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Functionality of the "Bio Reactor" producing insulin (english)

Researchers in Dresden succeed a break-through in the diabetes therapy utilizing artificial pancreas Human beta cells of the islets of Langerhans utilized in...
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diabetes and more
Important news for those concerned with all types of diabetes, associated autoimmune diseases, & health
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Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs

Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs | diabetes and more | Scoop.it
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University of Alberta Diabetes Institute Encouraged by Preliminary Results of Testing of ProtoKinetix Licensed AAGP™ Molecule in Islet Cell Transplantation - News Press Release | PharmiWeb.com

University of Alberta Diabetes Institute Encouraged by Preliminary Results of Testing of ProtoKinetix Licensed AAGP™ Molecule in Islet Cell Transplantation - News Press Release | PharmiWeb.com | diabetes and more | Scoop.it
ProtoKinetix (OTC: PKTX) (www.protokinetix.com) is pleased to be able to report a comprehensive transplantation testing program being conducted for the last two years in conjunction with the University of Alberta transplant research team. The Company
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Diabetes groups call for radical rethink of regulation governing insulin pumps

Diabetes groups call for radical rethink of regulation governing insulin pumps | diabetes and more | Scoop.it
A radical review of how insulin pumps are approved for use and then monitored once on the market is required, according to diabetes groups in United States and Europe. 
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US diabetics pay most for drugs, but world’s poorest bear the biggest economic burden

US diabetics pay most for drugs, but world’s poorest bear the biggest economic burden | diabetes and more | Scoop.it
More evidence US diabetics pay more for drugs than sufferers in comparable countries has emerged this month in a study assessing the diseases’ economic impact
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Digital Games for Type 1 and Type 2 Diabetes: Underpinning Theory With Three Illustrative Examples

Digital Games for Type 1 and Type 2 Diabetes: Underpinning Theory With Three Illustrative Examples | diabetes and more | Scoop.it
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ROR Inverse Agonist Suppresses Insulitis and Prevents Hyperglycemia in a Mouse Model of Type 1 Diabetes: Endocrinology: Vol 156, No 3

ROR Inverse Agonist Suppresses Insulitis and Prevents Hyperglycemia in a Mouse Model of Type 1 Diabetes: Endocrinology: Vol 156, No 3 | diabetes and more | Scoop.it
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Mice - who knows if it'll translate to humans?

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Using Additive Manufacturing To Print Glucose Sensors

Using Additive Manufacturing To Print Glucose Sensors | diabetes and more | Scoop.it
Engineers have developed a technique similar to inkjet printing that hey used to fabricate a new glucose sensor for the management of diabetes. The...
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New compound prevents onset of type 1 diabetes in animal models

Scientists from the Florida campus of The Scripps Research Institute (TSRI) have successfully tested a potent synthetic compound that prevents type 1 diabetes in animal models of the disease.
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Expert At UF: Breakthrough Made Vs. Type 1 Diabetes |

Expert At UF: Breakthrough Made Vs. Type 1 Diabetes | | diabetes and more | Scoop.it
The genes that increase the risk of Type 1 diabetes have lost their hiding place.
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Vaccine will cure diabetes: Scientist close to finding new wonder drug

Vaccine will cure diabetes: Scientist close to finding new wonder drug | diabetes and more | Scoop.it
BRITISH scientists are working on a jab that could provide a “longed-for” diabetes cure.
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Psychoactive Plant May Hold Key to Reversing Diabetes

Psychoactive Plant May Hold Key to Reversing Diabetes | diabetes and more | Scoop.it
A chemical found in ayahuasca has the potential to regenerate pancreas cells that have been lost to diabetes.
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03 » Genetics breakthrough by group that includes University of Florida expert will boost diabetes research » University of Florida

03 » Genetics breakthrough by group that includes University of Florida expert will boost diabetes research » University of Florida | diabetes and more | Scoop.it
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The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System

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Scientists have created insulin-producing cells that could replace injections

Australian scientists from the University of Technology, Sydney (UTS) , have created a line of insulin-producing cells that could eliminate the need for Type 1 diabetics to inject themselves with insulin. The development on its own is pretty...
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2015 DiabetesMine Patient Voices Contest - Life Hacks

