WARSAW, 26 July (APM) - Poland's health minister Łukasz Szumowski said this week that 700,000 packs of Euthyrox, a hypothyroidism drug that has been unavailable in Poland for months, has reached Polish wholesalers and pharmacies, reported Rzeczpospolita (pA2, p A15) on Thursday.
However, the drug remains unavailable for many pharmacists, patients and even members of the Supreme Pharmaceutical Council (NRA), the paper said.
Szumowski said other countries are also suffering from the drug crisis and patients should turn to Euthyrox's generics, which are not available in every dosage, while Glucophage for diabetes is now also reported as being increasingly scarce.
After the announcement on Wednesday at a press conference, patients rushed to pharmacies and were left confused that, despite the minister's statement, they cannot buy their medications. Meanwhile, pharmacists are in the first line of fire of patient discontent because of this disinformation.
Mariusz Politowicz from the NRA checked with Poland’s two largest wholesalers controlling around 60% of the Polish pharma market and found that they did not have Euthyrox in stock. Members from the Polish pharmacy employers (ZAPPA) also confirmed they have no stock. Some pharmacists suspect that pharmacies which are illegally owned by wholesalers were first in line to receive deliveries. Another possibility is that supply might have already been depleted, as monthly demand for Euthyrox in Poland is estimated at 650,000 packs.
Sales of generics increased by 50% during Euthyrox's shortage in Poland.
Sinemet CR 200/50 is unavailable in Poland
A Parkinson's disease treatment, Sinemet CR 200/50, is now completely unobtainable in Poland and its producer, Merck, is not planning to restart deliveries, reported Dziennik Gazeta Prawna (pA1, pA3) on Monday.
Sinemet CR200/50 was reported difficult to obtain early this year and its Polish distributor informed the Ministry of Health (MoH), the Chief Pharmaceutical Inspectorate and the registration office that problems regarding cooperation with one of the producers of the drug registered in Poland have resulted the stoppage of its production for the Polish market.
However, despite such news, the drug was added to July's drug reimbursement list, making it more difficult to obtain through direct imports. Patients can currently only obtain the drug directly from Germany without any reimbursement, which multiplies treatment costs tenfold, which will severely affect people aged over 75, for whom the drug was fully reimbursed to date. Meanwhile, other EU countries, such as Italy, have also reported shortages of Sinemet.
The only option for Polish patients suffering from the disease is currently to switch to Nakom Mite, but many patients report adverse effects, such as severe headaches from this. 70,000 people currently suffer from Parkinson's disease in Poland.
Overuse of antibiotics causes increase in antibiotic-resistant bacteria in Poland
According to Monday's report of the Supreme Audit Office, antibiotics are heavily overused in Poland and result in an increase in antibiotic-resistant bacteria infections, reported Gazeta Wyborcza (p8) on Monday.
Polish family doctors currently even tend to prescribe antibiotics for viral infections, making the bacteria increasingly resistant. Neither they, nor hospitals nor the MoH care sufficiently for patients and tests of the patient's bacteria are not conducted before an antibiotic is prescribed, nor is antibiotic use monitored in Poland.
The MoH made a commitment to the European Union in 2006 that it would establish a national centre for monitoring infections, drug resistance and the use of antibiotics, but no such centre has been established to date.
Poland has 300,000-500,000 drug resistant infections a year and the costs of their treatment are estimated at 800 million zlotys (€187.8 million).
Dozens of public hospital pharmacies will need to close
According to the amendment to the Pharmaceutical Law of 7 June 2018 that will come into effect on 1 August, in order to prevent illegal drug exports, it will be prohibited to combine medical activity with sales of medicinal products and so dozens of hospital pharmacies will have to be closed, reported Dziennik Gazeta Prawna (pA1, pA5) on Tuesday.
According to hospital representatives, the regulations will cause more harm than good. Closing the pharmacies will both deprive hospitals of a significant source of income, as well as patients of a convenient source of medications.
Some hospitals are trying to find new owners for their pharmacies so as not to be forced to close them. Nevertheless, close-to-hospital pharmacies tend to be very difficult businesses, because sales are mainly low-margin, as patients tend to buy prescribed, often reimbursable drugs and not dietary supplements that give the highest margin.
Despite the arguments that public hospitals would hardly be involved with illegal drug exports, the MoH is not planning to make any exceptions for them.
Disputes on Polish reimbursement incentives system continue
Last week, the Ministry of Economic Development proposed a report presenting the basics of the future reimbursement incentives system (RTR), which was not well received by either pharma representatives or the MoH, reported Puls Biznesu (p8) on Tuesday.
The long-awaited RTR is a programme intended to promote and financially support investments in R&D and production of medications for companies that have the best positive impact on the Polish economy.
Such companies would compete for the status of Partner of the Polish Economy (PPG) through their positive influence on the Polish pharma industry and investments in talents, R&D work and data analysis. Such PPGs would be ranked according to a complex scoring system and would receive a share of the support budget that reflects their position in the ranking. The annual assumed budget for the programme of 400 million zlotys (€94 million) would be co-funded evenly by the National Health Fund (NFZ) and the Medical Research Agency (ABM).
