Date: 2016-05-30
Type of information: Milestone
Compound: daratumumab (HuMax®-CD38)
Company: Genmab (Denmark) Janssen Biotech - J&J (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
development
Action mechanism: monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other tumors on which CD38 is expressed.
Disease: multiple myeloma, other cancer indications such as acute myeloid leukemia
Details: * On August 30, 2012, Genmab has announced a global license and development agreement for daratumumab (HuMax®-CD38), a human CD38 monoclonal antibody with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Daratumumab is currently in development for multiple myeloma and may have potential in other cancer indications such as acute myeloid leukemia. Under the terms of the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a backup human CD38 antibody.
Financial terms: Under the terms of the agreement, Genmab will receive an upfront license fee of $55 million (approximately DKK 327 million) and Johnson & Johnson Development Corporation (JJDC) will invest DKK 475 million, (approximately $80 million) to subscribe for 5.4 million new shares of Genmab at a price of DKK 88 per share. Genmab's closing share price on August 29, 2012 was DKK 67.85. The new shares will be issued by Genmab under the authorization to the board of directors from Genmab's shareholders granted at the annual general meeting on April 6, 2011. The new shares will be issued for cash without pre-emptive rights for Genmab's existing shareholders, and no person or entity other than JJDC will participate in the private placement. Genmab currently has 44,907,142 shares outstanding and after completion of the private placement the number of shares will be 50,307,142. After the issue of the new shares, JJDC will own 10.73% of Genmab's share capital. Genmab could also be entitled to up to $1 billion in development, regulatory and sales milestones, in addition to tiered double digit royalties. Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase I/II studies.
Latest news: * On May 30, 2016, Genmab announced it has achieved a $ 30 million milestone in its Darzalex® (daratumumab) collaboration with Janssen Biotech. The milestone payment was triggered by the first commercial sale of Darzalex® in Europe. The European Commission recently granted a conditional marketing authorization for daratumumab for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. This milestone was included in Genmab's previously issued financial guidance for 2016. * On March 9, 2016, Genmab announced it has reached a $ 5 million milestone in its daratumumab collaboration with Janssen Biotech. This is the second milestone payment triggered by progress in the ongoing Phase II study ("Carina" LYM2001) of daratumumab in non Hodgkin lymphoma. * On December 9, 2015, Genmab announced it has reached a $ 5 million milestone in its daratumumab collaboration with Janssen Biotech. The milestone payment was triggered by progress in the ongoing Phase II study ("Carina" LYM2001) of daratumumab in non Hodgkin lymphoma. * On November 19, 2015, Genmab announced it has achieved a $ 45 million milestone in its Darzalex™ (daratumumab) collaboration with Janssen Biotech. The milestone payment was triggered by the first commercial sale of Darzalex™ in the United States. On September 9, 2015, Genmab announced that Janssen-Cilag International has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The submission triggers a milestone payment of $ 10 million to Genmab from Janssen. The milestone was included in Genmab's financial guidance for 2015. * On July 9, 2015, Genmab announced that Janssen Biotech has completed the rolling submission of the BLA to the FDA for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The completion of the submission triggers a milestone payment of $ 15 million to Genmab from Janssen. The milestone was included in Genmab's financial guidance for 2015, which was updated on May 20, 2015. If daratumumab receives FDA approval, Genmab will receive a milestone payment from Janssen of $ 45 million associated with the first commercial sale of the product in the United States. However, it is not possible to precisely predict the timing of a potential marketing approval and first commercial sale; therefore, this milestone has not been included in the 2015 financial guidance at this time. * On April 16, 2015, Genmab announced it has reached the fifth milestone in its daratumumab collaboration with Janssen Biotech. The $ 10 million milestone payment was triggered by progress in the ongoing Phase III study ("Alcyone" MMY3007) which compares daratumumab in combination with bortezomib, melphalan and prednisone (VMP) to bortezomib, melphalan and prednisone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT). This news does not impact Genmab's 2015 financial guidance. * On November 26, 2013, Genmab has announced it has reached the first milestone in this collaboration. The milestone was triggered by progress in the clinical development of daratumumab. Genmab will receive a $ 8 million milestone payment from Janssen in connection with this event. * On September 21, 2012, Genmab has announced that its license agreement for daratumumab with Janssen Biotech has received antitrust clearance from the Federal Trade Commission and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino Act. This means that the license agreement has now become effective.
* On March 26, 2014, Genmab has announced it has reached the second milestone in its daratumumab collaboration with Janssen Biotech. The $22 million milestone payment was triggered by progress in the ongoing Phase II study of daratumumab in multiple myeloma patients who have received at least three different lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. This is the same indication for which daratumumab was granted Breakthrough Therapy Designation from the FDA in May 2013.
