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Novartis taps Alteogen in USD 3.2b subcutaneous biologics pact

Novartis taps Alteogen in USD 3.2b subcutaneous biologics pact

Novartis has entered an option and license agreement with South Korea-based Alteogen Inc. (KOSDAQ: 196170) to develop and commercialize subcutaneous formulations of multiple Novartis biologics using ALT-B4 (berahyaluronidase alfa), the recombinant human hyaluronidase at the core of Alteogen's Hybrozyme platform. If all options are exercised and all milestones achieved, Alteogen said it would be eligible to receive up to USD 3.223 billion, including option exercise fees, development and commercial milestones, and royalties on net sales.

The deal is structured as a tiered option-and-license arrangement: Novartis holds multiple options, each of which, upon exercise, converts into an exclusive license to develop and commercialize a specific product using ALT-B4. No upfront payment figure was separately disclosed; the company said the total includes option exercise fees, though individual amounts were not broken out. Royalties on net sales are confirmed but undisclosed.

The USD 3.223 billion ceiling is one of Alteogen's largest single ALT-B4 deals to date. The company described it as its fourth licensing agreement signed in 2026. The three preceding 2026 deals — with Tesaro (a GSK subsidiary) for subcutaneous dostarlimab at up to USD 285 million, with Biogen for two biologic products, and with an undisclosed global pharma company for a single asset at up to USD 365 million — each covered one or two products. The Novartis deal's USD 3.223 billion ceiling, benchmarked against the approximately USD 365 million per-product ceiling established in August, implies coverage of a broad product slate.

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ALT-B4 works by transiently depolymerizing hyaluronan in the subcutaneous extracellular matrix, facilitating dispersion and absorption of co-administered biologics. The technology competes directly with Halozyme Therapeutics' rHuPH20 (ENHANZE platform), which underpins more than a dozen approved subcutaneous products. ALT-B4 received its first regulatory validation when the US FDA approved a subcutaneous formulation of pembrolizumab using the enzyme in 2025. In June 2026, Alteogen presented preclinical data at the World ADC Summit showing enhanced systemic exposure and an improved safety profile for ALT-B4-enabled subcutaneous ADC delivery, extending the platform's potential scope.

In May 2026, the US Patent Trial and Appeal Board rejected Halozyme's petition to invalidate Alteogen's recombinant hyaluronidase manufacturing patent, and the European Patent Office indicated intent to grant a substance patent covering ALT-B4 the same month. Three of Alteogen's four 2026 deals followed that resolution.


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