Category: Diabetes 101

The heavy competition present in the modern insulins market has led to decreasing growth for Novo Nordisk, a Danish drug manufacturer. Novo Nordisk has found it more difficult to bring new products to the market due to the lack of growth in sales of modern insulin.

Despite being the world’s largest producer of insulin, Novo Nordisk shows a slowing of modern insulin sales. The company saw rising sales of diabetes treatment Victoza while modern insulin sales made up 43.6% of its total group sales for the second quarter of 2011.

The company expects full-year sales to rise by 11%, an increase over its earlier prediction of 8-10%. It also expects to see operating profits increase by 15-19% over its earlier prediction of 15%.

Jesper Brandgaard, Chief Financial Officer, expects sales of modern insulin to slow from quarter to quarter until a new product can be introduced. “All else equal, when you launch a new product you will have a fall in growth rates quarter by quarter, and the only way we can get growth going again is by launching a new product,” said Brandgaard. “We hope that degludec and degludec plus will come in and create new growth for our insulins in the United States.”

Brandgaard said that Novo Nordisk will soon be filing an application for registration of degludec in the U.S., although it could be a year to 18 months before the degludec is actually available to consumers. Brandgaard believes that degludec will become a “blockbuster,” or a drug that sells over $1 billion in a year.

Novo Nordisk blamed heavy competition from generic drugs in the oral anti-diabetic field. Healthcare reform across the world has also presented new challenges.

According to Swedbank analysist Johan Unnerus, “We expect modern insulin growth to slow ahead of approvals for the next generation of insulin, which will probably be late next year with the approval of degludec.” The approval of degludec will be a milestone for Novo Nordisk as both an ultra long-lasting insulin product and the premiere of the “next generation” of insulin.

Unnerus stated that the slow growth “leaves Novo a bit more exposed to any negative news or delays of degludec approval as the company faces slower growth.” Novo Nordisk has seen stiff competition from Sanofi-Aventis, manufacturer of Lantus.

Novo Nordisk saw its shares rise by 1.2% to 615 Danish crowns, though still trailing behind a previous high of 632 crowns.

Novo’s stock still beat out the European healthcare sector index and the Copenhagen bourse’s bluechip index, which rose 0.3% and 0.4% respectively.

Novo saw its earnings before interest and tax (EBIT) for the second quarter of 2011 reach over $1 billion, or 5.27 billion Danish crowns ($1.01 billion). Despite the growth, the numbers fell below the Reuters analyst estimate of 5.34 billion crowns. Novo’s second-quarter sales reached 16 billion crowns, which also placed it below analysts’ prediction of 16.57 billion for the quarter.

Victoza, Novo’s treatment for diabetes that stimulates the body into producing its own insulin, rose in sales by 322% to 1.25 billion crowns. That number eclipsed the analysts’ prediction of 1.22 billion.

Novo Nordisk’s sales of modern insulin rose by only 3% to 6.97 billion, falling far below predictions of 7.3 billion.

Two of Novo’s biggest competitors, AstraZeneca and Sanofi-Aventis, both raised their forecasts for 2011 revenues upon reporting their second-quarter earnings.

Boston Therapeutics has filed an abbreviated new drug application (or ANDA) with the Food and Drug Administration. The new drug appears in the form of chewable metformin, intended to help treat Type 2 diabetes.

The purpose of the medication is to aid in controlling blood sugar levels. It is to be used along with insulin or other medications for treating diabetes.

The CEO of Boston Therapeutics, David Platt, stated that this new medication complements Boston’s line of diabetes treatments. Boston also manufactures PZ-320, for management of blood glucose levels, and Ipoxyn, which treats limb ischemia.

According to chief technology officer Joan Sellers, Boston’s filing for this new ANDA represents a significant step in their diabetes treatment program.

Meals to Live has introduced a line of frozen meals specifically prepared by chefs for diabetics. This line of frozen meals will appear in grocery store freezers alongside other foods but is designed with the nutritional needs of diabetics in mind, offering diabetic-friendly foods such as Shrimp Jambalaya and Chili Relleno with Chicken and Ranchero sauce.

About 26 million Americans are currently living with diabetes and about 79 million have been diagnosed with pre-diabetes. Diabetics must take care when choosing their food as extreme blood glucose levels can be life-threatening. Meals to Live aims to alleviate the pressures on diabetics to choose healthy foods by presenting packaging with clear information about the nutritional value of its products, including sodium, fat, and fiber content. Meals to Live’s ultimate goal is to provide diabetic consumers with safe, healthy meal options that are just as convenient and easy to prepare as any other frozen meal. Meals to Live also offers several meals that are completely gluten-free.