2015 DiabetesMine Patient Voices Contest - Life Hacks | diabetes and more | Scoop.it
RT @DiabetesMine: @HopeWarshaw Thx hope! Pls help spread the word abt 2015 #Diabetes Mine Patient Voices Contest! http://t.co/YXIr1BLtRW -AT
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FDA is Sued for Failing to Regulate the Use of Glutens in Medicines

FDA is Sued for Failing to Regulate the Use of Glutens in Medicines | diabetes and more | Scoop.it
A consumer has filed a lawsuit against the FDA for failing to respond to a citizen's petition seeking the withdrawal of wheat gluten from medicines or updated product labeling.
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The Detrimental Consequences of Immunosuppressive Therapy in the Treatment of Type-1 Diabetes

Int Rev Immunol. 2015 Mar 20. [Epub ahead of print]
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More evidence for rise, and race difference, in U.S. celiac disease

(Reuters Health) – - More than one and a half million Americans have a severe immune reaction to the gluten protein in breads and other foods, and they are most often of European descent, according to
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Why Are There No Generic Insulins?

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Link here: http://www.medscape.com/viewarticle/841669?src=stfb 

 

Why Are There No Generic Insulins?

Miriam E Tucker

March 18, 2015 EDITORS' RECOMMENDATIONSFirst Biosimilar Insulin, Glargine, Approved in EUInsulin Market Heats Up as Biosimilars and Newer Forms Emerge Sanofi Sues Eli Lilly Over Challenge to Top Diabetes Drug LantusTopic Alert

Receive an email from Medscape whenever new articles on this topic are available.

 Add Diabetes, Type 1 to My Topic AlertDRUG & REFERENCE INFORMATIONHyperosmolar Hyperglycemic StateDiabetes Mellitus and PregnancyDiabetic Lumbosacral Plexopathy  

Why, nearly 100 years after the discovery of insulin, are no low-priced generic versions available?

The complicated answer to that question is explored in a special article published in the March 19 issue of the New England Journal of Medicine by Jeremy A Greene, MD, PhD, and Kevin R Riggs, MD, MPH, from Johns Hopkins University School of Medicine, Baltimore, Maryland.

Generic drugs account for more than 80% of prescriptions filled today, saving the healthcare system billions of dollars a year. In contrast to about a $4/month out-of-pocket cost for some generic pills, monthly costs for brand-name insulins range from $120 to $400.

The case of insulin — used by approximately six million people with type 1 and type 2 diabetes in America — differs from other drugs for a number of reasons, Drs Greene and Riggs explain.

Insulin's Canadian discoverers sold the patent to their university for $1, stating that profit was not their goal. Since then, a series of incremental technological advances have maintained the patents, while older formulations have been pulled from the market.

The recent move toward "biosimilars" — so-called because the properties of large molecules don't allow for exact copies as do generic small-molecule drugs — isn't likely to dramatically affect the cost equation either, the authors assert.

"The drugs that ultimately see extensive generic competition differ from those that attract few, if any, manufacturers. The history of insulin highlights the limits of generic competition as a public-health framework. Nearly a century after its discovery, there is still no inexpensive supply of insulin for people living with diabetes in North America, and Americans are paying a steep price for the continued rejuvenation of this oldest of modern medicines," the doctors write.

"Discoverers Didn't Intend Insulin to Become a Profitable Monopoly"

After identifying the glucose-lowering substance later known as insulin at the University of Toronto in 1921, Dr Frederick Banting and medical student Charles Best waited 2 years before seeking a patent and then only with the intent of publishing the extraction method, writing: "When the details of the method of preparation are published, anyone would be free to prepare the extract, but no one could secure a profitable monopoly."

In 1923, they teamed up with Eli Lilly, already an established pharmaceutical company, to produce the extract on a larger scale. They also licensed the rights to produce insulin to several other companies, including Denmark's Nordisk Insulinlaboratorium (which later merged with Novo Terapeutisk Laboratorium to form Novo Nordisk).

The next several decades brought successive improvements: adding protamine prolonged insulin's action, while zinc allowed it to be combined with short-acting insulin in a form patented in 1946 under the name "neutral protamine Hagedorn (NPH)," after its Danish founder. Lente, a slower version without protamine, came along in the mid-1950s.

These advances allowed for more dose-adjustment options and also extended the patents into the 1970s. Further innovations that improved purity pushed the patents ahead another decade, Drs Greene and Riggs say.

