people from seeking treatment for years. Then when offered treatment they often change doctors or delay.

RG: What other surprises were revealed in the new study?

SS: The fact that there’s a profound emotional burden on family members of a loved one with diabetes, yet so very little is known about it or done about it. We saw this for the first time in DAWN2 because we were evaluating spouses’ and other cohabitating adults’ experience on a larger scale.

DAWN2 shows us that this is an important aspect to address, particularly since this burden can be reduced.

Positive stories yield a new research field
On the positive side, we were surprised by the pocketful of positive, meaningful experiences a quarter to a third of people related about life with diabetes. We have thousands of hopeful, encouraging stories of meaning and inspiration.

DAWN2 researchers are now analyzing and coding thousands of personal stories we collected from four continents to see where people find positive images and turning points in living with diabetes, and we’re very excited about this as a new area of research.

If we can understand how people climb up their mountain of challenges, then maybe we can use these stories therapeutically. So DAWN2 may help us not just look at the burden of diabetes but also how we meet its challenges. And now we have a rich database to offer the global community from which to establish a research field. One we hope may also contribute to other chronic diseases.

RG: How open are health care professionals to changing their behavior?

SS: From our first study to DAWN2, we see greater openness and readiness on the part of healthcare professionals to partner with their patients. There’s a marked positive shift toward valuing patient empowerment and recognizing that the person with diabetes is the expert on his condition just as the professional is an expert in providing support, coaching and knowledge.

We also see the need for people with Type 2 diabetes, particularly, to speak up and get more actively engaged. Many people with Type 2 can be symptom free for years, and since few are cared for by diabetes specialists, they tend not to see their condition as serious or ask questions. Yet while diabetes is clearly serious, with information, hope, reassurance from their doctors, and a team effort, people can live a good and full life with diabetes.

So we need to find effective ways to get people with diabetes engaged, sooner, and sensitize and equip health professionals to respond.

Next steps
RG: How will the results of DAWN2 be used?

SS: Our next steps are for the national DAWN2 committees to begin to define concrete initiatives relative to emotional support, education and patient involvement that will help improve glycemic control and treatment outcomes in all our participating countries.

Over this year and next, we’ll also be ensuring that the study results are available to scientific publications and then publicly so anyone can apply to the committee to research the data and learn more.

For my 41 years living with diabetes, the last 10 working in the field, I see all too often the emotional toll diabetes extracts. My first book, The ABCs Of Loving Yourself With Diabetes, was expressly written to help readers develop greater emotional strength and resilience to better manage their care.

If you are having difficulty managing your diabetes look for sources of support — family, friends, social media sites, a coach or counselor, and tell your health care team.

Note: In full disclosure, Novo Nordisk has not asked me to write this blog. Personally, I applaud their investment in bringing greater awareness to the psycho-social dimension of living with, and managing, diabetes.

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Riva’s new book, Diabetes Do’s How-To’s, is available in print and Kindle, along with her other books, 50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It and The ABCs Of Loving Yourself With Diabetes. Riva speaks to patients and health care providers about flourishing with diabetes. Visit her website DiabetesStories.com.

For more by Riva Greenberg, click here.

For more on diabetes, click here.

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Diabetes Is the Price Vietnam Pays for Progress

Mr. Dang and many younger patients in the diabetes ward here at Nguyen Tri Phuong Hospital are casualties of rising affluence, his doctor says.

“I see more and more patients with diabetes,” said Dr. Tran Quang Khanh, who is chief of the endocrinology department, whose ward receives 20 new patients a day.

The precise reasons for a spike in diabetes cases are hard to pin down — people are living longer, for one — but doctors in Vietnam say the prime culprits are “Westernization and urbanization.”

“Now we have KFC and many fast-food restaurants,” Dr. Khanh said.

In a country where limbs were once shattered by ordnance and land mines, hospitals in Vietnam are treating an alarming caseload of “diabetes foot,” an infection that often begins as a minor scrape but then develops into a gangrenous wound because the disease desensitizes patients and compromises the healing process.

