Press review

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Pharma lobby expects more drug shortages in Germany

Country : Belgium, Canada, China, Europe, France, Germany, Italy, Japan, U.S., UK

Keywords :
BERLIN, 11 Sep (APM) - Drug shortages could emerge in the future due to a concentration of drug manufacturing, even if the supply situation eases after the first wave of the Covid-19 pandemic in the spring, pharma lobby BAH's managing director Hubertus Cranz has said, according to Süddeutsche Zeitung (SZ) on Tuesday (p14).
Drug manufacturing cannot be relocated "on short notice", as supplies require six months of planning, Cranz said.
A new expert advisory board is setting up a list of critical drugs on which pharma companies should stock up (APMHE 68759) and manufacturers operating in the EU should be kept here.

Syringe manufacturers warn about potential shortage

Manufacturers warn about a potential shortage of syringes in view of the coming mass vaccination campaign against Covid-19, Handelsblatt said on Monday (p22).
The European Biosafety Network has warned that around one billion syringes would be needed for the vaccinations in Europe only.
The EU is preparing a joint procurement for syringes and needles, in which Germany intends to participate.
The U.S., Canada and the UK have already signed contracts with Becton Dickinson, the world's largest manufacturer of syringes, on approximately 330 million syringes while B. Braun, the second-largest supplier, has signed contracts with around a dozen institutions and countries, including Japan.
However, manufacturers need to receive orders soon enough as production is planned six to 12 months ahead, Becton Dickinson told Handelsblatt. "There is still time to act. We also want to avoid the government having to resort to low-cost suppliers from other countries in the event of any supply bottlenecks," the company said.
However, a shortage of vaccines -if any- is more likely than of syringes, according to Meinrard Lugan, member of B. Braun board.

Europe is wasting opportunities in Covid-19 research

Europe is wasting opportunities in Covid-19 research as research centres cannot fully exploit their strengths against competitors in the U.S. and China, Handelsblatt says on Friday (p22-23).
The European research landscape is highly fragmented and only weakly networked within Europe according to an analysis made by the Vienna FAS Institute on behalf of Pfizer. FAS reviewed more than 11,000 scientific articles by almost 65,000 authors dealing with Covid-19 published up to the beginning of August.
U.S. and Chinese authors are clearly ahead, followed by the Italians (4) and British (5). Spanish researchers come 6th, French 7th and Germans 9th.
The analysis on joint publications showed European researchers are relatively one-sidedly focused on cooperation with the U.S. and UK.
U.S. and Chinese researchers have published by far the largest number of joint research publications, followed by co-publications by U.S. and British authors. The first intra-European combination, between Italy and the UK, follows only in fifth place. And continental European research alliances are even rarer.
FAS concluded that the UK plays a relatively strong role as a mediator or "broker" in research relations while intra-European cooperation is only weakly developed as well as between Europe and China.

EU in talks with BioNTech/Pfizer on vaccine deal

The agreement proposed by the European Commission to BioNTech and Pfizer to pre-order 300 million doses of its Covid-19 vaccine candidate would be the largest initial order ever, Frankfurter Allgemeine Zeitung (FAZ) (p22) Handelsblatt (p19) and SZ (p16) said on Thursday. (APMHE 68831)
In addition, Pfizer and BioNTech have confirmed their interest in a possible supply for the Covax Facility, established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (Cepi) and the World Health Organization (WHO) with the aim of providing emerging and developing countries, with rapid access to a broad portfolio of Covid-19 vaccine candidates.
Both companies have started manufacturing of the experimental vaccine, Pfizer in Belgium and BioNTech at two sites in Germany, in Mainz and Idar-Oberstein, FAZ said.

EU and Germany lag behind in vaccine deals

Germany and the European Union lag far behind the U.S. and the UK in securing supply of Covid-19 vaccines, Die Welt said on Sunday (p1 and 27).
The U.S. has secured 800 million vaccine doses, with an option for a further 1.4 billion doses at a later date, from six different manufacturers in preliminary agreements.
The UK has also concluded framework agreements with six manufacturers on at least 340 million doses for its 66 million citizens.
In contrast, the European Commission has so far only reached an agreement with AstraZeneca on 300 million vaccine doses, plus an option on 100 million additional doses. In total, however, this would not even be enough for a single vaccination of all 446 million inhabitants, Die Welt said.
Negotiations are ongoing with other companies. However, if the AstraZeneca vaccine flopped, the EU would be left completely empty-handed, Die Welt said.

