Scientific journal The Lancet Respiratory Medicine published the results of a randomized double-blinded study by INMARK®

Results of a study by INMARK® suggest that early administration of antifibrosis therapy allows to slow down the progression of idiopathic pulmonary fibrosis.

Scientific journal The Lancet Respiratory Medicine published the results of a randomized double-blinded study by INMARK®, which validated the effectiveness of Vargatef (nintedanib) versus placebo in patients with idiopathic pulmonary fibrosis (IPF) for 12 weeks, followed by a 40-week open trial.

INMARK® is a first clinical study that was targeted at evaluating the predictive value of biomarkers in patients with IPF, receiving antifibrosis therapy (nintedanib).

The results showed that even in patients with preserved lung function, a significant difference could be noticed in the rate of reduction of forced vital capacity (FVC) with a 12-week nintedanib versus placebo therapy.

Idiopathic pulmonary fibrosis (IPF) is a rare, chronic and lethal pulmonary disease which affect approximately 3 million people worldwide.

It causes progressive pulmonary fibrosis, leading to permanent and irreversible decrease in lung function and shortness of breath.

Due to the unpredictable progression of IPF and the irreversible decrease in lung function, specialists think that the treatment has to be administered as soon as possible.

INMARK® looked at the rate of change in CPRM, a biomarker, which has previously demonstrated the ability to predict the mortality due to IPF. The level of CPRM was measured from the beginning of the study till 12thweek. The study also measured t the proportion of patients with disease progression defined by the absolute reduction in FVC ≥10%  predicted or dead over 52 weeks.

Nintedanib treatment versus placebo for 12 weeks did not affect the rate of change in CRPM, however was associated with a decrease in the rate lowering of CRPM levels.

29% of patients in the trial experienced an FVC decrease of ≥10% predicted, or died over 52 weeks of follow-up, which demonstrated the progressive nature of IPF even in population with normal FVC value of ≥80%.

Within 12 weeks, patients treated with nintedanib exhibited reduced rate of decline in FVC versus patients receiving placebo (5,9 (18,5) mL/12 weeks in nintedanib group and −70,2 (13,1) mL/12 weeks in placebo group).

“Even in this population of patients with very well-preserved lung function, a difference in FVC decline could be demonstrated between patients treated with nintedanib vs. placebo over 12 weeks of treatment. Considering the unpredictable nature of IPF and the fact that loss of lung function is irreversible the results reinforce a growing body of evidence that early treatment of IPF is the best course of action.” commented Prof Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom and principle investigator of the study.

Dr. Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim, said “Biomarker research is a key driver of modern medicine with huge impact on the understanding of health and disease states, diagnosis, drug development, and prediction of disease course or response to therapy. INMARK was the first clinical trial to investigate the predictive value of biomarkers in IPF patients treated with an antifibrotic. Being poorly understood, IPF has been subject of increasing biomarker research for years with a main focus on identifying markers for prognosis.”

She added: “Pulmonary Fibrosis continue to have a devastating impact on people’s lives. Boehringer Ingelheim is committed to research such as the INMARK trial which helps our understanding of how interstitial lung diseases such as IPF progress in individual patients, and identify those who may respond best to treatment.”

Link: www.clinvest.ru

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THE RUSSIAN COMPANY TAKEDA ANNOUNCED REGISTRATION IN RUSSIA OF A NEW READINGS OF ADCETRIS® PREPARATION (BRENTUKSIMAB VEDOTIN)

Takeda Russia announced the launch of two new indications of Adsetris® on the Russian market:

1) the treatment of previously untreated patients with classical CD30 + Hodgkin’s lymphoma stage IV in combination with doxorubicin, vinblastine and dacarbazine;
2) the treatment of patients with CD30 + T-cell lymphoma of the skin after at least one line of previous systemic therapy.

The targeted drug brentuximab vedotin (BV) is a CD30 conjugate of a directional monoclonal antibody and an antitumor agent monomethylauristatin E (MMAE).  Brentuximab vedotin binds to the CD30 receptor on the surface of the tumor cell and, penetrating inside, causes its apoptosis and death.

