Year Established: 2013
Revenues: $32,753 (+16%)
Net Income: $5,687 (+7%)
R&D: $10,329 (+106%)
TOP SELLING DRUGS
|Imbruvica||chronic lymphocytic leukemia||$2,968||38%|
AbbVie’s revenues grew 16% to $32.8 billion in 2018 driven primarily by sales growth related to Mavyret, Imbruvica and Venclexta and the continued strength of Humira. The arthritis blockbuster again topped the 2018 list of top selling drugs, raking in $19.9 billion in sales—an increase of 8.2%. Biosimilar competition is expected to hurt Humira sales in 2019, but is not expected to be an issue in the U.S. until 2023.
Cancer drugs Imbruvica and Venclexta both reported positive growth. Imbruvica revenue was $3.6 billion, an increase of 39.5%, driven by market share growth in front-line chronic lymphocytic leukemia (CLL) and other approved indications. Venclexta increased its sales by more than 100% in 2018 primarily due to market share gains following FDA and EMA approvals in combination with Rituxan. Hep C drug Mavyret’s sales increased by more than 100% in 2018 after its approval by FDA and EMA in the second half of 2017 as well as further geographic expansion in 2018. Mavyret’s penetration into the market hurt revenues of fellow hep C drug Viekira, whose sales decreased by 76% in 2018.
AbbVie’s pipeline includes more than 60 compounds or indications in development across immunology, oncology and neuroscience, with additional targeted investments in cystic fibrosis and women’s health.
AbbVie achieved a number of regulatory milestones for several key products in 2018, including regulatory approvals for cancer drug Venclexta in combination with Rituxan (rituximab) and in combination with azacitidine or decitabine; Imbruvica was also approved in combination with rituximab for cancer treatment. In addition, the company introduced Orilissa, the first FDA-approved oral treatment in over a decade for the management of moderate to severe pain associated with endometriosis.
With more than 30 programs in mid- and late-stage development, some highlights from AbbVie’s pipeline advancements in 2018 including having completed registrational studies and submitted regulatory applications for the company’s next-generation immunology assets, upadacitinib and risankizumab, in rheumatoid arthritis and psoriasis, respectively. In addition, the company initiated several Phase 3 programs for these assets including studies for upadacitinib in atopic dermatitis and ulcerative colitis, as well as risankizumab in Crohn’s disease.
Extends R&D alliance with Calico
AbbVie and Calico extended their collaboration to discover, develop and market new therapies for patients with age-related diseases, including neurodegeneration and cancer.
Calico is the Alphabet-backed life sciences company that is led by former Genentech chairman and chief executive officer Arthur D. Levinson, Ph.D. Calico has a research and development facility in the San Francisco Bay Area and more than 150 employees.
The collaboration has been extended for an additional three years. Calico will be responsible for research and early development until 2022 and will advance collaboration projects through Phase IIa through 2027. AbbVie will continue to support Calico in its early R&D efforts and, following completion of Phase IIa studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits. AbbVie and Calico will each commit to contribute an additional $500 million to the collaboration.
Since 2014, the collaboration has produced more than two dozen early-stage programs addressing disease states across oncology and neuroscience and yielded new insights into the biology of aging.
In other R&D tie-ups, AbbVie and Calibr entered a collaboration to develop T-cell therapies aimed primarily at cancer, including solid tumors, leveraging advanced precision medicine technology. AbbVie gains exclusive access to Calibr’s switchable CAR-T platform for up to four years. The companies will work together to develop T-cell therapies directed to solid tumor targets identified by AbbVie.
AbbVie also has the option to develop additional cell therapies toward AbbVie-nominated targets and license existing Calibr cell therapy programs under development for hematological and solid cancers, including Calibr’s lead program.
Calibr plans to enter this lead candidate into clinical studies for lymphoma in 2019. In addition, the agreement provides AbbVie with an option to acquire an exclusive license to Calibr’s switchable CAR-T platform and programs within the first four years of the collaboration. The companies will share responsibility for preclinical development, and AbbVie is responsible for clinical development and commercialization. Calibr is eligible to receive success-based milestone payments and royalties.
Calibr’s cell therapy program is designed to enhance safety, versatility and efficacy through a proprietary modular “switchable” CAR-T cell that uses antibody-based switch molecules to control the activation and antigen specificity of CAR-T cells. Calibr’s technology may enable the development of universal CAR-T-based treatments across several types of hematological and solid tumor indications.
With Voyager Therapeutics, AbbVie entered an exclusive strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer’s disease and other neurodegenerative diseases. The collaboration combines AbbVie’s monoclonal antibody expertise, global clinical development and commercial capabilities with Voyager’s gene therapy platform that enables generating adeno-associated viral (AAV) vectors for the treatment of neurodegenerative diseases.
In healthy individuals, tau is an abundant protein in the brain that promotes cellular stability and function. In the diseased brain, altered tau accumulates, resulting in impaired brain function and neuronal cell loss. One of the limitations with current biologic therapies for neurodegenerative diseases is that only a small amount of drug makes it into the brain. This collaboration aims to develop a potential one-time treatment using Voyager’s gene therapy platform to reduce tau pathology through the delivery of an AAV vector antibody that encodes the genetic instructions to produce anti-tau antibodies within the brain.
Lastly, AbbVie took over full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). The investigational program comprises several clinical and preclinical compounds originally discovered and developed jointly by AbbVie and Galapagos. Galapagos will not pursue further research and development in CF, but is eligible for future milestones and royalties on commercialized programs. Galapagos retains the right to future development of GLPG-2737 in non-CF indications. AbbVie is eligible to receive undisclosed future milestones and royalties in non-CF indications.