Spain requested support from the European Globalisation Adjustment Fund (EGF) after 960 workers were laid off in 38 small and medium-sized companies in the shipbuilding ancillary sectors in Galicia between May 2019 and February 2020. Around 500 redundant workers are expected to participate in the support measures co-financed by the EGF.

The EU’s declining market share in global ship production and increased external

competition in the sector have had dire consequences on the ancillary shipbuilding industry in Galicia, according to the Commission’s proposal.

This is the first application to be examined under the 2020 EU budget and the seventh in the shipbuilding sector. The EGF aid will cover 60% of the total cost, which amounts to €3.4 million. The package aims to provide the former workers with career guidance, support in their job search, opportunities to learn new skills through vocational training, and tutoring and guidance after finding another job.

The report by rapporteur Valérie Hayer (RENEW, FR) recommending that Parliament approve the aid was passed by 645 votes to 33, with 9 abstentions (roll call vote results here).

Background

The European Globalisation Adjustment Fund was set up to help workers made redundant due to major changes in world trade patterns or as a result of unexpected financial and economic crises. Since its conception in 2007, the Fund has received 161 applications. Some €636 million has been requested to offer help to more than 151,000 workers and 4,429 young people who are not in employment, education or training.

Follow the Committee on Budgets on Twitter: @EP_Budgets

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October 20, 2020 Learning

IPforYou Malta: Intellectual Property and Illicit Trading seminar

Discover more about how intellectual property rights together with complementary actions in other areas can fight against and reduce the impact of illicit trade in fake goods.

The European Union Intellectual Property Office (EUIPO) and the Maltese Commerce Department of the Ministry for the Economy, Investment and Small Businesses are organising an online seminar as part of 2020 Malta SME Week. The seminar will look at various aspects of illicit trade in fake goods, the actions being taken to combat it and how businesses can protect their genuine products through trade mark and design registration

The seminar will be held on 27 October 2020 via ZOOM: Register here

Common Agricultural Policy up to 2027

MEPs will debate new rules governing the Common Agricultural Policy with Council and Commission, from 9.15 to 13.00. Direct payments to farmers and investment in rural development account for roughly a third of the EU budget. Reform efforts and incentives are needed for a more resilient and sustainable EU farm policy while ensuring fair market conditions for farmers, and affordable, healthy food for consumers. Details like labelling of vegetarian substitutes for meat might also be addressed.

You can follow the debate live on Parliament’s webstreaming and on EbS+

Ján JAKUBOV
(+32) 498 98 35 90
EP_Agriculture

Online plenary briefings by political groups

Leaders of political groups will hold briefings, starting at 10.30 (Greens/EFA), 12.00 (GUE/NGL) and 14.00 (S&D).

Parliament is using an interactive virtual press environment (with interpretation) based on Skype TX, in conjunction with the traditional EbS+ and Parliament’s webstreaming. To ask a question from a distance, use your Skype account to connect to VOXBOXEP and write your name and media organisation in the chat box.

In brief

Commission work programme 2021. MEPs will comment on the Commission’s work programme for 2021, to be presented by Commission Vice-President Maroš Šefčovič at 15.00.

Foreign Affairs recommendations. Parliament will discuss EU sanctions against the Belarussian authorities, responsible for violent repression of democratic protests. Furthermore, they will debate the upcoming review of the treaty on non-proliferation of nuclear weapons with HR/VP Josep Borrell.

Police violence in the EU. A debate with Council and Commission on police brutality in EU countries is scheduled at 17.00.

Votes

The first voting session starts at 09.15 and lasts until 10.30; results will be announced at 13.00.

MEPs will vote on amendments on

• Resolutions on the Digital Service Act (3) and on Artificial Intelligence (2)
• Recommendations on PESCO
• Implementation report on the EU-Moldova Association agreement
• Discharge 2018 reports on European Council and Council, and on the European Economic and Social Committee.

The second voting session lasts from 14.30 until 15.45, for the final vote on the two discharge reports 2018; results will be announced at 18.15.

The third voting session will last from 20.00 to 21.15, with final votes on legislative and non-legislative resolutions related to the Digital Service Act and Artificial Intelligence, and resolutions on EU-Moldova and PESCO. Furthermore, MEPs will vote on amendments to Parliament’s recommendations regarding Belarus, non-proliferation of nuclear weapons and on a first set of amendments to the Common Agricultural policy. The results will be announced at 23.00.

• European Investment Bank and Atriva Therapeutics sign financing agreement of €24 million for the research, development and clinical testing of the company’s lead product candidate against influenza and COVID-19
• Atriva’s ATR-002 molecule is the only host-cell targeting antiviral therapeutic specifically developed to treat severe respiratory infections caused by RNA (ribonucleic acid) viruses – it may prevent progression to critical-stage COVID-19 in hospitalised patients and holds strong potential in the current pandemic
• The EIB venture debt transaction is financed under the Infectious Diseases Finance Facility set up as part of Horizon 2020, the EU research and innovation programme for 2014-2020

The European Investment Bank (EIB) and Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, concluded a €24 million financing agreement today to facilitate the company’s development and clinical testing of a novel therapy treating severe respiratory infections with RNA viruses. RNA viruses cause diseases such as influenza, SARS and COVID-19. Atriva’s ATR-002, an oral small molecule, has been proven to block the viral propagation of SARS-CoV-2 in pre-clinical trials, making it a much-needed therapeutic option for patients with moderate to severe COVID-19 symptoms who require hospitalisation.

