07.20.18
Headquarters: London, UK
twitter.com/astrazeneca
www.astrazeneca.com
Headcount: 61,100
Year Established: 1999
Revenues: $22,465 (-2%)
Net Income: $2,868 (-16%)
R&D: $5,757 (-2%)
TOP SELLING DRUGS
While revenue was down for the year, AstraZeneca appears to be finally emerging from several years of declining sales. Between 2011 and 2017, the company saw more than $13 billion in lost revenue in established markets for its top selling drugs and expects to lose a further $1 billion in product sales. There’s no doubt the company faces continued challenges with strong competition from both branded and generic medicines, but product sales were up 4% in the fourth quarter of 2017, and 3% in the first quarter of 2018, and long-term prospects remain encouraging. Additionally, Brilinta and Farxiga each exceeded $1 billion in annual sales for the first time.
Newer products, Imfinzi for cancer and Fasenra for severe asthma, both performed well in 1Q18. Oncology sales saw growth of 39%, with Lynparza sales up 109% to $119 million, driven by regulatory approvals in the U.S.; Tagrisso sales grew 98% to $338 million; and Imfinzi sales reached $62 million as a result of the recent U.S. approval for stage III non-small cell lung cancer (NSCLC). Needless to say, this impressive growth was offset by the decline of Crestor sales in Europe and Japan.
AZ launched four new molecular entities in 2017, including its first respiratory biologic medicine, Fasenra and new cancer medicines, Imfinzi and Calquence. Additionally, key existing treatments Lynparza and Tagrisso gained new indications.
AZ and its global biologics R&D arm, MedImmune, won approval of Fasenra (benralizumab) in the U.S. and EU as an add-on maintenance treatment in severe eosinophilic asthma. They also gained FDA approval of Imfinzi for the treatment unresectable Stage III NSCLC, representing the company’s first immuno-oncology approval. Imfinzi is in development across several tumor types, both as monotherapy and with other medicines, and received accelerated approval from the FDA in May for the treatment of advanced bladder cancer. Also, in a recent trial, Imfinzi demonstrated superior progression-free survival (PFS) in NSCLC.
Additional oncology wins include expanded approval for Tagrisso for patients with newly diagnosed, EGFR-positive NSCLC based on results that showed significant PFS benefit (18.9 months versus 10.2 months) compared with standard of care. This past year, Tagrisso became AZ’s highest-selling oncology drug with sales of $955 million (up 126%), and, by the end of 2017, received regulatory approval in more than 60 countries.
AZ and partner Merck gained approval of Lynparza in Japan for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of BRCA mutation status. Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan.
Also, AZ and Acerta Pharma won approval of Calquence (acalabrutinib), a kinase inhibitor for the treatment of mantle cell lymphoma. Calquence was approved under the FDA’s accelerated approval pathway, based on overall response rate.
Moreover, the FDA recently approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalaemia, a serious condition characterized by high potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. The risk of hyperkalaemia increases significantly for patients with chronic kidney disease and for those who take common medications for heart failure.
In a blow to its late stage pipeline, AZ and Lilly recently discontinued the global Phase III trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer’s disease (AD). The decision was based on recommendations by an independent data monitoring committee, which concluded that the trials in early and mild AD dementia were not likely to meet their primary endpoints.
The company executed a several strategic ventures this past year, namely MedImmune’s spin out of six molecules from its early-stage inflammation and autoimmunity programs into an independent biotech company, Viela Bio. The new company will focus on medicines for severe autoimmune diseases by targeting the underlying causes of each disease.
MedImmune will contribute three clinical and three preclinical candidates, including inebilizumab, currently in Phase II development for the treatment of neuromyelitis optica, a rare condition that affects the optic nerve and spinal cord. It was granted Orphan Drug Designation in the U.S. and Europe. The transaction doesn’t include anifrolumab, in Phase III development for the treatment of lupus.
AZ also entered a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to develop and commercialize potential new medicines with the goal of accelerating development efforts. The new company, Dizal Pharmaceutical, has access to the scientific and technical capabilities of AZ’s Innovation Center China, and has exclusive rights to develop and commercialize three preclinical candidates from AZ’s pipeline in the areas of oncology, cardiovascular and metabolic diseases, and respiratory. The FIIF will contribute funding and arrange strategic partnerships.
