Laboratorios Farmaceuticos Rovi S A : ROVI informs on the evolution of the investigation of particulate matter having been seen in certain drug product vials of the Moderna COVID-19 vaccine distributed in Japan
August 29, 2021 at 05:02 pm EDT
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TO THE NATIONAL SECURITIES MARKET COMMISSION
Madrid, 29 August 2021
OTHER RELEVANT INFORMATION
Following the public relevant information published on 26 of August 2021 with registered number 11377, Laboratorios Farmacéuticos ROVI, S.A. (ROVI), in compliance with the information duties set out in article 227 of the Revised Text of the Securities Market Act, as an entity participating in the manufacturing process of Moderna's vaccine against Covid-19, and in relation to the notification of particulate matter having been seen in certain drug product vials of the vaccine distributed in Japan, informs that the investigation on this event continues to be conducted to determine what happened in the drug product fill/finish manufacturing process of the related batch.
As reported publicly by the laboratory owning the vaccine, Moderna, and the company in charge of distributing the vaccine in Japan, Takeda, unfortunately, the death of two individuals who had received the Moderna covid-19 vaccine have been reported. There is no evidence up-to-date that these deaths are caused by the Moderna covid-19 vaccine. In any event, there is a formal investigation underway to determine whether there is any connection.
As recently reported, the detection of this particulate matter in certain drug product vials is an event that is in the process of being investigated by ROVI in coordination with Moderna, Takeda and the health authorities. ROVI will continue to proactively assist in the investigation of this matter, waiting for its finalisation and the publishing of the relevant conclusions by Moderna and Takeda, of which ROVI will inform in due course.
Laboratorios Farmacéuticos ROVI SA published this content on 29 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 August 2021 21:01:04 UTC.
Laboratorios Farmaceuticos Rovi, S.A. specializes in the research, development, manufacturing and marketing of biological medications and specialty drugs. Net sales break down by family of products as follows:
- pharmaceutical products manufactured under contract (49%);
- prescription pharmaceuticals (45%): intended for preventing and treating venous thrombo-embolic disease, post-menopausal osteoporosis, muscle pain, tooth and mouth infections, angina, osteoarthritis, etc.;
- diagnostic products (6%): contrast products used in medical imaging with magnetic resonance, ultrasound, or X-rays. The group also offers hospital products and non-prescription pharmaceuticals.
Net sales break down by source of revenue between sales of products (50.6%), sales of services (49.3%) and sales of licenses (0.1%).
Net sales are distributed geographically as follows: Spain (33%), European Union (17.3%), OECD countries (45.9%) and other (3.8%).
Laboratorios Farmaceuticos Rovi S A : ROVI informs on the evolution of the investigation of particulate matter having been seen in certain drug product vials of the Moderna COVID-19 vaccine distributed in Japan
LABORATORIOS FARMACEUTICOS ROVI, S.A. 
