07.20.18
Headquarters: Paris, France
twitter.com/sanofi
www.sanofi.com
Headcount: 106,566
Year Established: 2004
Revenues: $41,991 (+4%)
Net Income: $11,192 (+1%)
R&D: $6,555 (+6%)
TOP SELLING DRUGS
In 2017, Sanofi posted a modest four percent growth to $42 billion. This was driven by the performance of Sanofi Genzyme, Sanofi Pasteur and emerging markets, which offset poor diabetes sales.
Sanofi Genzyme, the specialty care unit focused on the areas of rare diseases, multiple sclerosis, oncology, and immunology, grew 15%. Sanofi Pasteur, the vaccines division, increased 8%, while emerging market sales were up 6%. Diabetes and cardiovascular sales dropped 14%.
There are high hopes for Sanofi’s new launch, Dupixent, touted for being the first and only biologic medicine for the treatment of adults with moderate-to-severe atopic dermatitis. The drug was ranked No. 2 on life science commercial intelligence firm Evaluate’s biggest approvals for 2017; analysts expect it will bring in more than $4 billion in 2022.
Also in 2017, Sanofi launched Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The launches come as the key diabetes business struggles. Sales for its top seller Lantus dropped 13% to $5.2 billion.
In addition to Dupixent and Kevzara, Sanofi is looking to shore up diabetes losses with the continued global launch and ramp-up of Toujeo; Praluent for hypercholesterolemia; and Soliqua 100/33/ Suliqua, a combination of lixisenatide and insulin glargine treatment for diabetes, whose market access in the U.S. is progressing.
Ready to take on rare diseases
Sanofi made two deals recently to establish itself as a major global player in rare blood disorders. First, it spent $11.6 billion to acquire Bioverativ, a biopharma company focused on therapies for hemophilia and other rare blood disorders. Bioverativ was created from Biogen’s hemophilia-focused spinoff launched in early 2017.
Hemophilia represents the largest market for rare diseases, with approximately 181,000 people affected worldwide, which is expected to grow above 7% per year through 2022. Bioverativ has approximately $10 billion in annual sales.
Bioverativ’s extended half-life therapies, Eloctate [Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein] and Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched. In 2016, Bioverativ generated $847 million in sales and $41 million in royalties.
Sanofi believes factor replacement therapy will remain the standard of care in hemophilia for many years due to its safety and increasingly superior long-acting profile. Sanofi will be able to leverage Bioverativ’s clinical expertise and commercial platform to advance fitusiran, an investigational RNA interference (RNAi) therapeutic for hemophilia A and B, with or without inhibitors.
Bioverativ’s pipeline includes a Phase III program for cold agglutinin disease, and early stage research programs and collaborations in hemophilia, and other rare blood disorders, including sickle cell disease and beta thalassemia.
Most recently, Sanofi inked a deal to acquire Ablynx for $4.8 billion to strengthen its R&D strategy with the innovative Nanobody technology platform. The acquisition is part of Sanofi’s innovation efforts focused on technologies addressing multiple disease targets with single multi-specific molecules.
Nanobodies are a new class of next-gen biologics. Ablynx’s nanobody technology supports an extensive pipeline of more than 45 proprietary and partnered candidates for a range of therapeutic areas such as hematology, inflammation, immuno-oncology and respiratory diseases. Eight nanobodies have entered clinical development.
Also in 2017 Sanofi acquired Protein Sciences, a biotechnology company headquartered in Meriden, CT for $750 million. The principal product of Protein Sciences is Flublok, the only recombinant protein-based influenza vaccine approved by the FDA in the U.S. Protein Sciences received approval for Flublok from the FDA in October 2016.
Sanofi also divested its ACAM2000 small pox business to Emergent BioSolutions for $125 million. ACAM2000 (Smallpox Vaccine, Live) is the only vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. The deal includes a cGMP bulk manufacturing facility and a lease to a cGMP fill/finish facility, both U.S.-based, along with the existing staff of approximately 100 employees.
