FDA approves DARZALEX for relapsed multiple myeloma

In July 2016, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this patient population.  In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

Genmab will receive milestone payments totaling USD 65 million from Janssen associated with the first commercial sale of the daratumumab in combination with lenalidomide and dexamethasone and in combination with bortezomib and dexamethasone in the United States.  As this will occur quickly after this approval, Genmab is improving its financial guidance for the year.  See the Outlook section of this announcement for more information.

Genmab CEO Jan van de Winkel said:  "This is an exciting day for patients with multiple myeloma in the U.S., who will now have the opportunity to receive DARZALEX at an earlier point in treatment of their disease. 

"We believe daratumumab has the potential to become a backbone therapy for multiple myeloma."

The approval was based on data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.

Data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma was also submitted as part of the supplemental Biologics License Application (sBLA) for daratumumab in the newly approved indications in August 2016.

The FDA granted a Standard Review for the use of daratumumab in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 17, 2017 for the combination of daratumumab with pomalidomide and dexamethasone.

DARZALEX was initially approved by the FDA in November 2015 for the monotherapy treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and immunomodulatory agent.

OUTLOOK

Genmab is improving the 2016 financial guidance it published on November 2, 2016, due to the inclusion of daratumumab milestones totaling USD 65 million.

The milestones are associated with the first commercial sale of DARZALEX in combination with lenalidomide and dexamethasone, and bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy in the U.S. following FDA approval in this indication.

Operating Result

We expect our 2016 revenue to be in the range of DKK 1,650 — 1,700 million, an increase of DKK 450 million compared to the previous guidance.  We have increased our projected daratumumab milestones to DKK 1,020 million (previously DKK 570 million) due to inclusion of USD 65 million in milestone payments triggered by the first commercial sale of DARZALEX in combination with lenalidomide and dexamethasone, and bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. 

We expect DARZALEX royalties to remain in the range of DKK 400 — 450 million, based on an estimated USD 500 — 550 million of DARZALEX sales in 2016. The remainder of the revenue mainly consists of Arzerra^® royalties, DuoBody^® milestones, and non-cash amortization of deferred revenue.

We anticipate that our 2016 operating expenses will remain in the range of DKK 800 — 850 million.

As a result of the increased revenue, we now expect the operating income for 2016 to be approximately DKK 825 — 875 million, compared to DKK 375 — 425 million in the previous guidance.