WARSAW, Jan 12 (APM) - Officials in Poland have agreed to pharma industry requests and decided that, while the details of negotiations between the health ministry and drug companies will be public, information on risk sharing schemes (RSS) will not be revealed, reported Rzeczpospolita (pA17) and Dziennik Gazeta Prawna (pB4) on Wednesday.
RSS enable the national health fund to save up to 200 million zlotys (47.9 million euros) annually on drug reimbursement. While the drugs are sold by manufacturers at the official reference prices, pharma companies often agree to pay back some money under certain conditions, thereby effectively reducing drug prices.
There was a risk that, after revealing the details of the RSS, the companies will no longer be interested in drug reimbursement in Poland, as this would have an adverse effect on their negotiations on other European markets, where they can dictate higher prices for their products, reported both newspapers.
Ewa Rutkowska, a legal expert from the KRK Kieszkowska Rutkowska Kolasinski law firm, said that, while the decision to keep the RSS confidential is good, the effects of the new regulations will depend on how they are interpreted and whether all the documentation on risk sharing will actually be kept confidential, reported Rzeczpospolita.
Eculizumab could be withdrawn from the Polish market within several years
Eculizumab, which was added to the reimbursement list in January, could be withdrawn from Poland in several years because of badly designed regulations, reported Rzeczpospolita (pA17) on Thursday.
Eculizumab is an expensive drug that costs up to 150,000 zlotys (35,900 euros) and is used in atypical haemolytic-uremic syndrome. Experts agree that the reimbursement of the drug is a big success and an opportunity for approximately 40 patients, including 25 children, in Poland.
However, according to the regulations, the price of every originator reimbursable drug must be reduced by at least 25% by the manufacturer 10 years after the first registration, even if no generic equivalents are available on the market.
Experts say the regulations, which are theoretically supposed to improve access to expensive originator drugs, could lead to a situation in which the drug is withdrawn from the Polish market, as its manufacturer would not be interested in selling it at a lower price without any competition on the market, especially since it would affect its business strategy in other European countries.
Prices of immunosuppressants accelerating
Doctors are warning that increasingly more patients are withdrawing from transplant surgery, because they are concerned that they will not afford the immunosuppressants after the procedure, reported Rzeczpospolita (pA13) on Friday.
This most frequently applies to patients with kidney problems who choose to remain with dialyses, even though they could receive a transplant.
While doctors, patients and some deputies have raised the issue several times, the ministry of health always answers that the prices of some originator immunosuppressants are increasing because cheaper equivalents are added to the reimbursement list. The officials claim the equivalents are as good as the originator drugs, but doctors say that even a slight difference in the composition of the drug could result in the rejection of the transplant, thereby endangering patients.
Some examples of the drastic price increases since March 2017 include Valcyte, which increased from 316 zlotys (76 euros) to 817 zlotys (196 euros), Myfortic, which rose from 90 zlotys (22 euros) to 436 zlotys (104 euros), and CellCept, which soared from 3.2 zlotys (0.8 euros) to 100 zlotys (24 euros).
Celon Pharma’s trials of S-ketamine progressing well
Celon Pharma has recently announced that the first stage of Phase I of its S-ketamine trials in patients with drug resistant depression was completed successfully, reported Puls Biznesu (p8) on Monday.
The company started the trials at the end of 2017 and is administering S-ketamine to patients in the form of inhalations. Maciek Wieczorek, Celon Pharma’s chief executive, said the trials are progressing well in terms of patient reaction to the treatment and the schedule.
He said the company has a lot of data to analyse after the first stage of Phase I and that it could soon start administering S-ketamine to subsequent groups of patients. If all goes well, Phase II could start by the year end and end in 2019, while Phase III could take another two years.
Celon Pharma estimates the global market for its drug at $500 million.
While most of the company’s revenue is from sales of generics, Celon Pharma intends to develop a portfolio of innovative products. The S-ketamine R&D is Celon Pharma’s most advanced biotech project, for which it received a 12 million zloty (2.9 million euro) grant from the National Centre for Research and Development.
Bioton continues to work on insulin analogues
Robert Neymann, Bioton’s chief executive, said one of the company’s primary objectives for 2018 is to continue developing its insulin analogues, reported Parkiet Gazeta Gieldy (p4) on Tuesday.
According to Neymann, Bioton should complete the stage of adapting its insulin to mass production and begin the registration procedures in mid 2018. Bioton’s second major objective is to successfully complete its ongoing restructuring process and continue its expansion overseas.
Synektik will acquire Monrol Poland
Synektik, a Polish manufacturer of radiopharmaceuticals and distributor of medical devices, intends to buy Monrol Poland, a subsidiary of the Turkish Eczabasi Monrol, for 14.7 million zlotys (3.5 million euros) by the end of the first quarter of the year, reported Puls Biznesu (p5) and Parkiet Gazeta Gieldy (p5) on Wednesday.
Monrol, which also sells radiopharmaceuticals, entered the Polish market in late 2014 and embarked on an aggressive pricing policy, which affected the market and Synektik. This business strategy, however, proved unsustainable and resulted in the decision to exit the Polish market, which will certainly improve Synektik’s position and help it improve margins, reported both newspapers. The acquisition will increase the company’s share of the radiopharmaceuticals market from 33% to 39%, reported Puls Biznesu.
The company is currently working on an innovative cardiac radiotracer that could be used in the diagnostics of heart muscle perfusion. The current stage of research should end in 2018, after which the company wants to sign a partnership agreement in 2019, followed by the commercialisation of the product in the U.S. in 2021, reported Parkiet.
Mabion could soon file MabionCD20 in Europe
Mabion intends to file in Europe its innovative drug, MabionCD20, in the first quarter, reported Parkiet Gazeta Gieldy on Tuesday (p3) and on Friday (p5).
Mabion recently announced that it received positive initial opinions about the results of the MabionCD20 trials from an external company and additional opinions, encompassing a wider range of criteria should be issued within several weeks.
The company said all patients taking part in the Hodgkin’s lymphoma trials have completed their 46-week treatment and observation cycle and all the necessary data for assessing the trials had been gathered, reports the newspaper on Friday.
The final versions of the reports will be filed with the European Medicines Agency in the first quarter, followed by negotiations with the U.S. Food and Drug Administration.
Mabion is also preparing for a share issue on a foreign stock exchange, from which it hopes to obtain up to 440 million zlotys (105 million euros) to cover its debts, increase production capacity and finance R&D activities, reported the newspaper on Tuesday.
Farmina acquired Laboratorium Farmaceutyczne Avena
Farmina, the Polish manufacturer of essential medicinal products, acquired its direct market competitor Laboratorium Farmaceutyczne Avena, reported Puls Biznesu (p6) on Thursday.
Wojciech Swiderski, Farmina’s CEO, said the portfolios of both companies are similar and the acquisition will complement Farmina’s product range and production technology.
This is Farmina’s third acquisition in recent years after acquiring Germany's Spreewalder Arzneimittel in 2014 and Apipol-Farma in 2017. The company reported revenues of 40 million zlotys (9.6 million euros) in 2017, of which 10% was generated on foreign markets.