Press review

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New Medical Fund bill signed by president of Poland probed in parliament

WARSAW, 24 July (APM) - Poland's president Andrzej Duda presented a bill during the election campaign establishing a new medical fund which is to receive 4 bn zlotys (€900 million), which is now being questioned by parliament, reported Rzeczpospolita (pA12) on Monday, Dziennik Gazeta Prawna (pB5) on Wednesday and (pB10) and on Thursday and Gazeta Wyborcza (p4) on Saturday.
On the last straight in the presidential elections, Duda presented a new medical fund bill which is to receive four billion zlotys (€900 million) to facilitate access to innovative drugs and amend the reimbursement procedure.
However, the hastiness of the bill and the fact that the fund may be purely a reclassification from one place in Poland's state budget to another, is being questioned by the Polish parliament, reported all the newspapers.
The fund is expected to improve access to more expensive drugs, for instance in the emergency access to drug technologies (RTDL) procedure and offer conditional access to drugs, as well as encouraging pharmas to apply for the reimbursement of their drugs. It is expected to be targeted at oncology patients, patients with rare diseases and paediatrics reported all the newspapers.
Other changes include the introduction of long-awaited changes to the reimbursement procedure, although this route currently seems far too hasty.
It strengthens the role of the HTA Agency in the assessment of the level of innovation of drug technologies in oncology and rare disease drugs, as well as of the Economic Commission (KE) within the reimbursement procedure and reduces the role of the minister of health during the price negotiations.
According to experts, this could lead to fewer new drugs being included in the reimbursement lists. The doubts raised in parliament mean that work on the bill will continue by a special subcommittee, reported Rzeczpospolita and Dziennik Gazeta Prawna.
Furthermore, the deputy minister responsible for the drug policy in the Ministry of Health, Maciej Milkowski, who was supposed to decide at the end of this month on the first list of reimbursable drugs since the outbreak of the pandemic, has been sent on a forced vacation, which means that the ruling Law and Justice party (PiS) could make replacements within this department.
The annual fund for the reimbursement of drugs is 15 million zlotys (€3.5 million) and this could be PiS' back door to obtaining additional funds, warned Gazeta Wyborcza on Saturday.

Polpharma Biologics invests in new drugs

Polpharma Biologics, an innovative subsidiary of Polpharma, Poland's largest pharma known for producing originator drugs, generics and APIs, which concentrates on research and development into new and generic drugs, is planning further investments in R&D as well as launching new drugs onto the Polish market, reports Puls Biznesu (p4-5) on Friday.
Polpharma Biologics branched out from Polpharma in early 2019, but is still strongly supported by its parent company. It plans to start up a new production facility of innovative drugs from Polpharma Biologics' R&D portfolio by the end of this year. In addition to production, the company will also offer R&D and production services for third parties.
The company is currently working on two innovative drugs and seven biosimilars. According to the company's president, Jan Krzewinski, work on each of the projects from R&D to commercialisation will last eight to nine years and will require an investment of $150 million.
Apart from financial support from Polpharma, the company is also financed with National Centre for Research and Development (NCBiR) grants, but is looking into new options, including seeking debt financing through a banking syndicate over the coming six to 12 months.
One of Polpharma Biologics' most advanced products is Lucentis, a ranibizumab biosimilar developed within a joint venture with a German partner, Bioeq. Annual sales of the originator drug produced by Genentech used for treating eye illnesses on the U.S. market alone are $2 billion. The company expects to launch the drug on to the market in just over a year.
Another drug is a natalizumab (Tysabri) biosimilar used for treating multiple sclerosis. This drug is at the start of Phase III. The company has partnered with Sandoz to produce the drug, whereas Sandoz will be responsible for its global marketing.
Other biosimilars and two new innovative molecules are in the pre-clinical trial phase. Krzewinski said the company plans to launch one new drug every two years.

Biomed starts research into Covid-19 therapy

Biomed Lublin, a Polish tuberculosis (BCG) vaccine producer, is finally able to start its research into its immunoglobulin drug produced from plasma from Covid-19 survivors, reported Parkiet Gazeta Gieldy (p5), Puls Biznesu (p8) and Rzeczpospolita (pA16) on Wednesday.
The company has signed contracts with nine blood centres for supplying the plasma and is encouraging all Covid-19 survivors to donate their plasma to the research. The company has collected 10 litres of plasma so far, while 84 litres are in transit.
However, to fully start production, the company needs 150 litres, which it expects to collect within the coming two to three weeks. Production is expected to start in mid August and is expected to last 1.5 months.
Another 1.5 months are planned for the Institute of Haematology and Transfusion to examine the drug candidate followed by four months of clinical trials. The last stage is the registration process which could last up to 210 days. The final drug will be in the form of ampoules administered through an intramuscular injection.
Biomed's share price has risen more than 1100% over the past six months.

Pfizer received U.S. government subsidy for producing a Covid-19 vaccine

Pfizer has received an unprecedented $1.95 billion for producing 600 million Covid-19 vaccine shots together with BioNTech, a German biotech, while other biotechs working on the vaccine candidates are experiencing more modest share price increases than in recent months, reported Dziennik Gazeta Prawna (pA4) on Wednesday, Puls Biznesu (p12) on Wednesday, Parkiet Gazeta Gieldy (p10) and Rzeczpospolita (pA17) on Thursday, and Rzeczpospolita (pA23) and Puls Biznesu (p16) on Friday.
According to the agreement between the U.S. Government and Pfizer, the company will deliver 100 million shots of its vaccine to the U.S. government to administer to U.S. citizens free as early as this year. The vaccine candidate will start clinical trials this month, reported Parkiet Gazeta Giełdy and Rzeczpospolita on Thursday.
According to the analysis by Goldman Sachs, other companies competing for the production of a Covid-19 vaccine, such as Moderna or AstraZeneca together with Oxford University should have their vaccines ready by the end of the year.
Nevertheless, financial analytics suggest this is too late to prevent a possible second wave of the pandemic in the autumn. This and the fact that mortality caused by the virus is declining, is resulting in share price increases of biotechs working on Covid-19 vaccine slowing down, added Puls Biznesu on Wednesday.
Experts say between 70% and 85% of the global population needs to be vaccinated to achieve community immunity against the virus, whereas only 49% of U.S. citizens plan to be vaccinated, added Puls Biznesu on Wednesday.
The Polish government is also discussing how to vaccinate the largest possible proportion of the Polish population, despite the increasing anti-vax movement. One way is to amend the Epidemic Act of 2009 and add to it compulsory vaccination against Covid-19, added Dziennik Gazeta Prawna (pA4) on Wednesday.
Despite the announcements of over 200 biotechs working on Covid-19 vaccine-candidates and their rapid share price rises globally, some virology experts are sceptical about the vaccine candidates because their efficacy is still unknown and doubt they will achieve the promised deadlines, adds Puls Biznesu on Friday.
Meanwhile, Adam Noga, a Polish economist, criticises the global race to discovering a vaccine, as the remedy of the global pandemic should be a joint effort within the concept of effective competition and not a fierce race for the profits, concludes Rzeczpospolita on Friday.
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