TOP SELLING DRUGS
In 2014, AbbVie grew worldwide net sales by 6% to $20 billion, driven primarily by the continued strength of Humira and double-digit sales growth from other key products including Creon, Duodopa and Synthroid. Sales growth in 2014 continued to reflect the impact of the loss of exclusivity in the company’s lipid franchise, which resulted in the loss of $748 million of revenue in 2014 over the prior year. Generic competition began in November 2012 for TriCor, July 2013 for Trilipix and September 2013 for Niaspan.
AbbVie has major leading franchises in immunology, virology and a strong emerging franchise in oncology. Products are focused on treating conditions such as chronic autoimmune diseases, including rheumatoid arthritis, psoriasis, and Crohn’s disease; hepatitis C (HCV); human immunodeficiency virus (HIV); endometriosis; thyroid disease; Parkinson’s disease; complications associated with chronic kidney disease and cystic fibrosis; and other health conditions such as low testosterone.
AbbVie also has a pipeline of promising new medicines, including more than 30 compounds or indications in Phase II or Phase III development across such important medical specialties as immunology, virology/liver disease, oncology, renal disease, neurological diseases and women’s health.
AbbVie continued to advance its pipeline during 2014, and has more than 40 programs in clinical development, with 30 of those in Phase II or Phase III development across medical specialties as immunology, virology/liver disease, oncology, renal disease, neurological diseases and women’s health. There are 10 ongoing or recently initiated potential registration programs in oncology; completed late-stage clinical trials in virology, neuroscience and immunology.
During the year, the company secured regulatory approval in the U.S. for its interferon-free HCV treatment, Viekira Pak, as well as submitting its regulatory application in the EU, which was subsequently approved in January 2015. AbbVie also continued to advance its previously submitted regulatory applications in the U.S. for Duopa, which were also approved in January 2015, and completed several late-stage clinical trials, including Zinbryta (daclizumab) for the treatment of the relapsing/remitting form of multiple sclerosis (MS) and registrational programs for an expanded use of Humira for hidradenitis suppurativa. AbbVie also augmented its pipeline through strategic licensing and partnering activities including in-licensing duvelisib, a dual acting PI3 kinase inhibitor currently under investigation for use in a variety of hematological malignancies from Infinity.
The major event during the year for AbbVie was its acquisition of Pharmacyclics for $21 billion, for which it gained the flagship asset Imbruvica (ibrutinib) for hematologic malignancies. The acquisition expands AbbVie’s clinical and commercial presence in oncology.
Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor approved for four indications to treat three different types of blood cancers including chronic lymphocytic leukemia, mantle cell lymphoma and Waldenstrom’s macroglobulinemia. Imbruvica received FDA approval in 2013 and is the only therapy to have received three Breakthrough Therapy designations by the FDA. It is currently approved in more than 40 countries.
Potential further Imbruvica indications include solid tumors, as well as the potential to leverage AbbVie’s immunology expertise for the development of Pharmacyclics’ immunology program, and advance AbbVie’s efforts in hematologic malignancies.
AbbVie, along with Bristol-Myers Squibb (BMS), received Breakthrough Therapy Designation from the FDA for elotuzumab, an investigational humanized monoclonal antibody for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.
The designation is based on findings from a Phase II study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated MM patients.
In 2014 AbbVie entered into a number of new and innovative collaborations and licensing arrangements, including a partnership with Calico, the Google-based life sciences company. The two companies entered an R&D collaboration to discover, develop and market new therapies for age-related diseases, including neurodegeneration and cancer. Calico is funded by Google and led by former Genentech executives Arthur Levinson and Hal Barron.
As part of the deal, Calico will establish a new R&D facility in the San Francisco Bay Area with a focus on drug discovery and early drug development and AbbVie will provide scientific and clinical development support, as well as its commercial expertise.
AbbVie and Calico will initially contribute as much as $250 million to fund the collaboration with the potential for an additional $500 million each. Calico will be responsible for research and early development for the first five years and to advance collaboration projects through Phase IIa for a 10-year period.
AbbVie will support Calico in its early R&D efforts and, following Phase IIa studies, will have the option to manage late-stage development and commercial activities. Both parties will share costs and profits equally.
In terms of global expansion, AbbVie is investing $320 million to establish manufacturing operations in Singapore for small molecule and biologics active drug substance. Once completed, the facility will provide manufacturing capacity for compounds in AbbVie’s oncology and immunology pipeline to serve global markets. The investment is expected to result in additional headcount of more than 250 new employees. AbbVie anticipates the facility will be fully operational by 2019.
AbbVie’s operations in Asia currently include R&D functions in Tokyo, Japan and Shanghai, China, as well as commercial operations throughout the region. AbbVie currently employs 120 personnel in Singapore, supporting commercial operations, global R&D, and general operations.
AbbVie has been steaming ahead like a train since it departed from Abbott in 2013, planting itself firmly among the top Pharma companies. Whether or not it can sustain this growth will be interesting to see as it faces the impending doom of its massive money making anti-inflammatory drug Humira losing patent protection in the U.S. in December 2016. Humira accounts for more than half of AbbVie’s profits and accounts for more than 60% of its sales, so should it be worried about generic competition?
AbbVie may well have a stay of execution due to the fact that Humira is a biologic, so it’s not easy to manufacture it off a production line. On top of that, most countries in the EU have patents in place until 2018, so this should give them time to fill the hole that the loss of Humira may cause. There is indeed already a biologic ready to jump in the seat of Humira from India’s Cadila Healthcare, but it can’t make it into Europe until probably 2019.
AbbVie isn’t standing still, with a growing drug pipeline and the acquisition of cancer biopharma company Pharmacyclics in March this year, its hopes will be that Imbruvica (Pharmacyclics haematology product) will be able to hold up the financial fort. Also, bringing with it three drugs already in clinical trials, AbbVie looks like it’s going to be among Big Pharma for the long haul.