To continue today … Valeniva – 08/02/2022 at 08:11

(AOF) – Valneva, the vaccine specialist, confirms the signing of the Advance Purchase Agreement Amendment with the European Commission, the company announced on July 20, 20222, the period during which member states can exercise their right to expiry of withdrawal. Under this amendment, purchases of VLA2001, Valneva’s inactivated complete virus vaccine against Covid-19, by Member States consist of 1.25 million doses of VLA2001 in 2022, with an option to purchase a similar amount later this year for delivery in 2022.

The company plans to deliver the first doses of the vaccine to participating member states (Germany, Austria, Denmark, Finland and Bulgaria) in the coming weeks.

VLA2001 is the only inactivated and adjuvant Covid-19 vaccine to have received Marketing Authorization (MA) in Europe for use in primary vaccination in adults aged 18 to 50 years. VLA2001 was developed on Valneva’s cell-based Vero platform and makes use of Valneva’s JE vaccine production technology, Ixiaro®.

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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 of debt, boosted by net cash of nearly €350 million in April 2022.

Challenges

– a medium-term strategy based on research and development funding through the sale of 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 shot against chikungunya, the only inactivated and adjuvant vaccine against the full virus COVID-19, the candidate vaccine against human metapinomaviruses, parvovirus and norovirus;

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

– Good visibility of activity thanks to vaccine-specific agreements with: the British government (orders for 100 million doses of Covid-19 vaccines and options of 190 million by 2025, i.e. €1.4 billion 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 for marketing and distribution of 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 3 trials of a vaccine against Lyme disease and pending approval by the US authority to sell a vaccine against chikungunya and those of 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 a vaccine against Covid 19 in the UK, given the already strong competition;

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

The inevitable race for new movies

The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite losing patents since 2019 for its three-star products (Avastin, Herceptine, Rituxan) Roche has been able to replenish its portfolio By bringing new molecules to the market. However, discovering and releasing new drugs is increasingly expensive. AstraZeneca spends about $6 billion annually on research and development in the pharmaceutical industry where the patent life is only ten to fifteen years. This leads the laboratories to withdraw from certain activities. Thus, J&J, Pfizer, GSK and no doubt Novartis would soon prefer to refocus on specialty drugs and forgo any additional business.

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