Additionally, several collaborations from this past year are proving successful. For example, AZ’s global strategic oncology alliance with Merck to co-develop and co-commercialize Lynparza for multiple cancer types. Lynparza is a first-in-class oral PARP inhibitor, and in addition to current indications in breast and ovarian cancer, Lynparza is also being developed across several tumor types, including prostate and pancreatic cancers. The companies are developing Lynparza both as monotherapy and in combination with other potential medicines. The companies are also developing AZ’s selumetinib, a selective inhibitor of MEK, for multiple indications including thyroid cancer.
AZ’s clinical collaboration with Incyte Corp. is also advancing. The alliance was expanded to evaluate the efficacy and safety of epacadostat, Incyte’s investigational IDO1 enzyme inhibitor, in combination with AZ’s Imfinzi, a human monoclonal antibody directed against PD-L1, compared to Imfinzi alone. The exclusive collaboration allows the companies to conduct a Phase III trial in patients with Stage III NSCLC whose disease has not progressed following chemotherapy and radiation therapy.
Finally, another endeavor with Takeda aims to develop MEDI1341, an alpha-synuclein antibody as a potential treatment for Parkinson’s disease (PD). The companies aim to support the development of new PD medicines that seek to remove existing pathological alpha-synuclein aggregates, prevent their formation, or stop them from spreading, and as such potentially prevent or delay the onset of PD, or halt or slow its progression.
With these efforts, sales growth of new drugs, and an advancing pipeline, AZ is on track for a period of recovery in 2018.
twitter.com/astrazeneca
www.astrazeneca.com
Headcount: 61,100
Year Established: 1999
Revenues: $22,465 (-2%)
Net Income: $2,868 (-16%)
R&D: $5,757 (-2%)
TOP SELLING DRUGS
| Drug | Indication | 2017 Sales | (+/-%) |
| Symbicort | asthma | $2,803 | -6% |
| Crestor | cholesterol | $2,365 | -30% |
| Nexium | acid reflux | $1,952 | -4% |
| Pulmicort | asthma | $1,176 | 11% |
| Brilinta | antiplatelet | $1,079 | 29% |
| Farxiga | type 2 diabetes | $1,074 | 29% |
| Tagrisso | lung cancer | $955 | 126% |
| Faslodex | breast cancer | $941 | 13% |
| Zoladex | cancer | $735 | -10% |
| Seloken/Toprol-XL | hypertention | $695 | -6% |
| Synagis | RSV disease | $687 | 1% |
While revenue was down for the year, AstraZeneca appears to be finally emerging from several years of declining sales. Between 2011 and 2017, the company saw more than $13 billion in lost revenue in established markets for its top selling drugs and expects to lose a further $1 billion in product sales. There’s no doubt the company faces continued challenges with strong competition from both branded and generic medicines, but product sales were up 4% in the fourth quarter of 2017, and 3% in the first quarter of 2018, and long-term prospects remain encouraging. Additionally, Brilinta and Farxiga each exceeded $1 billion in annual sales for the first time.
Newer products, Imfinzi for cancer and Fasenra for severe asthma, both performed well in 1Q18. Oncology sales saw growth of 39%, with Lynparza sales up 109% to $119 million, driven by regulatory approvals in the U.S.; Tagrisso sales grew 98% to $338 million; and Imfinzi sales reached $62 million as a result of the recent U.S. approval for stage III non-small cell lung cancer (NSCLC). Needless to say, this impressive growth was offset by the decline of Crestor sales in Europe and Japan.
AZ launched four new molecular entities in 2017, including its first respiratory biologic medicine, Fasenra and new cancer medicines, Imfinzi and Calquence. Additionally, key existing treatments Lynparza and Tagrisso gained new indications.
