Scientific Research Institute of Highly Pure Biopreparations Resumes Production of Antioxidant

The Federal State Unitary Enterprise “State Scientific Research Institute of Highly Pure Biopreparations” FMBA decided to return to the market the original drug Rexod® (INN: superoxide dismutase), which was developed and produced by the Institute.

The drug is available in a new dosage form – solution for injection.

Superoxide dismutase is an endogenous acceptor of free oxygen radicals. Because of their excessive accumulation in the cells, pathological processes develop, and the current removes free radicals and prevents the formation of new hydroxyl and singlet radicals that are dangerous for the body.

An important pharmacological action of the drug is prevention of accumulation in the focus of inflammation of neutrophils, causing the destruction of nearby tissues.

The developers have conducted a number of studies and plan to expand the scope of the drug for the treatment of complications of radiation therapy of cancer, as well as in lateral amniotrophic sclerosis and in resuscitation practice.

Currently, the only indicator is the comprehensive prevention of the development of intraoperative complications in endoprosthetics of large joints using bone cement.


The medicine created in the Russian Federation has passed clinical trials as a remedy for tick-borne encephalitis

Antiviral drug triazavirin was developed by researchers of the Ural Branch of the Russian Academy of Sciences and the Ural Federal University.

Employees of the Krasnoyarsk State Medical University conducted clinical trials of antiviral drug triazavirin, developed by Ural researchers, and confirmed its effectiveness for tick-borne viral encephalitis (EEC). It was reported by the press service of the Ministry of Science and Higher Education of the Russian Federation.

According to statistics, the Krasnoyarsk Territory is considered the largest natural foci of tick-borne encephalitis in Russia. Over the past years, the incidence in the region has exceeded the average Russian indicators by 9.5 times. Despite the use of specific antiviral and immunotropic drugs, such as RNA-aza, ribavirin, panavir, ferrovir, new cases of disability and death of inhabitants of the region infected with encephalitis are recorded annually.

“Triazavirin, developed by researchers of the Ural Branch of the Russian Academy of Sciences (Ural Branch of the Russian Academy of Sciences) and the Ural Federal University (Ural Federal University, Yekaterinburg), proved to be an effective remedy against tick-borne encephalitis (EHE). Clinical trials conducted by Krasnoyarsk State Medical University “- said in a statement.

In search of effective treatments for tick-borne viral encephalitis, university staff decided to study the properties of triazavirin. This drug, which has been developed since the late 1980s, entered the pharmacy chain in 2014 and proved itself as a powerful tool against influenza viruses (including avian and swine), bronchial asthma, and also rubella, measles, and herpes. In addition, triazavirin has been shown to be effective against Ebola virus, Marburg hemorrhagic fever, and West Nile fever. The main mechanism of drug action is the blockade of viral RNA synthesis.

The study, conducted in the Krasnoyarsk Interdistrict Clinical Emergency Hospital, involved 73 patients with febrile forms of tick-borne viral encephalitis. The inclusion of triazavirin in the treatment regimen, as the scientists note, was accompanied by a decrease in all clinical manifestations of this disease: fever stopped by 2.3 times, intoxication syndrome by 1.8 times, catarrhal phenomena by 1.7 times faster.

“The results of the study allow us to assign triazavirin, taking into account the mechanism of its action in tick-borne viral encephalitis, to the group of etiotropic agents with good efficacy and tolerability,” the report says. In addition to the Krasnoyarsk Territory, the drug may be in demand in other regions – in the Urals, in Western and Eastern Siberia, where tick-borne encephalitis is an endemic disease.


UK and Russia sign MoU on Regulatory Cooperation on Medicines

Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health.

The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MoU) with its Russian counterpart; the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

This agreement will increase collaboration between the two bodies and further enhance cooperation in the field of regulation of medicines.

The MoU is designed to establish mechanisms of cooperation which will facilitate:

  • the exchange of information on medicines regulations
  • the exchange of safety information
  • cooperation on Good Manufacturing Practice (GMP) inspections
  • collaboration on enforcement activities

Dr Sam Atkinson, MHRA’s Director of the Inspection, Enforcement and Standards Division, said:

“Working in an increasingly global environment, the sharing of intelligence between medicines regulators is the cornerstone of protecting the health system worldwide.”

