WARSAW, 15 Nov (APM) - Contradictory interpretations of the Pharmacy Law mean only three cancer markers are currently produced in Poland and, because it is not profitable to import more, Polish cancer patients are often wrongly diagnosed, reports Rzeczpospolita (pA15) on Friday.
Experts want the regulations to be amended, as, following the report of the Supreme Audit Office (NIK) stating that the positron emission tomography (PET) tracers do not have the necessary certificates and are used illegally, they cannot use many cancer markers, such as fluorotyrosines (FET), radiopharmaceuticals used for diagnosing malignant brain tumours.
The regulations have been in force since 2003, but they also allow for the production of cancer markers by radiologists for their own needs. Meanwhile, the regulations are being interpreted much more restrictively. The certificates required to produce cancer markers, which have often been tailored to individual patients, can cost as much as a million zlotys (€430,000) which radiology centres cannot afford, while the half-life of some is very short, as little as a few minutes.
Meanwhile, the National Health Fund (NHF) does not provide full reimbursement for imported markers. The Ministry of Health claims it is currently working on the amendment of the regulations on radiopharmaceuticals.
Polish colon cancer patients have access to innovative treatments
The inclusion of innovative treatments, such as targeted therapies in the first and second stages of treatment, targeted therapies for chemotherapy-resistant cancers, as well as Trifluridine/tipiracil in the third and fourth stages of palliative treatment, in the reimbursement lists, means Polish patients suffering from colon cancer have now gained access to these treatments, report Gazeta Wyborcza in its Tylko Zdrowie supplement (p24-25) on Friday.
Biomed increases production after financial crisis
After being on the verge of bankruptcy from investing in a plasma fractionation plant, Biomed Lublin is recovering and starting to invest in its own drug production, especially in Onko BCG, reported Puls Biznesu (p7) on Wednesday and Parkiet Gazeta Gieldy (p05) on Thursday.
Half of the company's revenue is generated by Distreptaza and, according to Marcin Pirog, the company's new president, after restructuring, the company's sales are rapidly increasing in eastern European markets, reported both newspapers. Production capacity of the drug has increased from 0.6 to 1.5 million units a year after Biomed's investments in production lines last year, added Puls Biznesu.
Biomed's other products are a tuberculosis BCG vaccine, for which the Ministry of Health has recently placed an order for 4.5 million zlotys (€1,000,000), and Onko BCG, a drug used for treating bladder cancer.
Other products from Biomed's portfolio include haematogenous drugs produced from immunised plasma, such as anti-D gamma, which is used in the preventive treatment of Rh disease. Biomed is the only producer of such a treatment in Poland. The small supply of plasma in Poland means the company will use plasma imported from the U.S. from 2020, concluded both newspapers.
EMA's decision on Mabion's biosimilar is expected before Christmas
Mabion announced the submission of its answers to the second round of questions in the registration procedure at the European Medicines Agency for its oncology drug, Mabion CD20, and that it will meet the Federal Drug Agency to discuss the registration of the treatment for the U.S. market on 22 January 2020, reported Parkiet Gazeta Giełdy (p5) on Wednesday.
Mabion expects to receive the EMA's decision by the end of the year. MabionCD20, a Roche MabThera/Rituxan biosimilar, is also awaiting a decision from the EU Committee for Medicinal Products for Human Use. In addition to MabionCD20, the company is developing MabionMS and MabionEFGR, and has announced the start of three new projects by the end of the year.
Selvita plans to expand through acquisition
Selvita has recently split into an internal R&D division focusing on the production of new drugs, Ryvu Therapeutics, and a CRO services company, Selvita, which is focusing on rapid growth through acquisition, reported Puls Biznesu (p6) on Wednesday.
According to Dawid Radziszewski, a member of the company's management board, the company's first acquisition is planned for next year. It is analysing targets primarily from Poland, as well as eastern and central Europe, such as former Selvita contractors or companies looking for buyers.
The key to Selvita's growth may be its role in merging with companies that are too small for huge corporations such as Charles River and Evotec. Selvita expects to grow organically by 40% this year and by 30% in 2020. The company's acquisition objective is to acquire new skills and increase its scale, while gaining access to customers.
Neuca records steady growth at the end of the quarter
Neuca is steadily growing by 10% a year by increasing its presence on the independent pharmacy market (2,100 individual pharmacies currently belong to Neuca's partner programmes), producing its own prescription drugs under the Genoptim label and looking for growth opportunities in telemedicine services, reported Parkiet Gazeta Giełdy (p07) on Thursday.
Local authorities are cancelling health programmes due to budget shortages
Local authorities, such as of the City of Olsztyn and Czestochowa, needed to stop pneumococcal and flu vaccination programmes for elderly patients due to budget shortages caused by the increase in spending on education, reported Dziennik Gazeta Prawna (pA2) on Wednesday.
Other local authorities are also considering making such savings. The trend of looking for savings in health programmes is caused by the increase in salaries and allowances for teachers.