Press review


Falsified drug market flourishes during the Covid-19 pandemic

Country : Brazil, China, Europe, France, India, Italy, Japan, Poland, South Korea, Spain, U.S.

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WARSAW, 17 Apr (APM) - The wave of falsified drugs and dietary supplements marketed online as effective against or helping fight Covid-19 is rising, according to Interpol, Europol, the European Medicines Agency and the U.S. Food and Drug Administration, reported Dziennik Gazeta Prawna (p2) on Tuesday.
Last month, in a huge operation named 'Pangea', Interpol seized 37,000 falsified medicinal devices, such as face masks, disinfectants or coronavirus tests, arrested 121 people, took down 37 criminal groups and intercepted 4.4 million falsified drugs of an estimated value of €13 million. 2,500 websites selling products allegedly helping to cure Covid-19 have been closed.
Even in Poland, Aflofarm, a dietary supplements producer, broadcast a television advertisement for Neosine Forte as being effective against the coronavirus. It was stopped after two days.
Officials say, at a time of fear and disinformation, the internet provides fertile ground for such criminal operations, while buying and using suspicious products should be avoided, as they could be a health hazard.

Drugs crisis in Poland eases

The reopening of factories producing active ingredients in China and the lifting of the short term ban on drug exports from India on 6 April resulted in the Polish Ministry of Health (MoH) and the website, which monitors 1300 Polish pharmacies, recording an increase in drug availability in Poland, reported Dziennik Gazeta Prawna (pA7) on Wednesday.
According to Marek Tomków, vice president of the Supreme Pharmaceutical Chamber, the easing of the drugs crisis could be caused by patients using up the supplies of medicines they bought in the first wave with the start of the epidemic.
Despite the improvement of the drug situation, 39 drugs, such as Euthyrox N, are still unavailable. Nevertheless, the MoH has announced it would shorten the anti-export list to 500 drugs. Meanwhile, the current global situation and higher prices of imported active ingredients from Asia mean the MoH also expects drug prices to rise, which could result in a shortening of the reimbursable drug lists in the longer run.

Spending on antidepressants

Polish patients spent 200 million zlotys (€44.1 million) on antidepressants and sedatives last month. Between 9 March and 10 April, sales of tranquilisers and sedatives were reported to have increased by 24% (to 4.5 million packets), while the increase in sales of antidepressants and antipsychotics was reported at 33% (to 2.8 million packets) which experts relate to the stress caused by the Covid-19 pandemic, its economic impact and personal isolation, reported Dziennik Gazeta Prawna (pA8) on Thursday.

Polish SMA patients need access to innovative therapies, coordinated healthcare

According to experts, Polish patients suffering from spinal muscular atrophy (SMA), one of the most common orphan diseases, need to have access to screening tests for infants, coordinated healthcare, social welfare, adapted homes and access to innovative therapies, reported Rzeczpospolita (pA10-A11) on Tuesday.
Since 1 January 2019, the joint efforts of SMA communities, patient associations and medical experts has resulted in Nusinersen pharmacotherapy being included in the reimbursable lists for all SMA patients regardless of age and stage of the disease. New therapies, such as U.S. gene therapy AVXS-101, will be needed by patients.
Some 850-900 people suffer from SMA in Poland, 500 of whom are undergoing treatment.

Polish Academy of Sciences produces Covid-19 tests

Production of a working Covid-19 test developed by scientists from the Institute of Bioorganic Chemistry of the Polish Academy of Sciences (IBCH PAS) will start at Medicofarma's plant next week, reported Gazeta Wyborcza (p6) on Friday and Puls Biznesu (p9) on Tuesday.
The National Institute of Public Health has validated the effectiveness of the test and has announced that the first batch of 150,000 tests will be produced within two weeks. The research was co-funded by the Ministry of Science and Higher Education with a grant of 15 million zlotys (€3.3 million).
The tests will be produced from products and reagents from Future Synthesis, a start-up from Poznan, and A&A Biotechnology, a company from Gdynia. Medicofarma has acquired the licence for the test from IBCH PAS and will be responsible for its production and registration.
After the first batch of 150,000 reaches the MoH, Medicofarma will start selling the tests to Polish hospitals. A total of 188,000 Covid-19 tests have been conducted in Poland to date.

