Moderna, Inc. MRNA announced a manufacturing agreement with pan-European pharmaceutical company, Laboratorios Farmacéuticos Rovi, S.A. (Rovi) for manufacturing of Moderna’s COVID-19 vaccine candidate for markets outside the United States.
The companies have collaborated for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Rovi’s facility in Madrid, Spain, following a potential approval.
Per the agreement, Rovi will provide additional staffing required for the ongoing manufacturing operations at the site in order to support the production of hundreds of millions of doses of the candidate. These vaccine doses are expected to be available in ex-US markets in early 2021.
Moderna has signed a similar agreement with Catalent CTLT for large-scale, commercial fill-finish manufacturing of mRNA-1273 for the United States. Catalent will also be responsible for providing clinical supply services including support for Moderna’s phase III study for this candidate.
Earlier this week, Moderna stated that it is on track to deliver 500 million doses of 100 μg dosage of mRNA-1273 per year, which can possibly increase up to 1 billion doses per year, beginning 2021.
Moderna’s shares have rallied 232.2% in the year so far compared with the industry’s growth of 12.3%.
The company has completed enrollment in the phase II study evaluating mRNA-1273. The company has finalized protocol for the phase III design to evaluate mRNA-1273 based on the FDA’s feedback. The late-stage study will evaluate 100 μg dose of the vaccine candidate in approximately 30,000 participants. The company will conduct the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of NIH. Although the company anticipates to begin the study by the end of July, it is still subject to regulatory approval.
However, we note that competition in the COVID-19 vaccine field is increasing as several big pharma companies have joined the race. These include AstraZeneca AZN in collaboration with Oxford University, Pfizer PFE and German-partner BioNTech, J&J, and Sanofi in collaboration with Glaxo. With huge funds available, these big companies are unlikely to face any hiccups related to continuation of clinical studies or manufacturing capacities. Meanwhile, smaller biotechs like Moderna are generally dependent on funding arrangements from other big pharma companies, or government or private organizations.
Moderna’s share price has almost flat-lined since May-end and is yet to break the high of $87.00 set during mid-May. We note that encouraging phase II study data and preliminary data from the phase III study may boost the company’s shares going forward.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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