Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.
AbbVie and Capsida Therapeutics are expanding their gene therapy R&D alliance to the eyes. Capsida is in line to receive $70 million now and up to $595 million later, depending on the progress of the eye programs.
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Eli Lilly is paying $55 million up front to begin an alliance with Capsida Biotherapeutics pursuing gene therapies for central nervous system disorders. Capsida’s technology enables the delivery of a gene therapy to a single organ or multiple organs, a capability that could bring such treatments to a wider range of diseases.
The first regulatory approval of an allogeneic cell therapy goes to Atara Biotherapeutics. Other regulatory news highlights from the past week include proposed reforms of the FDA’s accelerated approval process, approval of the first gene therapy for bladder cancer, and a clinical hold for a biotech developing a new class of medicines.
Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon's drug lineup complements its own portfolio of autoimmune and inflammatory disorder products.
An Amgen drug led to weight loss that was sustained, clinical data that support advancing the molecule to a Phase 2 test expected to start in early 2023. While AMG 133 trails rival products from Novo Nordisk and Eli Lilly, Amgen hopes to offer patients a dosing edge.
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Amgen said its drug Lumakras met the main goal of a Phase 3 study in non-small cell lung cancer driven by a particular genetic mutation. The pharmaceutical giant offered no specifics, but the results set the stage for an interesting regulatory race with a rival drug from Mirati Therapeutics
Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused on developing small molecule alternatives to biologic medicines.
Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.
Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.
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FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded "undruggable" targets.
Capsida Biotherapeutics’ technology can engineer viral vectors that deliver gene therapies to central nervous system cells. With that capability, the startup was able to raise $50 million in Series A financing and a multi-drug research alliance AbbVie.
The acquisition brings Amgen a novel Phase 3-ready drug for gastric cancers. For Five Prime Therapeutics, the deal is a lifeline following a series of clinical and financial setbacks that left much of the biotech’s fortunes resting on its lead antibody drug.
The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ......
Sotorasib, a KRAS G12C inhibitor, showed an overall response rate and duration of response that analysts called approvable, but they noted the results have waned over time, and combinations may be the way forward.