“While one needs to be careful when comparing COVID-19 to the flu, it might be helpful that both diseases have overlaps in their mechanisms of infection,” said Ambroise Fayolle, EIB Vice-President in charge of innovation and transactions in Germany. “If, as Atriva’s research indicates, one small molecule can work to treat both diseases, this would be excellent news not only for the millions of people who fall ill from the flu every year but also for the many more who are affected by the coronavirus lately. An effective treatment would also lift a huge burden from our health systems and help mitigate the impact these diseases have on our daily lives and the economy. This is a case where EIB financing can contribute to addressing an extremely high unmet medical need, which is something I am proud of.”

Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said: “The European Union is doing all in its power to protect Europeans against coronavirus. The European Commission is coordinating the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery. With this loan to Atriva, the EU continues its support for the development of innovative Covid-19 treatments. Their therapy can add to the range of complementary solutions that we need to tackle this disease.”

Dr Rainer Lichtenberger, co-founder and CEO of Atriva, said: “The EIB clearly understands the need for an effective antiviral therapy against influenza and COVID-19 and the potential such a treatment holds to help patients around the world. We are grateful for the EIB’s support in advancing the clinical development of ATR-002 as an innovative host-targeting therapy against these prevalent and potentially devastating diseases. With the funding from the EIB, we can now take the next development steps –starting a Phase II study in patients with moderate to severe COVID-19 infections, followed by further clinical development work in influenza.” He continued: “When the coronavirus pandemic hit us all earlier this year, we saw that Atriva’s technology had the potential to play an important role in the fight against COVID-19, and we are excited to move forward in this work now. Our ultimate goal, though, is to develop a broad-spectrum antiviral drug that will also be effective against future viral outbreaks.”

ATR-002 has been developed specifically to treat respiratory viral infections by inhibiting MEK, a host cell factor required for the replication of various RNA viruses, including the influenza virus and SARS-CoV-2. Atriva’s pre-clinical studies, performed at the Universities of Tübingen and Münster, have demonstrated that MEK inhibition by ATR-002 also prevents SARS-CoV-2 replication.

In addition to its antiviral efficacy, ATR-002 shows a second beneficial effect: the MEK-inhibitor was able to significantly decrease pro-inflammatory cytokine and chemokine expression in cells. Cytokines and chemokines are proteins that coordinate the immune response throughout the body. In patients with COVID-19, ATR-002 could prevent a cytokine storm and the associated disease progression to a life-threatening condition.

This dual benefit, antiviral activity and immunomodulation, positions ATR-002 as a promising therapeutic candidate. Atriva has filed the respective patents with the European Patent Office. In addition, ATR-002 successfully completed a Phase I clinical trial in 2019 where it demonstrated excellent safety and tolerability in healthy volunteers.

Atriva will receive the EIB loan in three tranches upon the completion of pre-defined milestones. The funds will support the company’s R&D for ATR-002, including clinical trial expenses, the technical transfer and manufacturing ramp-up needed to reach a commercial scale, as well as regulatory, intellectual property, pharmacovigilance and market access activities. Atriva will now start a multinational, double-blind, randomised clinical Phase II study in hospitalised patients with moderate to severe COVID-19 infections.

The loan is backed by the Infectious Diseases Finance Facility (IDFF) set up as part of the EU’s Horizon 2020 programme. The IDFF is an example of successful collaboration between the European Commission and the EIB in the face of a health crisis. Through this facility, the EIB has supported European companies with total lending of around €400 million for developing cures, vaccines and diagnostics for various infectious diseases, most prominently the coronavirus.

Background information

The InnovFin Infectious Diseases Finance Facility (IDFF) is dedicated to supporting the fight against infectious diseases. This joint European Commission and EIB Group initiative is part of Horizon 2020, the 2014-2020 EU research and innovation programme. The IDFF enables the EIB to provide between €7.5m and €75m of funding to innovative players active in developing vaccines, drugs, medical and diagnostic devices and research infrastructure for combating infectious diseases. The financing mainly goes to projects that have completed the pre-clinical stage and need clinical approval for further development. The IDFF has been increased by €400 million to boost its capacity for tackling the outbreak of the coronavirus. The total EU contribution to the IDFF via Horizon 2020 is estimated at almost €700 million.

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company specifically pioneering the development of host-targeting antiviral therapies set up by a team of leading scientists in viral research and seasoned industry experts. The company aims to develop new antiviral therapies against different severe respiratory viral infections with a high unmet medical need, such as influenza and COVID-19. Atriva’s lead product ATR-002 is a first-in-class host-targeting agent, which inhibits viral replication in influenza and favourably modulates the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects (NCT04385420). The Company has initiated a Phase II study to evaluate efficacy in hospitalised COVID-19 patients while a Phase II study in influenza is planned to start in early 2021. Atriva Therapeutics is located in Tübingen and Frankfurt, Germany.