BioPharm Biz News Top Stories, Week of September 9/11/23-9/15/23
What were the big stories in the biopharma business last week? Here’s a look.
Sandoz is Finally Spinning Off from Novartis!!!
Novartis has been dithering for years over whether to spin off its generics and biosimilars business, Sandoz. And finally, on September 15, 2023, Novartis shareholders approved the proposed 100% spin-off. Along with it, the shareholders approved an ordinary capital decrease off the share capital of Novartis equivalent to the amount of the share capital of Sandoz, which only makes sense. Novartis shareholders and Novartis ADR holders will receive one Sandoz share for every five Novartis shares; and one Sandoz ADR for every five Novartis ADRs.
Joerg Reinhardt, Chair of Novartis, stated, “We welcome today’s decision by our shareholders to approve the Spin-off of our Generics and Biosimilars business, Sandoz, to create an independent company listed on the SIX Swiss Exchange.”
The spin-off should occur around October 4, 2023.
BMS Had a Busy Week
Bristol Myers Squibb (Princeton, NJ) announced results from its Phase II trial of BMS-986278 in progressive pulmonary fibrosis (PPF). The drug is a potential first-in-class, oral, lysophosphatidic acid receptor 1 antagonist. The trial demonstrated that twice-daily doses of the drug over 26 weeks decreased the rate of decline in predicted forced vital capacity by 69% compared to placebo.
The company also reported at its R&D Day that it would be cutting two mid-stage and four early-stage clinical programs. The two Phase II programs were a targeting heat shock protein 47 (HSP47) and a small interfering RNA (siRNA) for NASH. The early-stage programs included a CD47xCD20 bispecific program, a molecular glue for AML, a RIPK1 inhibitor and an anti-TIGIT lung cancer program.
Moderna Dropped 4 Clinical Development Programs
Moderna indicated it was culling four clinical development programs, including two that had previously been slashed by AstraZeneca. The two former AstraZeneca-partnered programs were VEGF-A (AZD8601) and IL-12 (MEDI1191). AZD8601 is an mRNA therapeutic being developed to treat patients undergoing elective coronary artery bypass surgery. MEDI1191 is a lipid nanoparticle candidate designed to drive local IL-12 production that was being evaluated with a PD-L1 checkpoint inhibitor, durvalumab, for advanced solid tumors.
Moderna also dropped its first-generation COVID-19 and flu combo vaccine (mRNA-1073). It was also getting rid of mRNA-1653, a vaccine candidate for pediatric human metapneumovirus and parainfluenza type 3 virus.
On a positive note, Moderna noted that its mRNA-based flu vaccine, mRNA-1010, hit all the co-primary endpoints across all four flu A and B strains per an interim analysis of a Phase III trial.