BERLIN, 29 May (APM) - German chemical-pharma industry lobby VCI is using its influence to obtain long-awaited tax measures, as the German government is preparing an economic stimulus package which might be worth up to €100 billion, Handelsblatt reports on Friday (p50).
VCI sees an opportunity in the debate about the right way to boost the economy. It is lobbying for tax breaks, credit deferrals or early relief, for example in the expansion of renewable energies.
The pharma lobby vfa calls for an expansion of the fiscal promotion of research and new pricing models more favourable to innovative products
The chemical industry has so far come through the crisis without any deep slumps and only a few employees are on short-time work, whereas pharmaceutical manufacturers have been operating at full capacity, Handelsblatt says.
Drug manufacturers are benefiting from the situation as they can highlight its importance for the research and development of new drugs.
Moderna takes leadership on mRNA vaccine
Moderna's chief executive Stéphane Bancel has put the U.S. biotech at the forefront of vaccine pioneers, Manager Magazin says on Friday (p64-65).
Bancel was so convincing at a meeting with U.S. president Donal Trump at the beginning of March that Moderna gained $483 million funding from Biomedical Advanced Research and Development Authority (BARDA) for Covid-19 vaccine development, whereas Johnson & Johnson obtained $456 million and Sanofi $30 million.
Moderna has taken the leadership on mRNA technology in vaccines, although the company started 10 years after German biotech CureVac.
The biotech initially focused on the development of mRNA- based drugs to combat cardiovascular diseases, kidney failure, cancer and cystic fibrosis with mega deals signed with AstraZeneca, Vertex and Merck & Co.
Bancel turned its attention to vaccine development in 2014 after realising that mRNA drugs were extremely difficult to develop. In 2016, he secured $125 million from the BARDA) for the development of a Zika vaccine.
'Too little information available on Moderna's Covid-19 vaccine candidate'
New York microbiologist and vaccine expert Peter Palese has expressed criticism that U.S. biotech has not disclosed sufficient medical information on its mRNA vaccine candidate intended to prevent Covid-19, FAZ said on Sunday (p55).
Moderna should not talk about the efficacy of its vaccine candidate after a Phase I trial and be more open about intense adverse events and not focus on its share price, FAZ said.
Two university studies are more reliable when it comes to scientific practice: Oxford University's Phase I study including more than 1,000 participants in partnership with AstraZeneca and Beijing university's study in 108 participants recently published in The Lancet.
Hopes in plasma therapy in Covid-19
Well-known plasma therapy used in Covid-19 patients could be a useful way of saving human lives, Die Welt said on Tuesday (p20).
This form of therapy does not rank very high on the list of top-innovative forms of treatment but it is useful as long as there is neither a vaccine nor a suitable drug.
Plasma therapies have not always proven to be useful in the past, but at least they are not has been known to have serious side effects.
In Germany, 106 Covid-19 patients will participate in the Capsid study at around 20 different hospitals.
Potential Covid-19 drugs disappoint
Drugs seen as great hopes against Covid-19 are either failing or showing much less efficacy as initially expected, said Handelsblatt on Tuesday (p22-23).
The data on malaria drugs chloroquine and hydroxychloroquine published in The Lancet last week were particularly disappointing, showing an increased risk of cardiac arrhythmia and of death for hospitalised patients.
Gilead's remdesivir proved its efficacy but only in some patients, those who need inpatient treatment but are not yet ventilated invasively, according to a large study initiated by the American National Institute of Infectious Diseases (NIAID). However, it showed almost no benefits in patients with particularly severe illnesses.
Experts concluded that Covid-19 treatment strategy should therefore include combination of antiviral drugs with other therapeutic approaches as well as combinations of several antiviral agents.
Japanese approval of Fujifilm's antiviral Avigan in Covid-19 postponed
Japan has not approved Fujifilm's antiviral Avigan (favipiravir) in May, contrary to original plans, as medical experts of Fujita Health University have not found sufficient evidence of the drug's efficacy in an interim report from a clinical study, FAZ reported on Wednesday (p18).
Japan's Health Minister Katsunobu Kato said on Tuesday that clinical testing could take until next month or longer. Japan is still planning an accelerated approval procedure if Avigan, already approved in Japan for influenza, proves to be blocking SARS-CoV-2 replication effectively.
Access to Covid-19 vaccines should be handled like HIV drugs
Access to Covid-19 vaccines should be organised in a similar way to how the World Trade Organisation's Doha Conference in 2001 could improve access to HIV drugs, whose annual costs fell from $10,000 to $100 in Africa, SZ reports on Friday (p16).
