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By PharmaCompass
2022-12-01
Impressions: 3484
In our second article of the Company Tracker series, we analyze AbbVie — a company that was spun out of Abbott Laboratories less than a decade ago. This Illinois-headquartered drugmaker holds a lot of promise, and analysts expect it to emerge as the world’s biggest pharma company by prescription sales, beating Roche, by 2028.
AbbVie has been quietly moving up the charts — in 2014, it was the world’s thirteenth largest drugmaker, with global revenues to the tune of US$ 19.96 billion (up from US$ 18.8 billion in 2013). And last year, despite not having a Covid vaccine or therapy in its armor, it moved up to the number four slot, just behind Johnson & Johnson, Pfizer and Roche, with a turnover of US$ 56.2 billion. This marked a 22 percent increase from its 2020 revenues (US$ 45.8 billion). In the first three quarters of 2022, AbbVie has generated US$ 42.9 billion in sales.
AbbVie is working in seven therapeutic areas, including immunology, hematologic oncology, neuroscience, aesthetics, eye care, virology and other specialty areas (women’s health and gastroenterology). AbbVie also has five technology platforms — targeted antibodies, targeted degradation, gene therapy, cell therapy and small molecules. In 2021, it invested US$ 6.5 billion in research and development.
Since its separation from Abbott, AbbVie has been led by Richard A. Gonzalez (68), who is the chairman of the board and the CEO. He is someone who has known the industry inside-out — at the time of taking charge, Gonzalez had worked for Abbott for 30 years. Overall, AbbVie employs approximately 50,000 people worldwide.
For AbbVie, Humira (adalimumab) and Imbruvica (ibrutinib) are the two highest revenue generators. Humira was the second and Imbruvica the seventh in the list of top drugs by worldwide sales in 2021.
Even though AbbVie is facing one of the steepest patent cliffs in the industry’s history, what with Humira slated to face the onslaught of eight biosimilars next year, the forecasts for the drugmaker are rather bright — according to extended consensus forecasts from Evaluate Pharma, AbbVie is expected to post a turnover of US$ 65.7 billion by 2028.
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Nine years of rapid growth, acquisitions and collaborations
AbbVie, which is today a global research-based biopharmaceutical company, has grown from strength to strength since its split from Abbott in 2013.
Perhaps the biggest reason behind the success of AbbVie has been Humira, Abbott’s top-selling drug that it had acquired through its purchase of Knoll Pharmaceuticals in March 2001. Humira is a monoclonal antibody approved in 2002 to treat autoimmune diseases. Humira clocked sales of US$ 20.7 billion in revenues last year, and was only behind Pfizer’s Covid vaccine — Comirnaty — in global sales. In the first three quarters of 2022, Humira has generated US$ 15.7 billion in sales.
AbbVie has also grown considerably through acquisitions. In 2015, AbbVie acquired Pharmacyclics for US$ 21 billion, giving it access to the latter’s blockbuster oncology drug Imbruvica. And in 2019, AbbVie announced the acquisition of Allergan for US$ 63 billion, giving it access to blockbuster drug Botox (onabotulinumtoxinA), along with other drugs like Vraylar, Juvederm and Ubrelvy. The acquisition was completed in 2020. The global market for botulinum toxin (sold under various trade names, including Botox) was estimated at around US$ 4.9 billion in 2020, and is projected to reach US$ 7.9 billion by 2026. Botox generated US$ 4 billion in sales in the first three quarters of 2022. The biosimilars of Botox have been around since 2019.
AbbVie plans to strengthen its neurological portfolio. This year, it has signed a US$ 1.28 billion pact with Sosei Heptares for the discovery, development and marketing of therapies for neurological ailments. And in March, the company acquired Syndesi Therapeutics for US$ 1 billion. This acquisition gives AbbVie access to Syndesi’s lead candidate SDI-118, a small molecule that is under evaluation to treat Alzheimer’s disease and major depressive disorder.
Another area of focus for this American drugmaker is ophthalmology. In September 2021, AbbVie and Regenxbio announced an eye care collaboration. Through this deal, the two companies will develop and commercialize RGX-314, an investigational gene therapy for wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases.
