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GEROPHARM was given permission to conduct clinical trials of insulin analogue glargine

15 March 2016

GEROPHARM Group consistently implements the import substitution strategy in one of the most socially important segments – the segment of drugs for the treatment of diabetes, namely in the segment of insulins.

In March 2016, the company received permission to conduct clinical trials of drug glargine – long-acting analogue insulin of local production: in the Russian market this category is represented only by foreign-made drug products. In 2015, the volume of Russian market of analogue insulins was 12 billion rubles (in consumer prices, according to IMS Health), and the consumption of glargine exceeded 5 billion rubles. In order to cover the country’s demand for these vital drugs, GEROPHARM is implementing a project on the creation of a new manufacturing site in Pushkin - investments in the project are estimated at 2 billion rubles.

Today, there is quite a wide range of insulins in the world: doctors and patients have access not only to genetically engineered short and medium-acting insulins but also to more modern generation of analogue insulins: due to the small modification in the drug's structure, which can be achieved by replacing amino acid sequence, they get a changed type of action: lispro and aspart are characterized by rapid time-action, which allows to simulate insulin peaks, glargine and degludec have long time-action that allows to keep basal insulin level, which is especially important for patients with type 1 diabetes, when insulin isn't produced in the body.

A full range of insulin products gives doctors and patients a choice for working out the best possible combination of insulin therapy, and as a result, an opportunity for people with this systemic disease to achieve the best result in maintaining a high quality of life.

The strategy of GEROPHARM Group is aimed at developing a full pipeline of all modern insulins of local production that will be available for patients in Russia. Today, the company produces genetically engineered human insulins: the plant GEROPHARM-Bio is the only manufacturing site in the country, which has all competences for substance synthesis, and thus, it produces essential drugs on the basis of a full cycle principle:from substance to finished filled drug forms in all modern delivery forms: vials, cartridges and syringe pens. The company has not only created a local production technology, but it has also achieved its highest cost-effectiveness, which allows to achieve the maximum quality of products, comparable to the quality of Western products, and also to compete in terms of price with products from India and China. Today, the share of Rinsulin® in the Russian market makes about 10%.

In 2014, the company finished the development of substances and production technologies of analogue insulins lispro and biphasic lispro, which was conducted under the state contracts within the Federal Target Program "PHARMA-2020". Currently, these drugs are at the stage of clinical trials.

To be a leader in the production of insulin is not the only company’s goal. Its another goal – to develop drugs at the level of international standards. Solving these problems as a whole, it is possible to offer the market new high-quality products and ensure the success of import substitution.

In order to cover the country’s demand for both genetically engineered insulins, which are already available to doctors and patients, and the analogue insulins, which are still under development, GEROPHARM is implementing a project on creation of a new manufacturing site. The total capacity of new and operating manufacturing platforms will be enough to cover 100% of country’s demand and develop export. The developed analogue drugs of local production have a high export potential as their production is carried out on the basis of all international standards.

The project on the construction of GEROPHARM’s new manufacturing platform is expected to be finished by 2016. The investments into the project of such scale are estimated at about 2 billion rubles: half of this amount of money – the company’s funds, the rest – the raised funds, and the funds allocated by the Industry Development Fund (IDF).

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