In a piece published in Foreign Affairs Magazine, U.S. law professor Jennifer Hillman said that international organisations, governments, companies, research institutes and non-governmental organisations have learned how to collaborate to fight HIV - "just what is needed now to efficiently manufacture a vaccine for Covid-19", SZ said.
Pharma industry has too much influence on IMI projects
The programme of EU Innovative Medicines Initiative (IMI) is largely led by pharma industry's agenda, as industry representatives outnumber other experts in six out of seven working groups, according to a report from the Corporate Europe Observatory (CEO) think tank, SZ reported on Monday (p13) (APMHE 67485
For instance, European pharma lobby EFPIA has voted against putting pandemic prevention on IMI's list of research projects in 2018. A planned partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) was never started, as "it was not lucrative for the pharma industry", SZ said.
German scientific academy calls for 'adequate' drug supply
Germany's national scientific academy Leopoldina has called for measures, "potentially a national reserve", to keep the national supply of drugs, protection equipment and medical devices "adequate" amidst a pandemic, FAZ reported on Thursday (p4).
Germany's healthcare system should become adaptive to long-term challenges - such as a pandemic, in several waves - based on digital early-warning systems, said Leopoldina experts in a statement on the Covid-19 crisis.
German health Ministry returns chloroquine donations
German Health Ministry has returned donated tablets of the drug chloroquine to a pharmaceutical company, Business Insider Deutschland said on Wednesday.
The Ministry told the online publication that the decision was taken "based on current knowledge". The tablets are "available again for the treatment of other diagnoses", the ministry added.
The decision follows a study showing that patients receiving chloroquine or hydroxychloroquine had a significantly higher mortality risk.
Roche's pricing policy on Covid-19 antibody test makes competitors nervous
The competition for Covid-19 antibody tests is getting tougher as the market leader Roche makes its competitors nervous with its pricing policy and public relations work, Handelsbatt said on Thursday (p22-23).
Roche is currently positioning itself with a particularly favourable price - 1.50 Swiss francs (€1.43), according to industry circles, whereas other providers in Germany offer prices of between €4 and €6.
Smaller companies fear being left behind. "Roche's price is a declaration of war," Erwin Soutschek, managing director of German diagnostics company Mikrogen told Handelsblatt.
In addition, the public support given to Roche's test by Health Minister Jens Spahn - saying it is "the best test" in terms of quality- also "caused irritation" in the industry as other tests are "equally effective". The Roche test is now actively requested by patients in laboratories at the expense of other suppliers.
Siemens Healthineers on Tuesday announced it plans to produce 50 million of its antibody test a month. It has obtained a CE certification and is awaiting a U.S. authorisation, Handelsblatt said on Wednesday (p19).
Qiagen sold cheap to U.S. competitor Thermo Fisher
Diagnostics company Qiagen, seen as the German most successful biotech, was sold cheap to U.S. competitor Thermo Fisher by chairman of the supervisory board, Håkan Björklund, Manager Magazin says on Friday (p14-15).
Björklund first defeated Qiagen's chief executive Peer Schatz who wanted the company to remain independent. Schatz, who had shaped the company since 1993, finally left.
After tough negotiations with several buyers, Björklund agreed in March to a deal of $39 a share - but Qiagen could be worth much more, given the increase in demand due to the Covid-19 outbreak, the monthly says.
German companies, such as Siemens Healthineers or Merck KGaA, did not put in an offer to keep the biotech in the country, Manager Magazin said.
Merck KGaA group defends itself against Covid-19 crisis
Merck KGaA group is managing to defend itself against the pandemic crisis thanks to a good mix between pharma, biotech and electronic businesses, said Handelsblatt on Thursday (p26-27) in analysis of its 2019 results.
Merck has made significant operational gains in 2019 and will probably continue to grow in 2020, albeit less vigorously than originally hoped for, it said.
The acquisition-driven restructuring of recent years and the focus on innovative business areas in pharmaceuticals, life sciences and electronic materials are bearing fruit.
However, Merck will focus on cost and debt reduction during the economic crisis to come, chief executive Stefan Oschmann said at the online general assembly on Thursday, ruling out "large acquisitions" until 2022, FAZ reports on Friday (p21).
Learning to live with Covid-19
People have to learn how to live with Covid-19 for some time as there is still high uncertainty over how efficient vaccines will be and whether appropriate medications will be found, virologist and European commission pandemic adviser Peter Piot told Der Spiegel on Saturday (p104-107).
It might be necessary to find a specific approach to control the immune response or a correct timing of intervention measures, including early preventive treatments for people who have been in contact with an infected person.
Piot, who was infected by the virus and hospitalised for a week in March, also spoke about his personal experience with the disease. Two months after being infected, he has started to work again but he is able to climb a few stairs only and is under blood thinners because of remaining atrial fibrillation.