AZ and its global biologics R&D arm, MedImmune, won approval of Fasenra (benralizumab) in the U.S. and EU as an add-on maintenance treatment in severe eosinophilic asthma. They also gained FDA approval of Imfinzi for the treatment unresectable Stage III NSCLC, representing the company’s first immuno-oncology approval. Imfinzi is in development across several tumor types, both as monotherapy and with other medicines, and received accelerated approval from the FDA in May for the treatment of advanced bladder cancer. Also, in a recent trial, Imfinzi demonstrated superior progression-free survival (PFS) in NSCLC.
Additional oncology wins include expanded approval for Tagrisso for patients with newly diagnosed, EGFR-positive NSCLC based on results that showed significant PFS benefit (18.9 months versus 10.2 months) compared with standard of care. This past year, Tagrisso became AZ’s highest-selling oncology drug with sales of $955 million (up 126%), and, by the end of 2017, received regulatory approval in more than 60 countries.
AZ and partner Merck gained approval of Lynparza in Japan for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of BRCA mutation status. Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan.
Also, AZ and Acerta Pharma won approval of Calquence (acalabrutinib), a kinase inhibitor for the treatment of mantle cell lymphoma. Calquence was approved under the FDA’s accelerated approval pathway, based on overall response rate.
Moreover, the FDA recently approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalaemia, a serious condition characterized by high potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. The risk of hyperkalaemia increases significantly for patients with chronic kidney disease and for those who take common medications for heart failure.
In a blow to its late stage pipeline, AZ and Lilly recently discontinued the global Phase III trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer’s disease (AD). The decision was based on recommendations by an independent data monitoring committee, which concluded that the trials in early and mild AD dementia were not likely to meet their primary endpoints.
The company executed a several strategic ventures this past year, namely MedImmune’s spin out of six molecules from its early-stage inflammation and autoimmunity programs into an independent biotech company, Viela Bio. The new company will focus on medicines for severe autoimmune diseases by targeting the underlying causes of each disease.
MedImmune will contribute three clinical and three preclinical candidates, including inebilizumab, currently in Phase II development for the treatment of neuromyelitis optica, a rare condition that affects the optic nerve and spinal cord. It was granted Orphan Drug Designation in the U.S. and Europe. The transaction doesn’t include anifrolumab, in Phase III development for the treatment of lupus.
AZ also entered a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to develop and commercialize potential new medicines with the goal of accelerating development efforts. The new company, Dizal Pharmaceutical, has access to the scientific and technical capabilities of AZ’s Innovation Center China, and has exclusive rights to develop and commercialize three preclinical candidates from AZ’s pipeline in the areas of oncology, cardiovascular and metabolic diseases, and respiratory. The FIIF will contribute funding and arrange strategic partnerships.
Additionally, several collaborations from this past year are proving successful. For example, AZ’s global strategic oncology alliance with Merck to co-develop and co-commercialize Lynparza for multiple cancer types. Lynparza is a first-in-class oral PARP inhibitor, and in addition to current indications in breast and ovarian cancer, Lynparza is also being developed across several tumor types, including prostate and pancreatic cancers. The companies are developing Lynparza both as monotherapy and in combination with other potential medicines. The companies are also developing AZ’s selumetinib, a selective inhibitor of MEK, for multiple indications including thyroid cancer.
AZ’s clinical collaboration with Incyte Corp. is also advancing. The alliance was expanded to evaluate the efficacy and safety of epacadostat, Incyte’s investigational IDO1 enzyme inhibitor, in combination with AZ’s Imfinzi, a human monoclonal antibody directed against PD-L1, compared to Imfinzi alone. The exclusive collaboration allows the companies to conduct a Phase III trial in patients with Stage III NSCLC whose disease has not progressed following chemotherapy and radiation therapy.
Finally, another endeavor with Takeda aims to develop MEDI1341, an alpha-synuclein antibody as a potential treatment for Parkinson’s disease (PD). The companies aim to support the development of new PD medicines that seek to remove existing pathological alpha-synuclein aggregates, prevent their formation, or stop them from spreading, and as such potentially prevent or delay the onset of PD, or halt or slow its progression.
With these efforts, sales growth of new drugs, and an advancing pipeline, AZ is on track for a period of recovery in 2018.
