For the second time, Genmab A/S finds itself at the threshold of transitioning into a commercial biotech and is planning to change its partnering approach to retain a more significant portion of the value of its pipeline products.
At face value, the circumstances might appear similar to the first time the biotech took the leap. In 2008, when Genmab began laying a path to market, it had three assets in Phase III testing. It had an option to co-promote one of them in the U.S. and Nordic countries, had regained rights to one and had yet to partner the third.
Today, Genmab has commercial rights outside North America to an antibody-drug conjugate (ADC) in pivotal Phase II testing, and another ADC in Phase I/II trials.
In both cases, management’s plan was to shift the company’s partnering strategy from one in which it relied on larger partners to commercialize all its products to one in which it retains commercial rights.
But while the first attempt saw the company lose nearly 80% of its value due to late-stage failures and rapidly increasing development costs, co-founder, President and CEO Jan van de Winkel believes Genmab’s share of blockbuster sales of Darzalex daratumumab now provides a platform for commercial growth.
Partner Johnson & Johnson launched Darzalex to treat fourth-line multiple myeloma (MM) in 2015. As J&J and Genmab have added on indications for Darzalex, the mAb against CD38 has already surpassed $1 billion in sales in a calendar year. On Nov. 17, Genmab received a $50 million milestone payment from J&J for achievement of that milestone.
“We now have the capital and the people that we can now hold on to these molecules.”
“We have a fantastic success story with Darzalex,” van de Winkel said. “A massive number of studies, over 60 clinical trials all operationalized by Janssen, and we have zero costs there