Genmab seeks $405 million from Janssen in arbitration over royalty payments

Published: Jun 10, 2022

By Alex Keown

BioSpace

Two months after Janssen won a ruling in arbitration over the licensing and marketing of multiple myeloma drug Darzalex Faspro (daratumumab), Genmab A/S is seeking a new arbitration ruling granted under its license with the larger pharmaceutical company.

In a brief announcement Thursday, Denmark-based Genmab said it is seeking $405 million-plus interest in accrued milestone payments for Darzalex Faspro. Additionally, the company is seeking a declaration that it is entitled to a new 13-year royalty term from the date of Darzalex Faspro’s first commercial sale.

The two companies first headed to arbitration two years ago, with Genmab claiming that it is entitled to royalties from the marketing of the drug for both the intravenous form of Darzalex, and Darzalex Faspro for subcutaneous administration. The company claimed it was entitled to royalties through the expiration of its patents, which are set to sundown at the end of this decade or in the early 2030s.

As BioSpace reported at the time, Genmab also said it was seeking arbitration to settle whether or not the Danish company is required to share in Janssen’s royalty payments to Halozyme Therapeutics. That company’s enzyme technology was used in the subcutaneous formulation of daratumumab.

In April, arbitrators ultimately ruled in favor of Janssen, a division of Johnson & Johnson. The tribunal of arbitrators said Janssen must pay Genmab royalties on sales of Darzalex in all countries where Genmab’s patents are applicable.

Regarding the question of royalties shared with Halozyme, the arbitration tribunal declared that Janssen is allowed to regulate those expenses on its own by separating the payments made to each company. When the ruling was handed down two months ago, BioSpace reported that Janssen is expected to subtract the difference of appropriate royalties paid to Halozyme from payments made to Genmab.

Darzalex, a next-generation CD38 antibody, was the first monoclonal antibody approved by the U.S. Food and Drug Administration to treat multiple myeloma. In 2019 a split-dosing program for Darzalex was approved in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. It is also approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of multiple myeloma patients who have had at least one previous therapy. Also, it is approved in combination with pomalidomide and dexamethasone for patients with multiple myeloma who’ve had at least two previous treatments, including lenalidomide and a proteasome inhibitor.

The FDA also approved Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

Genmab said it does not intend to provide additional comment on this new arbitration until the matter is settled. Although the company is pushing for a new arbitration hearing, Genmab said it continues to collaborate with Janssen on a successor to Darzalex.

Source: BioSpace