With the U.S. FDA’s approval of Seres Therapeutics Inc.’s BLA for the oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI), attention turned to the label, supply chain and other matters. During a conference call, officials answered questions from Wall Street regarding the launch of the product, broadly labeled for rCDI patients. Vowst will be made available in June. Shares of Seres (NASDAQ:MCRB) were trading midday at $6.04, down 36 cents.
Mounjaro surmounts obesity in phase III; Lilly seeks priority review
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds over 72 weeks, with the vast majority achieving at least a 5% decrease in overall body weight, significantly more than those receiving placebo. The results will help the company complete its rolling NDA targeting obese and overweight adults with weight-related co-morbidities. With use of a priority review voucher, Lilly expects action by the U.S. FDA as early as the fourth quarter of 2023. If approved, it would put the company’s drug toe-to-toe with Wegovy (semaglutide), Novo Nordisk A/S’ GLP-1 receptor agonist approved for weight loss in 2021. Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and a GLP-1 receptor agonist. Lilly gained approval of it in May 2022 as an adjunct treatment to diet and exercise to improve glycemic control in those with type 2 diabetes.
Pharmaessentia raises $462M in GDR offering to expand global footprint
Pharmaessentia Corp. raised $462.7 million in a global depositary receipt (GDR) offering on the Luxembourg Stock Exchange that marks the largest global health care GDR offering so far this year. The capital raise “reflects confidence in the market opportunity for our approved product and the potential of our pipeline,” said Pharmaessentia founder and CEO Ko-Chung Lin. Demand for Pharmaessentia’s GDR offering was three times greater than the number of shares offered, and the oversubscribed offering will fuel the company’s commercial growth strategy over the next few years.
Adcom will hear FDA’s issues with Lynparza to treat prostate cancer
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s sNDA for Lynparza (olaparib) for treating prostate cancer. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations. The sNDA asks for Lynparza to be combined with abiraterone and prednisone or prednisone for treating adults with metastatic castration-resistant prostate cancer, including patients with and without tumor BRCA mutations. After hearing from the FDA and the developers, the committee will pass its thoughts along to the agency.
Lawmakers huddling over plays to lower health care costs
The legislative pile-on continues as the U.S. Congress considers more ways to tackle health care costs while defending innovation. What’s different this time around is that lawmakers have broadened their focus beyond prescription drug manufacturers. But that’s not to say the biopharma industry is in a safe zone. Yesterday, a House subcommittee considered 17 draft discussion bills offered as solutions to lower costs by increasing transparency and competition throughout the health care playing field. Meanwhile, several Senate committees are working on separate drug pricing bills that likely will later be bundled together to be presented to the full Senate as a comprehensive package.
The BioWorld Insider Podcast: Better times ahead for the biopharma sector? Could be, the new numbers say
It used to be a lot easier to find partners. After two years of strong dealmaking, the volume and value of partnerships slid in the first quarter of 2023. M&As also are down compared to prior years. But there are some reasons to be cheerful. Looking at first quarter numbers and surveying the big picture on this BioWorld Insider podcast are Karen Carey, BioWorld’s managing editor and senior data analyst, along with Tim Shannon, a general partner at Canaan. Carey just wrote about biopharma deals and completed M&As in the first quarter. Shannon, who’s been with Canaan since 2009, has a new fund sporting $850 million in new capital, including an oversubscribed $650 million fund for seed and series A financings. They both offer their insights into the first quarter’s numbers and what may lie ahead.