Vaccine developers resist public pressure

Covid-19 vaccine developers are sticking to regular approval procedures despite public pressure to accelerate the process, said Handelsblatt (p25) FAZ (p18), SZ (p18) and Die Welt (p9) on Wednesday (APMHE 68815).
The pledge made by chief executives of nine pharma companies working on Covid-19 vaccines on Tuesday to only submit a product for approval or emergency use authorisation (EAU) if it demonstrates safety and efficacy in a large Phase III trial is "unusual".
Pharma companies are facing political pressure from the U.S. government, as President Donald Trump is trying to make the availability of a Covid-19 vaccine his so-called October surprise ahead of the elections at the beginning of November, FAZ reported on Monday (p15,19).

Brake on AstraZeneca Covid-19 vaccine

Hopes for a rapid breakthrough in the search for a vaccine against Covid-19 have been severely dampened with AstraZeneca pausing the Phase III trial on its candidate, Handelsblatt said on Thursday (p18-19).
AstraZeneca has stopped the trial on a vaccine candidate, seen as a very promising and among the most advanced, as a precautionary measure after one of the participants experienced serious health problems. (APMHE 68824)
According to science online portal Statnews, a female UK participant has developed a spinal inflammation called transverse myelitis and was hospitalised for a short time. It is possible that the event was an over-reaction to the Sars-CoV-2 spike protein or to the chimp virus vector, SZ says on Friday (p15).
Another male participant showed the same symptoms in June, but these were thought to be caused by an attack of multiple sclerosis in an undiagnosed patient and not by the vaccine.
Analysts from the investment bank Barclays say the news has dampened investor sentiment even if the company is acting extremely cautiously.
The fact that the company has suspended the study does not yet say anything about the future success or failure of the vaccine, Handelsblatt said, including Die Welt (p3) and FAZ (p22) on Thursday.
It is a good sign for clinical trials' and vaccine developers' integrity that AstraZeneca has respected its pre-defined stop rule and supervisors are investigating the case now investigating SZ said on Thursday (p12).
However, Kirill Dmitriev, who financed the approved vaccine Sputnik V through the Russian Direct Investment Fund (RDIF), took the opportunity to highlight "the much greater and proven safety of human adenoviral vectors" compared to AZN's chimpanzee adenovirus-based vector which is "a new, not yet tested technology" as well as messenger RNA-based vaccines.

BioNTech/Pfizer start German part of Phase III study on vaccine candidate

BioNTech and Pfizer have started testing their potential coronavirus vaccine BNT162b in Germany after vaccine regulator Paul Ehrlich Institut (PEI) gave the green light for the German part of their large Phase II/III study, Handelsblatt (p25) and Die Welt (p9) said on Tuesday.
"The involvement of study centres in Europe, and now also in Germany, is specifically aimed at supporting local approval," said BioNTech's chief executive Ugur Sahin.
If the clinical trials are successful, BioNTech and Pfizer plan to apply for approval of the vaccine as early as October.

J&J starts Phase II testing of Covid19 vaccine in Germany

Johnsons & Johnson's drug division Janssen received approval from vaccine regulator PEI for a Phase II trial of its Covid19 vaccine candidate in Germany, FAZ reported on Thursday (p22).
Janssen's candidate, which is a vector-based vaccine, can now be tested in a larger number in German participants, FAZ said.

Sanofi/GSK's Covid-19 vaccine to be priced under €10

The Covid-19 vaccine developed by Sanofi and GlaxoSmithKline is likely to cost less than €10 per dose, according to the head of Sanofi France, Die Welt said on Monday (p9). (APMHE 68799)
However, a final price has not yet been determined, said Olivier Bogillot on Saturday.

Roche launches combined Covid-19 and flu test in U.S.

Roche has received emergency approval from the U.S. Food and Drug Administration (FDA) for an automated combination diagnostic that can detect Sars-CoV-2 and influenza virus in the same sample, FAZ reported on Saturday (p23).
The diagnostic can process 1,056 samples in eight hours. It is thought to be useful in autumn when the flu season and Covid-19 pandemic are expected to infect large numbers of people, leading to similar respiratory symptoms.

'Killer acquisitions' to cancel competition make up 6% of takeovers in pharma

An economics study has estimated the percentage of so-called "killer acquisitions", company takeovers intended to kill a drug candidate that could mean competition for a top-selling product of the buyer, to 6% of all pharma takeovers, FAZ reported on Sunday (p20).
According to the study, chances of candidates acquired in a takeover to be developed further decreased by 29% if the buyer had a competing drug in its portfolio. Drug candidates acquired were 47% less likely to advance from Phase I to Phase II than self-developed candidates.
Also, takeovers became much more likely when a competitor drug was under development in the company to be acquired, which were mostly biotechs and start-ups. Only 20% of the drug developers relocated to the buyer, so the human capital was not a motivation, FAZ said.
As the deals were kept slightly below the threshold of reporting obligations, competition watchdogs were not alarmed - a pattern that could not be observed in takeovers where the competition was not an issue.
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