Press review

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German Health Minister under pressure to strike deal with EC deal on mail-order medicines

Country : Europe, France, Germany, Italy, Netherlands, U.S., UK

Keywords :
BERLIN, 12 June (APM) - Germany's Health Minister Jens is coming under increasing pressure from within his own party, CDU, to negotiate with the European Commission (EC) on mail-order sales of prescription drugs, Handelsblatt reported on Tuesday (p9).
Spahn is planning to meet European Commissioner Thierry Breton while infringement proceedings are underway against Germany for its handling of European online pharmacies, the newspaper said.
The ruling coalition agreed in 2014 to implement a ban on mail-order sales of prescription drugs, a long-standing demand of German pharmacists (APMHE 67651), despite the fact that it seemed contrary to EU legislation and rulings by the European Court of Justice (ECJ.
Spahn presented a draft law as a compromise, which does not prohibit mail-order pharmacies - but does oblige online pharmacies to adhere to the fixed price system for prescription drugs in force in Germany. But it is on stand-by while the EC has given an answer.

ECJ bans free samples of prescription drugs to pharmacists

The European Court of Justice (ECJ) has taken the decision to forbid pharma companies to distribute free samples of prescription drugs to pharmacists, based on a lawsuits started by Novartis against Teva's German generics business Ratiopharm in Germany, FAZ reports on Friday (p24).
The ECJ argued that prescription drugs must be used under a physician's supervision, so samples of over-the-counter drugs to pharmacists and of prescription drugs to physicians are still allowed.

German payer deficits totalled €1.33 billion in Q1 2020

The deficits of German statutory sick funds totalled €1.33 billion in the first quarter of 2020, driven by a cost increase of 5% for drugs and sick leaves - which are 13 times the deficits of €102 million from 2019's first quarter, FAZ reported on Saturday (p17).
Major payer TK saw a deficit of €658 million due to a cost increase of 4.5%, compared to €151 million in the first quarter of 2019. Member contributions decreased due to economy restrictions from the Covid-19 outbreak.
The deficits are not related to the healthcare costs from the outbreak, which conversely has led to savings from delayed surgeries and patients' reticence to go to doctors' offices, according to some payers. The full impact of Covid-19 will be seen in the second quarter.
The deficits also stem from new legislation intended to decrease payers' financial reserves, €20 billion at the end of 2019. Now, reserves are diminishing more quickly than expected and payers are might run out of reserves.
The government will more likely provide additional funding than let employee's social contributions increase, FAZ said.

A merger between AstraZeneca and Gilead would be superfluous

A merger between AstraZeneca and Gilead might be superfluous, said Handelsblatt on Tuesday (p29),
The merger talks between AstraZeneca and Gilead reported by Bloomberg and Handelsblatt (p17) Frankfurter Allgemeine Zeitung (FAZ) p20 and Süddeutsche Zeitung (17) on Monday were not confirmed by the companies.
The merged entity, worth almost $50 billion sales, would have a portfolio mainly focused on two rising pharmaceutical markets, cancer and viral infections and the only supplier able to compete against Covid-19 with both a drug and a potential major vaccine.
However, neither of the two really need this merger, Handelsblatt said.
Astra-Zeneca is currently at the beginning of a new, strong growth phase while Gilead could gain new momentum thanks to remdesivir and a number of new biotech alliances. The combination of virology and oncology has so far not proved very fruitful.
The synergy potential is likely to be very limited, as Gilead is already one of the most efficient pharmaceutical companies in the world. The two also have a well-established culture of inner innovation that could be damaged by a large-scale merger.

AstraZeneca's CEO has tripled company value since 2012

AstraZeneca's chief executive officer Pascal Soriot has tripled the company value to £110 billion since he joined the company at the end of 2012, making it the most valuable UK company, FAZ reported on Tuesday (p20).
Soriot contributed valuable experience from leading Roche's biotech business Genentech when patents of AZN's top-sellers were expiring and the pipeline was "almost empty". In 2014, he was able to fight off a hostile takeover bid of £55 per share made by Pfizer (APMHE 38412).
Today, AZN's share price has reached roughly £82. The company's collaboration with Oxford University's Jenner Institute on a Covid-19 vaccine is a sign of AZN's research power that the "energetic medical man" Soriot has built up, FAZ said.

Hydroxychloroquine studies' retraction is 'catastrophy for science'

The retraction of two studies on hydroxychloroquine in Covid-19 patients published in The Lancet and the New England Journal of Medicine (NEJM) is "a catastrophe for science", Gerd Antes, head of the German Cochrane Centre told Der Spiegel on Saturday (p103) and in Die Welty on Sunday (p52) (APMHE 67619).
The "safety mechanisms" usually applied by reviewers have been switched off in these cases. They should have noticed all the peculiarities now identified: that much of the data were implausible and contradictory and that the company supplying the data, Surgisphere, has only a handful of employees with highly odd qualifications.
As hydroxychloroquine has become a political issue after U.S. president Donald Trump backed it with emphasis, reviewers should have taken extraordinary care, Antes said.