Nevertheless, neither the NFZ nor the Polish Union of Pharmaceutical Industry Employers, including Polpharma, Adamed, Gedeon Richter, Sandoz and Teva, are satisfied with the draft. The pharmas are disappointed with the yearly budget which plummeted from the initially planned 12 billion zlotys (€2.81 billion) a year, while the mechanisms involved are complicated, with a great deal of unnecessary bureaucracy. On the other hand, the NFZ disagrees with co-funding the programme, claiming that its budgets, which come from patient taxes, should be spent on their treatment instead of investments in pharmas.
Novartis wants to increase number of clinical trials in Poland
Novartis, one of the world’s largest pharmas, is investing in clinical trials of innovative drugs and looking for new start-ups for cooperation in inventing new therapies, reports Puls Biznesu (p6, p7) on Friday.
During the Polish drug availability crisis, Paul van Arkel, president of Novartis Poland, said the MoH and Polish pharmas are already working towards easing the problem. But although the MoH has increased the healthcare budget to 6% of GDP, the pharma industry also needs government support, as this imbalance can lead to more correctly diagnosed patients without being able to treat them.
Novartis and its subsidiaries are growing by 5-6% a year, producing innovative treatments and biosimilars, but also investing in production. In 2018, the company reported revenue of 209 million zlotys (€49 million) and a profit of 8.9 million zlotys (€2 million).
Its subsidiaries, Sandoz Polska, which produces generics generated revenue of 219.9 million zlotys (€51.7 million) and a profit of 9.7 million zlotys (€2.3 million), while Lek ze Strykowa generated revenue of 1.65 billion zlotys (€388 million) and a profit of 30 million zlotys (€7 million).
Novartis has invested 750 million zlotys (€176 million) in its production line in Stryków, and although the drugs produced there are mainly exported, the factory is capable of covering half of Poland's needs for prescription drugs.
Novartis actively supports initiatives for start-up growth and invests 40 million zlotys (€9.4 million) per year in clinical trials. In 2018, it conducted 128 trials and is currently conducting 50 clinical trials for oncology treatments, such as lung, breast and blood cancers, melanoma and rare diseases, such as myelofibrosis and Cushing's syndrome. It also hopes to implement CAR-T therapy in Poland - a more expensive but efficient cancer treatment targeting cancer cells with use of the patient’s modified T-cells.
According to the Medical Research Agency (ABM), the Polish clinical trials market is worth 2 billion zlotys (€470 million), with 400-450 trials held each year. Recent simplification of the procedures has resulted in a 40% increase in the number of trials in the first half of this year.
Poland has increasingly more listed companies that conduct research into innovative treatments, such as Selvita, Celon Pharma, OncoArendi and Pure Biologics. Almost all clinical trials in Poland are funded by pharmas, whereas 40% of clinical trials in western Europe are non-commercial, scientific and academic research. The ABM's objective is make a shift towards non-commercial clinical trials in Poland.
Analysts believe in Selvita
Analysts from Pekao Investment Banking estimated Selvita's target share price at 82.9 zlotys (€19.7), which is roughly 23 zlotys (€5.5) more than their current price on the Warsaw Stock Exchange, reported Puls Biznesu (p6) on Wednesday.
The analysts say the Polish biotech is developing innovative drugs and believe the SEL120 project, which successfully passed pre-clinical trials, could bring the company 268 million zlotys (€63.7 million). SEL24, which is currently in Phase I, could generate 77 million zlotys (€18.3 million), with $4.8 million being transferred from Selvita's partner, Menarini, in the first half of 2020 once the drug passes Phase I. All of Selvita’s other early-stage projects were valued at 198 million zlotys (€47 million), the company itself at 340 million zlotys (€80.8 million) and its subsidiary, Northera, at 23 million zlotys (€5.5 million).
Polish biotechs did relatively well in first half
Investment analysts claim Polish biotech companies listed on the Warsaw Stock Exchange had a relatively good first half of the year, reports Parkiet Gazeta Gieldy (p7) on Friday.
Marcin Szuba from Lartiq TFI sees the highest potential in Medinice, which is working on a device used for treating cardiac arrhythmias, and Pure Biologics, working on antibodies that could be used in cancer immunotherapy.
Beata Szparaga-Wasniewska from Ipopema said while several biotech projects have moved to further stages of development, Polish biotechs have not signed any new partnerships or received milestone payments in the first half-year.
She added that potentially important events are still to come. Selvita could soon enter Phase I with its SEL120 drug and is already running Phase I for SEL24. Synektik completed Phase II for its cardiac marker, reaching milestones in its trials, OncoArendi is waiting for new scientific data and Celon Pharma, in Phase II with esketamine, intends to complete its trials by the end of the year and sign a partnership agreement.
What troubles Celon Pharma, however, is that sales of its asthma drug, Salmex, have been hit hard in Europe due to a legal dispute with GlaxoSmithKline, with a generic having been registered in the U.S.