LONDON – Evotec SE put the biggest ever headline figure on one of its pharma drug discovery collaborations, announcing a $1 billion deal with Eli Lilly and Co. in metabolic diseases. The Hamburg, Germany-based company will be responsible for the discovery of drug candidates for the treatment of diabetes and chronic kidney disease against targets identified by Lilly or Evotec, or sourced externally. Lily has rights to up to five programs, to be developed in the partnership and to take on any subsequent development, clinical validation and commercialization activities. The collaboration initially runs for three years. The up-front payment was not disclosed, but Evotec is eligible to receive milestone payments of up to $180 million per program, as well as tiered royalties on any products that make it to market.

Clinical hold clutches Dyne’s stock

The FDA clapped a clinical hold on the IND for a clinical trial of Dyne Therapeutics Inc.’s DYNE-251 for treating Duchenne muscular dystrophy in patients amenable to skipping exon 51. The agency is asking for more clinical and non-clinical information on the therapy, the company said. A response, including data from existing and ongoing studies in the second quarter of 2022, is expected to be filed to the FDA sometime in mid-2022, Dyne said. The IND to study DYNE-251, a phosphorodiamidate morpholino oligomer conjugated to a fragment antibody that binds to the transferrin 1 receptor, was submitted in December. The Waltham, Mass.-based company’s stock (NASDAQ:DYN) had sunk by 13% at midday.

Novavax’s protein-based COVID-19 vaccine wins approval in South Korea

South Korea’s Ministry of Food and Drug Safety has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known as NVX-CoV2373, in India, Indonesia and the Philippines, as well as an emergency use listing from the World Health Organization. The company expects to submit an EUA request to the FDA after one month, it said on Jan 12. 

Abbvie, Pfizer JAK inhibitors win refractory atopic dermatitis approvals at FDA

Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with refractory moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis. An FDA decision regarding Eli Lilly and Co.'s sNDA for baricitinib for the treatment of AD has yet to be issued.

US lawmakers urge government to become vaccine manufacturer

If it wants to end the global pandemic, the Biden administration must get the U.S. government more actively involved in the manufacture of mRNA vaccines, a group of Democratic senators and representatives told leaders of the White House COVID-19 Response Team. They urged the administration to immediately establish publicly owned vaccine manufacturing facilities and to use its authority under the Defense Production Act to require Pfizer Inc. and Moderna Inc. to transfer the technology needed to produce their vaccines. “In this race against a dangerous and rapidly mutating virus, the administration must act aggressively to expand global vaccine access and can do so in two significant ways,” the lawmakers wrote in a letter last week to Jeffrey Zients, the coordinator of the response team, and David Kessler, the chief scientific officer.

Levo gets hit with expected CRL for PWS drug after negative adcom

Not heeding earlier FDA advice has earned Levo Therapeutics Inc. a complete response letter (CRL) for its NDA seeking approval for intranasal carbetocin (LV-101) in hyperphagia associated with Prader-Willi syndrome. The CRL followed a 12-1 negative advisory committee vote in November. According to the company, the FDA’s Division of Psychiatry concluded that efficacy data available were insufficient for approval, though no safety or tolerability issues were raised. The agency recommended an additional study to confirm the results of the 3.2-mg dose.

Holiday notice

BioWorld's offices were closed in observance of Martin Luther King Jr. Day in the U.S. No issue was published Monday, Jan. 17.

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