Press review

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Medical Research Agency to subsidise development in Poland

WARSAW, 24 Jan (APM) - The Polish Medical Research Agency (ABM) has introduced a grant for non-commercial clinical trials of medicinal products and medical devices, reported Puls Biznesu (p4) on Tuesday.
The ABM is distributing a grant of 400 million zlotys (€94.3 million) on non-commercial clinical trials, of which 100 million zlotys (€23.6 million) has already been awarded. Almost 300 million zlotys (€70.8 million) is being funded by the National Health Fund to be distributed among state academic establishments and research institutes, with the remainder allocated to commercial research, either to fully cover costs or to co-finance research.
Dr. Radosław Sierpiński, acting president of ABM, says grants have already been awarded for R&D into innovative drugs and medical solutions, such as CAR-T immunotherapy treatment for leukaemia.
ABM's current objective is to open up to businesses to form public-private partnerships for developing new medicinal products and IT solutions based on artificial intelligence, which will support diagnosis and the work of specialists. Its main mission is to keep Polish innovations within the country, as many are being sold abroad, because of a lack of funding in Poland.
Almost 80 grant applications for projects of a value of around 1.5 billion zlotys (€355 million) have been received since the announcement of the grant contest in September 2019. This amount is a dozen or so times more than the whole amount of support.

Poland to resume work on reimbursement incentives system

The Ministry of Development announced it will resume work in February on the reimbursement incentives system (RTR) for pharmas to invest in the production of medicines in Poland and to improve the competitiveness of local pharmas, reports Rzeczpospolita (pA15) and Puls Biznesu (p2) on Friday.
The draft, which was to be implemented in 2018, is one way of helping to increase local production, combat shortages of drugs on the Polish market and give easier access to innovative therapies for Polish patients, reported both newspapers.
One pharma that acknowledged the competitiveness of the Polish market is AstraZeneca, which announced it would invest 1.5 billion zlotys (€355 million) in research and development, even without governmental support, added Puls Biznesu.

Launch of new medicinal programme has left patients without treatment

Despite the launch of a new drug programme, a gap in the regulations has resulted in transplant, lymphoma or leukaemia patients being left without any treatment whatsoever reported Gazeta Wyborcza (p5) on Saturday.
The efforts of specialists in infectious diseases resulted in the Ministry of Health (MoH) replacing the B.43 drug programme for patients suffering from immunodeficiency, who are at risk of infection with viral hepatitis B, such as transplant, lymphoma or leukaemia patients, in which they were treated with Lamivudine, with the B.106 programme, using newer drugs, Entecavir and Tenofovir.
However, the B.43 programme ended on 31 December 2019 after the announcement of the launch of the new B.106 programme. Meanwhile a tender needs to be announced for the new programme, leaving patients without any reimbursed medications from the start of this year. Health centres cannot expect to sign new contracts any earlier than in March.
Patients and doctors are left without a solution and no response from either the MoH or the National Health Fund (NHF). Some hospitals are trying to include their patients in another drug programme dedicated to patients already suffering from viral hepatitis B, but this workaround might not be suitable for all patients, may not be reimbursed by the NHF and could even be illegal.

Chief Pharmaceutical Inspectorate awaits EMA's instructions with inspections of metformin drugs

After December's discovery by the European Medicines Agency that metformin, a drug used for treating type II diabetes, may have been NDMA-contaminated, the Chief Pharmaceutical Inspectorate (CPI) has still not taken any steps to order inspections of Polish drug producers and is waiting for instructions from the EMA, despite MoH appeals to examine drugs in Poland, reported Dziennik Gazeta Prawna (pA1-A2) on Monday.
After discovering that many batches of drugs exceed the permissible NDMA contamination level, the MoH recommended continuing treatment, as the health benefits greatly exceed the risks of contamination, even though the scale of the problem is unknown.
According to the CPI, the EMA has already ordered an inspection of the detained batches of drugs and those in circulation by their producers, extending the deadline for announcing the results until 20 January 2020.
According to the National Medicines Institute, Polish drug producers have already filed over 60 applications for inspections for nitrosamines in products containing various sartans and metmorfin on their own initiative.

