Kristin Brooks , Managing Editor, Contract Pharma07.15.20
Headquarters: North Chicago, IL
twitter.com/abbvie
www.abbvie.com
headcount: 30,000
Year Established: 2013
Revenues: $33,266 (+2%)
Net Income: $7,882 (+39%)
R&D: $6,407 (-38%)
TOP SELLING DRUGS
In looking at AbbVie’s foreseeable growth drivers, in the first quarter of 2020 IMBRUVICA, VENCLEXTA, SKYRIZI continued to make strides. Revenues were up 10% in the quarter to $8.6 billion, despite a 15% decline in International Humira sales and a 29% drop in Mavyret sales, the company’s top sellers.
AbbVie’s investments in its hematologic oncology portfolio are paying off, with global revenues of $1.5 billion in 1Q20, up 32% with IMBRUVICA revenues of $1.2 billion, up 21% and VENCLEXTA sales reaching $317 million. We’re also keeping an eye on new immunology assets SKYRIZI, with sales of $300 million, and RINVOQ, which had sales of $86 million in 1Q20.
The company is recouping some of the lost Humira revenues with improved treatment options in rheumatoid arthritis and psoriasis. SKYRIZI, an IL-23 inhibitor boasts a 75% improvement rate at week 16 in moderate to severe plaque psoriasis and RINVOQ, a new oral selective and reversible JAK inhibitor, improves signs and symptoms in rheumatoid arthritis patients through 72 and 84 weeks, as well as inhibits structural joint damage in rheumatoid arthritis patients.
Strategic Moves
Last June AbbVie made a bold strategic move to buy Allergan for approximately $63 billion in an effort to diversify its portfolio, as the world’s best-selling drug, AbbVie’s flagship Humira, begins to feel the impact of biosimilar competition. Allergan brings the biggest name in medical aesthetics, Botox. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.
The companies recently got the go ahead from the U.S. Federal Trade Commission (FTC) for AbbVie's pending acquisition of Allergan. AbbVie agreed to sell several assets to settle objections to its purchase Allergan, divesting Brazikumab and Zenpep.
AstraZeneca will acquire brazikumab, an investigational IL-23 inhibitor in Phase IIb/III development for Crohn's Disease, and Phase II for ulcerative colitis. Nestle will acquire and take full operational ownership of Zenpep, a treatment available in the U.S. for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the deal.
In another, albeit less sensational acquisition, AbbVie enhanced its early stage oncology pipeline with Seattle-based Mavupharma, a privately held biopharma company focused on new approaches to target the STING (STimulator of INterferon Genes) pathway to treat cancer. Mavupharma's lead candidate MAVU-104, is a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections. Enhancing STING signaling has shown promise in a variety of tumor models.
R&D
AbbVie gained several significant approvals for key growth products. The FDA and EMA approved RINVOQ (upadacitinib), a once-daily oral Janus kinase (JAK) inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate.
Patients taking RINVOQ achieved clinical remission, a state characterized by almost no disease activity and symptoms, even without methotrexate.
AbbVie also has applications under review for RINVOQ for the treatment of active psoriatic arthritis supported by studies demonstrating RINVOQ met the primary endpoint of response at week 12 versus placebo, as well as non-inferiority versus Humira in terms of response at week 12.
In another big win, ORIAHNN recently became the first non-surgical, oral treatment option approved by the FDA for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women, with a treatment duration of up to 24 months. Uterine fibroids are estrogen and progesterone-dependent non-cancerous tumors and are the most common type of benign tumor in women of reproductive age.
Oncology Assets
IMBRUVICA, in combination with rituximab, was approved by the FDA for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This milestone marks the 11th FDA approval for IMBRUVICA since it was first approved in 2013 and the sixth in CLL, the most common form of leukemia in adults.
Also, the European Commission recently approved VENCLYXTO (venetoclax) in combination with obinutuzumab for patients with previously-untreated Chronic Lymphocytic Leukemia. Further, positive results from Phase III trial of VENCLEXTA (venetoclax) in combination with Azacitidine in patients with Acute Myeloid Leukemia (AML) demonstrated statistically significant improvement in the primary endpoints of overall survival and composite complete remission rate. AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options.
