07.20.18
Headquarters: New York, NY
twitter.com@pfizer_news
www.pfizer.com
Headcount: 90,000
Year Established: 1849
Revenues: $52,546 (-1%)
Net Income: $21,308 (+195%)
R&D: $7,657 (-3%)
TOP SELLING DRUGS
While 2017 wasn’t bad for Pfizer, it wasn’t anything to write home about either. Revenues dropped $278 million, or 1%, to $52.5 billion compared to 2016. Despite the falloff, Pfizer maintained its number one spot in this report by a wide margin—more than $10 billion.
The company’s two business segments—innovative health and essential health—generated revenues of $31.4 billion and $21.1 billion respectively, compared with $29.2 billion and $23.6 billion the year prior. Sales dropped in essential health most notably due to loss of exclusivity for several drugs, including Viagra, which reported revenues of $1.2 billion, a 23% drop.
While innovative health did post a small gain, sales of its largest revenue generator, the Prevnar family of pneumococcal vaccines, dropped 2% to $5.6 billion. At the same time, sales of the rheumatoid arthritis drug Enbrel dropped by 16% to $2.5 billion due to competition.
If there was one shining spot in Pfizer’s 2017 product portfolio it was the cancer drug Ibrance, which reported revenues of $3.1 billion, a 47% spike. The robust growth is attributable to the drug’s favorable benefit-risk profile, strong clinical data, and first mover advantage in this class of drugs.
Some experts say there is reason to believe that 2018 could be a better year for Pfizer. For one, Ibrance is looking at strong sales growth in the $1 billion range. There are also high expectations for Pfizer’s blood thinner Eliquis.
Last year wasn’t an active one on the acquisition front across the entire pharma landscape compared to previous years. However, things could be different this year after the U.S. enacted changes to its corporate income tax system in December. The new policy brings down corporate tax rates and creates a much friendlier business environment for M&A activity. After all, in October Pfizer did mention that is was evaluating options for its consumer healthcare business (read: divestiture or spinoff). If this does happen we could see the pharma giant on the M&A hunt to boost its pipeline.
Business development highlights
While the year was relatively quiet, at the very end of 2016, which falls in the first fiscal quarter of 2017 for Pfizer’s international operations, Pfizer completed the acquisition of AstraZeneca’s late-stage small molecule anti-infectives business, gaining commercialization rights primarily outside the U.S.
The agreement included development and commercialization rights to the newly EU approved drug Zavicefta, marketed products Merrem/Meronem and Zinforo, and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically addresses multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, which represents significant unmet medical needs in bacterial infections.
Pfizer paid $550 million upfront with a deferred payment of $175 million in January 2019. AstraZeneca is eligible to receive as much as $250 million in milestones, $600 million in sales-related payments, as well as royalties on sales of Zavicefta and ATM-AVI in certain markets.
In February 2017, Pfizer completed the sale of its global infusion therapy business, Hospira Infustion Systems, to ICU Medical for $1 billion. The Hospira Infusion Systems business includes IV pumps, solutions, and devices.
At the end of the year, Pfizer and Basilea Pharmaceutica amended their existing license agreement for Europe, Russia, Turkey and Israel for Basilea’s Cresemba (isavuconazole) to include China—with Hong Kong and Macao—and sixteen countries in the Asia Pacific region. Isavuconazole is an antifungal for the treatment of life-threatening invasive mold infections.
Basilea received an upfront payment of $3 million and is eligible to receive up to approximately $223 million in additional payments upon achievement of regulatory and commercial milestones related to China and the Asia Pacific region. In addition, Basilea will receive royalties in the mid-teen range on Pfizer’s sales in the territory. Pfizer is granted an exclusive license to develop, manufacture and commercialize isavuconazole in China, Hong Kong and Macao, and sixteen countries in the Asia Pacific region, including Australia, India, South Korea, Singapore and Taiwan.
In June 2017, Basilea signed a license agreement with Pfizer for Europe—excluding the Nordics—Russia, Turkey and Israel. Basilea received a $70 million upfront payment and is eligible for additional milestone payments of up to $427 million and mid-teen royalties on sales.
In January 2018, Pfizer and Sangamo Therapeutics formed a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene. Sangamo received a $12 million upfront payment from Pfizer. Sangamo will be responsible for the development of ZFP-TF candidates.
Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization for the C9ORF72 ZFP-TF program and any resulting products. Sangamo is eligible to receive potential development and commercial milestone payments of up to $150 million, as well as tiered royalties on net sales. With this agreement, Pfizer is expected to establish a strong foothold in gene therapy.
Also of note in the beginning of 2018, the FDA upgraded the status of Pfizer’s McPherson, KS manufacturing facility to Voluntary Action Indicated (VAI) based on an October 2017 inspection. The change to VAI status lifted the compliance hold that the FDA placed on approval of pending applications and is an important step toward resolving the issues cited in the February 2017 FDA Warning Letter.
