Both Genmab and Janssen have been exceptionally thrilled with the positive trajectory for their cancer treatment Darzalex since the first approval of the product in November 2015.

But more could follow, says Craig Tendler, VP of Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care at Janssen Research & Development, adding that he was exceedingly happy they managed to sign a deal with Genmab in the first place.

“We were very impressed with some of the initial Phase I data showing early evidence of the single-agent activity of Darzalex in a population of myeloma patients whose disease had progressed through multiple lines of treatment and in some cases stopped responding to all available therapies,” the VP explains in a email interview with MedWatch.

History and reputation

Genmab and Janssen struck a license deal for Darzalex in August 2012, giving the biotech a USD 55 million advance, while Janssen made an equity investment of USD 80 million and promised to pay biobucks along the way as well as royalties starting at 12 percent and possibly rising to 20 percent.

In spite of all the financial obligations, Craig Tendler thinks it is a great deal for Janssen. He believes Genmab settled on Janssen due to the group’s proven track record in the multiple myeloma area, the main indication for Darzalex.

“We believe it was based on our experience and track record of productivity in developing drugs such as Velcade and Doxil in multiple myeloma, as well as our reputation for being a dependable and highly committed industry partner in the myeloma research community,” the VP writes.

The commercial trajectory for Darzalex has been great since the launch in late 2015. The product is expected to have generated revenue of USD 530 million last year, and consensus among analyst estimates collected by Bloomberg suggest it will more than double this year.

Revenue is expected to reach USD 1.21 billion in 2016 and rise to USD 3.13 billion in 2020. Some analysts have even attached peak-sales estimates of as much as USD 7-10 billion to the drug.

The solid launch of the oncology drug has previously been hailed by a number of observers, among them Genmab co-founder and major shareholder Florian Schönharting who has called it “phenomenal”.

The next Darzalex

Aside from partnering on the Darzalex project, the two companies also collaborate on Genmab’s DuoBody platform technology. That partnership was initiated in July 2012, when they agreed to create up to ten bispecific antibodies. The partnership has since been expanded to include an additional ten candidates and shown good enough progress for Janssen to use 12 of its 20 options so far.

The US-based pharma company hopes to find the next Darzalex through that collaboration.

“We certainly hope so based on the pre-clinical models demonstrating that these therapies are capable of blocking more than one driver pathway of malignancy and that anti-tumor effect can potentially be better than blocking each alone,” Craig Tendler writes.

In May 2016, the parties announced that Janssen had reached an important milestone in the partnership by dosing the first patients with a drug developed on the DuoBody platform.

That happened in connection with a phase I study evaluating the human bispecific antibody JNJ-61178104 which targets two inflammatory disease targets and is used to treat autoimmune diseases. The trial is expected to conclude this month.

Study on standby

Two other programs had also reached the clinic at that point and edged closer to dosing the first patients. Those were JNJ-61186372 against non-small cell lung cancer (NSCLC), with a trial set to finish in October 2018, and the AML candidate JNJ-63709178, for which Janssen had hoped to wrap up a study in November 2016. But that program suffered a setback last summer.

In August, the study was put on clinical hold by the US FDA due to a Serious Adverse Event and patient recruitment was suspended.

“We are working with the FDA to address recommended changes to this study, and with appropriate guidance from the FDA, we hope to resume the study,” Craig Tendler explains.

 Serious setback for Genmab in DuoBody collaboration 

 Janssen: We are working with the FDA 

 Janssen wants more success from Genmab partnership

 Janssen exec: Commercial potential of Genmab deal will increase 

 Genmab CEO about wonder drug: ”It’s incredible”

- translated and edited by Martin Havtorn Petersen

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