Polish scientists research Covid-19 therapy

A group of researchers from the Institute of Biotechnology and Antibiotics at the Lukasiewicz Research Network managed by Malgorzata Kesik-Brodacka are developing a therapy against Covid-19 using a compound eliminating a Covid-19 enzyme, the Mpro protease, which is responsible for the multiplication of the pathogen, reported Gazeta Wyborcza (p1, p6) on Tuesday.
The group expects to receive bacterial strains producing large amounts of the Mpro protease within the coming 6-8 weeks and will look for substances to block the virus within the next six months. If the tests prove successful, the group will start developing a Covid-19 drug.

Biomed will use plasma from patients recovered from Covid-19 to search for a cure

Polish biotech, Biomed, expects to develop a Covid-19 therapy from the plasma of patients who recovered from the disease, while the Medical Research Agency (ABM) has guaranteed co-funding of the project of up to 5 million zlotys (€1 million), reported Rzeczpospolita (pA1, pA5) on Wednesday.
The method, which uses passive immunisation with Covid-19 antibodies, is already being tested in Italy, Spain, Japan and the U.S., and was approved by the U.S. Food and Drug Administration last week. 400 people have recovered from Covid-19 in Poland who could donate their plasma for the treatment, while Polish hospitals are registering the first donations.

Polish National Oncology Centre working on Covid-19 therapy

The Centre for Research and Development at the Maria Sklodowska-Curie Institute — Oncology Centre, with the Institute of Bioorganic Chemistry of the Polish Academy of Sciences (IBCH PAS) are developing a Covid-19 drug based on combining bacteriophages with nano antibodies planning its first in-vitro tests for the coming three months, reported Rzeczpospolita (pA11) on Thursday.

Insufficient Covid-19 tests are conducted in Poland

Insufficient Covid-19 tests are being conducted in Poland, as only patients with symptoms are eligible for testing, while hospitals struggle with availability of tests, and the MoH is importing fast antigen tests from South Korea of dubious accuracy, reported Gazeta Wyborcza (p3) and Rzeczpospolita (pA6) on Friday.
According to the MoH, Poland has the capacity to conduct 15,000-20,000 Covid-19 tests a day, but only 12,500 tests were registered on Wednesday.
The State Sanitary Inspectorate is still restricting the use of tests to patients with Covi-19 symptoms, such as fever, respiratory failures, coughing and breathlessness. As a result, Polish hospitals are testing their healthcare professionals on their own, reported Gazeta Wyborcza.
The MoH is ordering bulk quantities (50,000 tests being shipped this week, and tens of thousands in the following months) of 15-minute antigen Covid-19 tests from South Korea, for emergency wards. This purchase has been criticised by medical experts, because such tests are not as reliable as gene tests, and will first need to be compared to the other testing methods to establish their effectiveness in detecting the virus.

Polish oncology suffering from the Covid-19 pandemic

According to oncology experts, the Covid-19 pandemic has resulted in the MoH stopping work on oncology treatment funding programmes and opening access to innovative therapies, while such delays in legislation are endangering many cancer patients , who are in the high risk group of the pandemic, reported Rzeczpospolita (pA11) and Gazeta Wyborcza in its Tygodnik Warszawa Supplement (p7) on Friday.
450 patients are diagnosed and 270 die of cancer in Poland each day, so oncology experts want patients to be helped in dealing with cancer in the difficult pandemic times.
Patients need to be secured from possible exposure to Covid-19 and must be administered innovative drugs in drug programmes. These include pembrolizumab with chemotherapy in the first line of treatment of lung cancer and access to the first immunotherapy in the first line of treatment of small cell lung cancer, atezolizumab.