Research pacts
Pfizer entered several notable research collaborations during 2017. It also announced early this year its decision to end internal neuroscience discovery and early development efforts and re-allocate funding to other areas where the company has stronger scientific leadership.
In a deal with AbCellera Biologics, it formed a new therapeutic antibody discovery collaboration to apply AbCellera’s monoclonal antibody (mAb) screening platform to discover function-modulating antibodies against undisclosed membrane protein targets. AbCellera received an upfront payment and research support, and will be eligible to receive as much as $90 million in milestones, and royalties based on Pfizer’s development and commercialization of antibodies generated under this collaboration.
With Domain Therapeutics, a biopharma company specializing in new drug candidates that target G protein-coupled receptors (GPCRs), Pfizer entered a collaboration agreement to assess the impact of mutations on different signaling pathways engaged by GPCRs. Domain will use its bioSensAll technology to define signaling signatures for each of the wild-type and mutant receptors. The bioSensAll technology allows for easier understanding of signaling pathways activated by each candidate molecule, predicting its pharmacological profile. This makes it possible to choose at an early stage molecules that have the required activity but do not present side effects or induce tolerance to treatment.
The collaboration aims to validate potential targets across a range of therapeutic indications. Pfizer will use the results of specific mutations on intracellular signaling to guide further investigations in disease-specific models.
Lastly, with Encycle Therapeutics, a Toronto-based drug discovery company that enables the synthesis of a new type of constrained peptide called “nacellins,” Pfizer has entered a research collaboration to optimize certain nacellins, which were previously identified by Pfizer during a screening of Encycle’s nacellin library, that act on an undisclosed therapeutic target.
Nacellins are a type of peptide macrocycle that can often exhibit higher permeability, solubility, and stability compared to conventional constrained peptides.
Pipeline developments
On the cancer front, Pfizer and partner Merck have developed a robust immuno-oncology research pipeline involving close to 30 studies and 6,300 enrolled patients. In March 2017 the FDA approved Pfizer and Merck KGaA’s key immuno-oncology drug, Bavencio (avelumab), as first as well as a later line of therapy for patients suffering with metastatic Merkel cell carcinoma (or MCC). In September the European Commission approved Bavencio for this indication.
However, Pfizer reported in November that Bavencio failed to meet its primary endpoint in Phase III Javelin Gastric 300 trial, as a third line therapy for patients with advanced gastric cancer. The trial evaluated the efficacy of Bavencio based on the primary endpoint of overall survival as compared to chemotherapy. Pfizer and Merck are also exploring Bavencio in other gastric cancer settings such as first-line switch maintenance settings in the Javelin Gastric 100 study.
Pfizer expects data readouts from around seven more pivotal trials by 2019, includimg for Bavencio in the second-line lung cancer indication as well as the second-line ovarian cancer indication by the end of 2018 or early 2019. Additionally, data readouts from trials evaluating Bavencio in indications such as first-line maintenance therapy in gastric cancer, an earlier line of therapy for kidney cancer, first-line lung cancer, first-line bladder cancer, first-line ovarian cancer are also expected in 2019. Bavencio is expected to enable Pfizer to compete aggressively with other immuno-oncology players such as Merck, Bristol-Myers Squibb, and Roche.
In December 2017, Pfizer and Merck announced that their oral sodium-glucose cotransporter two (SGLT2) inhibitor, Steglatro (ertugliflozin), and fixed-dose combination therapy of ertugliflozin and sitagliptin, Steglujan, received approval from the FDA. These drugs are indicated as adjunct therapy in addition to diet and exercise for controlling glycemic values in adults with type two diabetes.
In the same month, Pfizer reached its primary endpoint in its Phase III trial, Embraca, which compared the efficacy of investigational PARP inhibitor, talazoparib, with a physician’s choice of standard of care chemotherapy, in patients with germline BRCA1/2-positive, locally advanced, or metastatic breast cancer.
Additionally, Pfizer also plans to explore the combination of avelumab and talazoparib in multiple cancer indications as well as a combination of Xtandi and talazoparib in prostate cancer.