“Formalising our already close working relationships with international counterparts helps facilitate this exchange of information.”

“This makes it easier for us to track down criminals, promote good practices internationally, and identify emerging safety trends to protect public health.”


New results of the Phase III clinical trial of Tafamidis

In the section of the newest clinical trials of the 22nd annual scientific conference of American society in heart failure there were the results of the sensitivity and post-hoc analysis. New analysis of death due to any cause has shown the benefits of Tafamidis in all subgroups.

For example, among patients with cardiomyopathy due to the wild-type  transthyretin and the hereditary form of the disease, the risk of death decreased by 29% and 31%, respectively. Pfizer Inc. announced that additional sensitivity analysis and post-hoc analysis that were conducted during the Phase III clinical trial of Tapamidis for the treatment of transthyretin family amyloid cardiomyopathy (Att-ACT) provided additional information about the action of the drug in subgroups of patients with cardiomyopathy due to the wild-type transthyretin and the hereditary form of the disease, and subgroups of patients with HSN I, II, and III FC NYHA1.

Tafamidis is the single experimental drug that has successfully passed the Phase III clinical trial, which evaluates its safety and efficacy for the treatment of the disease.

ATRT-CMC is a rare and poor diagnosed fatal disease associated with progressive heart failure for which there is no approved pharmacological therapy.

The primary results of the study were presented on August 27, 2018 at the Congress of the European Society of ECC 2018 cardiologists in Munich (Germany) and were simultaneously published on the Internet in the Nejm (“New Joggy Medical Medical Journal”).

Additional primary results showed that in comparing with placebo Tafamidis during 30 months greatly reduces the combination of death due to any cause and the frequency of hospitalization associated with cardiovascular manifestations of diseases, in patients with “wild type” ATRT-CMC and a hereditary form of the disease.

In addition, in comparing with the placebo, Tafamidis reduced the risk of death due to any cause in all subgroups (wild type disease, hereditary disease and functional classes NYHA I, II and III). “These additional data also confirm that Tafamidis is a promising cure for treatment of “wild type” ATRT-KM or hereditary disease,” Brenda Cuperston, the Senior Vice President and the head of the Development Defense, the main specialist of the drug department for the treatment of orphan diseases and the development of global products of Pfizer, said. – We are looking forward to get more information  from analysis of this study and continue to work with regulatory authorities of different countries to make this drug available for patients. ”

“Having received statistically significant results of the primary analysis of the Phase III clinical trial of Att-ACT, we sought to go deep into the efficacy of Tafamidis in these key subgroups of patients,Mathew S. Maurer said, Head Doctor of the Cathedral of the Center for the Study of Hypertrophic Cardiomyopathy at the Presbyterian Hospital in New York / the Clinic of the Columbia University, presenting the results of the Att-ACT study at the annual HFSA 2018 conference. – The additional analysis confirm the results presented at the ESC 2018 congress and published several weeks ago in the New Jognog Journal of Medicine, which emphasizes the importance of raising awareness about this potentially death disease and the importance of diagnosing the disease at earlier stage. ”

Taking into account severity of the disease and the lack of alternatives for the treatment, Pfizer approved advanced access to Tafamidis for the patients suffering from ATTR-CMC, which can benefit from the treatment before approval of the drug by supervisory authorities.

Access to such programs may differ depending on the country; health care providers are encouraged to contact the local Medical Department of Pfizer for more information.

Interested patients suffering from ATTR-CMC should contact with their doctors to discuss the expediency of treating by Tafamidis.

In 2012, Tafamidis received the status of an orphan drug for the treatment of ATTR-CMC in both EU and the United States, as well as in 2018 in Japan. In June 2017 and in May 2018, accordingly, the       Food and Drug Administration (FDA) decided to introduce an accelerated application procedure for the drug with the status of fundamentally new, breakthrough drug for the ATTR-CMP therapy.

In 2017, Tafamidis (Vyndaqel) was approved in the Russian Federation. This is the first and the single drug in Russia with an approved indication “for the treatment of transthyretin amyloidosis in adults with clinically apparent polyneuropathy in order to delay the development of disorders in peripheral nerves.”


Statins may suspend the development of diabetic retinopathy

According to experts from Chang Gun Memorial Hospital in Taiwan, diabetic patients taking statins have a reduced risk of diabetic retinopathy.

