BERLIN, 24 Apr (APM) - German biotech BioNTech, which is developing a vaccine against Covid-19, carries the country's hopes in the fight against the coronavirus, reported several German newspapers on Thursday and Friday.
The start of Phase I/II trials in Germany in partnership with Pfizer, announced on Wednesday (APMHE 67044
), was an opportunity to praise the biotech's agile work as well as the ability of German drugs' regulator Paul Ehrlich Institut (PEI ) to review the file in four days while keeping its usual high standards, Handelsblatt (p1, 4-5) Frankfurter Allgemeine Zeitung (FAZ) (p22), Süddeutsche Zeitung (SZ) (p1,15) and Die Welt (p1, 11) on Thursday
BioNTech's BNT162 programme includes four mRNA vaccine candidates, developed with Pfizer in Europe and the U.S and Fosun Pharma in China. Clinical trials in the U.S. and China are expected to be approved soon.
According to Handelsblatt, BioNTech has a technical advantage over its U.S. rival Moderna, which started clinical trials in the U.S. in March on mRNA-1273 because BNT162's dosage (1 µg to 100 µg) is lower than that of mRNA-1273 (25 µg to 250 µg).
Handelsblatt (p62) and SZ (p20) on Friday profiles BioNtech's co-founders, Ugur Sahin und Özlem Türeci, a married couple who founded the biotech in 2008 with Christoph Huber. All three are still on board as chief executive, chief medical officer and member of the supervisory board respectively.
BioNTech started with the financial support of Thomas and Andreas Strüngmann, who still own half the company. The market value of BioNTech, which went public on the U.S. Nasdaq in October 2019, soared from €3 billion at market launch to $21 billion in mid March, when it first announced that it was making rapid progress in the development of a vaccine, then fell back to around $11 billion on Thursday.
The company, with a 1,300 workforce, reported €109 million revenues and €180 million loss before tax.
FAZ on Friday (p8) says that PEI's president Klaus Cichutek is facing a great challenge: the vaccine regulator must not unnecessarily slow down the development of Covid-19 vaccines but neither must it allow an immature vaccine to come to market. "The important thing for us is that the vaccine must be effective and well tolerated - that is the ultimate goal," Cichutek said.
BfArM president in crisis communication mode
The president of the Federal Institute for Drugs and Medical Devices (BfArM), Karl Broich, has the job of maintaining a balance between the urgent need for effective drugs against Covid-19 and for high medical standards in approval procedure, FAZ said on Monday (p8).
Last week, Broich appeared at the side of Health Minister Jens Spahn to report on the numerous ongoing approval studies for drugs potentially useful against the coronavirus.
However, Broich, who has headed BfArM since 2014, is used to appear before the public in times of crisis and can stand the pressure. Two years ago, he successfully defended himself against accusations that BfArM was too lax on drug safety management.
Sanofi calls for 'EU pact' on Covid-19 vaccine production
Sanofi's head of vaccines David Loew has called for a pact between the vaccines' industry and the European Commission to financially support mass production of Covid-19 vaccines in the EU, he said an interview with FAZ published on Thursday (p22) (APMHE 67057
The industry has to work with governments now to build up a body which would conclude contracts with manufacturers to help ramping up production capacity and secure orders, similar to the Biomedical Advanced Research and Development Authority (BARDA) in the U.S..
"The European Union must decide how it can help speed up the process" as the U.S. and China are already very active to secure vaccines for their own use, Loew said.
Otherwise, the EU "will be extremely weakened" as "the countries which are the first to have a vaccine will be the first to come out of the economic crisis", Loew said.
Rollercoaster for Gilead's shares following preliminary results on remdesivir
Gilead's shares soared up 21% on the U.S. stock market on 17 April but fell by 6% on Thursday after early results on its experimental drug against Covid-19 remdesivir, FAZ (p24) and Handelsblatt online report on Friday.
