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J&J takes option on Genmab follow-up to Darzalex

Blockbuster partners look to next chapter - while takeover talk persists

Genmab

Johnson & Johnson’s longstanding alliance with Genmab has already produced one blockbuster drug for lymphoma – Darzalex – and it is now eyeing a follow-up candidate.

The US company’s Janssen Biotech unit has signed an option agreement with Genmab for HexaBody-CD38, billed as a “next-generation” antibody that targets the same CD38 protein as Darzalex (daratumumab) which is approved to treat multiple myeloma and made more than $2bn in sales last year.

Under the terms of the deal Genmab will develop HexaBody-CD38 for multiple myeloma and diffuse large B-cell lymphoma (DLBCL) through to the proof-of-concept stage. Janssen may then license the drug in return for a $150m fee and up to $125m in milestones, with Genmab also in line for a 20% royalty rate if the drug reaches the market.

The two companies have worked together since 2012 when Janssen acquired rights to Darzalex in a deal valued at more than $1bn, including an upfront payment of $55m, and the new deal will do little to quash perennial rumours that J&J may be tempted to buy the Danish biotech outright.

Since its approval and launch in the US in 2015 and Europe the following year for relapsed/refractory myeloma, the anti-CD38 drug has steadily been moved to earlier-stage therapy, including a first-line approval last year, which has helped maintain its sales velocity despite an increasingly crowded myeloma market.

Darzalex hasn’t been a total success, as last year Genmab and Janssen decided to abandon clinical trials of the drug alongside immuno-oncology drugs – Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) and J&J’s experimental PD-1 inhibitor JNJ-63723283 – after a higher death rate was seen in the combination groups.

With analysts nevertheless predicting that peak sales could reach upwards of $5bn a year, Janssen is looking to the future with HexaBody-CD38, as the drug could be used in Darzalex-resistant patients as well as expand the use of anti-CD38 therapies beyond myeloma.

Jan van de winkel

Jan van de Winkel

“As a result of our collaboration, Darzalex has dramatically improved outcomes for patients with multiple myeloma, yet there are still unmet needs for patients,” commented Genmab’s chief executive Jan van de Winkel.

“Encouraging preclinical data suggest that HexaBody-CD38 could be superior to daratumumab for certain tumour cell types and may expand and extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukaemia, and potentially beyond.”

If Janssen doesn’t decide to exercise its option for the new drug, Genmab retains the right to develop it on its own for Darzalex-resistant patients and any other indications “except those multiple myeloma or amyloidosis indications where Darzalex is either approved or is being actively developed.”

Article by
Phil Taylor

20th June 2019

From: Research

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