R-Pharm will bring technology for the early diagnosis of lung cancer to the Russian market

The R-Pharm group of companies, together with the British developer Oncimmune Holdings, have signed an exclusive agreement to introduce the EarlyCDT Lung product for early detection of lung cancer to the Russian and Eurasian Customs Union countries.

The development of Oncimmune is a specific blood test technology that facilitates the early detection of lung cancer among patients of major risk groups.

It helps to detect cancer cells with an accuracy of 92%, detecting autoantibodies in the blood, which are produced by the body at the very early stages of tumor development.

Currently, more than 70% of cases of lung cancer in Russia are in the third and fourth stages of the disease, which leads to poor prognosis for survival.

Early CDT Lung technology helps diagnose up to 4 years earlier than other methods – which will positively influence this trend.

Another important effect of the use of technology is the reduction of false positive diagnostics of lung cancer with CT.

“Russia has a huge potential for introducing screening techniques as a country with a high proportion of the population at risk.  The Oncimmune Holdings and R-Farm partnership will help expand the geography of EarlyCDT Lung as an early stage lung cancer screening product, ”said Adam M. Hill, CEO of the British company.

As part of the partnership, R-Pharm will have the opportunity to expand the geography of technology commercial use in the countries of the Commonwealth of Independent States (CIS).

Link: gmpnews.ru

GEROPHARM registered the first Russian insulin bioanalogue

GEROPHARM received a registration certificate for two-phase insulin lispro under the trade name RinLiz®.

These are the first Russian bioanalogues of ultrashort and medium duration insulin in the GEROPHARM portfolio.

The company plans to produce them on a full cycle basis – from substance to finished dosage form.

Now on the Russian market insulin lispro is represented only by foreign preparations from the company Eli Lilly.

The release of Russian biosimilars will make therapy more accessible for patients.

Preparations will take part in the public procurement procedure starting in fall 2019.

The total volume of the Russian insulin market lizpro and lispro mix is ​​more than 1.9 billion rubles. Moreover, they have a fairly high export potential, as they are world blockbusters.

According to internal estimates of the company, sales of insulin lispro in the world are about$6billion, and two-phase lispro is over 2.5 billion  and the European Union (not clear if these words are part of the sentence).

The development of technology and the organization of the production of biosimilars insulin lisprod was carried out within the framework of the state program of the Russian Federation “Development of the pharmaceutical and medical industry”.

The total cost of pharmaceutical development, clinical research and registration of RinLiz® and RinLiz® Mix 25 products amounted to about 408 million rubles, 114 of which were allocated by the Russian Ministry of Industry and Trade as a measure of state support.

In clinical trials, the first phase of which was conducted on the basis of the FSBI “NMITS Endocrinology of the Ministry of Health of Russia” and “Bioeq”, and about 290 people attended the 3rd of 17 clinics.

GEROPHARM became the first pharmaceutical company that conducted clamp studies in Russia. The company has even invested in the training of external experts in order to ensure that the quality of research is in line with world standards.

Clinical studies have successfully passed independent audits, the results of which were submitted to the Ministry of Health of the Russian Federation.

Link: gmpnews.ru

The permission for CT of the Russian drug for the treatment of Parkinson’s disease was obtained

The Ministry of Health of Russia issued a permit to LLC Rionis to conduct clinical studies of the first phase of the drug Prottremin (Diol) for the treatment of Parkinson’s disease.

Rionis is allowed to begin an assessment of the safety, tolerability and pharmacokinetic parameters of the drug on healthy volunteers.

This study is planned for nine months on the basis of the Siberian State Medical University.

Protremin was patented in Russia and abroad as an innovative drug with a pronounced dopamine-positive effect, eliminating parkinsonism symptoms at the level of the “gold standard of therapy” – Levodopa.
However, Protremin is not a precursor of dopamine, it does not inhibit the enzymes of it degradation, does not bind to the receptors of neurotransmitters.

The results of laboratory studies have shown that Protremin protects the brain from damage by neurotoxins – mitochondrial poisons in vivo and restores the affected neurons in an in vitro culture.

Link: gmpnews.ru

EMA is approving Zynteglo gene therapy for patients with beta-thalassemia

The Committee for Medicinal Products for Human Use (EMA) recommends granting conventional marketing authorization for Zynteglo gene therapy.

This is a drug for patients with beta-thalassemia (from the age of 12) who need regular blood transfusions and who haven’t found suitable donors for stem cell transplantation.

Thalassemia is a group of hereditary diseases of the hematopoietic system, which are characterized by impaired hemoglobin synthesis.  Therefore, the main symptom of thalassemia is anemia.

If the synthesis of β-chains is impaired, then it is a question of beta-thalassemia;  at the same time, other hemoglobin variants are formed that do not contain β-chains.  Beta-thalassemia is more common.  There are major, intermediate and minor forms;  the most serious disease is thalassemia of major form, while the minor one allows you to lead a near-normal life.

When developing the drug received the status of orphan.  The development of gene therapy is carried out with the support of EMA in the framework of the PRIME program (PRIority MEdicines).

This platform is designed to establish a dialogue with the developers of promising innovative products in the early stages.

Such interaction contributes to the formation of a more complete set of documents, allowing to speed up the evaluation procedure and make a decision in just 150 days, which is a record time today.

The decision to grant conventional marketing permission to Zynteglo was made at the March EMA meeting.

Another 3 drugs also received a favourable decision on the expansion of indications.

In order to obtain a conventional sale authorization, the data on the drug must indicate that the benefits of the drug outweigh the possible risks.  And the applicant must provide full clinical data in the future.

Link: gmpnews.ru

Johnson & Johnson introduces light adaptive contact lenses to the US market

Johnson & Johnson Vision brings light adaptive contact lenses to the US market. They are able to adapt to different levels of illumination; the Transitions technology is used, which is the same as for manufacture of glasses lenses.

