WARSAW, 25 May (APM) - Poland's Central Anti-Corruption Bureau has brought down an organised crime group responsible for illegally exporting drugs worth 100 million zlotys (€23.3 million) to Western Europe and Bulgaria over the past year, reported Dziennik Gazeta Prawna (pB5) on Wednesday.
The group of individuals detained are owners of pharmacy chains, owners and employees of pharma wholesalers, a doctor and the mastermind of the whole operation.
The authorities said the group was using blank, signed prescriptions to buy the rarest and most expensive drugs in pharmacies, which were then funnelled through an outpatient clinic and sold to a pharma wholesaler, which exported them.
The drugs included cancer, diabetes and specialised medicines for children, to which access in Polish pharmacies is often very restricted.
According to unofficial information, the recent raid is just the first of a series of operations to be carried out by the authorities, as the group was not even the largest of the dozen or so organisations of this type operating in Poland. Such illegal activities started in 2012, after the introduction of the Reimbursement Act.
The justice ministry is currently working on new regulations to give more tools to the authorities responsible for fighting organisations involved in illegal drug exports, which could account for as much as 2 billion zlotys (€465 million) per year. The issue is serious, because around 200 drugs are included in the list of drugs to which access is restricted in Poland due to illegal exports.
Experts discuss Polish biotech industry and its outlook
Experts discussed the state of the Polish biotech industry, its challenges and outlook, during the “Biotechnology in Poland” panel discussion, reported Dziennik Gazeta Prawna (pA11) on Monday.
The experts agreed that the industry needs qualified workers, money, infrastructure and good intellectual property regulations in order to grow. They noted that while conditions in Poland are promising, the industry lacks proper coordination and an appropriate scale, which results in Poland being years behind the most developed countries. One issue is financing, as the models available to companies are not aligned with their needs, especially in the more advanced stages of research.
One solution could be the Polish Development Fund, which established a subsidiary, Life Sciences, with 300 million zlotys (€69.8 million) at its disposal for promising biotech projects. So far, the company has invested 80 million zlotys (€18.6 million) in Selvita and Mabion.
Access to Parkinson’s drugs restricted
Wojciech Machajek from the Parkinson’s Foundation says access to innovative Parkinson’s treatment in Poland is extremely restricted, reports Gazeta Wyborcza (Tylko Zdrowie supplement, p5) on Friday.
Duodopa intestinal gel therapy, which costs 100,000 zlotys (€23,255) per year, is reimbursed for only 25 patients, while apomorphine therapy, which could become available at the turn of June and costs 40,000 zlotys (€9,302) per year, would be reimbursed for around 30 of the 100,000 Poles suffering from the disease.
Evaluation of regulations on curbing expansion of pharmacy chains
Representatives of the Polish health ministry and pharmacists have said that the introduction of regulations curbing the expansion of pharmacy chains a year ago has had no adverse impact on the market, reported Dziennik Gazeta Prawna (pB4) and Rzeczpospolita (pA17) on Tuesday.
Before the introduction of the regulations, pharmacy chains were warning that drug prices could increase by a dozen or so percent and the number of pharmacies could decline significantly.
However, Marek Tomkow, vice-president of the Supreme Pharmaceutical Council, said drug prices had increased at a standard rate of around 5% and, while the number of pharmacies is actually declining, the market is still highly saturated compared to other EU member states, with 15,000 pharmacies in total and one pharmacy per 2,500 patients, the two newspapers reported.
Officials also said that, contrary to the claims of the pharmacy chains, access to drugs in rural areas has not deteriorated, as around 50% of the 420 pharmacy licences issued have been for rural areas and small towns, the two newspapers reported.
Finally, the authorities expect the regulations to benefit the state budget, as large pharmacy chains do not usually pay taxes in Poland due to aggressive tax optimisation, which is not the case with individual pharmacies, reported Gazeta Prawna.
