07.11.22
Headquarters: North Chicago, IL
twitter.com/abbvie
www.abbvie.com
Headcount: 50,0000
Year Established: 2013
Revenues: $56,197 (+23%)
Net Income: $11,542 (+150%)
R&D: $7,084 (+8%)
TOP SELLING DRUGS
Operating as a single global business segment dedicated to research and development, manufacturing, and commercialization of innovative medicines and therapies, AbbVie’s portfolio of products include therapies that address complex and serious diseases. Key among its products are immunology therapies, namely Humira, which is sold in markets globally and accounted for approximately 37% of AbbVie’s total revenue in 2021, despite biosimilar competition in numerous markets.
Recently Abbvie resolved all U.S. Humira litigation with Alvotech, under which, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its patents. The resolution includes dismissal of the patent and trade secret litigation between the two companies.
Fast becoming another flagship product, Skyrizi (risankizumab), a biologic therapy for psoriasis administered as a quarterly injection following two induction doses, achieved sales nearing $3 billion, up 85% in 2021 and becoming third in line in sales. Meanwhile, Rinvoq (upadacitinib), an oral, once-daily selective and reversible JAK inhibitor to treat inflammatory diseases, with recent approvals and expanded indications saw sales up over 100%.
Abbvie’s next top seller Imbruvica, a hematologic oncology treatment developed and commercialized in partnership with Janssen Biotech, Inc., recently demonstrated significant survival outcomes in older adults. Primary seven-year data from Janssen’s Phase III trial of Imbruvica in lymphoma demonstrated the drug’s ability to reduce the risk of disease progression by 25% when combined with bendamustine-rituximab and rituximab. Abbvie is currently seeking approval for the treatment of pediatric and adolescent patients with chronic graft versus host disease. Results from Phase 1/2 iMAGINE trial showed an overall response rate of 78% with Imbruvica and after 20 weeks, sustained response rates were observed in 70% and 58% of treatment-naive and relapsed/refractory responders, respectively.
Additionally, legacy Allergan products continue to contribute to Abbvie’s momentum. Significant growth drivers in neuroscience include Vraylar and Botox Therapeutic. Vraylar (cariprazine) is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist. Its D3 binding profile may be linked to observed improvements in the negative symptoms of schizophrenia and to antidepressant effects in bipolar I disorder. Abbvie is seeking FDA approval of Vraylar for the adjunctive treatment of major depressive disorder, supported by a recent study that met its primary endpoint of statistically significant improvement in patients compared with placebo.
Meanwhile, Botox Therapeutic (onabotulinumtoxinA injection), a neuromuscular blocking agent that is injected into muscle tissue, is approved to treat numerous indications from headaches and urinary incontinence to spasticity.
Also, bolstering 2021 results, global revenues from the aesthetics portfolio were up 23% to $1.4 billion, with Botox Cosmetic revenues of $626 million, an increase of 27% and global Juvederm revenues of $432 million, an increase of 31%.
Syndesi’s lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. Synaptic dysfunction is believed to underlie the cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders.
In another recent acquisition, Allergan Aesthetics, an AbbVie company, acquired Soliton, Inc. complementing Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.
Meanwhile, several alliances and investments aim to address autoimmune, inflammatory and neuropsychiatric diseases. An exclusive worldwide license option agreement with Cugene Inc., aims to advance CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. AbbVie paid $48.5 million upfront and has an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. Currently in Phase 1, CUG252 is designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases.
Additionally, a new co-development and license agreement with Gedeon Richter Plc. will research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. Richter will receive an upfront cash payment, along with potential development, regulatory and commercialization milestones. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.
Finally, for $40 million upfront, an equity investment, and as much as $300 million in future development and regulatory milestones, a collaboration and license agreement with Caribou Biosciences will research and develop chimeric antigen receptor (CAR)-T cell therapeutics. Although CAR-T cell therapies have shown early promise in some cancer patients, overcoming the rejection of allogeneic CAR-T cells by the host immune system remains a key challenge. Employing Caribou’s CRISPR genome editing platform to engineer CAR-T cells to withstand host immune attack aims to enable the development of next-generation of “off-the-shelf” cell therapies for a broader patient population. AbbVie is responsible for all clinical development, commercialization, and manufacturing efforts.
