Update on J&J/Genmab's Daratumumab - Analyst Blog
Janssen Biotech, Inc., a Johnson & Johnson ( JNJ ) company, will be moving oncology candidate, daratumumab, into a new phase II study for multiple myeloma shortly. Janssen's partner, Genmab ( GNMSF ) announced that the new study will be conducted in multiple myeloma patients who have undergone at least three different lines of treatment including a proteasome inhibitor like Velcade (bortezomib) or Kyprolis (carfilzomib) as well as an immunomodulatory agent (IMiD) like Pomalyst (pomalidomide) or Revlimid (lenalidomide) or double refractory multiple myeloma patients.
The study will be conducted in two parts - Part 1 will determine the optimal regimen for daratumumab. Once initial data from Part 1 is out, the study will be expanded into Part 2. The study will basically determine the optimal dose and dosing schedule. Moreover, Genmab said that daratumumab's efficacy (overall response rate) and safety as a monotherapy will be evaluated.
We note that daratumumab was granted Breakthrough Therapy Designation by the FDA in May 2013 for this indication. In addition to being developed for multiple myeloma, daratumumab has the potential to be evaluated for other cancers like diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
Daratumumab is being developed under a collaboration agreement between Janssen and Genmab that was signed in Aug 2012. Janssen has the exclusive global right to develop and commercialize daratumumab.
While Genmab is currently a Zacks Rank #4 (Sell) stock, Johnson & Johnson holds a Zacks Rank #3 (Hold). Johnson & Johnson's target of filing for approval of more than 10 new products and more than 25 line extensions by 2017 should help lessen the impact of the genericization of key products in the pharma portfolio.
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