Rovi wins FDA nod to make Moderna's COVID vaccine at Spanish plant

As part of a long-term partnership between Spain’s Laboratorios Farmacéuticos Rovi and Moderna, the former company is bringing a new plant into the mix for production of COVID-19 vaccines bound for the U.S. market.

During an inspection in January, FDA staffers were satisfied with Rovi’s active substance manufacturing plant in Granada, Spain, effectively allowing Spikevax doses made at the facility to be sold in the U.S., Rovi CEO Juan López-Belmonte said on a Tuesday call with investors.

The FDA’s clearance of Rovi’s drug substance plant comes after the agency in September approved the company’s three injectable plants in or near Madrid to perform fill-finish syringe manufacturing of Spikevax, according to the CEO.

The manufacturing relationship between Rovi and Moderna is built on a 10-year partnership the two firms formed in 2022. At that time, Moderna promised to invest in Rovi’s Madrid facility to boost capacity there.

Last year, Rovi's CDMO business grew revenue 1% to 409 million euros, while the entire company’s revenue also increased by 1% to about 830 million euros.

Rovi’s CDMO services unit could grow further in the years ahead thanks to Novo Nordisk’s proposed acquisition of the CDMO giant Catalent, López-Belmonte said. Calling the deal a “tremendous opportunity,” the Rovi CEO noted that a significant player in the injectable CDMO business is likely going to be exiting the game.

Considering the timeline of contract manufacturing agreements, López-Belmonte said Rovi isn’t sure whether it’ll attract new customers this year because of the Catalent buyout. But the company does anticipate additional customers and volumes over the next few years, he said.

On the specialty medicines side of Rovi’s business, the company is hoping to turn a page on some manufacturing shortfalls and win a much-delayed FDA nod for Risvan, an intramuscular formulation of Johnson & Johnson’s antipsychotic drug Risperdal.

Rovi got its first complete response letter from the FDA, citing shortfalls in the application package, in September 2021. Then about a year later, the FDA issued a second rejection, and this time, manufacturing was cited as an additional problem. Back then, the agency flagged issues at a third-party supplier and highlighted observations noted during a pre-approval inspection of Rovi’s Madrid plant.

In July 2023, the FDA sent out another complete response letter, citing the pending resolution of manufacturing deficiencies. Rovi responded to four observations in September, and the FDA has set a new target decision date of March 29.

The company is currently looking for a commercialization partner for Risvan in the U.S.

Without a contribution from the U.S., the drug, known as Okedi in Europe, generated 14.4 million euros in sales in its second year on the European market, compared with 2.2 million euros in 2022. López-Belmonte described Okedi’s launch as above the company’s expectations, noting that the company has rolled out a salesforce across Europe.

The CEO expects the current monthly injection to reach its level of peak sales in the next three to four years. By that time, the company hopes to have developed an even longer-acting version that can be given once every three months.

Risvan/Okedi is the first product based on Rovi’s long-acting drug delivery technology, called ISM. The company is trying to apply the technology to developing an extended-release version of Novartis’ popular aromatase inhibitor Femara, although clinical development of an annual dosing regimen is currently on hold; a three-monthly formulation is moving into phase 1.

Besides Okedi, the heart medicine Neparvis and the cholesterol-lowing combo Orvatez each helped Rovi’s specialty pharma business, posting gains of 16% and 8% respectively in 2023.

For 2024, Rovi expects revenues to decline by mid-single-digit percentages. But the company also hopes factors such as a possible FDA approval of Risvan, higher demand for COVID vaccines and CDMO services growth will lift its performance.