Oncology Alliances
AbbVie and Genmab recently partnered to develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates, and to research future differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-gen bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 leveraging AbbVie's clinical expertise, antibody-drug conjugate (ADC) platform and global commercialization in hematological cancers.
AbbVie is paying $750 million upfront and Genmab has the potential to receive as much as $3.15 billion in additional development, regulatory and sales milestones for all programs as well as royalties on sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the companies will share profits on a 50:50 basis.
A global, exclusive collaboration with Jacobio Pharmaceuticals aims to develop and commercialize SHP2 inhibitors targeting a key node in cancer and immune cells. SHP2 is a key protein mediator of cell signaling and many tumors have genetic mutations, driving abnormal cancer cell growth which rely on SHP2 activity. Jacobio's early clinical stage assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity.
SHP2 also plays a key role to control cytokine production and immune cell response and is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities.
Expanding an alliance with Harpoon Therapeutics for HPN217, a B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC), the companies added up to six additional targets. These agreements are expected to advance and broaden the use of Harpoon’s TriTAC platform, which produces novel T cell engagers targeting both solid tumors and hematologic malignancies. In a transaction valued at a potential $510 million in upfront, milestone payments, and royalties, AbbVie has an option to exclusive rights to HPN217.
COVID-19 Efforts
AbbVie is collaborating with select health authorities and institutions globally supporting the experimental use of the HIV medicine, Kaletra/Aluvia (lopinavir/ritonavir) to determine antiviral activity as well as efficacy and safety of lopinavir/ritonavir in treating COVID-19.
AbbVie is supporting clinical studies with lopinavir/ritonavir, working closely with European health authorities and the U.S. FDA, Centers for Disease Control and Prevention, National Institutes of Health and Biomedical Advanced Research and Development Authority to coordinate on these efforts. The company has also joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19.
twitter.com/abbvie
www.abbvie.com
headcount: 30,000
Year Established: 2013
Revenues: $33,266 (+2%)
Net Income: $7,882 (+39%)
R&D: $6,407 (-38%)
TOP SELLING DRUGS
| Drug | Indication | 2019 Sales | (+/-%) |
| Humira | rheumatoid arthritis | $19,169 | -4% |
| Imbruvica | chronic lymphocytic leukemia | $3,830 | 29% |
| Mavyret | hepatitis C | $2,893 | -16% |
| Creon | cystic fibrosis | $1,041 | 12% |
| Leuplin | prostate cancer | $887 | -1% |
| Venclexta | Leukaemia, chronic lymphocytic (CLL) | $792 | 130% |
| Synthroid | hyperthyroidism | $786 | 1% |
| Synagis | RSV | $718 | -1% |
| Duopa | Parkinson’s disease | $461 | 7% |
| Skyrizi | psoriasis | $355 | n/a |
In looking at AbbVie’s foreseeable growth drivers, in the first quarter of 2020 IMBRUVICA, VENCLEXTA, SKYRIZI continued to make strides. Revenues were up 10% in the quarter to $8.6 billion, despite a 15% decline in International Humira sales and a 29% drop in Mavyret sales, the company’s top sellers.
AbbVie’s investments in its hematologic oncology portfolio are paying off, with global revenues of $1.5 billion in 1Q20, up 32% with IMBRUVICA revenues of $1.2 billion, up 21% and VENCLEXTA sales reaching $317 million. We’re also keeping an eye on new immunology assets SKYRIZI, with sales of $300 million, and RINVOQ, which had sales of $86 million in 1Q20.
The company is recouping some of the lost Humira revenues with improved treatment options in rheumatoid arthritis and psoriasis. SKYRIZI, an IL-23 inhibitor boasts a 75% improvement rate at week 16 in moderate to severe plaque psoriasis and RINVOQ, a new oral selective and reversible JAK inhibitor, improves signs and symptoms in rheumatoid arthritis patients through 72 and 84 weeks, as well as inhibits structural joint damage in rheumatoid arthritis patients.
Strategic Moves
Last June AbbVie made a bold strategic move to buy Allergan for approximately $63 billion in an effort to diversify its portfolio, as the world’s best-selling drug, AbbVie’s flagship Humira, begins to feel the impact of biosimilar competition. Allergan brings the biggest name in medical aesthetics, Botox. The combined company will consist of several franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology.
