On December 20, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Janssen Pharmaceutical K.K. has submitted a New Drug Application to the Ministry of Health, Labor and Welfare (MHLW) in Japan for the use of daratumumab (DARZALEX) for the treatment of adults with relapsed or refractory multiple myeloma (Press release, Genmab, DEC 20, 2016, View Source [SID1234517127]). The submission of the application triggers milestone payments totaling USD 10 million to Genmab from Janssen. Genmab is updating its financial guidance for 2016 to include the milestones. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are pleased that the first regulatory application for daratumumab in the Asia Pacific region has been submitted and look forward to the decision of the Japanese regulatory authorities," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We continue to be excited by the potential of daratumumab to make a positive impact on the lives of patients with multiple myeloma and their families."

The submission is built around three pivotal studies: the Phase II SIRIUS study (MMY2002), published in The Lancet in April 2016; the Phase III CASTOR study (MMY3004), published in The New England Journal of Medicine in August 2016; the Phase III POLLUX study (MMY3003), published in The New England Journal of Medicine in October 2016; and supported by several other studies.

OUTLOOK
MDKK Revised Guidance Previous Guidance
Revenue 1,720 — 1,770 1,650 — 1,700
Operating expenses (800) — (850) (800) — (850)
Operating income 895 — 945 825 — 875
Cash position at end of year* 3,650 — 3,750 3,650 — 3,750
*Cash, cash equivalents, and marketable securities
Genmab is improving its 2016 financial guidance published on November 21, 2016 due to the inclusion of daratumumab milestones totaling USD 10 million associated with the submission of the regulatory application for daratumumab in relapsed or refractory multiple myeloma in Japan.

Operating Result
We expect our 2016 revenue to be in the range of DKK 1,720 — 1,770 million, an increase of DKK 70 million compared to the previous guidance. We have increased our projected daratumumab milestones to DKK 1,090 million (previously DKK 1,020 million) due to inclusion of USD 10 million in milestone payments triggered by the submission of the regulatory application for daratumumab in relapsed or refractory multiple myeloma in Japan. We expect DARZALEX royalties to remain in the range of DKK 400 — 450 million, which are 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 895 – 945 million, compared to DKK 825 – 875 million in the previous guidance.

Cash Position
There is no change to the cash position at the end of 2016 of DKK 3,650 – 3,750 million as we expect to receive payment for the additional milestones shortly after year-end.

Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX and Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2016 that could materially affect the results.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 30,330 new patients are expected to be diagnosed with multiple myeloma and approximately 12,650 people are expected to die from the disease in the U.S. in 2016.3 Globally, it was estimated that 124,225 people would be diagnosed and 87,084 would die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5 Patients who relapse after treatment with standard therapies, including proteasome inhibitors or immunomodulatory agents, have poor prognoses and few treatment options.6

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the 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 an immunomodulatory agent.7 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.

Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).7,8,9,10,11

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, non-Hodgkin’s lymphoma, NKT-cell lymphoma, amyloidosis, and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.