Recombinant Technology

Recombinant technology came along first from Genentech and Lilly in 1978, when they inserted cloned insulin genes into bacteria and created Humulin R (rapid) and Humulin N (NPH) in 1982. Novo Nordisk's chemical conversion of bovine into human insulin to create its own recombinant insulin reached the United States by 1988.

 

Thus, "A new web of insulin patents, held by Lilly, Novo Nordisk, and Genentech, promised to stretch into the 21st century," the authors write.

Next, scientists began moving around amino acids to create new insulin analogs with different properties: In 1996, lispro became the first fast-acting insulin analog to be approved, with the aim of better minimizing postprandial glucose excursions, followed by aspart in 2000 and glulisine in 2004.

Long-acting synthetic analogs were also developed to reduce hypoglycemia and improve overall diabetes control. Glargine was first of these, on the US market in 2000, followed by detemir in 2005. The first patents on these products expired in June 2014.

Biosimilar, but Cheaper? 

Now with those patents expired, "biosimilars" have entered the picture. Lilly and Boehringer Ingelheim's biosimilar version of glargine was recently approved in the European Union.

 

In the United States, the same product received tentative approval from the Food and Drug Administration, but final approval is being held up for 30 months, until mid-2016, because Sanofi has filed a lawsuit claiming patent infringement.

Meanwhile, unregulated biosimilar insulins have appeared in countries with less strict regulatory policies, including China, India, and Mexico.

Even if biosimilar insulins do take hold in North America, they're not likely to produce the same cost saving as do generic drugs, given the additional data that will be required to prove their safety and efficacy, including immunogenicity studies.

 

Economists estimate that the price reduction for biosimilar insulins might not exceed 20% to 40%, in contrast to the 80% or greater cost savings from most other generic drugs, the authors point out.

A Series of Incremental Improvements 

Moreover, biosimilars aren't going to change the fundamental difference between insulin and many other types of drugs that have been copied to various degrees, the authors say.

 

"The incremental innovation has repeatedly precluded the formation of a generic insulin industry in North America when earlier patents expired. The history of insulin hasn't followed the standard chronology of pharmaceutical innovation, in which patent monopolies predictably give way to generic competition."

Indeed, "insulin is not a single entity but a family of related products that has evolved through incremental improvements. Subsequent iterations of insulin represented actual innovations, each one being safer, more effective, or more convenient than its predecessor."

Because of that, "generic drug manufacturers are unlikely to invest in producing older versions of insulin that may already be obsolete," Drs Greene and Riggs observe.

 

And this is the case despite the fact that studies don't consistently show that analogs produce better outcomes than do the older NPH and regular insulins, and the advantages should be weighed against the costs, particularly for patients without adequate health insurance.

"On the whole, it's hard to say that contemporary patients who cannot afford their insulin (let alone the patent-protected glucometers and test strips required to adjust the dose) are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago, had generics manufacturers introduced cheaper versions when patents expired."

The upshot, they say, is that "after generations of incremental innovation, insulin may be no more affordable than it was when the original patent holders sold their stake for $1 to ensure access to this essential medicine."

 

Dr Greene reports grant support from the National Science Foundation, the National Library of Medicine, and the National Institutes of Health. Dr Riggs reports grant support from the National Institutes of Health and nonfinancial support from the Johns Hopkins Berman Institute of Bioethics. 

N Engl J Med. 2015;372:1171-1175. Available at: www.nejm.org.

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BioLineRx’s Treatment for Type 1 Diabetes Effective in Preclinical Trials

BioLineRx Ltd. , a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today positive pre-clinical results for BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes.
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‘Smart Insulin’ More an Exciting Theory than Reality

‘Smart Insulin’ More an Exciting Theory than Reality | diabetes and more | Scoop.it
MIT researchers discuss the process of creating glucose-sensing insulin and whether if it will ever be available for people with diabetes.
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Promising celiac disease therapies on the horizon - Reuters

(Reuters Health) - Currently, a gluten free diet is the only way to manage celiac disease.
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Orgenesis Acquires MaSTherCel Orgenesis said today it is acquiring MaSTherCell, a cell therapy and regenerative medicine company focused on type 1 diabetes,

Orgenesis Acquires MaSTherCel Orgenesis said today it is acquiring MaSTherCell, a cell therapy and regenerative medicine company focused on type 1 diabetes, | diabetes and more | Scoop.it
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