Interview: "Generics enable investment in innovation"

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St. Petersburg pharmaceutical manufacturer VERTEX plans to commission the first stage of a new facility in the St. Petersburg Special Economic Zone by the end of 2024, where cosmetic and pharmaceutical products will be produced in the future. Georgy Pobelyansky, General Director of the company, gave his interview to the correspondent on the eve of the event.

Interview:
Figures
 
We have about 400 products, including about 280 items of medicines, including various preparations and dosages, cosmetics, and biologically active supplements of our own brands. On average, we produce 11 million packs of products per month, 135 million packs were produced last year. More than 90% of this figure is medicines.
 
About 74% of the company's drug sales in physical terms in 2023 and 76% in the first 5 months of this year are vital and essential drugs (from the VED list).
 
Over the last 5 years, about RUB 6 billion has been invested in the Company's facilities in the St. Petersburg Special Economic Zone. Partly these are borrowed funds. About 30% of the investments were made for the implementation of the project of the second facility of the company. According to the business plan, the payback period of the second facility project, taking into account three stages, will be 12.5 years.

Current state of the pharmaceutical market
 
Number one in terms of sales in packs is a cardiac drug with the active ingredient bisoprolol. But in terms of margins, we get a minimum from it. This is because it is included in the list of vital and essential drugs, the prices of which are controlled by the state. This is good for the consumer, but for manufacturers it is sometimes a problem, as a number of drugs may eventually be unprofitable to produce, and they disappear from pharmacies.
 
The main problem of the industry is money. If you want to develop, you have to constantly invest. And pharmaceutical manufacturers have a lot of additional costs of doing business.
 
Another market problem is the shortage of labour, the constant growth of salaries for line staff, which sometimes outstrips the level of competence. Now there is a shortage of employees with working specialities like engineers, apparatchiks.

The market has a tendency to stagnate, but in general it is its usual state with little dynamics. In order for it to develop rapidly, large-scale changes like a significant increase in population or, for example, a radical restructuring in the consumption of foodstuffs are needed. Now the market is expanding mainly by adding new products and their actions to what is already available. For example, probiotics to protect the GI tract after taking another drug and the like. There's also a growing trend in the dietary supplement market. Companies are actively promoting this story, and people who were previously sceptical about such products are now beginning to trust them more. The volume of purchases on marketplaces has also soared.

Market development vectors
 
We are constantly studying the generics market - it is, in fact, our "bread", which allows us to invest in innovative developments. At the same time, the focus of our attention is, of course, on the development of original drugs, which is the basis for strategic development. An original drug is such a "solid" thing that is difficult to copy, it has a fundamental value for any company, keeping it afloat.
 
Generics make treatment available worldwide, so they fulfil a socially important function. Manufacturers of original drugs cannot cover the needs of patients with them alone, and after the patent expires, the original drug will in any case have copies. Russian generics are produced using the same technologies and the same raw materials as foreign ones. Russia has very strict requirements for the production of medicines. So many Russian generics today are not only as good as foreign medicines in terms of quality, efficacy and safety, but can even surpass them, provided that all the necessary requirements for the production and suppliers of pharmaceutical substances are met.

Developing and bringing a generic drug to market takes three to four years on average. This is due to the fact that it goes through several stages. Among them are working out the composition and action - comparative studies may be conducted with the original drug, for some drugs also - studies on bioequivalence, therapeutic equivalence, then it takes several months to register the finished product. It takes about eight to ten years to develop and launch a drug with the original combination. Creating an original drug (with the original molecule) can take ten years or more. For both types of these drugs, the bulk of this timeframe is spent conducting several phases of research. Only 50% of the effort is development, registration and manufacturing. The other 50% is working with doctors, arguing and confirming that the product is effective, with clinical trials, including repeat trials, and working with patient communities.

Sanctions
 
Unfortunately, there are no manufacturers of technological equipment for the pharmaceutical industry in Russia. That is why we bought it in Europe from the best trusted suppliers. And these are companies from Italy and Germany. When everything was shut down because of the sanctions, we had to look for manufacturers in Russia and China to produce wear parts and spare parts. We plan to use only "China" at the new facility.
 
For cosmetics, most of the auxiliary substances were also bought in Europe. When we had to change the vector, we reorientated to other countries. China and India were, and still are, among the main suppliers of active pharmaceutical substances (APIs). Since these are friendly countries, there were no major difficulties with procurement. Russian substance manufacturers with whom we work are actively developing. We continued to buy something in Europe through a modified supply chain. But the most significant difficulties have been and remain in the procurement of auxiliary substances used for the production of medicines.
 
Also, since 2022, the company has been actively implementing a project on import substitution of consumables and parts for equipment - their development and purchase from Russian and Chinese manufacturers. Often these components are of higher quality than the original, as in the process of operation our experts identify technical nuances and features of materials that can be envisaged when creating replacement parts.
 
You will be able to present ingredients for the pharmaceutical industry to potential customers at the 27th International Exhibition of Ingredients for Food, Dietary Supplements, Cosmetics and Household Chemicals Global Ingredients Show, which will be held from 15 to 17 April 2025 (Moscow, Crocus Expo IEC, Pavilion 2, Floor 3, Hall 11).

Book a stand


Source: MASHNEWS

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