In the most severe cases, legs are amputated. If the limb can be spared, doctors perform a debridement, a grisly operation that seems more fitting for the trenches of Verdun than for a dynamic, modern metropolis like Ho Chi Minh City. The procedure involves cutting away rotting flesh and is performed several times a day at Nguyen Tri Phuong and four other hospitals in Ho Chi Minh City that have wards dedicated to diabetes care.

Doctors and government officials say no statistics are available on the number of amputations linked to diabetes in Vietnam, but Dr. Thy Khue, a pioneering diabetes researcher in the country, says the problem is “severe” and a particular strain on the health system because patients with amputated feet or legs tend to stay in hospitals for weeks. Diabetes foot exists in the West, but rates may be higher in Vietnam and other tropical countries because people tend to wear sandals outside and go barefoot around the house, leaving their feet more susceptible to injury, Dr. Khue said.

Diabetes rates are surging in many countries, but it is a particularly poignant paradox that, after so many years of war in Vietnam, peace is now partly marred by the afflictions of rising prosperity: clogged hearts, obesity and diabetes.

Official statistics in Vietnam show a vertiginous increase in Type 2 diabetes overall, the form of the disease that is linked to diet and lifestyle and in the West has reached epidemic levels, especially among the obese.

From just 1 percent of the adult Vietnamese population in 1991 — the year the first nationwide survey of diabetes was done in Vietnam — the rate climbed to 6 percent last year. And in Ho Chi Minh City, a survey in 2010 estimated that 1 in 10 adults had the disease.

Dr. Khue said diabetes was once the preserve of the very wealthy. But as people have moved from rice paddies into factories and offices, her patients today are from all walks of life.

“It’s not the disease of the very rich anymore,” she said. “Now poor and rich — everyone — can get diabetes.”

Jesper Hoiland, senior vice president of Novo Nordisk, the world’s biggest maker of drugs to treat the disease, said the number of people with diabetes in Vietnam was expected to climb higher as the country’s economy continues to grow — and as more people adopt modern, urban lifestyles.

“We are going to see a real pandemic in Vietnam in the coming years,” he said.

The International Diabetes Federation, a group that keeps statistics on the disease, calculates that 371 million people were afflicted with diabetes worldwide last year. Four out of five people with the disease live in poor or middle-income countries like Egypt, Guyana or Vietnam, the federation said.

“In today’s world, many more people are dying from overeating than from starvation,” Mr. Hoiland said.

Among the most severely affected are Pacific Islanders, where diabetes rates can go as high as nearly one-third of the population, as is the case in the tiny island of Nauru in Micronesia. Arab countries also have very high rates, according to data published by the federation. Nearly a quarter of the adult population in Saudi Arabia has diabetes, according to the data.

Investing For The Global Diabetes Epidemic

This week, fast-food king-pin McDonald’s (NYSE:MCD) unveiled in Japan its newest creation- Mega Fries. The three-quarters of a pound, 1142 calorie serving of french fries- while potentially delicious- underscores that our new diet of convenience and excess is having some sobering effects on our heaths. As the world moves towards less physical activity and increased consumption of nutritionally deficient foods with higher levels of sugar and saturated fats, obesity rates and its complications will continue to rise, globally.

Incidences of one of those complications- diabetes- is rising at an exponential pace.

For investors, we can find opportunities in this sobering statistic in the companies that are working towards a cure or treat diabetes.

A Growing Global Problem
The National Institute of Health estimates that obesity and related complications such as diabetes are our nation’s chief health concern. However, while most people tend to think of diabetes and obesity as a developed market problem, the two issues are spreading quite rapidly across the globe. Roughly, four out of five people suffering from diabetes are now located in developing markets. China alone, has 92.3 million diabetic citizens, while India’s diabetic population is over 50 million. Overall, there are nearly 371 million people across the globe that suffer from diabetes and plenty more that are in pre-diabetic stages.

However, there ranks are growing quite rapidly.


According to a new report from The International Diabetes Federation (IDF), at least one in 10 adults will have diabetes by 2030. Based on factors like aging, demographic changes, diet changes and increasing sedentary lifestyles, the group predicts that an estimated 552 million people could have diabetes in less than two decades’ time. Overall, the IDF expects the number of cases to jump by 90% with the biggest contributor of new cases coming from the emerging world. This new report echoes similar statements made by the World Health Organization and Centers For Disease Control.