In October, Pfizer published positive results from the phase two trial, evaluating investigational next-generation tyrosine kinase inhibitor, lorlatinib, in patients suffering with ALK-positive and ROS1-positive advanced non-small cell lung cancer (or NSCLC). This investigational drug has demonstrated meaningful activity in patients with lung tumors as well as brain metastases and may prove to be an effective option for heavily pretreated NSCLC patients.
twitter.com@pfizer_news
www.pfizer.com
Headcount: 90,000
Year Established: 1849
Revenues: $52,546 (-1%)
Net Income: $21,308 (+195%)
R&D: $7,657 (-3%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Prevnar | family pneumoccal vaccine | $5,601 | -2% |
Lyrica | epilepsy, neuropathy | $5,064 | 22% |
Ibrance | cancer | $3,100 | 46% |
Enbrel | rheumatoid arthritis | $2,452 | -16% |
Lipitor | cholesterol | $1,915 | 9% |
Xeljanz | arthritis | $1,345 | n/a |
Viagra | erectile dysfunction | $1,205 | -23% |
Sutent | cancer | $1,081 | -1% |
Premarin | menopause | $977 | -4% |
Norvasc | hypertention | $926 | -4% |
While 2017 wasn’t bad for Pfizer, it wasn’t anything to write home about either. Revenues dropped $278 million, or 1%, to $52.5 billion compared to 2016. Despite the falloff, Pfizer maintained its number one spot in this report by a wide margin—more than $10 billion.
The company’s two business segments—innovative health and essential health—generated revenues of $31.4 billion and $21.1 billion respectively, compared with $29.2 billion and $23.6 billion the year prior. Sales dropped in essential health most notably due to loss of exclusivity for several drugs, including Viagra, which reported revenues of $1.2 billion, a 23% drop.
While innovative health did post a small gain, sales of its largest revenue generator, the Prevnar family of pneumococcal vaccines, dropped 2% to $5.6 billion. At the same time, sales of the rheumatoid arthritis drug Enbrel dropped by 16% to $2.5 billion due to competition.
If there was one shining spot in Pfizer’s 2017 product portfolio it was the cancer drug Ibrance, which reported revenues of $3.1 billion, a 47% spike. The robust growth is attributable to the drug’s favorable benefit-risk profile, strong clinical data, and first mover advantage in this class of drugs.
Some experts say there is reason to believe that 2018 could be a better year for Pfizer. For one, Ibrance is looking at strong sales growth in the $1 billion range. There are also high expectations for Pfizer’s blood thinner Eliquis.
Last year wasn’t an active one on the acquisition front across the entire pharma landscape compared to previous years. However, things could be different this year after the U.S. enacted changes to its corporate income tax system in December. The new policy brings down corporate tax rates and creates a much friendlier business environment for M&A activity. After all, in October Pfizer did mention that is was evaluating options for its consumer healthcare business (read: divestiture or spinoff). If this does happen we could see the pharma giant on the M&A hunt to boost its pipeline.
Business development highlights
While the year was relatively quiet, at the very end of 2016, which falls in the first fiscal quarter of 2017 for Pfizer’s international operations, Pfizer completed the acquisition of AstraZeneca’s late-stage small molecule anti-infectives business, gaining commercialization rights primarily outside the U.S.
The agreement included development and commercialization rights to the newly EU approved drug Zavicefta, marketed products Merrem/Meronem and Zinforo, and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically addresses multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, which represents significant unmet medical needs in bacterial infections.
Pfizer paid $550 million upfront with a deferred payment of $175 million in January 2019. AstraZeneca is eligible to receive as much as $250 million in milestones, $600 million in sales-related payments, as well as royalties on sales of Zavicefta and ATM-AVI in certain markets.
In February 2017, Pfizer completed the sale of its global infusion therapy business, Hospira Infustion Systems, to ICU Medical for $1 billion. The Hospira Infusion Systems business includes IV pumps, solutions, and devices.
At the end of the year, Pfizer and Basilea Pharmaceutica amended their existing license agreement for Europe, Russia, Turkey and Israel for Basilea’s Cresemba (isavuconazole) to include China—with Hong Kong and Macao—and sixteen countries in the Asia Pacific region. Isavuconazole is an antifungal for the treatment of life-threatening invasive mold infections.
Basilea received an upfront payment of $3 million and is eligible to receive up to approximately $223 million in additional payments upon achievement of regulatory and commercial milestones related to China and the Asia Pacific region. In addition, Basilea will receive royalties in the mid-teen range on Pfizer’s sales in the territory. Pfizer is granted an exclusive license to develop, manufacture and commercialize isavuconazole in China, Hong Kong and Macao, and sixteen countries in the Asia Pacific region, including Australia, India, South Korea, Singapore and Taiwan.
In June 2017, Basilea signed a license agreement with Pfizer for Europe—excluding the Nordics—Russia, Turkey and Israel. Basilea received a $70 million upfront payment and is eligible for additional milestone payments of up to $427 million and mid-teen royalties on sales.
In January 2018, Pfizer and Sangamo Therapeutics formed a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene. Sangamo received a $12 million upfront payment from Pfizer. Sangamo will be responsible for the development of ZFP-TF candidates.
Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization for the C9ORF72 ZFP-TF program and any resulting products. Sangamo is eligible to receive potential development and commercial milestone payments of up to $150 million, as well as tiered royalties on net sales. With this agreement, Pfizer is expected to establish a strong foothold in gene therapy.
