Eyes on the New Year - 2024 has a Busy Start with Deals and Approvals

Deals 

The new year for the biopharma industry took off with the first major event, the J.P. Morgan Healthcare Conference in San Francisco. The most significant deals of the week were secured by Novartis, Merck, Johnson & Johnson, GSK and Alphabet's Isomorphic Labs.

Novartis struck deals in gastrointestinal and cardio therapies with the acquisition of Calypso Biotech for $250 million upfront, with another $175 million to follow, provided certain milestones are met. Calypso’s leading asset is CALY-002 for the treatment of multiple gastrointestinal conditions, targeting IL-15 cytokine. A license and collaboration agreement has also been established with Argo for two cardiovascular RNA interface candidates with $4.165 billion-plus royalties secured by the terms. Concerning the acquisition of Cytokinetics, Novartis has had cold feet and is reportedly withdrawing.

Boosting its oncology and immunotherapy pipeline, Merck announced the purchase of Harpoon Therapeutics, a cancer drug developer of T-cell engagers and cancer antibodies, for an estimated $680 million. Harpoon’s HPN328, currently in Phase I/II, targets advanced cancers linked to expression of DLL3 (delta-like ligand 3).

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Johnson & Johnson acquired Ambrx for $2 Billion. The business deal comes with their ADC currently in Phase I/II trials for advanced prostate cancer. The news follows a succession of ADC-, focused deals by J&J.  In December 2023, J&J bought the licensing rights for LegoChem Bioscience’s ADC for $100 million upfront and $1.7 billion in potential milestone payments. In February 2022, J&J paid $40 million upfront in a licensing and research deal with Mersana Therapeutics, potentially worth $1 billion.

GSK’s near future acquisition of Aiolos Bio comes with $1 billion upfront and $400 million in regulatory milestones. GSK’s Asthma pipeline will benefit from the biotech’s main asset, AIO-001, a monoclonal antibody targeting the thymic stromal lymphopoietin cytokine inflammation driver. The newly developed asthma treatment will require twice a year only administration. Aiolos Bio officially traded as an established company for just 77 days before the sale to GSK.

Alphabet’s Isomorphic Labs partnered with Elli Lilly and Novartis to utilize its Google DeepMind artificial intelligence platform to develop small molecule-based drugs. Lilly’s contract will see Isomorphic receive $45 million upfront and $1.7 billion in performance-based milestones and tiered royalties. The Novartis deal will give Isomorphic $37.5 million upfront and $1.2 billion in milestones and royalties.

For more details, see these reports in PharmaTell Studio:

PharmaTell Studio

PharmaTell Studio

PharmaTell Studio

 GLP-1's Safety News

The FDA’s review of GLP-1’s finds no evidence to link Novo Nordisk and Eli Lilly’s popular weight-loss and diabetes drugs to suicidal thoughts. The past several months have seen the agency investigate reports of suicidal thoughts or actions in GLP-1 patients. The review was based on the FDA’s Adverse Event Reporting System and concluded that there is no association between the use of GLP-1s and suicidal ideation. However, other GLP-1 side effects were brought to the FDA's attention, adding them to the list of the agency’s monitored medicines. Both drugs showed cases of alopecia (hair loss) and aspiration (a dangerous post-surgical condition in which people breathe food, vomit, or saliva into their lungs).

Last year, July saw the European Medicines Agency investigating Wegovy and Ozempic following two detailed Icelandic patient cases of suicidal ideation and self-harm recorded. The case reviews are ongoing.  An additional life-threatening condition in the form of a rare intestinal blockage called ileus could be linked to GLP-1 drugs. It has already been included in the drug’s label warnings.

For more details, see these reports:

PharmaTell Studio

PharmaTell Studio

FiercePharma

Approvals

Vertex / CRISPR Casegevy was approved two months early for transfusion-dependent beta-thalassemia (TDT). Investors will focus on pricing and patient starts as they begin commercializing the product.

See more details in PharmaTell Studio reports Here and Here

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