Lastly, another major transaction took place as this issue went to press when Sanofi sold off its European generics business for $2 billion. It made the deal with Advent International in order to focus on core areas of global medicines and emerging markets, specialty care and diabetes and cardiovascular. The deal is expected to close in the fourth quarter this year and the new business will be called Zentiva. Sanofi’s chief executive officer, Olivier Brandicourt, had planned to sell the business back in 2015 as part of a refocusing effort. Since then, Sanofi also sold its animal health business Merial, purchased Boehringer Ingelheim’s consumer health assets, and acquired the aforementioned Ablynx and Bioverativ.
Biologics pacts
In March of 2017 Sanofi and Lonza entered into a partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the biologics development pipeline of Sanofi with Lonza’s capability to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be approximately $285 million to be split equally between each company.
The initial phase of the facility construction began in 2017 and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.
Each party will share the available capacity in line with their equity shareholding in the joint venture. Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it. Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available. Lonza will construct the facility and will support the joint venture in its operations.
According to the companies, the strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.
In other biologics news, Sanofi Pasteur entered an agreement with MedImmune, the biologics R&D arm of AstraZeneca, to develop and commercialize monoclonal antibody MEDI8897 for the prevention of respiratory syncytial virus (RSV) in infants. According to the CDC, RSV is the most common cause of lower respiratory tract infections in children younger than 1 year in the U.S. and worldwide.
MEDI8897 is a highly potent monoclonal antibody (mAb) that neutralizes RSV by binding the RSV fusion (F) protein expressed on virions and infected cells; it has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season. It is being developed for the passive immunization of the infant population. MEDI8897 is currently being investigated in a Phase IIb study in preterm infants with plans for a Phase III trial in healthy full-term infants. MEDI8897 received fast-track designation from the U.S. FDA in 2015.
Sanofi Pasteur made an upfront payment of $140 million and will pay as much as $575 million in milestones. The two companies will share all costs and profits. MedImmune will continue to lead development up to the first approval, and AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi-Pasteur will lead commercialization activities.
AI-driven drug discovery
Pushing the innovation envelope, Sanofi penned a nearly $300 million deal with Exscientia, a company at the forefront of artificial intelligence (AI)-driven drug discovery. The research collaboration will focus on the area of metabolic disease.
According to Exscientia, delivery of new therapies for metabolic disease, such as diabetes, is hampered by a paucity of single targets that are amenable to drug discovery. To address this challenge, it says it will apply its platform to identify and validate combinations of drug targets that could work synergistically and be amenable to its bispecific-small-molecule design strategy—where a small molecule is designed to be compatible with two distinct drug targets.
Starting with over a thousand disease-relevant target combinations, Exscientia will triage opportunities and prioritize those with promising bispecific binding potential. Target pairs fulfilling these initial tractability criteria will pass through to Exscientia’s lead-finding platform in order to generate bispecific-small-molecule compounds that can further validate the biological hypothesis. Bispecific small molecules passing all these quality gates may progress to full candidate delivery projects for Sanofi.
As part of this agreement, Exscientia will be responsible for all compound design, while chemistry synthesis will be delivered by Sanofi. Further assays, preclinical experiments and subsequent trials for compounds progressing to the clinic will be managed by Sanofi, where Sanofi exercises the license option.
Portfolio update
At the beginning of February 2018, Sanofi’s R&D pipeline contained 70 projects including 36 new molecular entities and novel vaccines in clinical development. Twenty-five projects are in Phase III or have been submitted to the regulatory authorities for approval.
In January 2018, Sanofi and Regeneron announced that they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases.
In the same month Sanofi and Alnylam announced a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. Sanofi will obtain global development and commercialization rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B. Alnylam will obtain global development and commercialization rights to its investigational RNAi therapeutics programs for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02.
Sanofi recently signed a clinical collaboration agreement with Roche to explore the role of atezolizumab in combination with isatuximab in certain solid tumors, reflecting scientific evidence that checkpoint inhibition by CD38 may reverse resistance to PD-L1.
In December a supplemental biologics license application for dupilumab (partnership with Regeneron) was submitted to the U.S. FDA for uncontrolled, persistent asthma for patients aged 12 and over.
At the end of 2017, the Phase III program evaluating efpeglenatide (partnership with Hanmi), a weekly GLP-1 agonist, in type 2 diabetes was initiated.
