Innovative drugs are drugs that open up new possibilities in the treatment of diseases, which often up to a certain point did not respond to adequate therapy. Such a drug can help many patients whose treatment was ineffective or ineffective. To do this, it is important to correctly develop a strategy for introducing new drugs to the market. Evgeny Abramov, General Director of Takeda Pharmaceuticals LLC, spoke about the main challenges of the Russian pharmaceutical industry in this area.
What are the main difficulties you see with the launch of new drugs throughout the market ?
I think that the key challenges to bringing innovative drugs to the market are sometimes the lengthy process of accessing the Drug Lists. An important role is played by the lack of readiness of the medical infrastructure, which consists in a low level of awareness about the disease, the absence or incomplete implementation of diagnostic measures, as well as a well-arranged routing of patients and other problems that take a lot of time to solve.
What are Takeda Pharmaceuticals priorities in the development of new drugs, which nosologies are emphasized?
In January of this year, Takeda Pharmaceuticals completed the acquisition of Scheyer pharmaceutical company and strengthened its ability to develop and market innovative medicines, including for the treatment of rare diseases. The united company focuses on the development of drugs in the field of gastroenterology, including for the treatment of severe forms of diseases such as inflammatory bowel disease, hematology, including hemophilia therapy, oncology, which includes both malignant blood diseases and solid tumors, and therapy obtained from blood plasma. The company will continue to develop a neurological direction in which it has traditionally strong positions.
According to in your opinion, for what kind of nosol there is the greatest defi drug cit?
I think that in recent years, the pharmaceutical industry has made a major breakthrough in the development of completely new approaches to therapy, including such as biological, gene, and genomic, which can cure the most complex diseases. Pharmaceutical science is developing in parallel with medicine, which opens and allows to diagnose a large number of new, often rare in certain cases, even ultra-rare diseases or conditions. Therefore, the pharmaceutical industry faces a big challenge in finding solutions for the treatment of these diseases, and I am sure that in the near future we will witness that the concept of personal therapy will be implemented for patients in the literal sense.
For which of these nosologies the main problem is difficult What are the new drug launches? Why?
Difficulties in bringing innovative drugs to the market are very similar in most countries of the world. In part, they look objective and are associated, inter alia, with an insufficient volume of clinical trials, which may be associated with a limited population of patients suffering from rare diseases. In some cases, the patient’s serious illness and, consequently, his lack of the ability to wait for registration decisions, motivate regulators to make decisions about the possibility of state registration at earlier phases of clinical trials. In our country, there is no such practice yet.
The need to introduce new technologies and at the same time a limited population in need of therapy makes some drugs highly expensive even for the largest state budgets. An objective situation arises when the state that pays for the therapy for the patient and the manufacturer must seek a compromise, and it should not be otherwise. Therefore, there is a growing interest in the world in introducing alternative payment methods based on the principles of direct negotiations. There are cases when the state and the manufacturer of the drug came to an agreement on sharing financial risks, including for therapy that did not achieve the expected result. There is also the practice of setting the threshold for financing from the state budget, and if it is exceeded, the manufacturer covers the need for treatment at his own expense. I am sure that personalized drug therapy will lead us to a personalized approach to organizing the availability of the drug for the patient. Having no such practice in Russia, we, as a manufacturer, experience difficulties with access to the market, and at the same time I believe that the state budget would only benefit from such negotiations.
What are the successes associated with the output new drugs, were reached ?
The strategy for introducing new drugs to the Russian market is complex, it includes a serious study of medical issues, clinical and economic aspects. Our company also always evaluates the possibility of transferring production to the territory of Russia. To implement this solution, you can use your own company in Yaroslavl or a partnership with Russian manufacturers. I think that the main pride of our company last year was the recognition at the highest state level of the two countries of the project to transfer the production of orphan drug for the treatment of multiple myeloma to our production site in Yaroslavl. The project was included in the joint plan for economic cooperation between Russia and Japan, approved by the President of the Russian Federation and the Prime Minister of Japan. We will do everything possible to achieve our production plans and ensure access for Russian patients to this drug innovation produced in Russia.
On March of this year, Takeda Pharmaceuticals announced the withdrawal of three prep products from the market the rats, which occupied a large volume of the market and were included in the list of vital drugs. How will this affect patients and the healthcare system? Are there any alternatives on the market, including from your company ?
The cessation of drug supplies is associated with a global review of the portfolio and the need to re-equip production to produce other drugs. The Takeda Pharmaceuticals company is actively researching and aims to increase the availability of modern and innovative medicines for patients. In this regard, the company regularly optimizes its product portfolio and seeks opportunities for the production of new drugs. At the same time, there are a sufficient number of Russian and foreign analogues of withdrawn drugs on the Russian market, which means that Takeda Pharmaceuticals’s decision to withdraw three drugs from the Russian market will not have a significant impact on providing patients with essential and essential drugs.