Press review

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Drug shortages crisis in Poland appears to have been averted

WARSAW, 21 Aug (APM) - Some 21 drugs are currently unavailable in Polish pharmacies, far fewer than in the first half of the year, reported Dziennik Gazeta Prawna (pA8) on Monday.
The unavailable drugs include Nitrendipinum Egis, a hypertension drug, and Anticol, a drug for alcoholic patients.
According to the European Commission's reports, further problems with drug availability may arise because of temporary closures of Chinese active pharmaceutical ingredient (API) factories in the first half of the year.
One of the recommended solutions would be to move API production to Europe and to establish a central supply of drugs for EU countries.

Falsified Xarelto exported to UK by Polish wholesaler

A total of 380 packs of falsified Xarelto, an expensive anticoagulant that is difficult to obtain and which is illegal to sell outside Poland, was exported to the UK by a Polish wholesaler in the middle of 2019, while the information has only just been publicised, reported Dziennik Gazeta Prawna (pB1) on Tuesday.
Experts say this is an example of a defective control system, both in terms of illegal drug exports and falsified drugs. It is estimated that the recent annual value of illegal drug exports from Poland is 2 billion zlotys (€450 million), whereas the value of falsified drugs in Poland was 300 million zlotys (€68 million) in 2019.
A third of the falsified drugs do not contain APIs and a fifth contain APIs that differ from those specified on the packaging. Half the drugs bought online may be falsified.

Sanofi snaps up Principia Biopharma

Sanofi is buying Principia Biopharma, a U.S. company specialising in treating multiple sclerosis (MS) and autoimmune diseases, reported Puls Biznesu (p9) on Tuesday.
This will be the second largest global pharma acquisition after Gilead bought Forty Seven, an oncology drug producer, for $4.9 billion.

Biomed Lublin starts producing its Covid-19 drug

Biomed Lublin, a Polish tuberculosis (BCG) vaccine producer, has finally collected the amount of plasma needed from Covid-19 survivors and has started producing its immunoglobulin drug, reported Parkiet Gazeta Gieldy (p5) and Rzeczpospolita (pA17) on Tuesday and Parkiet Gazeta Gieldy (p1, p5), Rzeczpospolita (pA16, pA23) and Gazeta Wyborcza (p14) on Wednesday and Parkiet Gazeta Gieldy (p6) on Thursday.
Biomed has signed a consortium agreement with Independent Public Clinical Hospital No. 1 in Lublin and the Institute of Haematology and Transfusion governing the financing and scope of the research of the immunoglobulin.
Biomed is planning to complete production of the drug in 1.5 months. On completing the necessary procedures, such as four-month clinical trials starting October, as well as the registration processes, the drug is expected to be launched in 2021.
Biomed has become one of Poland's largest listed biotechs. Its capitalisation is over 1.5 billion zlotys (€340 million), reported the newspapers on Tuesday.
The drug is expected to reduce the Covid-19 mortality rate by 50-80% and could be used not only to combat the virus, but even for prohpylaxis. It will be in the form of ampules
Administered intramuscularly, Biomed's top priority will be Polish patients, but if it has access to larger quantities of plasma from Covid-19 survivors, it may also supply foreign customers. Grzegorz Czelej, a Polish senator has appealed to the European Commission to create plasma banks, which will collect and store plasma when the number of Covid-19 survivors is high, added the newspapers on Wednesday.

Pharma companies worldwide researching Covid-19 vaccines

According to the World Health Organization (WHO), 7 Covid-19 vaccine-candidates are currently in Phase II, but other companies are racing against time to produce an effective drug combating the virus, reported Dziennik Gazeta Prawna (A3) on Wednesday.
Two vaccine candidates are being researched in India, by Zydus Cadila and Bharat Biotech and both are already in Phase II. The latter expects a working vaccine to be ready in early 2021 and is capable of producing 300 million shots a year.
Another Indian company, Serum Institute of India (SII), is the only company in the world capable of producing 1.5 billion units of any drug and has already contracted production of the first batches of the vaccine researched by the University of Oxford and AstraZeneca.
Novavax's vaccine candidate entered Phase II on 3,000 volunteers in South Africa on Monday, while another U.S. vaccine candidate entering Phase II is from Johnson & Johnson. Both are receiving U.S. government support.
The German vaccine candidate from CureVac has started Phase I and has already registered for Phase II. Another European vaccine candidate is a drug produced by the Italian ReiThera and Lazzaro Spallanzani National Institute for Infectious Diseases, which is just entering Phase I.
Polish scientists from the Poznan University of Medical Sciences headed by professor Andrzej Mackiewicz are also working on a vaccine candidate. They expect to produce a prototype in a month.
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