Pharma resets priorities on clinical trials due to Covid-19
Pharmaceutical companies are resetting priorities in research by postponing several trials not related to Covid-19, Handelsblatt said on Monday (p20).
According to the clinicaltrials.gov database, the number of clinical trials involving the novel coronavirus has quadrupled to more than 1,600 since the beginning of April. At the same time, drug development in other therapeutic areas is being slowed down as the number of interrupted and delayed clinical trials has increased 15-fold in the last two months compared to the usual figures, according to Evaluate Pharma.
The main reasons for this are the higher safety requirements and limited hospital capacities in therapeutic areas not related to coronavirus.
According to Bayer's head of R&D Jörg Möller, most of the delays could be made up. However, the pandemic could shift the industry's focus somewhat more towards drugs for treating infectious diseases and vaccines, he added.
Observers largely agree that the pandemic could indirectly contribute to accelerating the ongoing digitalisation in clinical research.
In Germany, where reluctance towards digital studies and technical hurdles are still high, the current crisis is likely to profoundly change practices, according to IQVIA's Frank Wartenberg.
Germany needs to discuss drug pricing before Zolgensma launch
Germany needs a national debate on drug pricing, as its mechanisms for limiting drug prices is failing vis-à-vis one-time gene therapies, such as Novartis's spinal muscular atrophy (SMA) therapy Zolgensma (onasemnogene abeparvovec), which is likely to be launched shortly at a price close to €2 million, SZ reported on Saturday (p34-35).
As pharma companies can set launch prices freely and cost-effective prices are negotiated to take effect only one year after launch, all SMA patients, or with any rare disease treatable through a gene therapy, might be treated within the first year, SZ said.
Germany must find mechanisms for "stopping costs shooting up", as 300 gene and cell therapies are under development to date and could be launched in the next few years, chair of the drug commission of the German medical association (AkdÄ) Wolf-Dieter Ludwig told SZ.
Health sector will get massive EU subsidies
The European Commission wants to mobilise €9.4 billion for its new "EU4Health" programme, to be launched in 2021 - an increase of more than 2,000% over the current budget, Handelsblatt says on Friday (p9). (APMHE 67535
In no other area is the planned increase in funding as strong as in health care, the newspaper points out.
European Health commissioner Kyriakides said that the program represented a "paradigm shift" in European health policy, called last week by French president Emmanuel Macron and German Chancellor Angela Merkel.
The authority wants to use the money to create strategic reserves for medical equipment, to fund professional training for doctors and nurses and exchange programmes, so that they can also be used in other EU countries if necessary. In addition, the states will be able to apply for funds for their health systems, for example to fight cancer.
German hospitals ill-prepared to prevent severe infections
Germany's healthcare system is ill-prepared to prevent severe infections, according to the Sepsis Foundation, FAZ reported on Wednesday (p34).
Too many hospitals are not qualified for many services they offer, resulting in up to 20,000 preventable sepsis mortalities a year, it said.
Too few quality assurance measures have been implemented in hospitals and medical staff is not qualified in infectiology. Therefore, pharma companies' reluctance to develop antibiotics is a bigger problem in Germany than in the UK, Sweden or the U.S..
Also, rates of flu and pneumococcal vaccinations in Germany cover half the percentage of the population of those in the UK, U.S. or Australia - diseases that often lead to sepsis, FAZ said.
Sanofi to sell Regeneron shares worth $12 billion
Sanofi announced on Monday it will sell the majority of its 20% stake in Regeneron, which is worth $12 billion - and Regeneron will repurchase shares worth $5 billion, FAZ reported on Wednesday (p22) (APMHE 67484
, APMHE 67500
Sanofi, which owns 23.2 million Regeneron shares, plans to keep about 400,000 shares in its U.S. partner to support their collaboration. Sanofi's chief executive Paul Hudson said that the funds from this transaction would be used to drive the French company's growth and innovation strategy.
Now, Hudson must prove that he can find investments more useful than a stake in Regeneron for the $50 billion Sanofi has available for acquisitions. It is questionable how solid the partnership between the two company remains without a large capital investment, FAZ said.
Vertanical develops new dosage form for cannabis drug VER-01
German cannabis drug maker Vertanical is developing a new dosage form for its painkiller candidate VER-01 for which the company plans Phase III testing to start this year, FAZ reported on Thursday (p18).
Vertanical's chief executive Clemens Fischer, a former Novartis executive, wants VER-01 to become a blockbuster drug among prescription painkillers within four years for chronic pain patients "without the need to light a joint". So far, the company has one-digit million sales of medical cannabis, FAZ said.