WARSAW, 10 Jan (APM) - FamiCordTx, a subsidiary of the Polish Stem Cell Bank (PBKM), has acquired an exclusive licence for using chimeric antigen receptor technology (CAR-T) in Europe, Russia and Turkey and will soon start to introduce and test the technology in Poland, reported Parkiet Gazeta Gieldy (p03) on Saturday.
The company plans to acquire a licence from the Chief Pharmaceutical Inspector to start production of a CAR-T medicinal product, after which it will start its clinical trials, and, after successful completion, it will apply to the European Medicines Agency (EMA) for registration. FamiCordTx will assign 15 million zlotys (€3,532,320) for purchasing the licence, conducting clinical trials and developing the technology in 2020-2023.
Two other oncology CAR-T therapies have been registered in Europe since 2018: Tisagenlecleucel and Axicabtagene Ciloleucel. Their therapy costs around $400,000. According to Tomasz Oldak, R&D director of PBKM, board member and co-founder of FamiCordTx, his company’s therapy will be much cheaper and offered to patients from Poland and neighbouring countries. Later, the company plans to expand production to local FamiCord laboratories and distribute the therapy to Turkey, Spain, Portugal and Russia.
Polish local authorities fight anti-vax movement
According to the National Institute of Health, the number of children who are not being vaccinated in the Pomeranian region has increased to 11.7 per 1,000 patients, which is the highest number in the whole country, reports Gazeta Wyborcza (p8) on Friday.
To counteract the trend, the Bydgoszcz, Krakow, Poznan, Wroclaw, Gdansk and other local authorities have enacted regulations promoting the qualification of vaccinated children for public nursery schools and crèches. This will help prevent the spread of contagious diseases such as recurring pertussis (1,600 cases in 2019) and measles (1,500 cases in 2019).
2020 will be decisive year for Polish listed biotechs
Polish biotechs listed on the Warsaw Stock Exchange (GPW) and NewConnect will reach their key milestones in the coming months, which will have major impact on their future funding and valuation, reported Parkiet Gazeta Gieldy (p03) on Tuesday and (p05) on Thursday.
Pure Biologics saw its share price soar 80% last year. It is working on six simultaneous projects, including originator biological therapies for cancer. The most advanced immunology product is Multibody. The completion of its first animal trials is planned this year.
Selvita recorded a 56% hike in its share price after splitting into Selvita and Ryvu Therapeutics, while Celon Pharma noted a 27% share price increase due to high expectations of its drug, Esketamine.
OncoArendi Therapeutics and Mabion saw share price falls, the former due to delays in research, sales of shares by former key employees and a lack of the previously announced partnership agreement, while Mabion has not yet received a decision expected from the Committee for Medicinal Products for Human Use (CHMP) on MabionCD20's registration in Europe.
Scope Fluidics has two flagship projects, namely: PCRONE, a system of automatic analysis of genetic material of bacterial and viral pathogens, and BacterOMIC, a device for rapidly assessing of antibiotic-resistance in bacteria. The launch of the latter is planned for the middle of this year.
Experts say Ryvu Therapeutics is still waiting to be assessed, as it will need to reach its milestones. The signature of a partnership agreement, nomination of a clinical trials candidate and completion Phase I will affect its share price.
OncoArendi, whose share price plummeted 30%, is expecting the toxicology results for its OATD-02 project and the completion of phase 1B of the OATD-01 project in the first quarter of the year. It is also planning to sign an agreement with a strategic partner by the end of the year. The agreement is expected to be worth between €200 and €400 million, added the newspaper on Thursday
Celon Pharma is completing Phase II for esketamine, for treating drug-resistant depression and, according to experts, it has a 75% probability of success. The next big step for the company will be to sign a partnership agreement for the product.
Mabion's results will depend on the meeting with the U.S. Food and Drug Administration (FDA) planned for 22 January, the further clarification of the questions posed by the European Medicines Agency (EMA) and the scaling of the production process. Selvita's share price will probably depend on the company's successful acquisitions.
E-prescriptions have become compulsory in Poland
Every prescription written out for patients from 8 January will need to be electronic, although the paper prescription will still be accepted in pharmacies, reported Rzeczpospolita (pA1, pA13) and Gazeta Wyborcza (p15) on Wednesday and Dziennik Gazeta Prawna on Thursday.
E-prescriptions will be accepted at a pharmacy with a four-digit code sent to a mobile phone or by e-mail, and the patient's Polish identification number (PESEL).
Standard e-prescriptions are valid for 365 days, while a prescription for antibiotics is valid for seven days, for intoxicants and psychotropic drugs 30 days and for immunology medications 120 days. Additionally, every prescription issued together with the dosages of medications can be checked on the patient's personal Internet account, reported Rzeczpospolita.
Meanwhile, some doctors, especially the older ones, still have problems with issuing e-prescriptions. According to the Minister of Health, the doctors can contact a special helpline or watch tutorial videos that have been prepared on YouTube.
No penalties are expected yet for individual doctors who continue to write out traditional, paper prescriptions, added Gazeta Wyborcza, although there will be penalties for clinics which have contracts with the National Health Fund and which will not comply with the e-prescription system by the end of June, added Dziennik Gazeta Prawna.