• Agreement to manufacture pre-filled syringes for a global pharmaceutical company
• Production will take place on one state-of-the-art high-speed filling line at ROVI’s subsidiary’s (ROIS) facility in Madrid

Madrid, Spain - 25 April 2024 – Laboratorios Farmacéuticos Rovi, S.A. (hereinafter, “ROVI”), a pan-European pharmaceutical company that specialises and engages in the research, development, contract manufacturing and licensing of small molecules and biological medicines, has announced today that its subsidiary ROVI Pharma Industrial Services, S.A.U. (hereinafter “ROIS”) has entered into an agreement to support the manufacture of pre-filled syringes for a global pharmaceutical company.

Under the terms of the agreement, ROIS will provide a high-speed production line at the ROIS’ San Sebastián de los Reyes facility in Madrid, with an estimated annual capacity of 100 million units. The agreement includes the technology transfer for aseptic filling and has a commercial production term of five years subject to the terms of the agreement, beginning on the date of manufacture of the first commercial lot. After the technology transfer and regulatory approval, commercial production is expected to commence in 2026. As from 2027, which is expected to be the first full recurrent manufacturing year, the ROVI´s Group CDMO division expects to have a positive revenues increase impact ranging between 20% and 45% over 2023 sales.

ROIS is well-equipped to support the production of pre-filled syringes given its deep expertise in the current good manufacturing practice (cGMP) production of sterile injectable products across both vials and pre-filled syringes.

Juan López-Belmonte Encina, Chairman and Chief Executive Officer of ROVI, said: “We are delighted to be able to support in the manufacture of medicine that is able to prolong the life of millions of people. Our proven experience in the manufacture of high-valued-added injectables and the expansion of our production capacities have positioned us to help meet the rapidly growing demand, which requires a high degree of technological capability.”

About ROVI

ROVI is a pan-European pharmaceutical company that specialises and engages in the research, development, contract manufacturing and licensing of small molecules and biological specialties. The company, in a continuous expansion process, has subsidiaries in Portugal, Germany, the United Kingdom, Italy, France and Poland and has a diversified marketing portfolio of over 40 products, among which its flagship product, Bemiparin, now present in more than 60 countries all over the world, should be highlighted. Likewise, ROVI markets its enoxaparin biosimilar, developed in-house, in Europe and this product is already present in 40 countries. ROVI is continuing to develop the ISM® technology platform, a leading-edge line of research in the field of prolonged drug release, with proven advantages.

ROVI Pharma Industrial Services, S.A.U. (“ROIS”) is ROVI’s wholly owned CDMO platform (contract development and manufacturing organization). ROIS offers high-quality, sterile fill & finish services for pre-filled syringes & vials. With its readily available, flexible capacity, ROIS can effectively address structural market under-capacity in mRNA vaccines, biosimilars and complex injectable products in multiple dose forms (vials, pre-filled syringes, cartridges).

For more information, please visit www.rovi.es.