Oncology is another key area for AbbVie. In September 2020, AbbVie tied up with Chinese firm I-Mab for cancer therapies. The two companies will develop and commercialize lemzoparlimab, an anti-CD47 monoclonal antibody discovered and developed by I-Mab for the treatment of multiple cancers.
In June 2020, AbbVie and Genmab had announced a broad oncology collaboration. In November 2022, US Food and Drug Administration (FDA) accepted for priority review the biologics license application (BLA) for epcoritamab, co-developed by AbbVie and Genmab, for the treatment of relapsed/refractory large B-Cell lymphoma (LBCL). If approved, epcoritamab will become the first subcutaneous bispecific antibody available for the treatment of LBCL. FDA’s approval is expected in May 2023. And in October 2022, AbbVie announced that the European Medicines Agency (EMA) has validated its marketing authorization application for epcoritamab for the same indication.
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Focuses on Skyrizi, Rinvoq to make up for drop in Humira sales due to biosimilars
Humira has clearly been the jewel in AbbVie’s crown. Humira is the world’s all-time best-selling drug that has generated more than US$ 200 billion in revenues over the last two decades. It snatched the crown for the most successful drug from Lipitor (atorvastatin), a cholesterol-lowering drug, which has accumulated around US$ 160 billion in full-year sales in 23 years.
Humira is now approved in the US for use in 11 indications, which includes five pediatric approvals. But in 2023, Humira will face considerable competition from biosimilars. Seven Humira biosimilars that have received FDA approvals will be launched in 2023, — Amjevita (Amgen), Abrilada (Pfizer), Cyltezo (Boehringer), Hadlima (Samsung Bioepis), Hyrimoz (Sandoz), Hulio (Viatris) and Yusimry (Coherus BioSciences). Amgen’s Humira biosimilar will hit the market in January 2023, while Boehringer Ingelheim’s Cyltezo — the first “interchangeable biosimilar” competitor — will be launched in July 2023.
AbbVie expects a 45 percent (plus or minus 10 percent) erosion in Humira sales in 2023. Biosimilars of Humira have already been launched in Europe. The drug’s European patent expired in October 2018.
To prepare for the loss in Humira sales, AbbVie is focusing on its two new immunology drugs — Skyrizi (risankizumab) and Rinvoq (upadacitinib). In January 2022, Rob Michael, AbbVie's vice chairman and president, said the company believes that Rinvoq and Skyrizi at peak will be greater than Humira (in terms of sales). Rinvoq and Skyrizi generated US$ 4.6 billion in combined sales in 2021. The company expects the two drugs to generate over US$ 15 billion in sales by 2025.
Skyrizi, first approved in 2019, is an anti-IL-23 antibody approved in the US and Europe for the treatment of three inflammatory diseases, including psoriasis, psoriatic arthritis and Crohn’s disease. It is currently in phase 3 for the treatment of ulcerative colitis. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie. Global Skyrizi net revenues were US$ 2.9 billion in 2021. In the first three quarters of 2022, the drug has brought in sales worth US$ 3.6 billion.
Rinvoq, approved by FDA in 2019, is an oral JAK1 selective inhibitor approved for six indications— rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis and active non-radiographic axial spondyloarthritis. The drug received its latest FDA approval for active non-radiographic axial spondyloarthritis in October 2022. It is being investigated for three additional indications — Crohn’s disease, Takayasu arteritis and giant cell arteritis. Globally, Rinvoq generated US$ 1.6 billion sales in 2021, an increase of over 100 percent. It has netted US$ 1.8 billion in the first nine months of 2022. Its increase in revenue was mainly driven by regulatory approvals and expansion of indications.
Imbruvica (Ibrutinib), approved in 2013, is an oral Bruton’s tyrosine kinase inhibitor indicated for the treatment of adult patients with blood cancers such as chronic lymphocytic leukemia (CLL) as well as certain forms of non-Hodgkin lymphoma and chronic graft versus host disease. The drug is now the only BTKi with 12 FDA approvals across seven indications, including five hematologic cancers and cGVHD. It is available in three formulations — capsules, tablets and oral suspensions.
