A biotechnology maker of novel oncology and drug-delivery therapies, Halozyme Therapeutics, expects three Enhanze programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products, expecting revenue of up to $300 million between 2019 and 2021 from potential milestone payments.
Halozyme has collaboration agreements for the Enhanze technology with Roche, Pfizer, Janssen, Baxalta, AbbVie, Eli Lilly, Bristol-Myers Squibb and Alexion.
Halozyme said in the announcement that their accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. It also hopes to realize the potential lifetime milestone payments related with existing Enhanze partnership programs in development, which are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.
Dr. Helen Torley, president and the CEO, said: “Looking ahead, our Enhanze business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts.”
She noted that in the oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019.
Halozyme expects in the first quarter of 2019 FDA positive responses on the Biologics License Application (BLA) filed by Enhanze partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin).
In the second half of 2019, Enhanze partner Janssen Biotech, aims to be filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.