Also of note in the beginning of 2018, the FDA upgraded the status of Pfizer’s McPherson, KS manufacturing facility to Voluntary Action Indicated (VAI) based on an October 2017 inspection. The change to VAI status lifted the compliance hold that the FDA placed on approval of pending applications and is an important step toward resolving the issues cited in the February 2017 FDA Warning Letter.
Research pacts
Pfizer entered several notable research collaborations during 2017. It also announced early this year its decision to end internal neuroscience discovery and early development efforts and re-allocate funding to other areas where the company has stronger scientific leadership.
In a deal with AbCellera Biologics, it formed a new therapeutic antibody discovery collaboration to apply AbCellera’s monoclonal antibody (mAb) screening platform to discover function-modulating antibodies against undisclosed membrane protein targets. AbCellera received an upfront payment and research support, and will be eligible to receive as much as $90 million in milestones, and royalties based on Pfizer’s development and commercialization of antibodies generated under this collaboration.
With Domain Therapeutics, a biopharma company specializing in new drug candidates that target G protein-coupled receptors (GPCRs), Pfizer entered a collaboration agreement to assess the impact of mutations on different signaling pathways engaged by GPCRs. Domain will use its bioSensAll technology to define signaling signatures for each of the wild-type and mutant receptors. The bioSensAll technology allows for easier understanding of signaling pathways activated by each candidate molecule, predicting its pharmacological profile. This makes it possible to choose at an early stage molecules that have the required activity but do not present side effects or induce tolerance to treatment.
The collaboration aims to validate potential targets across a range of therapeutic indications. Pfizer will use the results of specific mutations on intracellular signaling to guide further investigations in disease-specific models.
Lastly, with Encycle Therapeutics, a Toronto-based drug discovery company that enables the synthesis of a new type of constrained peptide called “nacellins,” Pfizer has entered a research collaboration to optimize certain nacellins, which were previously identified by Pfizer during a screening of Encycle’s nacellin library, that act on an undisclosed therapeutic target.
Nacellins are a type of peptide macrocycle that can often exhibit higher permeability, solubility, and stability compared to conventional constrained peptides.
Pipeline developments
On the cancer front, Pfizer and partner Merck have developed a robust immuno-oncology research pipeline involving close to 30 studies and 6,300 enrolled patients. In March 2017 the FDA approved Pfizer and Merck KGaA’s key immuno-oncology drug, Bavencio (avelumab), as first as well as a later line of therapy for patients suffering with metastatic Merkel cell carcinoma (or MCC). In September the European Commission approved Bavencio for this indication.
However, Pfizer reported in November that Bavencio failed to meet its primary endpoint in Phase III Javelin Gastric 300 trial, as a third line therapy for patients with advanced gastric cancer. The trial evaluated the efficacy of Bavencio based on the primary endpoint of overall survival as compared to chemotherapy. Pfizer and Merck are also exploring Bavencio in other gastric cancer settings such as first-line switch maintenance settings in the Javelin Gastric 100 study.
Pfizer expects data readouts from around seven more pivotal trials by 2019, includimg for Bavencio in the second-line lung cancer indication as well as the second-line ovarian cancer indication by the end of 2018 or early 2019. Additionally, data readouts from trials evaluating Bavencio in indications such as first-line maintenance therapy in gastric cancer, an earlier line of therapy for kidney cancer, first-line lung cancer, first-line bladder cancer, first-line ovarian cancer are also expected in 2019. Bavencio is expected to enable Pfizer to compete aggressively with other immuno-oncology players such as Merck, Bristol-Myers Squibb, and Roche.
In December 2017, Pfizer and Merck announced that their oral sodium-glucose cotransporter two (SGLT2) inhibitor, Steglatro (ertugliflozin), and fixed-dose combination therapy of ertugliflozin and sitagliptin, Steglujan, received approval from the FDA. These drugs are indicated as adjunct therapy in addition to diet and exercise for controlling glycemic values in adults with type two diabetes.
In the same month, Pfizer reached its primary endpoint in its Phase III trial, Embraca, which compared the efficacy of investigational PARP inhibitor, talazoparib, with a physician’s choice of standard of care chemotherapy, in patients with germline BRCA1/2-positive, locally advanced, or metastatic breast cancer.
Additionally, Pfizer also plans to explore the combination of avelumab and talazoparib in multiple cancer indications as well as a combination of Xtandi and talazoparib in prostate cancer.
In October, Pfizer published positive results from the phase two trial, evaluating investigational next-generation tyrosine kinase inhibitor, lorlatinib, in patients suffering with ALK-positive and ROS1-positive advanced non-small cell lung cancer (or NSCLC). This investigational drug has demonstrated meaningful activity in patients with lung tumors as well as brain metastases and may prove to be an effective option for heavily pretreated NSCLC patients.