Johnson & Johnson’s Janssen Pharmaceutical Cos. plans to seek regulatory approval of more than 10 new drugs, each one projected to reach blockbuster status by generating annual revenue of more than $1 billion, the company said today.

The company cited a dozen late-stage drug candidates it said will drive that projected growth. The plurality, four, have oncology indications.

They include: The human anti-CD38 antibody daratumumab for multiple myeloma, developed under an up-to-$1 billion licensing deal with Genmab inked in 2012; the modified oligonucleotide imetelstat for myelofibrosis, co-developed with Geron under an up-to-$935 million collaboration; the FGFRi kinase inhibitor JNJ-493 for urothelial cancer; and the androgen receptor signaling inhibitor JNJ-927 (ARN-509) for pre-metastatic prostate cancer, inherited when J&J acquired Aragon Pharmaceuticals for up to $1 billion in 2013.

Oncology is one of J&J’s five therapeutic areas of focus. The other four are cardiovascular and metabolism, infectious diseases and vaccines, immunology, and neuroscience. Within those other areas, Janssen cited as drivers of future growth:

  • Three infectious disease compounds—The uridine-based nucleotide analog AL-335 for hepatitis C; the oral nucleoside analog AL-8176 for respiratory syncytial virus; and JNJ-872 (VX-787), a first-in-class oral polymerase inhibitor for influenza A. J&J inherited the first two last year when it acquired Alios BioPharma for about $1.75 billion, and is co-developing JNJ-872 under a $30 million-plus collaboration with Vertex Pharmaceuticals inked last year.
  • Three neuroscience compounds—the NMDA receptor antagonist esketamine for treatment-resistant depression; the anti-nerve growth factor antibody fulranumab for osteoarthritic pain, licensed from Amgen under an up-to-$434 million licensing deal signed in 2008; and the Orexin-2 antagonist JNJ-922 for primary insomnia.
  • Two immunology compounds—the anti-Interleukin-23 monoclonal antibody guselkumab for psoriasis, discovered and developed by Janssen using the Human Combinatorial Antibody Library (HuCAL) antibody technology licensed from MorphoSys; and the human anti-interleukin-6 monoclonal antibody sirukumab for rheumatoid arthritis, co-developed with GlaxoSmithKline.

Daratumumab and esketamine have both received Breakthrough Therapy Designations from the FDA. 

Janssen also said it plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the European Medicines Agency this year for daratumumab in double refractory multiple myeloma. The submission will be based on Phase II data, which the company said will be presented at the upcoming American Society of Clinical Oncology annual meeting, to be held May 29–June 2 in Chicago.

Additionally, Janssen told analysts, it will also pursue approvals for more than 40 line extensions of existing and new medicines by 2019.

Four of those are Phase III indications being pursued for daratumumab as part of combination therapies—Relapsed/refractory multiple myeloma in combination with lenalidomide/dexamethasone (MMY3003); relapsed/refractory multiple myeloma in combination with bortezomib/dexamethasone (MMY3004); frontline multiple myeloma transplant ineligible patients in combination with bortezomib, melphalan, and prednisone (MMY 3007); and frontline multiple myeloma transplant ineligible patients in combination with lenalidomide and low dose dexamethasone (MMY 3008).

 

[This report corrects information from an earlier version on the developer of guselkumab and the licensor of the compound's Human Combinatorial Antibody Library (HuCAL) antibody technology].








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