Adsetris® is available in the form of a lyophilisate for the preparation of a concentrate for the preparation of a solution for intravenous infusions.  BV first was registered in Russia on February 26, 2016.  for the treatment of patients with recurrent / refractory CD30 + Hodgkin lymphoma after autologous stem cell transplantation and patients with recurrent / refractory systemic anaplastic large cell lymphoma, and since December 26, 2016 it has also been registered for the treatment of patients with CD30 + Hodgkin lymphoma with an increased risk of recurrence or progression of the disease after autologous stem cell transplantation.

The goal of Takeda Company is to contribute to improving the quality of life of patients with the help of the latest achievements in medicine.

Registration on the Russian market of new testimony Adcetris® is a vivid example of the implementation of the course adopted by the company.
This antibody and its introduction into clinical practice provides patients who have exhausted the resources of classical treatment regimens, long-term remission, the possibility of carrying out transplantation of hematopoietic stem cells and gives them a chance for a complete cure.

Hodgkin’s lymphoma (HL) is a malignant tumor disease of the lymphatic system. HL are ill mainly at the age of 18-35 years.  In 95% of all cases, there is a CD30 antigen on the surface of HL cells, which is a therapeutic target for BV.

The main task of the first line of therapy for patients with HL is to achieve the maximum number of complete and long-term remissions.  Polychemotherapy (PCT) is the standard of treatment for HL in Russia, the USA and Europe, but despite this, 15-30% of patients who received first-line drugs develop relapses of the disease or primary resistance is observed.

The standard component of PCT, bleomycin, leads to pulmonary toxicity in 10% of patients, andmortality among patients with pulmonary toxicity due to bleomycin is observed in 10-20% of patients.
Thus, patients with newly diagnosed HL need more effective and safe therapy.

The results of BV are based on data from a Phase 3 registration study, ECHELON-1, in which patients with previously untreated classical Hodgkin’s lymphoma stage III or IV were included;  664 patients were assigned to the brentuximab group of vedotin, doxorubicin, vinblastine and dacarbazine (A + AVD) and 670 patients to the group of doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) [3]. The primary endpoint in the study adopted modified progression-free survival (mVBP).

Two-year MBHD in groups A + AVD and ABVD was 82.1% and 77.2% (p = 0.04).  The use of the A + AVD regimen by 23% reduced the risk of progression, death or the need for second-line therapy, which reduced the need for high-dose chemotherapy with stem cell autotransplantation by 33%.

The results of ECHELON-1 made it possible to register BV in combination with AVD for the treatment of patients with newly diagnosed HL in the USA and in Europe.

Link: www.clinvest.ru

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Russian scientists are working to create a vaccine for hepatitis C

About 3 million Russians suffer from a disease that is considered incurable – hepatitis C.

Despite the fact that over the past few years, the incidence in the country has decreased, about 15 thousand people die from the effects of chronic hepatitis C every year.

The main danger of the disease is in its asymptomatic course.  According to the WHO, only 20% of those infected will find out in time about the diagnosis.

The rest do it until the moment when it is too late to go to the doctor.  A mass vaccination could be the solution to the problem, but there is currently no vaccination.

Therefore, scientists from different countries, including Russia, are working to solve this problem.

Since 2015, a synthetic peptide vaccine against hepatitis C has been developed at the VN Orekhovich Research Institute of Biomedical Chemistry. It is based on artificially created peptide constructs that contain parts of the E2 protein of the hepatitis C virus. This protein is unique in that its antibodies are not detected in  all patients, that is, the immune system for some reason does not recognize it.

In experiments on laboratory animals, these peptide fragments worked perfectly.

They forced the body of mice and rats to produce antibodies capable of binding viral envelope proteins.  That is, the rodent immune system is activated.

Moreover, the scientists thus obtained antibodies were tested on the hepatitis C virus, extracted from the blood plasma of five sick people.  They were also effective against “human” viral particles.

The authors say that if they succeed in choosing the right adjuvant — a complex of substances that boosts the immune response, the antigen dose, route and route of administration — then the resulting drug will be effective precisely against those types of hepatitis C that are common in Russia.

Link: gmpnews.ru

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The second stage of clinical trials of a drug for the treatment of systemic lupus erythematosus has begun in China

Chinese scientists have begun the second phase of clinical trials of the drug for the treatment of an autoimmune disease – systemic lupus erythematous.

The new patent-protected drug SM934, which is a water-soluble artemisinin derivative, was developed by researchers at the Shanghai Institute of Pharmacology at the Academy of Sciences of China ANC.