Experts support increasing compulsory pneumococcal vaccinations to 13-valent

10-valent pneumococcal vaccines (PCV-10) have been used in Poland since 2017 when they became compulsory, but because it has been noticed that the remaining three serotypes have strengthened, vaccinology experts are urging the government to invest in 13-valent vaccinations (PCV-13) to better protect children, while making savings on healthcare spending in the future, reports Rzeczpospolita (pA11) on Friday.

Polish pharmacies still have drug shortages

Polish pharmacies reported shortages of 422 medications in December last year, but some can be found in pharmacies abroad, reported Gazeta Wyborcza (p13) on Thursday.
One of these cases is Merck's Novothyral, a non-reimbursable medication used to treat thyroid diseases, for which there is no substitute on the Polish market. The company is announcing new delayed estimated delivery dates, while patients are becoming anxious. The latest announcement stated that Novothyral will be available from 27 January.
According to the MoH, the situation of drugs in Polish pharmacies is constantly being monitored and if the desired treatment is unavailable, it recommends using generics.

Cancer patients to undergo chemotherapy at home

The NHF has issued a draft order prepared with oncology experts for consultation which will allow cancer patients to undergo individual chemotherapy procedures using special infusers at home and without the need for hospitalisation, reported Dziennik Gazeta Prawna (pB10) on Wednesday.
The specially designed infusers will continuously administer cytostatics to patients. Their small size means they can be used without disrupting everyday life. The draft will also amend the regulations of joint drug purchases for medicinal facilities, as the prices of medications such as trastuzumab can range from the minimum to the maximum by 476.7%.
The NHF has announced it will provide better access to innovative treatments for patients by promoting biosimilars and joint drug purchases.

Poland takes up defence against anti-vax parents

Increasing pressure from parents refusing to vaccinate their children has led to the Supreme Medical Council and the Chief Sanitary Inspectorate introducing instructions for doctors and educational activities at schools to counteract the spread of the anti-vax movement, reported Dziennik Gazeta Prawna (pA7) on Wednesday.
Additionally, the first pro-vaccination advice centre has been established, where specialists will answer any doubts related to vaccination and vaccination programmes, as well as giving consultations to individual patients. According to Jarosław Pinkas, the chief sanitary inspector, the plan is to have at least two such clinics per voivodship.
The proposed activities are expected to combat the recent spread of parents refusing to vaccinate their children. According to recent data, the number of such cases increased from 30,090 in 2017 and 40,342 in 2018 to 44,475 in 2019.

Pharmena plans overseas expansion with Plexus Ventures

Pharmena, a Polish dermocosmetics and dietary supplement producer has partnered with Plexus Ventures to boost sales on foreign markets and is broadening its portfolio with the 1-MNA molecule used in non-alcoholic steatohepatitis (NASH) treatment, reported Parkiet Gazeta Giełdy (p6) on Wednesday.
Pharmena has presented the 1-MNA pre-clinical trials to selected Big Pharma companies, and Plexus Ventures' role will be to find potential partners to further develop the molecule, licensing or selling all the rights to the molecule.
1-MNA could be Pharmena's break from its recent difficulties in making sales, as there is currently no dedicated treatment for NASH. The company claims worldwide sales in this sector will be $35-$40 billion by 2025.

OncoArendi's OATD-01 gained orphan drug status

OncoArendi, a biotech specialising in research, development and commercialisation of drugs, received orphan drug status for OATD-01 from the Food and Drug Administration (FDA) in its primary indication of treating sarcoidosis, reported Parkiet Gazeta Giełdy (p3) on Saturday.
The orphan drug status will enable the FDA to apply the scientific advisory procedure in the clinical trials phase, shorten further phases of trials and provide other benefits for the company, such as tax relief, a shorter and cheaper drug evaluation and registration procedure, longer patent protection and an additional seven-year exclusivity period on sales. OATD-01 also gained the orphan drug status for treating idiopathic pulmonary fibrosis in February last year.
OncoArendi received a positive grant recommendation from the National Centre for Research and Development (NCBiR) in November 2019 for OATD-01 in the sarcoidosis indication. The grant will be for 22.4 million zlotys (€5.3 million), whereas the whole budget is estimated at 34.6 million zlotys (€8.2 million).
The company is also awaiting toxicology results for OATD-02 and Phase 1b results for OATD-01 in this year's the first quarter. Sarcoidosis is an autoimmune disease affecting 1.3 million patients worldwide, with no effective treatment to date.
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