In August 2022, the FDA approved a new oral suspension formulation of the drug as the first and only BTKi treatment for pediatric patients with chronic graft-versus-host disease. This is the first pediatric indication for the drug. Globally, Imbruvica generated US$ 5.4 billion sales in 2021, a rise of 1.8 percent in comparison to 2020. In the first three quarters of 2022, it has generated US$ 3.5 billion in sales. Janssen Biotech, which commercializes Imbruvica outside of the US alone and co-exclusively with AbbVie in the US, reported US$ 2.9 billion in sales in the first nine months of 2022. The blockbuster cancer drug is unlikely to face generic competition until 2032.
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New CAR-T technology, promising experimental drugs may bring more growth
Over the last couple of years, AbbVie has bagged several drug approvals. In August this year, Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate-to-severe loss of jawline definition. Juvederm Volux XC is the first and only hyaluronic acid filler to receive FDA approval for jawline definition.
In September 2021, FDA approved AbbVie’s Qulipta (atogepant) tablet as the first and only oral CGRP receptor antagonist specifically developed as a preventive treatment of episodic migraine in adults. In June 2022, AbbVie submitted a supplemental NDA to the FDA for Qulipta for the preventive treatment of chronic migraine in adult patients. If approved, Qulipta would be the first gepant (oral calcitonin gene-related peptide receptor antagonist) approved for the preventive treatment of episodic and chronic migraine. It expects an FDA decision in the first half of 2023. AbbVie also submitted a marketing authorization application for Qulipta with the EMA.
In October 2021, Allergan Aesthetics announced FDA’s approval of Vuity (pilocarpine HCI 1.25 percent ophthalmic solution) as a treatment for presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition.
In September this year, AbbVie and California Institute for Biomedical Research (Calibr) reported the positive clinical data from a phase 1 study on a new CAR-T technology which uses “switchable” cells that aim to eliminate the life-threatening side-effects of this type of immunotherapy. Switchable CAR-T therapy is a novel universal chimeric antigen receptor platform for safe control of T-cell activation. AbbVie had entered into a collaboration with Calibr in 2018.
Over the next two years, AbbVie hopes to bag the approval of over a dozen new products or indications. One such drug is ABBV-951 (foscarbidopa/foslevodopa), an experimental treatment for motor fluctuations in patients with advanced Parkinson’s disease. In May this year, AbbVie submitted an NDA to the FDA, based on phase 3 results that demonstrated statistically significant improvement. If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs. ABBV-951 approval is expected in early 2023.
Similarly, AbbVie’s oral oncology drug being developed for myelofibrosis — Navitoclax — is currently in phase 3 trials. Other promising drugs in phase 3 trials are Veliparib (a PARP inhibitor being investigated to treat BRCA mutation-associated breast cancer and ovarian cancer), Aztreonam-Avibactam combination (for the treatment of complicated gram-negative bacterial infections) and Teliso-V. Teliso-V (telisotuzumab vedotin) is a c-Met antibody-drug conjugate being developed for non-small cell lung cancer with c-Met over-expression. There are currently no approved cancer therapies for this indication.
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Our view
AbbVie has shown remarkable growth over the last nine years since it was spun out from Abbott Laboratories. Its turnover increased from US$ 18.8 billion in 2013 to US$ 32.7 billion in 2018 and US$ 56.2 billion in 2021.
AbbVie’s pipeline includes 58 programs, including 27 drugs in oncology; nine drugs in neuroscience; eight drugs in immunology; four drugs in eye care; three drugs and seven programs (devices) in aesthetics.
The drugmaker has eight state-of-the-art R&D research centers and 14 manufacturing centers. It also has a contract manufacturing division — AbbVie Contract Manufacturing — that provides CMO services for biologics, potent drugs, oral solid dose, topical, eye care, microbial fermentation, prefilled syringes, hot melt extrusion, fill/finish and custom APIs. Therefore, the drugmaker has what it takes to deliver on both R&D and manufacturing.
Given these promising details, AbbVie is expected to cross US$ 65 billion in turnover within the next five years, if not earlier, and emerge as the world’s biggest pharma company by prescription sales, beating Roche.
(All financial and drug pipeline-related information has been taken from the AbbVie website.)
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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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