The researchers, based on information from the National Taiwan Health Insurance Policy Database, undertook a comparative analysis of patients with type 2 diabetes and high cholesterol, among whom about 19,000 patients took statins, the same amount didn’t take statins. Monitoring during 7 years found out that among participants who took statins diabetic retinopathy appeared in 2004 patients (10.6%), while in the group who did not take these drugs, the disease developed in 2269 participants (12%).

The experts also noted that the use of statins was associated not only with a lower demand in invasive treatment of eye diseases, but also with a reduced risk of diabetic retinopathy.

However, according to Dr. Seth Martin, a Johns Hopkins Medicine scientist, the results of this study require careful analysis and confirmation. He notes that the main reason for taking statins is to reduce the risk of cardiovascular diseases, and the positive impact of these drugs on diabetic patient vision is an additional benefit.


Valenta Farm presents an innovative formulation of a benzodiazepine drug

A new unique formulation of Fenazepam® developed by Valenta Pharm appeared in the drugstores of our country at the beginning of December. It is Phenazepam® orally dispersible tablets 1mg N10.

Innovative dosage form is a result of the seven-year efforts made by the Company, as well as significant investment in the development and research. Phenazepam® is a unique benzodiazepine drug, which hasn’t any analogues on the Russian market.

Consumer characteristics of the new dosage form are:

– additional control of course therapy;
– the best subjective tolerance of the therapy;
– it isn’t necessary to swallow and drink water, the tablet dissolves in the mouth;
– provides a more rapid achievement of drug maximum concentration in blood: up to 29% faster compared with the traditional tablet dosage form.

The drug is produced by new technology in accordance with Good manufacturing practice (GMP) at the modern high-tech research and production complex of Valenta Ph. JSC.

“The introduction in standard practice of orally dispersible dosage forms available for use in various branches of medicine is a very promising way for increasing the therapy effectiveness and optimizing the treatment. In psychiatry the main advantage of CCT is a possible fast therapeutic effect that is comparable in strength to the effect of the oral dosage form, as well as a significant increase of patient compliance and the early adherence to the therapy. The creation of new orally dispersible dosage forms of anxiolytic drugs intended for rapid relief of acute manifestations of anxiety syndrome is of particular concern ”- Sergey Nikolayevich Mosolov, professor, doctor of medical sciences, Honoured scientist of the Russian Federation, head of the Psychiatric Research Institute of Psychiatry said.


A drug for the treatment of cancers was approved in the USA

The FDA approved Vitrakvi (Loxo Oncology) in fast forward for the treatment of cancer in adults and children with a certain genetic mutation (biomarker). As noted by the FDA, this is a second drug approved for the treating of tumors regardless of their location.

Vitrakvi is intended for the treatment of adults and children with various neoplasms with mutations characterized by a fusion of the TRK gene and with the progressive disease after therapy. Such mutations are rare and located in many body parts.

The efficacy of the drug was studied in three clinical studies involving 55 patients with solid tumors and fusion of the TRK gene with metastases and those who didn’t have surgery, as well as patients with progressive disease after treatment.

According to the data obtained, the overall response rate was 75%. In 73% of patients, the response was maintained for at least six months, and in 39% – for one year or more. Among the tumors responded to the therapy are soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.

Side effects associated with taking Vitrakvi were: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased levels of liver enzymes.


Defeated virus: will the flu become a second smallpox?

With the arrival of the first colds, the number of cases of acute respiratory viral diseases increases, the most serious of which is considered the flu.

According to the World Health Organization (WHO), from 10 to 15% of the world’s population is infected with influenza viruses, which leads to death, including economically developed countries.

It is proven that vaccinal prevention is one of the most effective ways to fight the flu. According to experts, when vaccine and circulating strains occur, vaccination reduces the incidence of diseases in the population by 50-60%. The effectiveness of vaccine prevention of influenza is confirmed not only by clinical studies, but also by statistical data: from 1996-2017 vaccination coverage in Russia increased from 0.2% to 46.5%, which made it possible to reduce the incidence of influenza by 155 times and bring vaccination to the most important tasks. This year, an innovative drug which will allow us to solve the problem of the incidence of influenza appeared on the domestic pharmaceutical market in the Russian Federation.

