WARSAW, 21 Feb (APM) - Shortages of 386 drugs are reported in Poland, 48 of which have no substitutes and no change in the dependence on China for active ingredients could worsen the situation due to the coronavirus outbreak, reported Dziennik Gazeta Prawna (pB6) on Tuesday and (pA6) on Wednesday.
According to the GdziePoLek report, 88 mg Euthyrox N for treating thyroid diseases, is currently unobtainable, but Merck should resume supplies in late February or early March. Sinemet CR 200/500 for Parkinson's disease has been discontinued, Hitoff with Pramipexole will not be restocked and its replacement, Oprymea, is listed as being on the verge of running out.
Other unavailable medications are Azyter, Betadrin, Betnovate C ointment, Dalacin cream, Duracef 0.5/5 ml, Methotrexat-Ebewe 10 mg, Systen50, Systen Conti and Vetira 500 mg.
The situation has improved for diabetes drugs with metformin, such as Glucophage XR and its substitutes, but availability of Formetic 500 is still declining, reported Dziennik Gazeta Prawna on Wednesday.
Former deputy health minister Krzysztof Landa expects the situation to worsen, not only in Poland but within the whole of the European Union because of the coronavirus outbreak in China. Too many drug producers depend on active ingredients from Chinese factories and if these factories close, or suppliers cannot transport the ingredients, the situation could become serious for anyone depending on them.
Jorg Geller, president of Affordable Medicines For Europe, a non-profit European parallel imports organisation, said production of active ingredients needs to return to local factories, as Chinese factories will sell their products to the highest bidder, namely the U.S. market. European countries need to revise their drug pricing policies and the Polish government will need to restructure its drug strategy and prices and consider parallel imports, added Dziennik Gazeta Prawna on Tuesday.
Mucoviscidosis patients need access to innovative therapies
During a debate organised by Rzeczpospolita, pulmonology experts from the Polish Mucoviscidosis Association (PTM) said Polish patients suffering from mucoviscidosis and idiopathic pulmonary fibrosis (IPF) need better access to innovative therapies to match EU and U.S. standards, reported Rzeczpospolita (pA10-aA11) on Tuesday.
PTM is fighting for the reimbursement of drugs, access to pancreatic enzymes, antibiotics and causative treatments, as well as the easing of the eligibility requirements for antifibrinolytic drug programmes.
Polish and Iranian scientists working on arteriosclerosis vaccine
Professor Maciej Banach with his team from the Medical University of Lodz and scientists from Mashhad University of Medical Sciences in Iran are developing an arteriosclerosis vaccine, which is planned to reach the market in 2026.
The vaccine is a proprietary method of reducing the level of LDL cholesterol by blocking its metabolism. The vaccine will be in the form of an injection and will need four rounds, one every two weeks, to be fully effective. The vaccine has been tested on mice and will enter clinical trials mid-year.
Polish oncology needs reforms
After a heated debate in the Polish parliament, when 2 billion zlotys (€ 470 million) were allocated to national television and radio instead of oncology, politicians from the opposition parties, experts and cancer patients are concerned that oncology treatment did not receive additional funds, especially when the Polish cancer mortality rate is among the highest in Europe, reported Dziennik Gazeta Prawna (pA6) and Gazeta Wyborcza (p6) on Wednesday and Gazeta Wyborcza (p4-5) on Thursday.
Although the budget for Polish oncology is increasing each year and allowing patients to gain increasing access to drug programmes or innovative drugs, experts say Polish oncology primarily focuses on randomly minimising the number of cancer deaths and not on creating a comprehensive oncology programme to increase the comfort of life of cancer patients.
In response to this debate, the government presented its National Oncology Strategy, a 10-year plan for restructuring Polish oncology, which encountered severe criticism from oncology experts because it is purely wishful thinking with no action plan.
Polish pancreatic cancer patients wait for innovative therapies
During the last American Society of Clinical Oncology (ASCO) congress in San Francisco, oncology experts expressed their views on innovative therapies treating pancreatic cancer, which greatly extend life expectancy, report Gazeta Wyborcza (p24) on Friday.