Meals to Live was founded by Cole Egger. “After working with a number of diabetes support groups, I saw first-hand the frustrations these individuals face every day as they try to adhere to certain nutritional requirements and I was surprised to learn that there is nothing in the grocer’s freezer specifically for them,” said Egger, current CEO of Meals to Live. “Our meals provide a delicious, convenient alternative while meeting the nutritional needs of those living with diabetes, or anyone looking for flavorful, healthy meals.”

The diabetic-friendly Meals to Live can be found in grocery stores around the United States. Product carriers include Walgreens, Randall’s/Tom Thumb, Publix, Sprouts, Ralph’s, Raley’s, and Brookshire’s. The suggested retail price is $3.99 to $4.99. Customers can also purchase Meals to Live directly from the company’s website at mealstolive.com.

Cole Egger was motivated to introduce a line of diabetic-friendly frozen meals upon learning about the difficulties faced by a family friend in finding nutritionally sound food in a convenient and tasty package. Egger consulted with Jeremy Womble, chef for the Dallas Cowboys, in developing the line. Womble himself suffers from Type 2 diabetes.

Meals to Live’s line of entrees rate low in saturated fat, trans fat and sodium in addition to being high in fiber. Containing from 18g to 58g of carbohydrates, Meals to Live uses whole grains in its foods to provide low-GI energy that keeps diabetics active without causing swings in blood glucose.

Meals to Live also produces a diabetic-friendly product called Glucose Quick Sticks. These flavored powder packets dissolve quickly and provide a blood glucose boost for when low blood sugar strikes.

Learn more about Meals to Live by visiting http://www.mealstolive.com.

You may have seen him on Bravo TV’s “Top Chef,” but Sam Talbot now has his sights set on promoting Type 1 diabetes awareness. Talbot has joined “Life First,” a diabetes awareness campaign. Himself a Type 1 diabetic, Talbot seeks to increase awareness for diabetics in general and to stress that diabetics can lead full and active lives if they have access to blood glucose monitoring technologies.

“Many people view their diabetes as a barrier that prevents them from doing all the things they want to do,” Talbot said. “But instead of having diabetes be the focus of your life, ‘Life First’ means accepting your diabetes and taking control of it, every day, so that you can live your life on your terms.”

Talbot is an executive chef at Surf Lodge, located in Montauk, New York, in addition to being executive chef at Imperial No. 9, a restaurant in the Mondrian Soho Hotel. Talbot is familiar with the balancing act between managing diabetes and living a full and active life, and he intends to help other diabetics understand both the physiological and mental aspects of the disease, aiding them in managing their blood glucose levels as well as their outlooks and attitudes.

Sam Talbot seeks to be a driving force in the “Life First” campaign, relating his experiences with other diabetics and educating them on living successfully with the disease. There are approximately 26 million people in the United States living with diabetes.

Pharmaceutical company Kamada LTD. has been granted an Orphan Drug Designation for Alpha-1 Antitrypsin (AAT) product, which is used to treat Type 1 diabetes. Kamada LTD. specializes in the development, manufacture and marketing of special life-saving drugs and procedures.

Kamada’s new AAT must be subjected to a Phase I/II clinical trial. The AAT is administered by IV and has been approved by the FDA. “We are excited to enter the diabetes field and hope to bring a global breakthrough in the treatment of juvenile diabetes and potential cure,” said Kamada spokesperson David Tsur, Chief Executive Officer of Kamada.

Kamada will be publishing interim reports in 2012, or final reports if the trials are completed within that time frame.

The FDA approved Kamada’s AAT for treatment of Alpha 1 deficiency in July of 2010. The AAT is marketed in the United States by Baxter.

Type 1 diabetes causes the destruction of pancreatic beta cells, which produce insulin. Due to the reduction in insulin production, the body’s natural insulin levels must be altered so that glucose levels in the bloodstream do not enter dangerous territory. Diabetes treatments with AAT products are intended to reduce or prevent inflammation that destroys the pancreatic beta cells. It has been shown that although AAT is present in diabetics, it does not function at normal capacity.

The United States Juvenile Diabetes Research Fund states that there are 3 million cases of juvenile diabetes in the nation, with 30,000 new cases added each year.

According to the Centers for Disease Control, there are 10 million Type 1 diabetes patients worldwide with 100,000 new diagnoses added each year. The Juvenile Diabetes Research Fund of Israel states that 50,000 Type 1 diabetes cases are known in Israel with 200 new diagnoses each year.