All in all, the growing number of people who suffer from the disease will push the global spending for diabetes to reach $48 to $53 billion by 2016. That’s some serious spending amounts and could be lucrative opportunity for investors.

A Diabetes Portfolio
Given just how big of an epidemic that diabetes has become, investors may want to contribute some capital to the sector. Many major pharmaceutical firms like Eli Lilly (NYSE:LLY) or Sanofi (NYSE: SNY) have divisions devoted to diabetes care and treatment. However, some of the best opportunities could be in the firms that specialize in the diseases care.

While there are several new therapy’s in the works for diabetes care- such as MannKind’s (NASDAQ: MNKD) inhaled insulin drug Afrezza- injectable insulin still remains at the bread and butter of the industry. Novo Nordisk (NYSE:NVO) became one of the first manufacturers of insulin in 1923 and currently supplies more than half of the world’s dosage. The position is being strengthened in the emerging world as Novo has undergone a pricing strategy-in places like Africa and India- that helps get its insulin products into the hands of the poor for dirt cheap. Given the population sizes of these markets, Novo believes that over time volume of insulin sold will lead to serious profits. As such, investors may want to go with the leader in the space.

The diabetes sub-sector is the largest market for medical devices. Analysts estimate that in the U.S. alone will reach $20 billion by next year. Investors can play the device angle through several avenues from syringe manufacturers like Retractable Technologies (NYSE:RVP) and West Pharmaceutical (NYSE:WST), glucose monitors through Becton, Dickinson and Company (NYSE:BDX) or cutting edge insulin pumps through Insulet Corporation (NASDAQ: PODD).

Finally, one of the sad potential side-effects of diabetes is kidney failure and millions of people around the world suffer from this condition. DaVita (NYSE:DVA) owns and operate kidney dialysis centers with primarily focus on the United States. The company’s future potential hasn’t gone unnoticed as America’s favorite value investors- Warren Buffett- has taken a sizable stake in the firm. Incidentally, Buffett also holds a stake in Becton; Dickinson. Retail investors may want to follow suit as the epidemic continues to grow.

The Bottom Line
Sadly, diabetes is quickly becoming a global epidemic. As inactivity and high fat diets continue to seep into our lifestyles, the problems will compound themselves. Within these grim statistics, investors can find opportunities with the companies that are fighting this epidemic. The previous stocks represent a good starting point for further research.

UPDATE 1-Novo Nordisk obesity drug results underwhelm investors

* High-dose liraglutide only slightly better than 1.8 mg

* Placebo-adjusted weight loss 4 pct at 3 mg dose

* Shares fall 4 pct on worries over obesity potential

(Adds analyst comments, latest shares)

COPENHAGEN, March 18 (Reuters) – Overweight and obese diabetes patients given high doses of Novo Nordisk’s drug liraglutide achieved 6 percent weight loss in a clinical trial, only slightly above the loss seen in those on a lower dose.

The Danish group, the world’s biggest insulin producer, said on Monday it was pleased with the results. But investors worried about where it left Novo’s strategy for a premium-priced high-dose obesity treatment and shares in the company fell 4 percent.

Novo Nordisk said subjects with Type 2 diabetes achieved 6 percent weight loss with 3 milligrams of liraglutide in the advanced Phase III trial compared to 5 percent in those on 1.8 mg.

Patients given a placebo also lost 2 percent of their weight, so the placebo-adjusted loss for the higher dose was 4 percent, analysts noted.

“Five and 6 percent is on the low side in efficacy, but it is important to note that it is enough to be approved by the FDA (U.S. Food and Drug Administration),” said Michael Friis Jorgensen, senior analyst at Alm Brand.

He said the share price reaction was harsh but reflected broader uncertainty about Novo’s prospects, following an earlier setback for new diabetes drug Tresiba in the key U.S. market.

“We are pleased about the outcome of this trial and look forward to getting the results from the two remaining trials in the SCALE programme,” said Mads Krogsgaard Thomsen, chief science officer at Novo.

Soren Lontoft Hansen, an analyst at Sydbank, endorsed Thomsen’s view, arguing the results were “robust” – but an analyst at a major bank, who asked not to be quoted before he published on the subject, said the results were only “so so”.

