Year Established: 1886
Pharma Revenues: $45,572 (+8%)
Net Income: $14,714 (-3%)
R&D: $12,159 (+7%)
TOP SELLING DRUGS
|Stelara||psoriasis, Crohns’ disease, ulcerative colitis||$7,707||21%|
|Xarelto||deep vein thrombosis, pulmonary embolism||$2,345||1%|
Johnson & Johnson (J&J) managed to grow its pharma sales 8% to $45.6 billion in 2020, despite the negative impact of COVID-19 on demand and lower sales of Remicade due to biosimilar competition.
Immunology product sales account for the largest share of J&J’s portfolio and were strong in 2020. Revenues in the segment grew 8% to $15 billion driven by the strong uptake of Stelara (+21%) in Crohn's disease and Ulcerative Colitis.
Oncology product growth was strong too, recording a 16% climb to $12.4 billion during the year. Positive segment performance was backed by strong sales of Darzalex (+40%) in all lines of therapy and the launch of a subcutaneous formulation in the U.S. and E.U., and Imbruvica, which grew 21% due to global market penetration.
Neuroscience product sales were $6.5 billion, an increase of 4% compared to the prior year, while Infectious Disease sales grew 5% to $3.6 billion due to positive performances by Symtuza and Juluca. Pulmonary Hypertension products grew to $3.1 billion, an increase of 20% driven by the uptake of the hypertension drug Opsumit (+24%). Lastly, Cardiovascular/Metabolism/Other product sales dropped 6% to $4.9 billion because of competition.
J&J continued to make positive pipeline progress during 2020. Some recent approvals include: Darzalex Faspro, the first FDA-approved treatment for patients with newly diagnosed light chain (AL) amyloidosis; Cabenuva, which received U.S. FDA approval and European Commission authorization for the first complete long-acting injectable HIV treatment; and Tremfya, which gained European Commission approval as a first-in-class treatment for Active Psoriatic Arthritis (PsA).
Notable regulatory submissions to U.S. FDA and European authorities include amivantamab for treatment of patients with metastatic non-small cell lung cancer; BCMA CAR-T Therapy and Darzalex separately for the treatment of relapsed and/or refractory multiple myeloma; Paliperidone Palmitate 6-Month for treatment of schizophrenia in adults; and Xarelto for a new indication to expand use in patients with peripheral artery disease.
In other pipeline news, Janssen received positive CHMP opinion for Spravato nasal spray for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder. During the year, Janssen also acquired rights to a novel gene therapy, pioneering treatment solutions for late-stage age-related macular degeneration.
Covid-19 vaccine update
During this past year’s race to get Covid-19 vaccines to people around the world, J&J made headlines, but not in a positive way. Initially, J&J’s vaccine was going to be a game changer because it requires just one dose, compared to the two-dose mRNA counterparts from Pfizer and Moderna.
However, as this issue went to press, J&J was told by FDA that it would have to throw away 60 million doses of its Janssen Covid-19 Vaccine, which received Emergency Use Authorization from the federal regulator in February 2021. This recent action is on top of another 15 million doses that had to be discarded earlier this year. Both actions are related to contamination issues with Johnson and Johnson's vaccine and AstraZeneca's vaccine. They were being made at a shared contract manufacturer, Emergent BioSolutions, and somehow there was contamination between the two vaccines.
While J&J hasn’t become the player in the Covid-19 vaccine market initially thought because of these manufacturing issues, the company continues its roll-out efforts. Doses that have made their way to U.S. were made at the company’s Netherlands plant, while Emergent’s facility in Baltimore remains shuttered pending further regulatory investigation. The firm also continues to broaden distribution efforts to other countries around the world.
J&J’s acquisitions in 2020 included Momenta Pharmaceuticals, a company that discovers and develops novel therapies for immune-mediated diseases, and all rights to the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees from XBiotech.
In August 2020, J&J paid approximately $6.5 billion to acquire Momenta. The acquisition was driven by the significant opportunity seen in Momenta’s lead candidate nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation from the U.S. FDA.
In addition, Janssen said it plans to retain Momenta’s presence in Cambridge, MA, increasing J&J’s existing innovation footprint and capabilities in the greater Boston area.
With XBiotech, Janssen entered a deal to acquire all rights to the investigational compound bermekimab for $750 million. Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development at the time of the deal for the treatment of atopic dermatitis and hidradenitis suppurativa. According to the company, it is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care.
Janssen assumed responsibility for bermekimab’s clinical program, working closely with XBiotech as it completes the ongoing Phase 2 studies in atopic dermatitis and hidradenitis suppurativa. Should Janssen pursue bermekimab indications outside of dermatology, XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations.
At the very end of 2019, J&J struck a deal to acquire TARIS Biomedical, a biotech specializing in novel drug delivery technology for the treatment of bladder diseases, including cancer. The company's lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. TARIS maintains a research presence in Lexington, MA and is part of Janssen R&D's Oncology Therapeutic Area. TARIS technology arose from research conducted at MIT's Koch Institute for Integrative Cancer Research.
In January 2021, J&J entered a couple R&D alliances of note. With the German independent research institute, BioMed X, a new research project with Janssen Research & Development LLC was formed to discover novel transport mechanisms in the human intestinal tract which could be utilized for oral delivery of diverse therapeutic modalities.
Biologics such as monoclonal antibodies have transformed the treatment of immune-related diseases, but need to be delivered by injection, which may have higher barriers to use compared to oral delivery. The collaboration was facilitated by Johnson & Johnson Innovation.
In another research tie-up formed at the beginning of this year, Janssen entered a pact with TenNor Therapeutics to leverage a multitargeting drug conjugation platform developed by TenNor to discover new therapies to treat nontuberculous mycobacteria (NTM) diseases. The agreement was also facilitated by Johnson & Johnson Innovation.
The collaboration builds on the scientific know-how and background intellectual property of TenNor associated with its multitargeting drug conjugation technology. The companies will collaborate to bring complementary expertise together to discover new treatment modalities for NTM diseases.