Kamada is a publicly-traded (TASE: KMDA) pharmaceutical company that produces specialty medications and other therapeutics with chromatographic purification techniques. Kamada manufactures over 10 biopharmaceuticals which see distribution in over 15 countries.

Glassia, an FDA-approved pharmaceutical, is Kamada’s flagship product, marketed in the US by Baxter. Kamada is also developing an AAT by inhalation, which is undergoing Phase II/III trials in the EU. Five clinical trials of this inhaled AAT have already been concluded. Kamada will also soon undergo a Phase II/III trial of a rabies IgG treatment product in the US.

Smartphones have just become quite a bit more useful for diabetics and other patients who rely on regular injections of medication. A software engineering firm called Linxter, Inc. has begun to roll out a free phone application that keeps track of injections for patients with diabetes and multiple sclerosis, among other conditions which require frequent medication injections.

Linxter, Inc., based in Cooper City, Florida, began developing their TrackMyShots application after it was suggested by a friend with multiple sclerosis, according to CEO Jason Milgram. The app is designed to replace a patient’s injection logbook and will track the date, time, and location of injections.

The TrackMyShots application is freely available on the Windows Phone 7 platform. The Android app store will see the release of TrackMyShots in late August and iPhone users will be able to download the app in late September.

Visit http://www.trackmyshots.com for more information about the app.

Computer security firm StaffSecurity has revealed flaws in the software controlling insulin pumps that could allow malicious attackers to take control of the pump and even endanger the health of the user.

The vulnerability was revealed at a computer security conference held in Las Vegas. Jay Radcliffe, himself a diabetic, broke the news about the security flaws: “My initial reaction was that this was really cool from a technical perspective. The second reaction was one of maybe sheer terror, to know that there’s no security around the devices which are a very active part of keeping me alive,” said Radcliffe. If hackers were able to exploit the flaws in the devices, they could alter their operation and modify the wearer’s insulin levels.

Research teams at the Massachusetts Institute of Technology and University of Massachusetts are staying one step ahead of these vulnerabilities, already working to remove the security flaws. The teams are developing jammers that patients would wear, thereby disrupting any attempts to execute malicious software through a wireless connection to the pump.

Hackers have exposed security flaws in medical devices in the past. The 2009 Conficker viruses infected hospital computer systems and hundreds of MRI devices around the world, although there was no damage reported. The research teams at MIT and the University of Massachusetts stress that while the security flaws are serious and could potentially cause health problems, there have been no reports in which medical devices were intentionally used to threaten a patient’s health. The teams are working to stay a step ahead of software vulnerabilities and to close them before they become a problem.

 

New Research On Obesity and Insulin Resistance: While researchers know that it is obesity that leads to many cases of type 2 diabetes, researchers are partly stumped as to why excessive weight leads to insulin resistance and then to diabetes. At the Joslin Diabetes Center, scientists have found a new way in which obesity affects the body. They have found that in altering the production of proteins in which affects other proteins that are combined together.

The scientists began by examining levels of proteins in the livers of obese people in the lab of Mary-Elizabeth Patti, M.D., they’re findings consisted of a decrease in the number of certain proteins that regulate RNA splicing.

Dr. Patti, the Assistant Professor of Medicine at Harvard Medical School explains, “When a gene is transcribed by the cell, it generates a piece of RNA. That piece of RNA can be split up in different ways, generating proteins that have different functions.” Additionally, Dr. Patti stated, “In the case of these proteins whose production drops in the livers of obese people, this process changes the function of other proteins that can cause excess fat to be made in the liver. That excess fat is known to be a major contributor to insulin resistance.”

Through this study, researchers also showed that the RNA splicing proteins were decreased in the samples of the liver muscle from the obese people studied during their tests.

Through more research, the representative RNA-splicing protein called SFRS10 was examined. The SFRS10 levels dropped in muscle and liver in obese people and in over-fed mice as well. The tests showed that the SFRS10 helped to regulate the protein referred to as LPIN1, which plays a huge and important role in synthesizing fat. In their research of mice, researchers found that when they suppressed the production of SFRS10, more triglycerides developed which is a type of fat that circulates in blood.

Dr. Patti discusses the research further, “More broadly, this work adds a novel insight into how obesity may induce insulin resistance and diabetes risk by changing critical functions of cells, including splicing. This information should stimulate the search for other genes for which differences in splicing may contribute to risk for type 2 diabetes. Ultimately, we hope that modifying these pathways with nutritional or drug therapies could limit the adverse consequences of obesity.”

The World Health Organization Collaborating Center, International Diabetes Center, and Mayo Clinic of Minneapolis, MN, have named Phil Southerland as the new Director of Health Care Policy, Planning and Patient Advocacy.