The company’s latest eye care innovation VUITY (pilocarpine HCl ophthalmic solution) was approved by the FDA for presbyopia or age-related blurry near vision, in adults. This is a first-of-its-kind treatment for this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. The daily eye drop works in as early as 15 minutes and lasts up to 6 hours, to improve near and intermediate vision without impacting distance vision.
The FDA also approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. This is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine. Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days in adults with episodic migraine compared to placebo, with the majority of patients experiencing between a 50-100% reduction in the 12-week treatment period. This is AbbVie’s third treatment across the full spectrum of migraine.
In recent pipeline news, AbbVie submitted a New Drug Application to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. The submission is based on Phase 3 results demonstrating statistically significant improvement in “On” time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD, offering the potential for improvement in motor fluctuations in patients with advanced Parkinson’s disease.
Finally, Teliso-V, an antibody-drug conjugate, is being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression. Earlier this year the FDA granted the drug Breakthrough Therapy Designation supported by data from an ongoing Phase 2 study. The primary endpoint of overall response rate was 53.8% in the c-Met high group and 25% in the c-Met group at reported interim analysis.
twitter.com/abbvie
www.abbvie.com
Headcount: 50,0000
Year Established: 2013
Revenues: $56,197 (+23%)
Net Income: $11,542 (+150%)
R&D: $7,084 (+8%)
TOP SELLING DRUGS
Drug | Indication | 2021 Sales | (+/-%) |
Humira | rheumatoid arthritis | $20,694 | 4% |
Imbruvica | chronic lymphocyti leukemia | $5,408 | 2% |
Skyrizi | psoriasis | $2,939 | 85% |
Botox | Therapeutic neuromuscular blocking agent | $2,451 | 77% |
Venclexta | leukaemia, chronic lymphocytic (CLL) | $1,820 | 36% |
Vraylar | schizophrenia, Bipolar 1 | $1,728 | 82% |
Mavyret | hepatitis C | $1,710 | -7% |
Rinvoq | rheumatoid arthritis atopic dermatitis, ulcerative colitis | $1,651 | >100% |
Restasis | dry eye | $1,290 | 64% |
Creon | cystic fibrosis | $1,191 | 7% |
Operating as a single global business segment dedicated to research and development, manufacturing, and commercialization of innovative medicines and therapies, AbbVie’s portfolio of products include therapies that address complex and serious diseases. Key among its products are immunology therapies, namely Humira, which is sold in markets globally and accounted for approximately 37% of AbbVie’s total revenue in 2021, despite biosimilar competition in numerous markets.
Recently Abbvie resolved all U.S. Humira litigation with Alvotech, under which, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its patents. The resolution includes dismissal of the patent and trade secret litigation between the two companies.
Fast becoming another flagship product, Skyrizi (risankizumab), a biologic therapy for psoriasis administered as a quarterly injection following two induction doses, achieved sales nearing $3 billion, up 85% in 2021 and becoming third in line in sales. Meanwhile, Rinvoq (upadacitinib), an oral, once-daily selective and reversible JAK inhibitor to treat inflammatory diseases, with recent approvals and expanded indications saw sales up over 100%.
Abbvie’s next top seller Imbruvica, a hematologic oncology treatment developed and commercialized in partnership with Janssen Biotech, Inc., recently demonstrated significant survival outcomes in older adults. Primary seven-year data from Janssen’s Phase III trial of Imbruvica in lymphoma demonstrated the drug’s ability to reduce the risk of disease progression by 25% when combined with bendamustine-rituximab and rituximab. Abbvie is currently seeking approval for the treatment of pediatric and adolescent patients with chronic graft versus host disease. Results from Phase 1/2 iMAGINE trial showed an overall response rate of 78% with Imbruvica and after 20 weeks, sustained response rates were observed in 70% and 58% of treatment-naive and relapsed/refractory responders, respectively.
