Diabetes Mellitus

Diabetes mellitus − is a genetically driven disease which cannot be cured by current level of medicine, wherefore patients have ot recieve insulin several times a day for life.

If patient with diabetes mellitus does not recieve adequate treatment, this leads to severe irreversible complications (blindness, renal failure, circulatory, and nervous system disorder), i.e. incapacitation.

0,8 - 1,2%
of the total population occurs the world type 1 diabetes mellitus (insulin dependend)
approx. 6%
of the total pouplation have type 2 diabetes mellitus that becomes «insulin dependend»
from 2 to 5%
of people need daily administration of insulin for life.


Insulin - what is it ?

Insulin or insulin-containing medicines are medicinal products used for treatment of patients with diabetes mellitus, a disease caused by insufficient production of insulin in β-cells of Langerhans islets of the pancreas, wherefore cells cannot appropriately utilize glucose.

Thus, in order to ensure adequate carbohydrate metabolism, it is necessary to have sufficient quantity of glucose in blood and sufficient quantity of insulin to let this glucose enter the cells. In case of insufficiency or complete absence of insulin, glucose cannot enter the cell, which results in energy deficiency and in order to survive the cell seeks other sources of energy and finds them. Most often it’s fat tissue.

As a result of lipolysis, the cell obtains the energy necessary for survival, but residues (ketone bodies or acetone) which always form if this route of energy production is used start intoxicating the body and at a substantial concentration can lead to ketoacidosis and even lethal outcome.


History of insulin

In 1921 Canadian physiologist Sir Frederick Banting was the first to perform successful isolation of insulin and was able to use it for treatment of patients. Up until 1921 diabetes mellitus was an incurable disease due to the absence of effective medicines. In 1923 Banting and Macleod received Nobel prize for discovery of insulin.
Frst report of hypoglycaemic action of sulfonylurea derivatives, development of Lente type insulins
1940s
1950s
Creation of first antidiabetic medicines opened a new era in treatment of diabetes mellitus
Frst studies of pharmacokinetics of insulin, discovery of proinsulin and its structure.
1960s
1970s
Production and implementation of highly purified medicinal products of insulin
For the first time insulin is synthesized in Russia under the guidance of N.A. Yudaev
1972
1980 - 1990s
Use of recombinant DNA technology for industrial scale production of human insulin. Introduction of insulin pens
Forms of insulin
Animal insulin
Starting from 1924, it was manufactured from pancreas of bovine cattle and pigs. Currently, production and use of insulins of animal origin in developed nations practically came to an end because diseases, in particular viral infections, are transmitted to humans through substances from animal organs.
It is manufactured beginning from 1982 using two methods: the first – via transformation of porcine insulin, and the second method - genetic engineering by alteration of DNA site.
Human insulin

Currently, more than 90% of insulin consumed worldwide is produced by genetic engineering . The most promising from the clinical point of view are genetically modified or analog insulins with either ultra short or long, peakless action. In some patients these medicinal products ensure most complete disease compensation.

There are many forms of insulin used for treatment of diabetes mellitus.

They are classified according to onset of action and effect duration:

  • Rapid-acting (ultra-short-acting)
  • Short-acting
  • Intermediate-acting
  • Long-acting
  • Combined (pre-mixed)
Insulin in Russia and in the world

World Diabetes Day is celebrated annually on the birthday of Frederick Banting (November 14), in recognition of his merits as one of the discoverers  of insulin, Frederick Banting , born on November 14, 1891.

Diabetes mellitus (further referred to as DM) occurs in the population of all countries and among all ethnicities. DM is a prime medical and social problem of humanity ( as AIDS and cancer) due to high prevalence, chronicity and impossibility of full recovery from the disease, possibility of cardiovascular and other complications. According to World Health Organization estimated more than 190 million people worldwide suffer from diabetes mellitus. By 2030 this number is likely to more than double.

Only three international pharmaceutical companies have developed and implemented into manufacture the technology of human insulin: Novo Nordisk (Denmark), Eli Lilly (USA) and Sanofi-Aventis (Germany). At the moment they control the worldwide market of insulin, supplies and prices. Each of these companies has its own technology for insulin production.

Animal insulin has left the worldwide market , turnover of human genetically engineered insulin stopped growing, the leading place by sales is occupied by the analog insulin of a new generation.