The companies recently got the go ahead from the U.S. Federal Trade Commission (FTC) for AbbVie's pending acquisition of Allergan. AbbVie agreed to sell several assets to settle objections to its purchase Allergan, divesting Brazikumab and Zenpep.
AstraZeneca will acquire brazikumab, an investigational IL-23 inhibitor in Phase IIb/III development for Crohn's Disease, and Phase II for ulcerative colitis. Nestle will acquire and take full operational ownership of Zenpep, a treatment available in the U.S. for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the deal.
In another, albeit less sensational acquisition, AbbVie enhanced its early stage oncology pipeline with Seattle-based Mavupharma, a privately held biopharma company focused on new approaches to target the STING (STimulator of INterferon Genes) pathway to treat cancer. Mavupharma's lead candidate MAVU-104, is a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections. Enhancing STING signaling has shown promise in a variety of tumor models.
R&D
AbbVie gained several significant approvals for key growth products. The FDA and EMA approved RINVOQ (upadacitinib), a once-daily oral Janus kinase (JAK) inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate.
Patients taking RINVOQ achieved clinical remission, a state characterized by almost no disease activity and symptoms, even without methotrexate.
AbbVie also has applications under review for RINVOQ for the treatment of active psoriatic arthritis supported by studies demonstrating RINVOQ met the primary endpoint of response at week 12 versus placebo, as well as non-inferiority versus Humira in terms of response at week 12.
In another big win, ORIAHNN recently became the first non-surgical, oral treatment option approved by the FDA for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women, with a treatment duration of up to 24 months. Uterine fibroids are estrogen and progesterone-dependent non-cancerous tumors and are the most common type of benign tumor in women of reproductive age.
Oncology Assets
IMBRUVICA, in combination with rituximab, was approved by the FDA for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This milestone marks the 11th FDA approval for IMBRUVICA since it was first approved in 2013 and the sixth in CLL, the most common form of leukemia in adults.
Also, the European Commission recently approved VENCLYXTO (venetoclax) in combination with obinutuzumab for patients with previously-untreated Chronic Lymphocytic Leukemia. Further, positive results from Phase III trial of VENCLEXTA (venetoclax) in combination with Azacitidine in patients with Acute Myeloid Leukemia (AML) demonstrated statistically significant improvement in the primary endpoints of overall survival and composite complete remission rate. AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options.
Oncology Alliances
AbbVie and Genmab recently partnered to develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates, and to research future differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-gen bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 leveraging AbbVie's clinical expertise, antibody-drug conjugate (ADC) platform and global commercialization in hematological cancers.
AbbVie is paying $750 million upfront and Genmab has the potential to receive as much as $3.15 billion in additional development, regulatory and sales milestones for all programs as well as royalties on sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the companies will share profits on a 50:50 basis.
A global, exclusive collaboration with Jacobio Pharmaceuticals aims to develop and commercialize SHP2 inhibitors targeting a key node in cancer and immune cells. SHP2 is a key protein mediator of cell signaling and many tumors have genetic mutations, driving abnormal cancer cell growth which rely on SHP2 activity. Jacobio's early clinical stage assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity.
SHP2 also plays a key role to control cytokine production and immune cell response and is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities.
Expanding an alliance with Harpoon Therapeutics for HPN217, a B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC), the companies added up to six additional targets. These agreements are expected to advance and broaden the use of Harpoon’s TriTAC platform, which produces novel T cell engagers targeting both solid tumors and hematologic malignancies. In a transaction valued at a potential $510 million in upfront, milestone payments, and royalties, AbbVie has an option to exclusive rights to HPN217.
COVID-19 Efforts
AbbVie is collaborating with select health authorities and institutions globally supporting the experimental use of the HIV medicine, Kaletra/Aluvia (lopinavir/ritonavir) to determine antiviral activity as well as efficacy and safety of lopinavir/ritonavir in treating COVID-19.
AbbVie is supporting clinical studies with lopinavir/ritonavir, working closely with European health authorities and the U.S. FDA, Centers for Disease Control and Prevention, National Institutes of Health and Biomedical Advanced Research and Development Authority to coordinate on these efforts. The company has also joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19.