Inno-Gene DNA Research Centre started production of their own Covid-19 tests

The DNA Research Centre, an Inno-Gene subsidiary, has started producing Covid-19 gene tests in line with the World Health Organization's (WHO) guidelines, as well as serological tests detecting the virus' IgM and IgG antibodies, reports Parkiet Gazeta Giełdy (p7) on Friday.
The company claims it is able to produce 1,000 gene tests and 2,500 serological test a day. It is listed as a regional laboratory of the MoH but, apart from working with orders financed by the National Health Fund, the company will work for local authorities looking for tests for their healthcare and office workers.

Initial results of using remdesivir and chloroquine in Covid-19

The New England Journal of Medicine has published the initial results of using Remdesivir in cases of Covid-19 which are promising, although the first chloroquine trials show that the cardiac adverse effects may be too severe to use it in the global pandemic, reports Gazeta Wyborcza (p14-15) on Friday.
Of 53 patients at different stages of Covid-19 infection to whom remdesivir was administered under the compassionate use procedure, the medical condition of 36 has significantly improved, while 13 died. As the results may be promising, the therapy needs more testing into the stage of development of the infection for most effectively administering the drug. Seven more simultaneous Remdesivir trials are being held around the world.
Nevertheless the severe cardiac adverse effects of using chloroquine, a malaria drug discovered in 1830s, in Covid-19 patients has led to the discontinuation of the 81-patient clinical trial held in Brazil. The patients were given the drug together with the antibiotic azithromycin or ceftriaxone, but a large group of patients developed abnormal pulses, two of whom died of ventricular tachycardia.
Another trial held in France with hydroxychloroquine, a different anti-inflammatory and malaria therapy, has led to an abnormal pulse in patients. Experts say the results do not rule out chloroquine or hydroxychloroquine from Covid-19 research, but indicate the need to conduct more research and trials.
The St Louis Washington University School of Medicine has also announced the start of its 500 Covid-19 patient trial using Chloroquine, hydroxychloroquine and their combination with azithromycin.

Ryvu to develop anti-inflammatory drugs with Galapagos

Ryvu, a subsidiary of Selvita, has announced its €53.5 million tie-up with the Belgian company, Galapagos, on research and development of innovative molecules for treating inflammatory diseases, reports Puls Biznesu (p2) and Parkiet Gazeta Giełdy (p4) on Friday. (APMHE 66966)
SEL24, the companyss drug for treating acute myeloid leukaemia (AML) has passed Phase I and is starting Phase II, while SEL120, which is currently in Phase I, could become registered as an orphan drug at the end of March.
The company is planning to sign another one or two cooperation agreements by the end of the year.

Selvita expects increase in its services during pandemic

Selvita, an outsourcing biotech listed on the Polish Stock exchange, expects a doubling of demand for its services because of the pandemic, reported Parkiet Gazeta Giełdy (p2) on Tuesday.
Selvita does not conduct its own research into Covid-19 therapies but conducts laboratory work for other pharmas during the lockdown. The company's sales increased by 37% compared to 2019 and, in March, its order pipeline was 80 million zlotys (€17.6 million), 43% higher than at the same time last year.
According to Boguslaw Sieczkowski, president of Selvita, despite the difficult conditions, the company plans to make its first acquisition in Central Europe by the end of the year.

Bioton recovers with new distribution strategy

Bioton reported revenue of 202 million zlotys (€44.5 million) revenue in 2019 compared with 241 million zlotys (€53 million) in 2018, and a net loss of 126.6 million zlotys (€28 million) compared to 26.2 million zlotys (€5.8 million) in 2018 having written-off a 146.4 million zloty (€32.3 million) net loss caused by the results of its subsidiary Biolek, African swine fever (ASF) in China and the Covid-19 pandemic, reported Parkiet Gazeta Gieldy (p4) on Thursday.



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