STAT+: Pharmalittle: We’re reading about a troubled Novo plant, pressure on the Novavax board, and much more

Top of the morning to you. Gray skies are hovering overhead right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are hunting for cups of stimulation as we approach the corporate nerve center. Yes, we are off the Pharmalot campus today as we gear up for a few days of serious and interesting chatter. Meanwhile, here are a few items of interest to help you on your own journey. We hope you have a smashing day and, of course, do stay in touch. …

A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the U.S. Food and Drug Administration standards, a serious designation that could further delay the approval of drugs made in the facility, including some from Scholar Rock and Regeneron Pharmaceuticals, STAT tells us. The FDA inspection of the plant over the summer found a litany of issues, some related to cat hair, pests, and equipment failures. Last week, the agency told Novo that the plant is classified as “official action required,” a regulatory term meaning the site is in an unacceptable state of compliance. The plant was previously owned by Catalent, which was one of the largest contract manufacturers serving the pharmaceutical industry. Novo acquired the Indiana plant, along with two other facilities, as part of its parent company’s acquisition of Catalent last year. The Indiana plant has had a history of issues going back several years that are now causing major challenges for biotechs that rely on the facility for approval. 

Shah Capital has urged the Novavax board to pursue a sale of the company, citing a third consecutive year of poor roll-out of its Covid-19 shot, Reuters reports. In its letter, he company’s second largest shareholder recommended that Novavax capabilities will “have far greater potential in the hands of a large capable pharma entity.” Shah Capital owns a 7.2% stake in Novavax. Himanshu Shah, founder and chief investment officer of the fund, maintained that Novavax could get a valuation of “at least $5 billion” based on the commercial potential of its vaccines. He also believes that the “political picture” and scientific evidence were in Novavax’s favor. Novavax has a market valuation of about $1.35 billion, as per LSEG data. The fund’s latest move is its second attempt to push for change at the company. Last year, Shah Capital had withdrawn its campaign against the re-election of three directors on Novavax’s board, after the company struck a licensing deal with Sanofi. A series of critical marketing missteps have led to Nuvaxovid, a protein-based Covid-19 shot, taking only 2% of market share last season, Shah wrote in his letter.