What Novartis's $3.2 Billion Enzyme Licensing Deal Means for Formulation

Novartis has entered into an option and license agreement with Alteogen Inc. to develop and commercialize subcutaneous formulations of multiple Novartis products, using a recombinant human hyaluronidase enzyme called ALT-B4.¹ The agreement gives Novartis a series of options to secure exclusive development and commercialization rights across several of its products, with Alteogen eligible to receive up to $3.2 Billion in option fees, development and commercial milestones, and royalties on net sales if every option is exercised and every milestone is met.

The deal is the fourth licensing agreement of this kind signed this year involving the same underlying enzyme platform, reflecting accelerating industry interest in converting intravenous biologics into subcutaneous formulations.¹

What Does the Enzyme Do?

ALT-B4, also known as berahyaluronidase alfa, works by temporarily breaking down hyaluronan, a structural component of the extracellular matrix that normally limits how much fluid tissue can absorb at once.¹ By depolymerizing hyaluronan at the injection site, the enzyme creates space for co-administered therapeutics to disperse and absorb more rapidly, allowing biologics that would typically require intravenous infusion to instead be delivered via subcutaneous injection. This class of enzyme has become a recognizable lever in biologics formulation over the past several years, since it addresses a persistent bottleneck: many large-molecule drugs, particularly monoclonal antibodies administered in high volumes, simply cannot be injected subcutaneously without a mechanism to help the tissue accommodate the dose.

What Are the Effects On Development and Manufacturing Teams?

Subcutaneous conversion programs reshape manufacturing and supply chain planning in ways that infusion-only products do not.¹ Converting an intravenous product to subcutaneous delivery typically means redesigning fill-finish operations around prefilled syringes or autoinjectors rather than vials for infusion bags, adjusting formulation to support smaller injection volumes and higher concentrations, and revisiting stability and container-closure strategies. It also has commercial implications: subcutaneous formulations can reduce dependence on infusion center capacity, shorten administration time, and support at-home or self-administration models, all of which have become priorities as health systems look to manage infusion chair capacity and patient convenience simultaneously.

The scale of the agreement also signals how large pharmaceutical companies are approaching platform licensing for delivery technology.¹ Rather than developing hyaluronidase or comparable enzymes internally, Novartis is opting to license access to an established platform with multiple options across its portfolio, a structure that lets the company evaluate applicability across different molecules and modalities before committing to full development on any single product.

Tae-Yon Chun, PhD, CEO, Alteogen, said in a press release,¹ "Novartis is a world-leading pharmaceutical company at the forefront of the global healthcare industry and has evaluated the application of ALT-B4 across multiple modalities for subcutaneous formulation development. This agreement demonstrates the technological strength and commercial value of Alteogen's Hybrozyme platform."

The deal is another data point in a broader industry trend: platform-level licensing of delivery-enabling technologies, rather than one-off formulation partnerships, is becoming a more common route for large biopharmaceutical companies to diversify their subcutaneous pipeline without building proprietary enzyme technology from scratch.¹ As more of these agreements are signed, development teams evaluating their own portfolios may increasingly weigh licensing established delivery platforms against investing in internal formulation science.

How Widespread Is this Shift Across the Industry?

Takeda's January 2026 agreement with Halozyme illustrates how far subcutaneous conversion has spread beyond oncology and rare disease.² The deal grants Takeda exclusive access to Halozyme's hyaluronidase-based platform for vedolizumab, a therapy for ulcerative colitis and Crohn's disease with more than one million patient-years of exposure worldwide.

Robert Hollowell, head of global product and launch strategy, Takeda, said in a press release,² the collaboration would "offer greater flexibility in vedolizumab treatment, improve patient experience, and continue our focus on high-impact partnerships." With inflammatory bowel disease prevalence projected to exceed 10 million patients globally by 2032, the deal underscores sustained manufacturing demand for subcutaneous formats.

References

1. Alteogen Inc. Alteogen enters option and license agreement with Novartis for development and commercialization of Hybrozyme™-enabled subcutaneous products. PR Newswire. Press Release. September 2, 2026. https://www.prnewswire.com/news-releases/alteogen-enters-option-and-license-agreement-with-novartis-for-development-and-commercialization-of-hybrozyme-enabled-subcutaneous-products-302867513.html
2. Takeda Pharmaceutical Company Limited. Takeda announces global collaboration and license agreement with Halozyme to continue advancing vedolizumab with ENHANZE® drug-delivery technology. Takeda. Press Release. January 8, 2026. https://www.takeda.com/newsroom/newsreleases/2026/collaboration-and-license/