Contact lenses are called Acuvue Oasys and are intended for everyday use. One pack is for 2 weeks.

The lenses contain an additive that responds to different levels of ultraviolet light. It allows the lenses to return to the original color at normal illumination or dimming for 90 seconds.

J & J states that photochromic lenses help the eye to recover faster from bright sunlight. Therefore, these lenses allow less squinting; at the same time, they reduce the halo effect or flashes around the light source at night.

However, they are not used as a substitute for sunglasses or other eye protection from ultraviolet light.

The FDA approved these lenses for the first time in April last year, in particular, considering the clinical study involved 24 patients, where the ability to drive a car at night and daytime was studied.

Evidence of negative influence of the lenses on the ability to drive or vision was not found.

Link: pharmvestnik.ru

The first antidote to Dabigatran was approved in Russia

Boehringer Ingelheim announced the authorization of Idarucizumab in Russia. This is a specific antagonist of oral anticoagulant Dabigatran (Pradax)

Idarucizumab is intended for patients taking Dabigatran when a quick elimination of the anticoagulant effect is required, including when emergency surgery is necessary and for life-threatening or uncontrolled bleeding.

The drug was approved on the base of the results of the Phase III study RE-VERSE AD.

The study showed that the antidote immediately and completely eliminates anticoagulant effect of Dabigatran in the vast majority of patients. The median time to perform surgery or emergency procedure was 1.6 hours.

In 93.4% of cases, researchers rated perioperative hemostasis as normal. The median time to stop bleeding was 2.5 hours.

Idarucizumab is a Fab fragment of a human monoclonal antibody that binds to Dabigatran with high affinity, which is approximately 300 times more than the binding ability of Dabigatran to thrombin.

The binding of Idarucizumab to Dabigatran allows you to quickly and steadily neutralize the anticoagulant effect of the latter, and Idarucizumab does not have its own procoagulant effects.

Link: chemrar.ru

X7 Research at IPhEB Russia 2019

X7 Research took part in the last IPhEB Russia 2019 exhibition in St. Petersburg.

IPhEB is the most Russian pharma event hosting a wide range of exhibitors in the field of pharma ingredients, finished dosage, machinery, equipment, technology and outsourcing. This event is the unique opportunity to initiate business and build partnerships in the booming Russian and CIS pharma markets.

The WHO developed a new strategy to fight the flu

The World Health Organization adopted a new strategy to fight the flu for 2019-2030.

Its goal is preventing seasonal outbreaks of the disease more effectively, improving the control over the transmission of the virus to humans from animals and preparing for the next flu pandemic, which, according to experts, is inevitable.

According to Tedros Adanom Gebreyesus, the WHO CEO, the risk of transmitting a new influenza virus from animals to humans and the potential occurrence of a pandemic is real.

The only question is when it happens. He urged to be prepared for a major outbreak of influenza, stressing that its consequences could cost mankind much more than the cost of the necessary preventive measures.

The WHO recalls that, according to experts, about 1 billion people suffer from influenza every year, while from 3 to 5 million diseases are severe. The number of fatal cases ranges from 290 to 650 thousand per year.

As the most effective remedy for this disease, the WHO recommends vaccination, emphasizing that it is important to immunize people who may face complications, as well as medical professionals.

Tedros Adan Gebreyesus noted that the world is now better than before prepared for a new flu pandemic, but this is not enough.

The task of new strategy is to bring the health care to necessary level to combat a major outbreak of the disease.

The implementation of new strategy will allow countries to increase the level of diagnosis of other infectious diseases such as Ebola and Middle East respiratory syndrome.

Link: pharmvestnik.ru

FDA approved Valsartan Generic 

The FDA approved a new generic valsartan to control blood pressure.

It was a mean to solve the problem of reduced supplies after some pharmaceutical manufacturers recalled their valsartan drugs because of the potential risk of cancer.

The FDA is reviewing the marketing application for the generic valsartan manufactured by Indian company Elkem Laboratories Ltd, prior to its approval.

The approved drug is a generic of Novartis’ Diovan original product.

The FDA chief executive officer, Scott Gottlieb, said that, given the shortage of drugs, the FDA uses a number of strategies to mitigate its effects on patients.

Mr. Gottlieb also noted that the agency has given priority to the task of reviewing marketing applications for valsartan drugs to mitigate the effects of drug shortages on the health care.

The FDA also examined the manufacturing processes at Alkem’s facilities and concluded that the company used proper analytical methods to demonstrate that the new generic does not contain potentially carcinogenic NDMA or NDEA impurities that have already caused global withdrawal of valsartan and some other sartans.

Link: chemrar.ru

EMA accepts the application for authorization of Bavencio for renal cell carcinoma

The European Medicines Agency (EMA) accepted for consideration a authorization application from Merck KGaA for Bavencio (avelumab) for the treatment of patients with advanced renal cell carcinoma (CRP).

The regulator is considering the application for the use of Bavencio in combination with Inlyta (axitinib), which was submitted on the results of Phase III pivotal clinical trial (CI) JAVELIN Renal 101.

JAVELIN includes more than 30 research programs; more than 9 thousand patients with more than 15 different types of tumors take part in researches.

In addition to RCC, Bavencio therapy for breast cancer, gastric cancer / gastroesophageal cancer, head and neck cancer, Merkel carcinoma, non-small cell lung cancer and urothelial carcinoma is being investigated.

The CI results were published in the New England Journal of Medicine in February 2019.

The FDA also accepted an application for this combination of drugs for distributed RCC for an accelerated review.

CRP is the most common form of kidney cancer, which occurs in 2–3% of adults with this disease.

Link: pharmvestnik.ru