Policy & Regulation
Moderna, ROVI Team On OUS Fill-Finish Manufacturing of Moderna's COVID-19 Vaccine Candidate
9 July 2020 - - US-based clinical stage biotechnology company Moderna, Inc. (NASDAQ: MRNA) and pan-European pharmaceutical company Laboratorios Farmacéuticos Rovi, S.A. (BME: ROVI), have forged a collaboration for large-scale, commercial fill-finish manufacturing of Moderna's mRNA vaccine candidate against COVID-19 (mRNA-1273) at ROVI's facility in Madrid, Spain.

As part of the agreement, ROVI will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate intended in principle to supply markets outside of the US starting in early 2021.

ROVI will also hire additional staffing required to support manufacturing operations and production.

mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.

On July 8, the company's Phase 2 study of mRNA-1273 completed enrollment. Moderna's Phase 3 study of approximately 30,000 participants, is expected to begin in July 2020.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients and to protect populations from vaccines preventable diseases.

mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programmes with AstraZeneca PLC and Merck and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services.

ROVI is a pan-European pharmaceutical company specialising and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties.
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