WARSAW, 29 Mar (APM) - Experts say Polish officials should regulate the cannabidiol (CBD) oil market with the introduction of medical cannabis in Poland, as it is gaining momentum, reported Dziennik Gazeta Prawna (pA7) on Tuesday.
CBD is not included in the list of psychoactive substances and, according to current medical knowledge, it does not have addictive or intoxicating properties, whereas it could theoretically be used as an antipsychotic.
CBD is currently used by patients with cancer, epilepsy and Crohn’s disease, but experts say there are no guidelines and no supervision of actual therapies, while producers are not willing to take any responsibility for establishing standards of its use.
Prescriptions will be valid much longer
Poland's Ministry of Health (MoH) wants to significantly increase the validity of regular and e-prescriptions to reduce waiting times to doctors, which is being criticised by health experts, reported Rzeczpospolita (pA13) on Wednesday.
Prescriptions are currently valid for a maximum of 30 days from the date on which they are written out, or from the date explicitly specified by the doctors, enabling them to prescribe drugs for therapy lasting a year.
According to the new bill, regular prescriptions would be valid for one year and e-prescriptions for two years. Health experts and doctors say it is unacceptable to allow patients to undergo therapies for two years without any health examinations and that, while the MoH’s objective of reducing waiting times is good, the solution presented could be dangerous.
Michal Byliniak from the Supreme Pharmaceutical Council said the solution would be more acceptable if patients were required to consult pharmacists on whether they should re-visit their doctors before the start of each period of treatment, but this would require adding responsibilities for pharmacists.
He added that another issue applies to the availability of particular drugs, as pharma manufacturers plan production on the basis of a three to six-month demand and expiry dates for most drugs are around three years.
Neuca will invest its profits in clinical trials
Poland’s largest pharma wholesaler, Neuca, improved its revenues and net profit by 4% in 2018, mainly on the back of pharmacy sales of products under its own brands, and intends to invest in telemedicine and clinical trials, reported Parkiet Gazeta Gieldy (p5) on Saturday.
Neuca benefited from the introduction of regulations favouring individual pharmacies over pharmacy chains due to the structure of its customer base and the fact that it controls 30% of the market of individual pharmacies.
Neuca wants to invest in telemedicine and clinical trials, which is why it bought the Malopolskie Centrum Medyczne clinic in Krakow in October 2018. The company intends to invest a total of 120 million zlotys (€27.9 million) this year in these areas.
Neuca reported revenues of 7.75 billion zlotys (€1.8 billion) and a net profit of 98.1 million zlotys (€22.8 million) in 2018.
Pharmena wants to increase product portfolio
Polish biotech Pharmena is continuing its expansion with dietary supplements and the development of its TRIA-662 particle, reported Parkiet Gazeta Gieldy (p3) on Monday.
While the company’s priority is to register its 1MNA molecule in Asia and Australia as a new food ingredient, which could happen within 12 months or so months, enabling further commercialisation outside Europe, Pharmena is also hoping to find a partner for its TRIA-662 R&D project in 2020, which could generate revenues of $100 million.
The non-alcoholic fatty liver disease and pulmonary hypertension markets on which the company wants to compete with its new drug are estimated at, respectively, $35 billion and $5 billion.
Pure Biologics received R&D grant
Pure Biologics received a 30.1 million zloty (€7 million) grant from the National Centre of Research and Development for its R&D project regarding a lung cancer drug, reported Parkiet Gazeta Gieldy (p4) on Thursday.
The total cost of the project is estimated at 39.9 million zlotys (€9.3 million).
Spectrum Cannabis wants to increase imports of medical cannabis
Spectrum Cannabis, the only licensed importer of medical cannabis in Poland, intends to substantially increase imports to meet market demand and register additional varieties of the product, reports Puls Biznesu (p7) on Friday.
The company wants to increase its imports from 15.5kg in March to 50kg by the end of April, and launch production of medical cannabis in Denmark at the end of July, which should enable larger shipments in the future.
Polish patients currently only have access to the 19% THC variety of the product which, according to experts, is not suitable for many of them.
Spectrum cannabis claims the decision to introduce this particular variety of the product with the highest possible concentration of 19% THC was initially dictated by the fact that it could be used by the largest group of patients in Poland.
Spectrum claims it has already filed an application to also import the 10% THC and 9% CBD varieties of medical cannabis dedicated to patients undergoing radio and chemotherapy or those with cancer metastases, suffering from severe pain. It believes the new variety of the product should become available on the Polish market within three months. It also intends to apply for the registration of a third variety of medical cannabis and CBD oil.
Selvita to start trials in U.S.
The U.S. Food and Drug Administration has given the go-ahead for Selvita to start trials of SEL120, reported Puls Biznesu on Wednesday (p8) and Parkiet Gazeta Gieldy on Wednesday (p5) and Friday (p3).
The trials will be held with patients suffering from acute myeloid leukaemia and myelodysplastic syndromes and will start in the third quarter of the year.
Phase I will have the objective of determining the safety of SEL120 and specifying the dosage for subsequent phases, reported both newspapers.
The trials will be held at five study centres in the U.S., and the drug will be administered to 30-40 patients, which should cost 20 million zlotys (€4.7 million). The company wants to continue developing SEL120 on its own until the end of Phase IIa, which should be achieved by the end of 2022, after which it wants to commercialise the project, reported Puls Biznesu.
The company also hopes the indications for SEL120 will be broadened in the future, as the CDK8 affected by the drug is also responsible for other diseases. SEL120 is a selective CDK8 and CDK19 inhibitor which could be used for treating haematological, bowel or nipple cancers, reported both newspapers.
The FDA’s decision means Selvita will receive $400,000 from the Leukaemia & Lymphoma Society (LLS), with which the company partnered in 2017. LLS’ overall support for achieving all the milestones was set at $3.25 million, reported both newspapers.
Selvita’s most advanced project applies to the development of a dual pan-PIM/FLT3 kinase inhibitor, SEL24, which is currently in Phase I/II and is licensed to the Italian Menarini Group, reported both newspapers.
So far, Selvita has received 20 million zlotys (€4.7 million) from Menarini, but the total sum could be as high as 360 million zlotys (€83.7 million) if all milestones are reached, reported Puls Biznesu.
Selvita’s CEO Pawel Przewiezlikowski said the company intends to split into two independent companies, one focusing on the R&D of its own cancer drugs and the other providing laboratory R&D services for other businesses.
Both firms will be listed on the Warsaw Stock Exchange. The split, which is to take place in the last quarter of the year, is to facilitate daily operations of both companies and enable exercising individual growth strategies, reports Parkiet on Friday.