Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others.

In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze.

The technology consists of recombinant human hyaluronidase PH20 (rHuPH20) and is used to overcome resistance to bulk fluid flow in the extracellular matrix, allowing high volumes of large molecules to be delivered under the skin.

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The enzyme has been licensed to nine pharmaceutical and biotech companies for co-formulation with their proprietary products on a target-by-target basis and is used in three markkete products: Subcutaneous formulations of Roche’s Rituxan (rituximab) and Herceptin (trastuzumab), as well as Takeda’s Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

License agreements bring Halozyme upfront payments, development and commercial milestones, and royalties on net sales, and looking ahead to 2020 CEO Helen Torley to said on a Q4 financial call that the firm is “very excited for the next few anticipated launches of products utilizing Enhanze, as they are expected to represent an important inflection point for our royalty revenue growth.”

Specifically, she highlighted J&J division Janssen Pharmaceuticals’ Darzalex (daratumumab) and Roche’s fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase.

“These next two launches are for drugs at a very different time point in their growth cycle compared with the drugs currently commercialized utilizing Enhanze,” she told investors. “Darzalex and Perjeta are both multi-billion dollar products, where the IV form of the drug still enjoys high-double digit growth and has a long runway on its intellectual property.”

Darzalex SC

Darzalex, the multiple myeloma monoclonal antibody pulled in sales of over $2 billion in 2019 for Janssen Pharmaceuticals, but in July last year the firm completed regulatory submissions in the US and EU for the subcutaneous formulation of the drug, co-formulated with Halozyme’s Enhanze.

The subcutaneous (SC) version of the MAb can be given in a three to five minutes subcutaneously, versus three to four hours for the IV, and if approved could be launched in the second half of this year.

“The potential value proposition of daratumumab SC is strong,” Torley told stakeholders. “Janssen has stated that subcutaneous formulation of Darzalex is a core part of their future growth strategy, supporting their goals of expansion into the frontline setting in addition to treatment in the community setting.”

Perjeta and Herceptin SC

This week, the US Food and Drug Administration (FDA) accepted Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer, making it another potential commercial product utilizing Ehanze.

“Roche has stated they expect to launch in the US in 2020 and we would anticipate launch in the EU in 2021, following the approval,” said Torley.

“The subcutaneous fixed-dose combination of Perjeta and Herceptin is an important first, combining two therapeutic antibodies in a single fixed-dose formulation, utilizing Enhanze, enabling a five minute to eight minute subcutaneous injection, compared with 1.5 hours to 2.5 hours for the sequential IV administration of Herceptin and Perjeta.”

While Halozyme has not provided any specifics regarding milestone payments and potential royalties from these drugs, the firm said cumulative milestone revenues for the three-year period, 2020 to 2022 is likely to be $350 million to $450 million, while potential royalties could reach approximately $1 billion in 2027, based on current pipelines.

For the full year 2019, Halozyme reported sales of $196 million, up 29% year-on-year.