Press review


EMA not investigating problem of NDMA-contaminated metformin - Polish press

Country : Australia, Japan, Poland, U.S.

Keywords :
WARSAW, 5 June (APM) - According to the U.S. regulator, the metformin used in diabetes drugs may be more contaminated with carcinogenic NDMA than was previously believed and local drug producers are being consulted, while the European Medicines Agency (EMA) seems not to have initiated an investigation, reported Dziennik Gazeta Prawna (pB6) on Monday.
The problem originates from the global dependency on Asia for active pharmaceutical ingredients, as 80% of APIs used on western markets are produced in Asian countries, where production conditions cannot be controlled.
The EMA's current recommendation is not to stop treatment with metformin, as this can cause more harm than its contamination. Even so, pharmaceutical and pharmacy associations want steps to be taken to address the issue of dependency on Asian APIs and to mobilise government support to move API production to the EU.

Bioton optimistic about its future

After the global pandemic, the stoppage of the Distreptaza promotion and distribution agreement with Biomed-Lublin and the 196 million zloty (€45 million) loss in 2019, Bioton, an insulin producer listed on the Warsaw Stock Exchange, claims the problems are temporary and will be resolved soon.
Revenue from the 15-year framework agreement signed in 2018 with Yifan are forecast at 250 million zlotys (€56 million) over the coming three years, reported Parkiet Gazeta Gieldy (p5) and Rzeczpospolita (pA19) on Tuesday.

Shares of companies conducting Covid-19 vaccine research are soaring

Share prices of companies racing to produce the first working Covid-19 vaccine or drug are soaring on global stock markets, which could lead to a speculative bubble, reported Parkiet Gazeta Gieldy (p11) on Monday and (p16) on Tuesday.
According to the Milken Institute think tank, research is currently being conducted into 141 Covid-19 vaccines and 223 cures. One of the first companies to announce work on a Covid-19 vaccine was the U.S. company, Vaxart, which, together with a biopharmaceutical company, Emergent BioSolutions, expects to produce an oral vaccine.
Its share price has soared by 640% since the beginning of the year. Altimmune started working with the University of Alabama on an intranasal Covid-19 vaccine. Its share price has climbed by 300% since the beginning of the year.
Japan's AnGes, which is working with Osaka University, is conducting research into an innovative type of DNA vaccine. Its share price has rocketed 320% since the beginning of the year.
Inovio Pharmaceuticals, which has started clinical trials on 40 patients and expects to produce a million vaccines for further research or urgent cases, has received $5 million from the Bill & Melinda Gates Foundation and has seen its share price increase by 300% since the beginning of 2020.
Additionally, Novavax, which has started clinical trials on patients in Australia, watched its share price soar by 1200%. Other major pharmas, such as Johnson & Johnson and GlaxoSmithKline have not observed such significant increases.
Moderna, which is listed on Nasdaq, is said to be the closest to producing a Covid-19 vaccine. It is working with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and has reached Phase I. The U.S. government has subsidised the project with $500 million. The company's share price has risen 180% since the beginning of the year.
Experts from the Financial Crisis Observatory say the speculative bubble is currently only affecting individual companies and not the whole biotech sector, reported Parkiet Gazeta Gieldy on Monday.
According to the London School of Hygiene and Tropical Medicine, 169 groups were conducting research into a Covid-19 vaccine in May.
Nature listed the companies at the most advanced stages as CanSiono Biologics in cooperation with the Beijing Institute of Biotechnology, Sinovac Biotech, Sinopharm with the Beijing Institute of Biological Products and Wuhan Institute of Biological Products, Oxford University with AstraZeneca and a biotech consortium of Fosun Pharma and Pfizer.
According to Reuters, the first mass clinical trials of the most promising of 14 vaccine candidates should start in July, added Parkiet Gazeta Gieldy on Tuesday.

Funding success for NodThera

NodThera, a Ryvu Therapeutics subsidiary, received £44.5 million from its share issue as a part of its overall £80.8 million financing of its inflammasome inhibitor project, reported Parkiet Gazeta Gieldy (p5) on Thursday.
The new investors include global biotech funds, such as Novo Holdings A/S, Cowen Healthcare Investments and Sanofi Ventures.
NodThera's main activity is research and development into an innovative NLRP3 inflammasome inhibitor used in diseases caused by chronic inflammations. The company has received permission to use the Research and Development Centre for Innovative Medicines facility built before Selvita and Ryvu Therapeutics split.

Selvita plans acquisitions

According to its four-year strategy, Selvita is planning to spend 350 million zlotys (€80 million) on development and acquisitions and to increase its laboratory space from 4,500 to 10,000 square metres for around 135 million zlotys (€30 million) by the end of 2022, to be financed with internal funding, debt finance and public grants, reported Parkiet Gazeta Gieldy (p6) on Thursday.
The new laboratory facility will allow the company to increase its range of services to include phenotypic testing using high-content screening technology and AI, as well as in-vivo testing. The company is also planning to increase its staff by 40%, by employing scientists returning to Poland and foreign experts.
According to the Polish Economic Institute (PIE), the current pandemic has caused private investors to shift their attentions to biotechs and governments to consider biotechnology in their development strategies.
According to Senior 2020, global venture capital investments in the sector are increasing exponentially: from $3.5 billion in 2010 to $18.8 billion in 2019.
But, according to the OECD, the share of Polish companies on the global biotech market is modest. Polish companies spent $240 million on R&D in 2017, which is 1/200 of U.S. spending and 1/6 of spending by German companies on R&D.

Supplies of medical cannabis to Poland obstructed by the pandemic

Polish patients have been facing shortages of medical cannabis on the market since the end of 2019, while every current delivery, such as the April and May shipments, is bought out within two hours of reaching wholesalers, reported Rzeczpospolita (pA10) on Tuesday.
According to Malgorzata Lukowicz, director of the Neurological Rehabilitation Clinic of the Children's Memorial Health Institute, 370,000 Polish patients could benefit from therapy with medical cannabis in fighting migraines, neuropathic pains, spinal pains, oncological diseases and Parkinson's disease.
Spectrum Therapeutics, one of the two distributors of dried medical cannabis, has announced another shipment to reach Poland next week. According to Samia al-Hameri, a pharmacist and president of the Santa Herba foundation, the products of the other distributor of dried hemp, Aurora Deutschland, are constantly available in wholesalers, but pharmacies can only order specified amounts.
Meanwhile, according to Jerzy Przystajko, a pharmacist and a member of the Razem (Together) political party, the solution to the problems with the lack of availability of medical cannabis and its high distribution prices of around 65 zlotys (€15) per gram could be solved by an amendment to the Act of Counteracting Drug Abuse enabling the cultivation of narcotic cannabis for medical purposes.



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.