Global Pharma Briefs: News from Sanofi, BMS, Merck KGaA, Novo NordiskBy
A roundup of news from China (BeiGene), Denmark (Novo Nordisk), France (Sanofi), Germany (BMS, Evotec, Merck KGaA), and the US (Moderna).
BeiGene Gets OK for Commercial Supply Mfg at Biologics Facility
BeiGene, a Beijing-based pharmaceutical company, has received approval from the China National Medical Products Administration (NMPA) to begin manufacturing commercial supply of tislelizumab, its anti-PD-1 antibody for treating certain cancers, at its biologics facility in Guangzhou, China.
At over one million square feet and 8,000 liters of biologics capacity approved for commercial supply, this wholly owned facility will immediately begin production of commercial supply of tislelizumab for the China market.
An additional phase of construction is currently in progress to bring total capacity to 64,000 liters, which is expected to be completed by the end of 2022.
Novo Holdings Invests $8 M in Biologics Start-Up
Novo Seeds, the early-stage investment and company creation team of Novo Holdings, a wholly owned holding company for Novo Nordisk A/S and Novozymes, is leading an EUR 7-million ($8-million) seed investment into Bactolife, a Danish start-up developing biological solutions to reduce the risk of gastrointestinal infections in animals and humans.
Founded in 2017, Bactolife has developed a technology based on nanobodies for the management of bacterial virulence without the use of antibiotics. Its proprietary platform consists of technology for selecting and producing virulence inactivating proteins (VIPs), without targeting growth or killing the bacteria directly. VIPs are stable and can be produced in large-scale using systems for biomanufacturing.
Novo Holdings now has nine bioindustrials venture-backed companies, totaling over $130 million, in its portfolio besides the large holdings in bioindustrial companies, Novozymes and Chr. Hansen. The investment in Bactolife marks Novo Holdings’ third investment within bioindustrials in 2021.
Source: Novo Holdings
Sanofi Completes $358-M Acquisition of Kiadis
Sanofi has completed its $358-million acquisition of Kiadis Pharma, an Amsterdam-based clinical-stage company developing therapeutics based on natural killer (NK) cells.
Kiadis’ proprietary platform is based on allogeneic or “off-the-shelf” NK cells from a healthy donor. NK cells seek and identify malignant cancer cells and have broad application across various tumor types. The platform has the potential to make products across a range of liquid and solid tumors and create synergies with Sanofi’s immuno-oncology pipeline.
Kiadis’ NK cell-based medicines will be developed alone and in combination with Sanofi’s existing pipeline and platforms.
Evotec, BMS Launch $20-M Innovation Pact
Bristol-Myers Squibb (BMS) and Evotec, a Hamburg, Germany-based drug-discovery and development company, have launched beLAB2122, a translational $20-million innovation pact.
beLAB2122 brings together academic institutions from the Rhine-Main-Neckar region of Germany with the goal of advancing investable drug-discovery and early-development projects.
Merck KGaA, TU Darmstadt Extend Research Pact
Merck KGaA has extended its existing 15-year strategic joint research collaboration with the Technical University of Darmstadt (TU Darmstadt) by an additional five years.
As part of the realignment of this partnership, both partners want to set up a joint research platform, “Sustainability Hub,” which will be open to all business sectors of Merck KGaA and all departments of the TU Darmstadt.
Four focus areas for joint research projects have been defined: (1) circular economy; (2) digital sustainability; (3) responsible handling of raw materials and new alternatives; and (4) innovative processes and procedures inspired by biology. Initial projects are to be started in the second half of 2021. Full details of the four focus areas can be found here.
Merck KGaA will provide additional annual funding for national and international academic collaboration partners that are joining TU Darmstadt to make the joint Sustainability Hub research platform broader and more international.
Source: Merck KGaA
Moderna Reports Progress of its mRNA Vaccine Franchise
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced clinical progress from its mRNA vaccine franchise.
The company reported new positive interim Phase I data from its respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) and new seven-month interim Phase II data from its cytomegalovirus vaccine candidate.
Building on its COVID-19 vaccine clinical development experience, the company plans to invest resources and continue to use its mRNA platform to accelerate the development of its mRNA vaccine pipeline.
To date (as reported on April 14, 2021), Moderna has entered 14 different mRNA vaccine candidates into clinical trials.
A-S Medication Solutions Recalls Acetaminophen Tablets
A-S Medication Solutions, a Libertyville, Illinois-based company that provides medication dispensing solutions, is voluntarily recalling 198,350 bottles of acetaminophen extra strength (500-mg) tablets, to the consumer level due to mislabeling.
The company is recalling 100-count bottles contained in Health Essentials Kits distributed by Humana, a Louisville, Kentucky-based health insurance company, to its members. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.
The bottles are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between January 14, 2021 and March 15, 2021 nationwide in the US. Expiration dates are either July 31, 2022 or August 31, 2022.
Source: US Food and Drug Administration