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Valneva: The green light for a vaccine in Europe is becoming clearer – 05/19/2022 at 15:14

(AOF) – Finally, good news for Valneva, which has subsequently jumped more than 10% to €11.07. After months of stalling, the European Medicines Agency (EMA) has agreed to file a marketing authorization file for the biotech inactivated full virus vaccine candidate against Covid-19, VLA2001.

Acceptance of the file means that VLA2001 leaves the progressive data review process to enter the formal evaluation process by the EMA Committee for Medicinal Products for Human Use (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization request, the company confirms that it can obtain a favorable opinion from the CHMP in June 2022.

“In a favorable scenario where the CHMP will issue a positive opinion, the European Commission will examine the recommendation and make a final decision on the Millennium Ecosystem Assessment provided that that opinion arrives before 12 June in accordance with the activated clause in the contract. Remedial plan It is also possible for Valneva during this period itself, with the aim of agreeing to a “compromise” and possibly contracting directly with some member states that would require them to receive doses of the vaccine,” asserts Invest Securities.

Thomas Lingelbach, CEO of Valneva, commented: “EMA’s acceptance of the VLA2001 registration file submission is an important step towards obtaining a marketing authorization for the product. We remain fully committed and work alongside the regulatory authorities, EU Member States and the European Commission to make more technologies available. Conventional and Proven COVID-19 Vaccination for Europeans”.

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the main points

– Specializes in developing preventive vaccines against infectious diseases with limited treatment options;

– The turnover of 348 million euros derives from Europe with 56%, ahead of the Americas (27%), then Asia – Oceania (9%), Africa and the Middle East (8%);

– Business model: portfolio of diversified vaccines for the general public, funding of clinical developments through specialized infrastructure, two commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights to third parties;

– the capital owned by 13.02% of the Grimaud la Corbière Group and 8.19% of BPI France, Frédéric Grimaud chairs the 5-member supervisory board, and Thamas Lingelbach the board of directors;

Strong balance sheet of €307 million in equity against €42 million in debt, boosted by net cash of nearly €350 million in April 2022.

Challenges

– a medium-term strategy based on financing research and development through the sale of the Ixiaro and Dukoral vaccines, expansion of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships that strengthen the group’s assets;

– An innovation strategy rooted in the business model, rich with a portfolio of 398 patents and backed by 173 million euros in research and development costs, with 3 main assets and 3 pre-clinical programmes: the only vaccine in clinical development against Lyme, the only vaccine to be obtained from single dose against chikungunya, the only inactivated and adjuvant full virus COVID-19 vaccine, candidate vaccine against human metabinomerovirus, parvovirus and norovirus;

– Environmental strategy: energy efficiency, waste reduction, optimal use of water and a reduction of carbon dioxide emissions by 5%, compared to 2016, by 2025;

Good visibility of activity thanks to vaccine agreements with: the British government (orders for 100 million doses of Covid-19 vaccines and options for 190 million by 2025, 1.4 billion euros in total), with Pfizer to co-develop and sell one against Lyme disease ( $308 million), with US authorities for Ixiario against Japanese encephalitis ($70 million), with Bavaria Nordic to market and distribute specialized vaccines, with Batavia Biosciences to develop an inexpensive polio vaccine, with the Putantan Institute against Chikungunya in low-income countries.

Challenges

– In 2022, the launch of Phase III trials of a vaccine against Lyme disease and pending approval by the US authority to sell a vaccine against chikungunya and the European Union for Covid 19 (60 million doses);

Travel allergy from sales of vaccines already on the market (against Japanese encephalitis and cholera);

– Uncertainty about the commercial success of the vaccine against Covid 19 in the UK, given the already strong competition;

– 2022 targets: excluding the Covid vaccine, sales volumes between 430 and 590 million euros and research and development expenditures between 65 and 75 million euros.

Oncology supports laboratory performance

Oncology generated $163 billion in revenue in 2021 (out of an industry total of $613 billion), an increase of 11.9%, according to GlobalData. Its average annual growth has been 15.4% over the past 20 years. This increasingly competitive segment is dominated by a few heavyweight companies such as MSD (Merck & Co. Inc.), Roche and BMS.

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Immuno-oncology, a specialty that has led this market for ten years, supports research. GlobalData estimates that this sector could reach 180 billion in 2026. The major players are looking to strengthen themselves in this field. Pfizer recently acquired Canadian biotech Trillium Therapeutics for $2.3 billion. After this operation, the American group obtained two promising molecules in the treatment of leukemia.

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