In July 2018, Petrovax NPO Farm received a registration certificate for Grippol® Quadri, which is the first domestic tetravalent vaccine against influenza. Vaccination has already become available in this surveillance in 2018/2019, it is allowed to use from the age of 18, but clinical studies are currently being conducted on the efficacy and safety of its use in childhood.

According to leading experts in the field of infectious diseases, the results of clinical trials of the first domestic tetravalent vaccine showed that it is well tolerated, has a low-reactive vaccine and has a favorable safety profile. An assessment of immunogenicity has shown that tetravalent vaccination, which allows analysis of 5 ug of antigens of two types of virus and two viruses, does not provide trivalent reference vaccines for the control of strains and outperforms them in relation to the fourth strain, the influenza B virus, which is not included in trivalent viruses.

Currently, production vaccines are produced only in 6 countries of the world – Australia, Germany, Canada, New Zealand, the USA and France, this year in this honorary list the Russian Federation entered. New domestic vaccination is not inferior to high-quality foreign analogues, because It meets the requirements of GMP and has a number of pharmacoeconomic advantages. According to experts, its use will provide up to 265 thousand cases of flu for the season and save more than 2.5 billion rubles of state budget, compared with traditional trivalent vaccines.

Author: Elizaveta Mikitenko

Drugs for the treatment of multiple sclerosis are included in the List of drugs for the treatment of high-cost nosologies

In accordance with the Government Regulation of the Russian Federation No. 2738-p of 10 December, a drug product is included in the list of drugs for patients with hemophilia, cystic fibrosis, pituitary ganosis, painful Gaucher syndrome, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after transplantation of organs and/ or tissues.

“Multiple sclerosis is among the most common autoimmune diseases of central nervous system. The disease is mainly observed among young and fit-for-duty population at the age of 18-45 years, this disease quickly leads to disability. Our task is to prevent this process. This year the drug was included in the list of drugs for “high-cost nosology programs”, which allows us to expand the range of available treatment options for first-line multiple sclerosis therapy. A new therapy will allow you to control more effectively the incidence of the disease and reduce the risk of progression of disability by 38% 3. Katherina Pogodina, Managing Director of Janssen in Russia and the CIS, stated that the company made maximum efforts to achieve minimum price all over the world.

Plegridi belongs to the group of interferons. It is a necessary interferon beta-1a, which is derived from polyethylene glycol. It is used to treat adult patients with relapsing-remitting multiple sclerosis. PEGylation helps to increase molecule stability, reduces their immunogenicity, prolongs the effect, and also allows to reduce the frequency of administration – one Plegridi injection per two weeks.

The community of expert consultants considers the expansion of therapeutic options for multiple sclerosis within the framework of the federal“ High-Cost Nosology Program” to be a significant breakthrough. PEGylated interferon allows to reduce the frequency of injections for the patient by 6 times. “Obviously, the therapy can increase patient’s compliance, which makes it possible to achieve greater success in treating consuming the same or less resources, ” Yan Vladimirovich Vlasov, President of the All-Russian Public Organization of Multiple Sclerosis Patients and Disabled, said.


In the United States clinical trial Russia’s drug Vizomitin were launched

The university project “Ions of Skulachev” and “Mitotech” reported that Phase III clinical trial of ophthalmic drug Vizomitin had been launched in the United States. It was among the drugs that could reach the final phase of research in the United States. If the studies are successful, Vizomitin can be registered by the FDA.

The active ingredient of the drug is the mitochondria-targeted antioxidant SkQ1, which is able to penetrate into the mitochondria of living cells and protect them from oxidative damage. As a result, the drug has a mild anti-inflammatory effect and accelerates tissue regeneration.

About 500 patients with dry eye syndrome will take part in the multicenter study. The main task of the study is to confirm the previously obtained data that SkQ1 accelerates the healing of corneal injuries occuring at dry eye syndrome, as well as eliminates the clinical manifestations of the disease and increases the resistance of the eyes to dry air.

The latter parameter will be estimated with the special system Ora CAE® (controlled unfavorable environment). Its use allows to simulate the stress conditions in a standardized way where a patient with “dry eye syndrome” periodically falls.

According to Maxim Skulachev, the CEO of Mitotech, the results of a clinical trial will be obtained in the latter half of 2019. “Thus, the first Russian medicine can be launched on the US market already in 2020-2021,” he said.