  • Insulin Glargine - Sanofi-Aventis (Germany);
  • Insulin Lispro - Eli Lilly (USA);
  • Insulin Glulisine - Novo Nordisk (Denmark)

According to the legislation of the Russian Federation, diabetes mellitus qualifies as a socially significant disease. On May 8, 1996, a decree of the President of RF was issued «Regarding measures of state support of people, of patients with diabetes mellitus», and on October 7, 1996 the Federal program «Diabetes mellitus» was initiated.

There are more than 10 million people suffering from this disease in Russia – with regards to this parameter our country occupies the fourth place in the world.

Currently Russian patients with diabetes mellitus generally «use the needle» of three Western manufacturers, these are Eli Lilly (USA), Novo Nordisk (Denmark) and Sanofi-Aventis (Germany), which are worldwide leaders and occupy approximately 98% of the Russian market of insulin with a volume of more than 350 mln dollars a year.

As a matter of fact, the last two companies have their own manufacturing facilities in Russia, but they do not provide a full manufacturing cycle of insulin, but only perform filling of an imported substance. Three Russian companies – «Farmstandart», «Medsintez», and «Gerofarm» - manufacture insulin, but they produce it on the basis of substance purchased abroad, so they actually only mix it with solutions and perform packaging of produce.

In 2012 enterprise LLC «ENDOGENICS» was registered as part of a Russian-Chinese project. Charter capital of LLC «ENDOGENICS» amounts to 100 000 USD. As their contribution the participants deposited the following shares:

Chinese company Gan&Lee Pharmaceuticals - 51% of the charter capital (51 000 USD)
Russian company LLC «Farmaktiv» - 49% of the charter capital (49 000 USD)

Joint Russian and Chinese venture company was created in order to construct a manufacturing facility for production of a full range of finished drug products of insulin. According to previously signed agreements, LLC «ENDOGENICS» will receive from the Chinese company Gan&Lee Pharmaceuticals the technology for full cycle of production of classical genetically engineered insulin and its analog of ultra-short and long action for 70 mln USD.

Chinese company Gan&Lee Pharmaceuticals possesses a proprietary technology for full cycle of production of a full range of insulins. This technology of «molecular chaperones» was first discovered by the company Gan&Lee Pharmaceuticals, patents for this technology are received in many countries of the world.

Chinese company Gan&Lee Pharmaceuticals will transfer to LLC «ENDOGENICS» the production technology for substances of the full range of analog and гgenetically engineered forms of insulin: Glargine, Lispro, Aspart Lispro Mix, Aspart Mix, and also other forms.

Estimated cost of construction of a manufacturing facility in RF for production of all the aforementioned insulins will amount to 140 mln USD ( including 70 mln USD investment into manufacturing technology).

LLC «ENDOGENICS» is planning to transfer a 20% share of the company to the state RF. LLC «ENDOGENICS» is planning to pay 3% royalty from the sales of insulins in RF to Gan&Lee Pharmaceuticals, in its turn Gan&Lee Pharmaceuticals is willing to transfer to LLC «Farmaktiv» its share of 51%.
In case of project implementation, the state budget will receive more than 100-150 mln USD yearly as the following revenues:

100 mln USD planned saving on purchase of domestically produced insulins
30-40 mln USD income tax and 5-10 mln USD as dividends

Guarantees

Officially more than 3 mln patients (type 1 and 2, those included into the official registry of patients RF) are entirely dependent on supplies of insulin by Western manufacturers, the real number of not diagnosed patients with diabetes mellitus in RF is 13,6 mln people. ( see full interview of Head endocrinologist of the country, academician of RAS and RAMS, director of the Endocrinological scientific centre Ivan Dedov in the newspaper «Argumenty i fakty»..

Interruption of insulin supply even for a month would mean death for the majority of these people.

The state spends more than 350 mln USD from public funds on purchase of insulins,thus investing into the economy of Western countries.

. In the current political situation involving implementation of sanctions against Russia, acquisition of modern technologies by a Russian parastatal company and creation on their basis of a full manufacturing cycle for all types of insulin on the territory of the Russian Federation will ensure return on investment for the project in less than a year and will provide an opportunity of complete and definitive refusal of dependency from other countries.

Implementation of the «Insulin» project will help all Russian pharmaceutical manufacturers to overcome the «mental stumbling block» and lay a course for full import substitution.

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