Bavarian Nordic A/S plans to buy two travel vaccines plus a phase III vaccine candidate from Emergent Biosolutions Inc. for about $380 million. Emergent will receive a $270 million up-front payment and perhaps as much as $110 million in future milestone payments. The vaccines are Vivotif for preventing typhoid fever and Vaxchora for preventing cholera. Both oral vaccines have U.S. FDA and European approvals. Bavarian Nordic is also getting U.S.-based R&D facilities, a biologics manufacturing facility in Switzerland and EU/U.S.-based commercial operations with their salesforce. Emergent bought Paxvax Corp., which owned the two vaccines, in August 2018 for the same amount as it’s getting in the up-front: $270 million.

New US CMS drug payment model strikes discordant note with industry

The trio of new drug payment models that made their debut yesterday in the U.S. is playing to mixed reviews. Two of the models to be tested by the U.S. Centers for Medicare & Medicaid Services (CMS) Innovation Center seem to “address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall health care system,” the Biotechnology Innovation Organization (BIO) said. But with the Accelerating Clinical Evidence Model, which is expected to reduce Medicare payment for some Part B drugs with accelerated approval, BIO said that, once again, “CMS is calling into question FDA’s science-based approval process for innovative medicines.”

Newco news: Newly public Coya takes on neurodegenerative disease with Tregs

Fresh off an end-of-year IPO, Coya Therapeutics Inc. is gearing up for clinical testing with its lead Treg-enhancing biologic in neurodegenerative disease, aiming to build on a wealth of academic-generated data highlighting the potential of Treg therapy to attack the neuroinflammation underlying diseases such as amyotrophic lateral sclerosis and Alzheimer’s disease. “Inflammation has been discovered to be a key driver of these neurodegenerative diseases,” said CEO Howard Berman, who co-founded the Houston-based company in 2020, even as he was watching his own father suffer the effects of cognitive decline. 

Breaking new ground with knotbodies, Maxion raises $16M series A 

Maxion Therapeutics Ltd. has raised $16 million in a series A to take forward a new method for drugging G-protein coupled receptors (GPCRs) and ion channels with antibodies. The technology brings together naturally occurring knottin peptides that are derived from sources such as snake venom and which can engage GPCRs and ion channels, with antibodies that deliver them to these notoriously difficult, shape-shifting targets. The resulting combinations are called knotbodies. Maxion already has discovered knotbodies against several therapeutically relevant targets, based on publicly available knottins and existing antibodies.

With new infusion of capital, Zelira gears up for phase II/III trials of cannabinoid drug for autism 

Medicinal cannabis company Zelira Therapeutics Ltd. secured $8.6 million in cornerstone funding from U.S.-based Cantheon Capital LLC that will progress Zelira’s Hope1 cannabinoid medicine to formal phase II/III clinical trials for behaviors associated with autism spectrum disorder. The funding will be provided under a special purpose vehicle (SPV) for which Zelira will contribute its Hope1 product, intellectual property and real-world data for 55% equity ownership of the SPV. “I am very pleased that we are now at the third stage of our launch, learn and develop strategy for validation and commercialization of cannabinoid-based medicines,” said Osagie Imasogie, Zelira’s chairman.

US False Claims actions up in 2022, but dollar value of settlements flat over 2021

The False Claims Act (FCA) is perhaps the primary vehicle for U.S. federal authorities to extract penalties and fines from life science companies for violations of the law, but a new report by Gibson Dunn & Crutcher LLP suggests a mixed signal. The report notes that the U.S. Department of Justice (DOJ) recovered $2.2 billion via the FCA last year, but while that is not a conspicuous number for the past decade plus, what was conspicuous was that those sums were recovered by the second highest level of FCA actions settlement in the history of the FCA, suggesting that DOJ is keen on enforcement with no regard to the size of the target.

Also in the news

Albireo, Aprea, Arrowhead, Assembly, Astrazeneca, Athersys, Avidity, Bicycle, Biocon, Bioxcel, Bristol Myers Squibb, Calibr, Can-Fite, Codagenix, Engene, Eumentis, Exelixis, Eyenovia, Formosa, Fusion, Galera, Glycomimetics, Immunitybio, Ipsen, Kalvista, Lemonex, Macrogenics, Maia, Merck, Mineralys, Mirum, Monopar, Morphoceuticals, Nervgen, Neurona, Ocean, Opthea, Pfizer, Propella, Puretech, Purple, Radiomedix, Relief, Sentia, Seres, Soligenix, Supernus, Telix, Valneva, Vaxart, Verve, Xilis