The ground-breaking compound therapy developed by a team led by Dr Peter Galle from the University Medical Center in Mainz, combining atezolizumab and bevacizumab, which greatly improves life expectancy and quality of life, is awaiting registration, but it is not known when it will be available for Polish patients.
The currently used sorafenib, less effective than the compound therapy, is only available to half the patients qualifying for the treatment. Another innovative drug is irinotecan liposome, which has already been registered in the European Union, but is used in Poland in only a few cases nationally, as the drug is not yet reimbursed.
The usual method of treating pancreatic cancer in Poland in its early stages is still surgical tumour removal and, in later stages, chemotherapy. Some 3,500 patients are diagnosed with this cancer in Poland each year.
Polish Ministry of Health shortens reimbursement list
According to microscopic colitis patient associations, drugs containing budesonide steroid (Entocort and Cortiment), and mesalazine (Asamax, Pentasa and Salofalk) have been removed from reimbursement lists, reported Gazeta Wyborcza (p17) on Friday.
Cortiment was only returned to the reimbursement lists because of strong patient lobbying.
Pharmas among most innovative companies in Poland
According to Rzeczpospolita's annual ranking, drug producers, such as Selvita (first place), Olimp Lab and ZF Polpharma, are among the most innovative companies in Poland in terms of R&D spending, R&D employment ratio and patenting, report Rzeczpospolita (pA1, pA20-A21) on Friday.
Delay in EMA's opinion weakens Mabion's shares
Mabion has received a response from the U.S. Food and Drug Administration (FDA) in its registration inquiry, but the delay in the European Medicines Agency's (EMA) recommendation caused its share price to plummet, reported Parkiet Gazeta Giełdy (p6) on Tuesday and (p7) on Thursday, and Puls Biznesu (p19) on Thursday.
Mabion, which has developed MabionCD20, a Roche rituximab (MabThera) biosimilar used for treating lymphomas, leukaemia and autoimmune diseases, has two scenarios for registering the drug on European markets, either registering MabionCD20 for production on a small scale, followed by registration of commercial production, or withdrawing the application for small-scale production and re-applying for mass production.
The company plans to respond to the EMA's additional questions at the session of the Committee on Medicinal Products for Human Use on 24-27 February or at the beginning of March.
Celon Pharma buys Japanese patent for kinase inhibitors
Celon Pharma has bought a patent for a kinase inhibitor, PI3K, for use in oncology, immunology and inflammatory diseases in Japan, reported Parkiet Gazeta Giełdy (p04) on Thursday.
The kinase inhibitor is now at the final pre-clinical stage and is being researched as a part of the PIKCel project subsidised by the National Centre for Research and Development (NCBiR). This will be followed by toxicology tests, formulation of the drug and Phase I and II trials. The total project cost is 23.5 million zlotys (€5.5 million) to be partially covered with an NCBiR grant of 15.3 million zlotys (€3.6 million).
Celon has another patent in Japan for FGFR inhibitors for use in medicines in the CELONKO project valued at 54.7 million zlotys (€12.8 million) with an NCBiR grant of 38 million zlotys (€8.9 million).
Celon Pharma's other research projects include cBITE, a drug-candidate for cancer immunotherapy and CITY, a drug-candidate for treating leukaemia and solid tumours.
Celon is waiting for the results of a Phase II trial of Exetamine, used for treating unipolar drug-resistant depression, and a possible partnership agreement to be signed this year.
Sanofi Pasteur to start work on coronavirus vaccine
Sanofi Pasteur, with the Biomedical Advanced Research and Development Authority (BARDA), a U.S. Department of Health and Human Services office, will conduct research into a coronavirus vaccine, reported Rzeczpospolita (pA24) on Thursday.
The vaccine-candidate is planned to be announced and enter in-vitro tests in six months, with human trials a year later and is expected to reach the markets in three to four years in the best-case scenario.
Sanofi will use its experience with the Sars vaccination research and conduct its DNA recombination to create a vaccine-candidate. Other companies which started their collaboration with BARDA in developing the vaccine are Johnson & Johnson and Regeneron Pharmaceuticals.
At least 75,000 cases of infections have been reported and over 2,000 deaths caused by coronavirus have been confirmed to date.