Additionally, legacy Allergan products continue to contribute to Abbvie’s momentum. Significant growth drivers in neuroscience include Vraylar and Botox Therapeutic. Vraylar (cariprazine) is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist. Its D3 binding profile may be linked to observed improvements in the negative symptoms of schizophrenia and to antidepressant effects in bipolar I disorder. Abbvie is seeking FDA approval of Vraylar for the adjunctive treatment of major depressive disorder, supported by a recent study that met its primary endpoint of statistically significant improvement in patients compared with placebo.
Meanwhile, Botox Therapeutic (onabotulinumtoxinA injection), a neuromuscular blocking agent that is injected into muscle tissue, is approved to treat numerous indications from headaches and urinary incontinence to spasticity.
Also, bolstering 2021 results, global revenues from the aesthetics portfolio were up 23% to $1.4 billion, with Botox Cosmetic revenues of $626 million, an increase of 27% and global Juvederm revenues of $432 million, an increase of 31%.
Acquisitions and Alliances
For $130 million upfront and potential additional payments of as much as $870 million based on certain milestones, AbbVie recently acquired Syndesi Therapeutics SA, expanding its neuroscience portfolio with novel modulators of the synaptic vesicle protein 2A. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder.Syndesi’s lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. Synaptic dysfunction is believed to underlie the cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders.
In another recent acquisition, Allergan Aesthetics, an AbbVie company, acquired Soliton, Inc. complementing Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.
Meanwhile, several alliances and investments aim to address autoimmune, inflammatory and neuropsychiatric diseases. An exclusive worldwide license option agreement with Cugene Inc., aims to advance CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases. AbbVie paid $48.5 million upfront and has an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. Currently in Phase 1, CUG252 is designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases.
Additionally, a new co-development and license agreement with Gedeon Richter Plc. will research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. Richter will receive an upfront cash payment, along with potential development, regulatory and commercialization milestones. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.
Finally, for $40 million upfront, an equity investment, and as much as $300 million in future development and regulatory milestones, a collaboration and license agreement with Caribou Biosciences will research and develop chimeric antigen receptor (CAR)-T cell therapeutics. Although CAR-T cell therapies have shown early promise in some cancer patients, overcoming the rejection of allogeneic CAR-T cells by the host immune system remains a key challenge. Employing Caribou’s CRISPR genome editing platform to engineer CAR-T cells to withstand host immune attack aims to enable the development of next-generation of “off-the-shelf” cell therapies for a broader patient population. AbbVie is responsible for all clinical development, commercialization, and manufacturing efforts.
R&D Pipeline
Abbie anticipates the approval of more than dozen new products or indications in its key therapeutic franchises over the next couple of years. Among recent approvals are additional indications for key products as well as approvals for new products in eye care and migraine. Rinvoq has been approved by the FDA for the treatment of moderate to severe atopic dermatitis and adults with active psoriatic arthritis (PsA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers, and for the treatment of adults with active ankylosing spondylitis and moderate to severe ulcerative colitis. Additionally, the FDA approved Skyrizi for the treatment of adults with active PsA after demonstrating significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo, marking the drug’s second FDA-approved indication.The company’s latest eye care innovation VUITY (pilocarpine HCl ophthalmic solution) was approved by the FDA for presbyopia or age-related blurry near vision, in adults. This is a first-of-its-kind treatment for this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. The daily eye drop works in as early as 15 minutes and lasts up to 6 hours, to improve near and intermediate vision without impacting distance vision.
The FDA also approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. This is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine. Qulipta demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days in adults with episodic migraine compared to placebo, with the majority of patients experiencing between a 50-100% reduction in the 12-week treatment period. This is AbbVie’s third treatment across the full spectrum of migraine.
In recent pipeline news, AbbVie submitted a New Drug Application to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. The submission is based on Phase 3 results demonstrating statistically significant improvement in “On” time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD, offering the potential for improvement in motor fluctuations in patients with advanced Parkinson’s disease.
Finally, Teliso-V, an antibody-drug conjugate, is being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression. Earlier this year the FDA granted the drug Breakthrough Therapy Designation supported by data from an ongoing Phase 2 study. The primary endpoint of overall response rate was 53.8% in the c-Met high group and 25% in the c-Met group at reported interim analysis.