Positive results were first leaked at the end of last week, said FAZ on Saturday (p24) and Handelsblatt (p21) and Die Welt (p1) on Monday. It was reported that remdesivir showed rapid recovery in fever and respiratory symptoms on the basis of an internal video forum of the University of Chicago hospital participating in the study.
However, several analysts remained cautious as the results, though looking promising, were not published.
On Thursday evening, results from studies in China reported by the Financial Times were rather negative. However, Gilead and the World Health Organization (WHO) pointed out that the study was yet incomplete and the results had been unintentionally made public.
Disappointing results for chloroquine and hydroxychloroquine
Chloroquine and hydroxychloroquine, once seen as potential important treatment against Covid-19, have not shown the expected effectiveness in two studies, Handelsblatt said on Thursday (p19). (APMHE 67046
First in-vitro tests and one study on 100 participants in China raised hopes that they could slow down the proliferation of Covid-19.
However, a study on patients in U.S. veterans hospitals showed a higher death rate for patients receiving hydroxychloroquine along with standard care or hydroxychloroquine plus antibiotic azithromycin compared to patients that did not receive the drug.
A study conducted in Brazil on chloroquine+azithromycin show a similar higher death rate, Handelsblatt said.
Bayer under pressure to rebuild profitable pharma portfolio
Bayer is under pressure to rebuild a pharma portfolio that would be able to generate high revenues to compensate for patent cliffs on best-selling drugs Xarelto and Eylea in four of five years, Manager Magazin says on Friday (p48-53).
Bayer's chief executive Werner Baumann told the magazine that his goal was to "very quickly have a pharmaceutical portfolio again that grows faster than the market".
Stefan Oelrich has been appointed head of pharma to bridge the gap. He argues that five drugs in late-stage development in cancer and cardiology are able to generate €4 billion annual revenues but the pipeline needs to be refilled, Manager Magazin says.
Bayer has invested in early-stage projects, such as early-stage candidate against Parkinson's disease developed by subsidiary BlueRock and has hired an experienced pharma manager Mariane De Backer to find new investments among biotechs.
However, a significant acquisition in the pharma division, bringing quick revenues, is currently impossible as the group is highly indebted following its $63 billion acquisition of agricultural group Monsanto in 2018.
"The group has no longer much room for manoeuvre, everything has to work out as planned," according to Ulrich Manns, a pharmaceutical expert who advises investment fund Union Investment.
Image change for biotech investor Dietmar Hopp
Dietmar Hopp, co-founder of software company SAP and billionaire investor in German biotech, is once again undergoing an image change, FAZ on Friday reports (p20).
Hopp hit the headlines in recent months when football fans attacked him verbally as the "billionaire owner" of a football club. However, he has now become "a world saviour" for his investment in biotech, FAZ says in a portrait as he turns 80 on Sunday.
German biotech Curevac, which he has supported from the beginning, is developing a vaccine against Covid-19 based a very promising, new technology.
Merck KGaA invests in viral and gene therapy service offering
Merck is investing €100 million in a second production facility for viral and gene therapy service offering at its U.S. site in Carlsbad, FAZ reported on Wednesday (p20).
The facility will open next year. "Viral vector manufacturing has transitioned from a niche industry to the cornerstone of the future of biopharmaceuticals," said head of Merck Life science division Udit Batra.
Chances of surviving cancer rising in Europe
The chances of surviving cancer are increasing in Europe thanks to better diagnostics and effective therapies, according to a study Die Welt said on Tuesday (p10).
The epidemiology team headed by Carlo La Vecchia at the University of Milan sees significant decreases in the mortality rate in men for stomach cancer and leukaemia and in women for ovarian cancer and leukaemia.
However, the number of women dying from lung cancer is still increasing in Europe and Poland is the only country in the EU where the death rate is rising significantly.
La Vecchia and fellow researchers have been publishing mortality forecasts for the current year and comparative overviews for recentyears, both for the EU and in detail for the six most populous member states (Germany, France, Great Britain, Italy, Poland and Spain) since 2011.