WARSAW, Feb 16 (APM) - Poland's chief sanitary inspector, Marek Posobkiewicz, claims that, while requirements for storing vaccines specified by their manufacturers allow for a significant margin of error, the recent case of inappropriate storage conditions in some regions of Poland was certainly in breach of regulations, reported Dziennik Gazeta Prawna (pA5) on Tuesday.
Posobkiewicz said that while it is impossible to determine whether incorrectly stored vaccines always pose a risk to patient health and lives, doctors should not make the decision arbitrarily and the vaccines should be disposed of.
He added that the officials regularly audit health institutions that vaccinate patients and all abnormalities are reported. The health institutions are obliged to address them, after which the audits are repeated. Posobkiewicz claims he is only aware of cases of administering incorrectly stored vaccines in the Lubuskie region and if evidence is found of similar practices in other regions of Poland, the prosecution office will certainly be notified.
Posobkiewicz said the exact reasons for administering vaccines that should have been disposed of have not yet been established, but the officials will consider implementing additional systems and countermeasures to prevent this from being repeated in the future. He concluded that the case should be considered an isolated incident, as it applied to 10 healthcare institutions and 448 patients who received incorrectly stored vaccines, which, however remained safe and effective.
EMA entitled to disclose documentation filed by pharmas
In three separate rulings of February 5, the European Court of Justice (CJEU) ruled that the European Medicines Agency is entitled to disclose the documentation filed by pharmaceutical companies, as the documentation itself should not the treated as fully confidential, reported Rzeczpospolita (pA18) on Monday.
The cases applied to documentation filed by Pari Pharma, PTC Therapeutics International, as well as MSD Animal Health Innovation and Intervet International. The companies claimed the EMA had no right to disclose the documentation they had filed. However the CJEU ruled the plaintiffs had not presented conclusive evidence that the disclosure of the documentation should be considered a breach of trade secrets. The information disclosed by the EMA applied to a drug similarity comparison, a clinical trials report and five toxicology reports.
Experts say the Polish Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products very rarely agrees to disclose any documentation filed by pharmas, even if it is requested by entities which may have a valid legal interest in accessing it. This applies both to companies developing innovative therapies and to those producing generics, as the former may want to check whether the patent protection for their products is respected, while the latter could use it to help launch new generics onto the market.
Standards of kidney cancer treatment should be improved
Patient organisations and experts are urging the officials to improve the standards of kidney cancer treatment and provide access to modern molecular drugs, reported Rzeczpospolita (pA10) on Thursday.
Experts say kidney cancer is diagnosed in 4,500 Polish patients each year and is the sixth most common type of cancer, mainly affecting men. According to estimates, over 50% of patients diagnosed with the disease die of it, mainly prematurely. They add that the therapies currently used are suboptimal compared to those using modern, molecular drugs, such as the tyrosine-kinase inhibitor, cabozantinib, and nivolumab.
Experts say the effects of treatment could be significantly improved if the officials were to agree to reimburse new drugs, especially since one of them, cabozantinib, already received a positive reimbursement recommendation from the HTA Agency in June, 2017, provided that the manufacturer agrees to significantly reduce the price of the therapy.
The analysis conducted by the agency showed that the drug could help reduce the risk of death by 34% and increase life expectancy without progression of the disease by 49% compared with everolimus, and by 40% compared with axitinib.
On the other hand, nivolumab did not receive a positive recommendation even though the analysis showed it could reduce the risk of death by 15% and increase the life expectancy of patients by 27%, because the agency assessed the treatment as not cost-effective.
Biomed Lublin selling Distreptaza rights to Bioton
Biomed Lublin is selling the rights to its key product, Distreptaza, to Bioton, reported Puls Biznesu (p5) on Tuesday and Parkiet Gazeta Gieldy (p6) on Wednesday.
According to the agreement, Bioton will have exclusive right to sell Distreptaza in Poland over the coming five years. Distreptaza accounts for around 30% of Biomed’s revenues and the deal is estimated at 45 million zlotys (10.8 million euros). The company intends to double its production capacity of the drug in the third quarter of the year. Biomes’s chief executive, Marcin Pirog, says the collaboration with Bioton will help Biomed significantly boost sales of Distreptaza and reduce operating expenses, reported both newspapers.
Pirog added that, if the collaboration progresses well, the companies could consider a similar arrangement for selected Asian markets. Distreptaza is a prescription drug used in chronic adnexitis, haemorrhoids and endometritis and is registered in Kazakhstan, Uzbekistan, Tajikistan, Kyrgyzstan, Mongolia, Georgia and Armenia, reported Parkiet.
Conference on multiple myeloma will be held in Warsaw
Experts will discuss multiple myeloma treatment options during a conference being held in Warsaw today and Saturday, reported Rzeczpospolita (pA11) on Thursday.
Professor Anna Dmoszynska, head of the Polish Multiple Myeloma Group and conference co-organiser, said multiple myeloma, while still incurable, is considered a chronic disease, because the available therapies have significantly evolved in recent years.
She added that the first two monoclonal antibodies, daratumumab and elotuzumab, received positive recommendations in 2015 and 2016 from, respectively, the U.S. Food and Drug Administration and the European Medicines Agency.
The CASTOR study demonstrated that daratumumab, combined with bortezomib and dexamethasone, reduced the risk of progression of the disease and death by 61%, while the POLLUX study showed that daratumumab, combined with lenalidomide and dexamethasone, reduced the risk of progression of the disease and death by 63%. The median life expectancy of multiple myeloma patients has recently doubled from three to six years, while experts believe the launch of new therapies could increase this to 10-20 years.
The Current and Future Perspectives of MM & other Haematological Malignancies Treatment conference will be held on 16-17 February in Warsaw and will host three prominent experts, professor Philippe Moreau from France, Enrique Ocio from Spain and professor Roman Hayen from the Czech Republic.
Approximately 9,500 Poles are currently diagnosed with multiple myeloma.