Laboratorios Farmaceúticos Rovi SA

Lonza's move comes amid several seismic shifts in the CDMO market. In a bid to corner contracts on next-generation medicines, production juggernaut Lonza is picking up one of the world’s biggest biologics manufacturing facilities from its Swiss compatriot Roche. Lonza is laying out $1.2 billion in cash to acquire Genentech’s factory in Vacaville, California, where it already has plans to plug in another 500 million Swiss francs ($561 million) to expand the plant in the coming years, the CDMO said Wednesday. The deal will help Lonza bulk up large-scale biologics manufacturing capacity for both commercial-scale mammalian contract manufacturing and clinical-stage projects, the company explained in a press release. The Vacaville facility boasts bioreactor capacity of around 330,000 liters, making it one of the world’s biggest biologics manufacturing sites by volume, Lonza said. As part of the acquisition, Lonza will extend job offers to around 750 Genentech staffers currently employed at Vacaville. Lonza is already looking to the plant’s future, too. The company plans an expansion project worth around 500 million francs to help “satisfy demand for the next generation of mammalian biologics therapies.” The CDMO will take over the supply of the products currently manufactured in Vacaville by Roche. Lonza will provide committed volumes over the medium term before phasing out the Roche products as the site transitions to serve the CDMO’s customers. Lonza and Roche expect the deal for the facility to close in the second half of 2024. Once the acquisition is complete, the Vacaville site will join Lonza’s Biologics division, which operates manufacturing facilities in Switzerland, Singapore, Spain, the United States and the United Kingdom. Lonza has high hopes for the new facility and is upgrading its mid-term guidance from 2024 through 2028 in turn. The manufacturer now expects sales to grow 12% to 15% over the four-year stretch, up from a previous window of 11% to 13%.  Lonza is beefing up its manufacturing capacity as the global CDMO landscape faces seismic changes. Novo Holdings’ proposed $16.5 billion acquisition of Catalent—and the related $11 billion sale of three manufacturing sites to Novo Nordisk—is set to take some major contract manufacturing space off the open market. Eli Lilly CEO David Ricks has questioned the implications of the merger on his company’s relationship with Catalent given Lilly’s competition with Novo in diabetes and obesity treatments. Other companies are trying to seize the opportunity to expand their own CDMO offerings. Juan López-Belmonte, CEO of Laboratorios Farmacéuticos Rovi, recently described the Novo-Catalent deal a “tremendous opportunity” for the Spanish company to win over injectable CDMO business in the years ahead. Meanwhile, several U.S. lawmakers are advancing a draft bill targeting several Chinese biotech companies, including the CRO and CDMO giants WuXi AppTec and WuXi Biologics. The bill would forbid “foreign adversary biotech companies of U.S. national security concern” from getting federal contracts or working with companies that seek such contracts. If enacted, companies that develop drugs offered under the federal Medicare and Medicaid programs would have to choose other contractors. The two WuXi firms have become major contract manufacturers and R&D partners for many biopharma companies large and small, including Lilly for its Zepbound and Mounjaro. Last year, WuXi AppTec generated 65% of its revenue from its customers in the U.S. The potential void created by WuXi’s woes and the Novo-Catalent buyout could represent about 20% of global CDMO market share, analysts at Intron Health wrote in a note Tuesday. The team suggests the majority of the open share will be redistributed to other Western CDMOs, and Lonza, as an established CDMO player, is “well placed to benefit," the Intron team said.

The COVID vaccine manufacturing relationship between Rovi and Moderna is built on a 10-year partnership formed in 2022. 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.

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five , the company is also looking to make a serious investment in the UK. According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines. Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19. For the manufacturing of the vaccines, the company will open a large-scale mRNA manufacturing center which will manufacture their Covid-19 vaccine and other vaccines for flu and RSV. Construction is expected to start as early as this year, with the first vaccines due to be produced in 2025. While there is no confirmation on the size, cost or even the location of the new facility, and inquiries from Endpoints News to Moderna have not been answered, the Financial Times said the facility could be located anywhere between London, Oxford and Cambridge, dubbed the “Golden Triangle.” The FT said the site will manufacture up to 250 million doses per year, including some for export, and the deal, which will last 10 years, will be finalized this summer and be worth 1 billion pounds ($1.2 billion). “We are committed to global public health, and as we continue to expand internationally, we are pleased to bring local mRNA manufacturing to the UK. We look forward to establishing our research and development activities and capabilities in the country,” said Moderna CEO Stéphane Bancel. The UK has been anxious to seek support from the big pharma players as it looks to carve out a special place for the Golden Triangle. R&D also runs deep in the UK as it does offer some key attractions to drug and vaccine developers, as well as a large and notable scientific community. However, the UK is not the only country that Moderna is looking to set up shop for vaccine manufacturing. The company is investing 530 million euros ($560 million) in Spain through its manufacturing partnership with ROVI and is establishing manufacturing capabilities in Australia and Canada.