WARSAW, Nov 17 (APM) - Access to pain treatment is still restricted in Poland despite new regulations on patients' rights to therapy coming into effect six months ago, reported Gazeta Wyborcza on Wednesday (p4) and Thursday (p22).
It said 20% of Poles experience chronic pain, while doctors consider pain to be as an intrinsic element of being sick, instead of looking for ways of reducing it.
Many are unaware of how to effectively treat chronic pain or are afraid of using strong opioid drugs, while the institutions for which they work often lack proper standards specified for pain treatment. Additionally, waiting times to specialised pain treatment clinics financed by the national heath fund (NHF) are often three to four months.
Furthermore, Poland has fewer than 200 such clinics and, according to the Supreme Audit Office (NIK), 70% of Poles do not have sufficient access to them. NIK also says that staff did not measure pain levels experienced by patients in 94% of audited hospitals, while 70% have no procedures for treating pain and 60% have no specialists responsible for treating pain.
This leads to overconsumption of over-the-counter analgesics. Poles spent over 2 billion zlotys (472 million euros) on these in 2015. Meanwhile, Polish patients suffering from chronic pain receive one fifth of the amount of opioid drugs prescribed to patients from other EU member states, even though such medicines are already reimbursed by the NHF.
GLG Pharma may soon start clinical trials
GLG Pharma intends to start Phase I trials for its triple negative breast cancer drug, GLG-801 at the end of the first quarter of 2018, reported Puls Biznesu (p8) and Parkiet Gazeta Gieldy (p7) on Wednesday.
The company expects to complete Phase II in 2019 and look for a partner interested in continuing to develop the drug. The aim is to conduct the trials in a manner enabling the drug to be ultimately registered as a medicine for combination therapies.
GLG Pharma believes a partnership agreement could bring it 12-40 million zlotys (2.8-9.4 million euros) from the initial payment and is simultaneously working on an intravenous form of the drug, GLG-805, which should enter pre-clinical trials in 2018, reported both newspapers.
The company is also developing an innovative formulation of a commonly used solid tumour drug, to improve its safety and efficacy, in another project, GLG-Doce-Safe. The intravenous form of GLG-502 should enter pre-clinical trials in 2019. The overall cost of the GLG-Doce-Safe project is estimated at 30.2 million zlotys (7.1 million euros), of which 22 million zlotys (5.2 million euros) could be provided by the National Centre for Research and Development, reported both newspapers.
Selvita investigates death of clinical trial patient
Selvita, is investigating the death of a patient taking part in the clinical trials of its SEL24 particle and is preparing all the necessary documentation for the U.S. Food & Drug Administration, reports Parkiet Gazeta Gieldy (p6) and Puls Biznesu (p7) on Friday.
SEL24 clinical trials were suspended by the FDA in October, following the death of a participating patient as a result of cardiac problems. Krzysztof Brzozka, Selvita’s president, said the company found no evidence that that death was due to the administration of SEL24, as the drug does not affect blood coagulation, reported Puls Biznesu.
The company will soon submit all the necessary documentation to the FDA, after which the regulator will have 30 days to decide whether the trials can be resumed, reported both newspapers.
The suspension of the trials forced Selvita to delay its share issue plans, from which it intends to obtain 140 million zlotys (33 million euros) to continue the development of several innovative oncology projects, reported both newspapers.
Celon Pharma to focus on innovative drugs
After Celon Pharma’s third-quarter results announcement, CEO Michal Wieczorek said sales of its asthma drug, Salmex, could soon increase and that the company is focusing on the development of innovative drugs, reports Parkiet Gazeta Gieldy (p5) on Friday.
While the company’s revenues remained level after three quarters of the year, compared with the corresponding period of 2016, at 81.2 million zlotys (19.2 million euros), its net profit plummeted from 35.1 million zlotys (8.3 million euros) to 19.4 million zlotys (4.6 million euros).
Wieczorek claims the results were affected by last year’s milestone payments and dates of Salmex exports, which will take place this year in the last quarter. He adds that Salmex’s share of the markets, where it is actively being distributed by the company’s partners, such as Austria, Croatia and Lithuania, has increased by several percentage points and exceeded the 20% mark.
Wieczorek believes Celon’s future is not with generics, but with innovative drugs, which is why it intends to focus on starting clinical trials of its esketamine inhalant and FGFR inhibitor. Celon Pharma is also starting to work with Plexus Ventures, which will be responsible for commercialising the company’s projects, and has started to establish an R&D centre in Kazun Nowy.