Southerland, 29, is the CEO of Team Type 1 and a known advocate for global diabetes awareness.

Southerland’s new job as the Director will include providing support for the Center’s five-year collaborative effort with the Chinese Ministry of Health to promote diabetes self-care with programs sponsored by the Center for Disease Control and Prevention. Southerland will work to eliminate discrimination against children and young adults with Type 1 diabetes in China. Southerland will also help with similar programs in the Middle East, the Asia Pacific region and in Latin America. The goal of Southerland’s efforts will be to show that those with diabetes can be healthy and productive so long as they receive adequate medical care for their conditions.

Dr. Roger Mazze, Head of the WHO Collaborating Center, IDC and Mayo Clinic, believes that Southerland is more than qualified for the job. “Due to Phil’s extraordinary experience in working with governments around the world and influencing policy to provide the necessary services and supplies for children with diabetes, we felt it was important to have him work with us on this significant undertaking in China. He will assist our efforts around the world to improve patient self-care and help governments align their policies to ensure people with diabetes enjoy the same rights and opportunities as all individuals within their countries.”

Southerland was diagnosed with Type 1 diabetes himself at only seven months of age. He founded Team Type 1 in 2005 to aid diabetics in taking an active role in the management of their disease by sponsoring a bicycling team to promote the group. Despite Southerland’s young age, Team Type 1 has become a global initiative, making a difference in the lives of countless diabetics across the world. Team Type 1 now features a highly competitive athletics program, sponsoring over 100 athletes from 11 countries in addition to its philanthropic efforts throughout the world, which includes work in developing countries and a sports research wing focused on diabetics.

“Every day, our athletes are proving that with proper care and access to insulin and supplies, anything is possible with diabetes,” said Southerland of Team Type 1’s success. “Every child in the world should have the opportunity to live a full, healthy life, free from the discrimination that often accompanies a diagnosis. I’m honored to be able to assist the World Health Organization in its global mission to make that a reality.”

The World Health Organization funds over 800 collaborating centers around the world that perform activities and events in support of the WHO. The International Diabetes Center and Mayo Clinic was featured as a collaborating center in 1986 for its work in diabetes education as well as in information technology and translation. It is one of only two diabetes centers designated by the WHO in the United States; 32 such centers have been designated worldwide.

An event sponsored by the Congressional Black Caucus Foundation made an effort to raise diabetes awareness in the black community of North Carolina. The Spirit of Healthy Living tour visited Greenville, North Carolina, recently and spent time at the Greenville Community Christian Church. The Church is located at 1104 N. Memorial Drive. Spirit of Healthy Living is a faith-based initiative that seeks to educate black communities about the risks and dangers involved with Type 2 diabetes.

Muriel Cooper is the senior media manager for the Congressional Black Caucus Foundation. Cooper stated that the event goal, dubbed Wellness and Diabetes Day, was to “partner with churches because we know churches represent a significant influence over their congregations. . . while we start the relationship, we are looking for local communities to continue it.” Spirit of Healthy Living hopes that by connecting to communities through their faith, they can make inroads into helping those communities understand diabetes and the risks it poses.

The Wellness and Diabetes Day was opened with Congressman G.K. Butterfield delivering an opening speech, followed by a variety of educational activities including healthy cooking demonstrations, free health screenings, and activities for children and youth.

“Anyone in their community who is concerned about their health and being healthy and/or preventing illness was welcome to come,” said Cooper. The event was family-friendly, open to the public and free to attend, and Cooper hoped that the event would educate families together about being healthy, hoping that it will “start promoting healthy lifestyles within families.”

The issue of diabetes is especially important among black communities because studies have demonstrated that they are more at risk of developing Type 2 diabetes. “We know in the African-American community, it is the fifth leading cause of death,” said Cooper. The event sought to educate the black community about ways to reduce their risk of developing Type 2 diabetes and to help those with diabetes keep it under control.

There is a diabetes self-management program offered by the Pitt County Health Department in addition to a support group for diabetics to share their experiences. The Brody School of Medicine, part of East Carolina University, maintains a Diabetes Self-Care Program that aids diabetics in managing the disease. According to Robin High, the nutrition program director of Pitt County Health Department, these support groups function alongside the diabetes education programs so that diabetics receive aid “not just from our diabetes team but also from each other.”

For additional information on diabetes information and assistance, individuals may log on to spiritofhealth.org. Or, if someone would like more information on local diabetes support programs in the Greenville, North Carolina, area, contact Robin High at 902-2388 at the Pitt County Health Department or at 744-3038 to reach the Brody School of Medicine Diabetes Program.