Moderna among five projects of U.S. 'Operation Warp Speed'

Moderna's Covid-19 vaccine candidate mRNA-1273is of the five vaccine development projects funded under the U.S. government's 'Operation Warp Speed', according to The New York Times, FAZ reported on Wednesday (p19) (APMHE 67629).
Moderna's chief executive Stéphane Bancel has called for a European innovation support under the form of an agency, such as the U.S. Biomedical Advanced Research and Development Authority (BARDA) to foster development Covid-19 vaccines.
In an interview with French economy newspaper Les Echos, Bancel claimed that BARDA could offer know-how and financial incentives, which are needed to start drug developments in areas "that the pharma industry would not necessarily start on its own", FAZ said.

Human challenge studies could be ethical to speed up vaccine development

Human challenge studies, in which volunteers would be deliberately infected with Covid-19, could be ethical, as fewer participants would be needed to find vaccine candidates suitable for Phase II trials among more than 100 candidates and all trials could be accelerated considerably, SZ says on Friday (p14).
Over 28,000 volunteers from 100 countries have registered with the 1 Day Sooner initiative who would be willing to receive "not only an underexplored vaccine but also a potentially deadly virus". WHO has provided guidelines for these kinds of studies for Covid-19.
Tens of thousands have participated in Human challenge studies in the last 50 years to find vaccines or cures for malaria, cholera or typhoid fever - but the risk was manageable in most cases, as opposed to SARS-CoV-2, for which no therapy is available to date, SZ said.

Europe late to agree on its own vaccine alliance

The joint initiative led by Germany, France, Italy and the Netherlands to build up a European Covid-19 vaccine alliance has started late, Die Welt said on Sunday (p28) (APMHE 67660).
The U.S. has already negotiated national agreements with some of the largest vaccine manufacturers.
European countries have initially hoped for a joint worldwide initiative. The mistake should have become clear at the EU Commission's pandemic donor conference in early May when the U.S. was the only member of the G7 that did not participate in the funding round.

Partnerships between universities and pharma companies should be made easier - expert

Partnerships between universities and pharma companies should be made easier to foster EU drug manufacturing and reduce shortages, chemistry professor Till Opatz told FAZ in an interview published on Tuesday (p32).
Partnerships are limited, as EU rules for cross-subsidisation are interpreted very strictly in German legislation. Universities should not become "pharma industry's extended work benches" but could help find environment-friendly manufacturing procedures that would comply with EU regulation, Opatz said.

WHO's financing dilemma

The World Health Organization (WHO) faces a dilemma to fund its activities as the U.S. has stopped financing the institution, wrote Die Welt on Wednesday (p4).
The WHO might be increasingly dependent on voluntary donations from private foundations, companies, governments or international organizations, already representing 80% of its $4.4 billion budget for 2018/2019.
After the withdrawal of the U.S., providing 15% of its budget, the Bill & Melinda gates Foundation would become the largest donor (12% of the current budget).
However, private payments are earmarked for specific purposes and cannot be used by the WHO on its own authority. According to critics, this leads to the fact that especially those projects which promise quick and measurable success are implemented.
Voluntary donors cannot be the ones which determine WHO's development policy and agenda, German social democrat member of Parliament Heike Baehrens told Die Welt.

Patent protection in jeopardy

Patent protection is in jeopardy as many call for lifting intellectual rights on future Covid-19 vaccines in order to get affordable prices, Wirtschaftswoche writes on Friday (p38-39).
Médecins sans Frontières has demanded that there should be "no patents and no privileges in distribution" for the vaccine in an open letter to Chancellor Angela Merkel.
The dispute about patent protection for a Covid-19 vaccine raises the question on whether the state should protect an intellectual property right.
Based on several studies, researchers found that research efforts slacken once a patent has been granted. Others say that patent law is increasingly being misused as an instrument of corporate strategy to slow down competition, Wiwo writes.
To address the issue, Nobel Prize winner Michael Kremer suggested to offer companies a purchase guarantee at a fixed price for their drugs, so that they can do more research into drugs for certain diseases.

Lilly's CSO says approval of monoclonal antibody for Covid-19 thinkable in September

Daniel Skovronsky, Eli Lilly's chief scientific officer has said that an approval of a monoclonal antibody for Covid-19 is thinkable in September, even before the first vaccines would be approved, SZ reports on Friday (p16).
Lilly is conducting clinical trials on two monoclonal antibodies for Covid-19 therapy and prevention that could lead quickly to approval, especially in a therapeutic setting, if patients treated would not need hospitalisation, SZ said.

Novartis supplier ITM says its radiotherapy is 'milestone in medicine'

Munich-based radiotherapy and radiodiagnostics company ITM, who is supplying lutetium-177 for Novartis's cancer drug candidate Lu-PSMA-617, has said its own radiotherapy is a "milestone in medicine", as data from hospitals on pancreatic, intestinal and lung cancer are "fantastic", SZ reports on Friday (p38).
The company received the Medical Innovation Product Award in 2019 for a compound that can be used as cancer diagnostics and cancer therapies, depending on which radionuclide is included, gallium-68 to tag neuroendocrine tumour cells in imaging or lutetium-177 to destroy these.
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