New migraine drug approved in U.S.
The U.S. Federal Drug Administration has approved its first migraine-relieving drug, Aimovig, reported Puls Biznesu (p20) on Tuesday.
Aimovig, developed by Amgen and Novartis, blocks the protein that causes and sustains migraine. The drug has to be injected and the annual price of treatment will be $6,900. Although patients using Aimovig did not suffer from any adverse effects during clinical trials, its long-term effects are still unknown.
Aimovig will be the first migraine drug on the market, although Lilly, Teva and Alder are currently working on similar medications.
Approximately five million U.S. patients suffer from migraine.
Selvita results improving
Selvita, a Polish biotech specialising in cancer drugs, generated a net profit of 20 million zlotys (€4.7 million) in the first quarter of the year, four times more than in the corresponding period of 2017, reported Parkiet Gazeta Gieldy (p6) on Thursday.
The SEL212 project run by Nodthera, in which Selvita holds a stake and which recently received additional funding of 42 million zlotys (€9.8 million) from external investors, had the biggest impact on the company’s results. Boguslaw Sieczkowski, Selvita’s CEO, said this is a good example of a well-conducted investment, as the company invested 5 million zlotys (€1.2 million) in the SEL212 project between 2012 and 2016.
Selvita intends to invest 400 million zlotys (€93 million) between 2017 and 2021, increasing its market capitalisation from the current 908 million zlotys (€211.2 million) to 2 billion zlotys (€465 million). The company works closely with such entities as H3 Biomedicine, Merck, Menarini Group and the Leukaemia and Lymphoma Society.
Biomed plans to boost sales
While Biomed’s revenues declined in the first quarter of the year to 7.1 million zlotys (€1.7 million), from 8.9 million zlotys (€2.1 million) in the corresponding period of 2017, the company is planning further investments to get back on track, reports Parkiet Gazeta Gieldy (p4) on Friday.
The decline in revenue is directly related to the stoppage of its plasma-based Nanogy. The company simultaneously increased sales of its high-margin products, namely BCG and Onko-BCG vaccines and Distreptaza. Biomed is also in the process of doubling Distreptaza production capacity and tripling its Onko-BCG capacity, which should be achieved in the third quarter of the year.
Celon’s asthma drug could soon be available in Germany
Celon Pharma has completed the registration procedure for its asthma drug, Salmex, in Germany, report Parkiet Gazeta Gieldy (p7) and Rzeczpospolita (pA30) on Friday.
Once the German regulator fully approves the drug, Salmex should become available on the market in the last quarter of 2018 under the brand name Salfutin. The sales potential is high, as the German market for the originator drug is estimated at 3.5 million inhalers per year, the two newspapers reported.
Salmex is the main revenue generator for Celon Pharma and is currently being sold in Poland and several other smaller European countries. The drug should soon become available in Scandinavia, and the company is also attempting to register it in the U.K., the two newspapers reported.
IPO for OncoArendi Therapeutics
OncoArendi Therapeutics, a Polish company working on an innovative drug that could be used in pulmonary diseases, is being floated on the Warsaw Stock Exchange, reports Puls Biznesu (p12) on Friday.
The company’s most advanced project is OATD-01, which could be used in asthma, sarcoidosis or pulmonary fibrosis. OncoArendi has just completed Phase I, while Phase II could start in early 2019.
OncoArendi is the world’s first company to reach such an advanced stage of development of chitinase inhibitors and the third Polish company starting clinical trials of an innovative drug.
Furthermore, OATD-01 is one of the few potential asthma drugs that can be administered orally, rather than by inhalation, which enables greater control of doses.
OncoArendi is simultaneously conducting research into potential cancer drugs such as its arginase inhibitor, OATD-02, which has entered pre-clinical trials, and the YKL40 chitinase inhibitor.
The company intends to run the projects on its own up to Phase III, when it will look for potential partners to help it complete the trials and market the products.