The first stage of clinical trials of a new drug has already been completed, and the second stage began in one of the Shanghai hospitals.

Systemic lupus erythematous, one of the most common types of lupus erythematous, is an autoimmune disease in which the human immune system mistakenly attacks healthy tissues of the body, causing damage to the joints, skin, kidneys, blood cells, brain, heart and lungs.

One of the hallmarks of lupus is a rash on the face, resembling butterfly wings in outline.
In China, nearly one million people are reported to have lupus erythematous.

Since the causes of the origin and development of the disease remain unclear, the development of new drugs for this disease causes difficulties.

According to the ANC, the drug SM934 is an oral drug with a low dosage and a pronounced effect.  It can modulate autoimmune reactions and restore the body’s immune balance.

Link: gmpnews.ru

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Sanofi gets rights to Tamiflu in the US market

The French group Sanofi has signed an agreement with Roche on the transfer of rights to the antiviral drug Tamiflu (oseltamivir) in the United States.

Sanofi will receive exclusive rights to Tamiflu over-the-counter in the United States.  This drug is intended for the prevention and treatment of influenza.

Alan Main, executive vice president of consumer healthcare at Sanofi, said that this is a strategic and important deal for the company, as the company seeks to bring innovations to the market on an ongoing basis.

Link: gmpnews.ru

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Trastuzumab and bevacizumab biosimilars enter the US market

For a long time, Roche’s three drugs, Rituxan, Herceptin and Avastin, dominated the global market.

However, on July 18, their competitors appeared – Amgen and Allergan introduced the biosimilars of Herceptin preparations for the treatment of HER2-positive breast cancer and Avastin for the treatment of colorectal cancer to the USA, which threatened the total sales volume of two originators produced in 2018.

Mvasi, Avastin’s biosimilar from Amgen, became the first biosimilar of the drug, which was approved by the FDA at the end of 2017. The American regulator approved Kanjinti, Herceptin’s biosimilar, in June of this year.

These biosimilars will enter the market at a wholesale price that is 15% lower than the price of
reference biotech drugs.

For Amgen and Allergan, the departure from Roche’s “settlement” will help get more dividends in terms of sales, while for other competitors the outlook may be bleak.

Rituxan, whose sales in the US in 2018 amounted to $4.24 billion, could be hit by the following biosimilars.

Link: pharmvestnik.ru

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FDA Approved Bayer Gadavist Contrast Agent Contrast Agent

Bayer Gadavist (gadobutrol) is the first and only contrast agent for use in cardiac magnetic resonance imaging (CMRT) in adult patients with diagnosed or suspected coronary heart disease (CHD) and has been approved by the FDA.

This decision is based on the data of two prospective multicenter open phase non-randomized blind clinical trials of the third phase, where diagnostic results of MRTT were studied using gadobutrol to assess significant coronary artery disease.

CMRT is a medical imaging technology for non-invasive evaluation of the function and structure of the cardiovascular system.  Daniel Berman, Head of the Cardiac Imaging and Nuclear Cardiology Department of the Heart Institute of the Cedars-Sinai Medical Center, said that approval of the Gadavist contrast agent is an important step in creating a validated non-invasive method for assessing the condition of patients with the most common form of heart disease in the world.

This method is derived from MRI and uses the same basic principles as MRI, but is optimized for use in the diagnosis of diseases of the cardiovascular system.

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A historic mutual recognition agreement between FDA and EMA was signed

The FDA and EMA have confirmed the inclusion of Slovakia in the mutual recognition agreement. The activities of this country’s GMP inspectorate received a positive assessment.

The authorities announced this on Friday, July 12, before the deadline (July 15), which was set aside for all parties to sign the contract.

Now, the FDA has recognized the results of GMP inspections conducted by the inspectorates of all 28 EU member states.

The EMA, in turn, agreed with the FDA that the results of inspections carried out by inspectors from the United States would not require repeated inspections from the European regulator.

The process of mutual recognition of the results of GMP inspections has been developing since 1998, after the EU and the USA signed the mutual recognition agreement, which included a “pharmaceutical application”, according to which it was possible to rely, to a limited extent, on the results of inspections conducted by EU and US regulators, respectively.

Link: pharmvestnik.ru

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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

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