The fact there was just a marginal benefit from using the highest dose was a particular concern for the company’s high-price strategy, he added.

Novo wants to turn the injected drug – already on the market as a treatment for Type 2 diabetes under the brand name Victoza – into a multibillion-dollar-a-year product for the seriously obese.

While some in the industry are sceptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity, Thomsen believes the approach can offer cost-effective benefits.

Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.

Novo Nordisk expects to complete the two remaining Phase III

trials in the so-called SCALE clinical trial programme by mid-2013.

When used in diabetes as Victoza, liraglutide is given at daily doses of either 1.2 or 1.8 mg. Novo, however, has been betting on a higher dose to produce greater weight-loss in the obese.

Novo Nordisk shares were down 4.2 percent at 1245 GMT, underperforming a 0.4 percent fall in a European drugs sector index .

(Reporting by Johan Ahlander, Stine Jacobsen and Ben Hirschler; Editing by Tom Pfeiffer)

((johan.ahlander@thomsonreuters.com)(+46 707 211027)(Reuters Messaging: johan.ahlander.reuters.com@reuters.net))

Keywords: NOVONORDISK/

UPDATE 1-Novo Nordisk obesity drug results underwhelm investors

* High-dose liraglutide only slightly better than 1.8 mg

* Placebo-adjusted weight loss 4 pct at 3 mg dose

* Shares fall 4 pct on worries over obesity potential

(Adds analyst comments, latest shares)

COPENHAGEN, March 18 (Reuters) – Overweight and obese diabetes patients given high doses of Novo Nordisk’s drug liraglutide achieved 6 percent weight loss in a clinical trial, only slightly above the loss seen in those on a lower dose.

The Danish group, the world’s biggest insulin producer, said on Monday it was pleased with the results. But investors worried about where it left Novo’s strategy for a premium-priced high-dose obesity treatment and shares in the company fell 4 percent.

Novo Nordisk said subjects with Type 2 diabetes achieved 6 percent weight loss with 3 milligrams of liraglutide in the advanced Phase III trial compared to 5 percent in those on 1.8 mg.

Patients given a placebo also lost 2 percent of their weight, so the placebo-adjusted loss for the higher dose was 4 percent, analysts noted.

“Five and 6 percent is on the low side in efficacy, but it is important to note that it is enough to be approved by the FDA (U.S. Food and Drug Administration),” said Michael Friis Jorgensen, senior analyst at Alm Brand.

He said the share price reaction was harsh but reflected broader uncertainty about Novo’s prospects, following an earlier setback for new diabetes drug Tresiba in the key U.S. market.

“We are pleased about the outcome of this trial and look forward to getting the results from the two remaining trials in the SCALE programme,” said Mads Krogsgaard Thomsen, chief science officer at Novo.

Soren Lontoft Hansen, an analyst at Sydbank, endorsed Thomsen’s view, arguing the results were “robust” – but an analyst at a major bank, who asked not to be quoted before he published on the subject, said the results were only “so so”.

The fact there was just a marginal benefit from using the highest dose was a particular concern for the company’s high-price strategy, he added.

Novo wants to turn the injected drug – already on the market as a treatment for Type 2 diabetes under the brand name Victoza – into a multibillion-dollar-a-year product for the seriously obese.

While some in the industry are sceptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity, Thomsen believes the approach can offer cost-effective benefits.

Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.

Novo Nordisk expects to complete the two remaining Phase III

trials in the so-called SCALE clinical trial programme by mid-2013.

When used in diabetes as Victoza, liraglutide is given at daily doses of either 1.2 or 1.8 mg. Novo, however, has been betting on a higher dose to produce greater weight-loss in the obese.

Novo Nordisk shares were down 4.2 percent at 1245 GMT, underperforming a 0.4 percent fall in a European drugs sector index .

(Reporting by Johan Ahlander, Stine Jacobsen and Ben Hirschler; Editing by Tom Pfeiffer)

((johan.ahlander@thomsonreuters.com)(+46 707 211027)(Reuters Messaging: johan.ahlander.reuters.com@reuters.net))

Keywords: NOVONORDISK/