Press review

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Poland lacks inspectors to combat illegal drug exports

Country : Poland

Keywords :
WARSAW, 20 Apr (APM) - While Poland’s justice ministry intends to apply serious measures to battle against illegal drug exporters, these efforts could be in vain because of a lack of pharmaceutical inspectors, reported Rzeczpospolita (pA17) on Wednesday.
Poland has about 130 pharmaceutical inspectors, many of whom are approaching retirement age. The Chief Pharmaceutical Inspectorate acknowledges the problem and says it arises from the fact that requirements of potential candidates are very high compared to salaries.
Additionally, as candidates could have connections with entities involved in illegal drug exports, they must all be vetted thoroughly.
Marek Tomkow, vice-president of the Supreme Pharmaceutical Council, said that not only is the job underpaid, but it also involves a great deal of responsibility and stress. Furthermore, pharmaceutical inspectors in Poland have less actual power and tools available to them than those in other EU member states.

Deputy health minister on healthcare funding

Marcin Czech, deputy health minister responsible for drug policy, was interviewed on healthcare funding in Monday’s Rzeczpospolita (pA16).
Czech said the introduction of the Reimbursement Act had revolutionised the Polish healthcare system and that the authorities intend to amend it shortly, with approximately 30 organisational improvements.
He added that comparing the quality of treatment and access to drugs in Poland with other EU countries is unfair, as Poland’s spending of 4.5%-4.7% of GDP is much lower, making it impossible to match Western European countries with their 9-11% of a much higher GDP.
Czech also said it is important to rationally consider drug prices in Poland and not sound alarm bells every time the reimbursement list is updated and the prices of certain brands of drugs increase, because other equivalents, which are never more expensive, are introduced simultaneously.
One of the changes, however, is that the reimbursement list will be updated every three months instead of every two, which will go some way towards addressing the issue of constant price changes.
Czech said that while patients, doctors and pharmas all have their own views on how the system should work, the health ministry is trying to strike a balance between what is possible or affordable and what will benefit the largest possible group of patients, which naturally leads to discontent from some groups.
He added that with the current level of public health insurance contributions it is impossible to squeeze more out of the system without increasing spending as a percentage of GDP, which should rise to 6% by 2025.
Finally, Czech added that drug prices in Poland are already among the lowest in Europe and that without increasing taxes - which is a controversial topic and will not be publicly accepted - the national health fund will not be able to significantly improve healthcare financing.

Kidney cancer patients do not have access to innovative drugs

Jakub Zolnierek from the Maria Sklodowska-Curie Institute of Oncology in Warsaw has said Polish kidney cancer patients do not have sufficient access to the latest, most effective drugs that are available in Western countries, reported Rzeczpospolita (pA11) on Tuesday.
Zolnierek said that while several molecular targeted drugs are already registered in Poland, this is insufficient, and that another issue is the non-reimbursement of immunotherapy drugs. He added that Polish doctors already have some positive experience with using cabozantinib (Ipsen’s Cabometyx) and that the next step should be to add it to the reimbursement list, as the drug is highly effective and can often be used in patients who have developed resistance to older medicines.
The Polish HTA Agency issued a positive recommendation for cabozantinib in July 2017, and experts and patients are currently waiting for a further decision from the health ministry.

Bioton back in favour

Bioton’s share price has increased by 60% since the beginning of the year, while the company appears to be getting back on track with its financial results, reported Parkiet Gazeta Gieldy (p7) on Tuesday.
In 2017, the Polish insulin manufacturer reported revenue growth of 30% to 361.6 million zlotys (€86.7 million) and an operating profit of 18 million zlotys (€4.3 million), compared with an operating loss of 13.9 million zlotys (€3.3 million) in 2016.
Bioton reported a substantial increase in revenues generated on Asian markets, which was important for the investors as the company’s biggest shareholder is from China. However, Bioton’s main market is still Poland, where it increased its revenues by almost 33% to 141.5 million zlotys (€33.9 million) in 2017. It also managed to increase sales in other markets such as South Korea, with 25% growth to 71.8 million zlotys (€17.2 million), Australia with a 52% increase to 43.7 million zlotys (€10.5 million) and China, up 13.6% to 37.7 million zlotys (€9 million).

Celon Pharma intends to grow on exports

Celon Pharma is planning to significantly increase revenues generated from exports in the coming years, thanks to the launch of its asthma drug in Scandinavia, Germany and the U.K., reported Parkiet Gazeta Gieldy (p5) and Puls Biznesu (p6 & 7) on Wednesday.
Celon increased its exports from 6.8 million zlotys (€1.6 million) in 2016 to 7.2 million zlotys (€1.7 million) in 2016 thanks to just two drugs, Salmex and Aromek. In 2017, Salmex was sold primarily to Lithuania, Austria, Croatia, Georgia and Belarus. Sales of 170,000 packets of Salmex abroad accounted for 20% of the company’s total sales volume. However, it has already started selling Salmex in Scandinavia in 2018 and intends to launch it in Germany and register it in the UK in the third quarter of the year, which should significantly boost the level of revenues generated from exports, reported both newspapers.
Simultaneously, Celon is working on innovative projects, including an esketamine-based depression drug, an FGFR kinase inhibitor that could be used in bladder, stomach and non-small cell lung cancers and a PDE10a inhibitor that could be used in schizophrenia and Huntington’s disease, reported Puls Biznesu.

OncoArendi Therapeutics floats on Warsaw stock exchange

OncoArendi Therapeutics, a Polish pharma working on several new drugs, was to float on the Warsaw Stock Exchange on Thursday, reported Parkiet Gazeta Gieldy (p5) on Wednesday, Puls Biznesu (p16) on Thursday and Parkiet Gazeta Gieldy (p4) on Friday.
OncoArendi’s most advanced project is a potential asthma drug. The company is also working on other drugs that could be used in cancer treatment. During its recent public offering, OncoArendi obtained 58 million zlotys (€13.9 million), most of which will be used to supplement R&D grants which the company has already received.
In terms of its business model, OncoArendi intends to focus on signing partnership contracts with larger players and selling licences for the drugs it develops, reported Puls Biznesu.
Parkiet Gazeta Gieldy (p4) on Friday reports that the float has taken place, adding that while the company is involved in a broad range of research regarding drugs that could be potentially used for treating asthma, sarcoidosis, cancer and pulmonary fibrosis, its only medicine in clinical trials is OATD-01, which targets asthma and sarcoidosis.

Adamed opens new R&D centre

Adamed pharma has opened a new R&D centre and plant in Pabianice, which will help the company separate R&D work from general production, thereby improving the efficiency of the whole process, Rzeczpospolita (pA25) reported on Thursday.
Adamed’s R&D centre will be used to produce, optimise and register biotechnological and clinical batches. It will also enable the company to identify, optimise and improve the production parameters of its drugs at the stage of laboratory work.
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