In December 2017, the FDA lifted the hold on clinical studies with fitusiran (an investigational RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B; partnership with Alnylam), including the Phase II open-label extension (OLE) study and the ATLAS Phase III program.
twitter.com/sanofi
www.sanofi.com
Headcount: 106,566
Year Established: 2004
Revenues: $41,991 (+4%)
Net Income: $11,192 (+1%)
R&D: $6,555 (+6%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Lantus | diabetes | $5,221 | -13% |
Lovenox | thrombosis | $1,779 | 3% |
Aubagio | multiple sclerosis | $1,770 | 23% |
Plavix | heart attack, stroke | $1,661 | 2% |
Toujeo | diabetes | $921 | 28% |
Renagel/Renvela | hyperphosphatemia | $905 | -11% |
Myozyme/Lumizyme | Pompe disease | $891 | 11% |
Cerezyme | Gaucher disease | $824 | flat |
Fabrazyme | Fabry disease | $815 | 9% |
Aprovel | hypertension | $780 | 4% |
In 2017, Sanofi posted a modest four percent growth to $42 billion. This was driven by the performance of Sanofi Genzyme, Sanofi Pasteur and emerging markets, which offset poor diabetes sales.
Sanofi Genzyme, the specialty care unit focused on the areas of rare diseases, multiple sclerosis, oncology, and immunology, grew 15%. Sanofi Pasteur, the vaccines division, increased 8%, while emerging market sales were up 6%. Diabetes and cardiovascular sales dropped 14%.
There are high hopes for Sanofi’s new launch, Dupixent, touted for being the first and only biologic medicine for the treatment of adults with moderate-to-severe atopic dermatitis. The drug was ranked No. 2 on life science commercial intelligence firm Evaluate’s biggest approvals for 2017; analysts expect it will bring in more than $4 billion in 2022.
Also in 2017, Sanofi launched Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The launches come as the key diabetes business struggles. Sales for its top seller Lantus dropped 13% to $5.2 billion.
In addition to Dupixent and Kevzara, Sanofi is looking to shore up diabetes losses with the continued global launch and ramp-up of Toujeo; Praluent for hypercholesterolemia; and Soliqua 100/33/ Suliqua, a combination of lixisenatide and insulin glargine treatment for diabetes, whose market access in the U.S. is progressing.
Ready to take on rare diseases
Sanofi made two deals recently to establish itself as a major global player in rare blood disorders. First, it spent $11.6 billion to acquire Bioverativ, a biopharma company focused on therapies for hemophilia and other rare blood disorders. Bioverativ was created from Biogen’s hemophilia-focused spinoff launched in early 2017.
Hemophilia represents the largest market for rare diseases, with approximately 181,000 people affected worldwide, which is expected to grow above 7% per year through 2022. Bioverativ has approximately $10 billion in annual sales.
Bioverativ’s extended half-life therapies, Eloctate [Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein] and Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched. In 2016, Bioverativ generated $847 million in sales and $41 million in royalties.
Sanofi believes factor replacement therapy will remain the standard of care in hemophilia for many years due to its safety and increasingly superior long-acting profile. Sanofi will be able to leverage Bioverativ’s clinical expertise and commercial platform to advance fitusiran, an investigational RNA interference (RNAi) therapeutic for hemophilia A and B, with or without inhibitors.
Bioverativ’s pipeline includes a Phase III program for cold agglutinin disease, and early stage research programs and collaborations in hemophilia, and other rare blood disorders, including sickle cell disease and beta thalassemia.
Most recently, Sanofi inked a deal to acquire Ablynx for $4.8 billion to strengthen its R&D strategy with the innovative Nanobody technology platform. The acquisition is part of Sanofi’s innovation efforts focused on technologies addressing multiple disease targets with single multi-specific molecules.
Nanobodies are a new class of next-gen biologics. Ablynx’s nanobody technology supports an extensive pipeline of more than 45 proprietary and partnered candidates for a range of therapeutic areas such as hematology, inflammation, immuno-oncology and respiratory diseases. Eight nanobodies have entered clinical development.
Also in 2017 Sanofi acquired Protein Sciences, a biotechnology company headquartered in Meriden, CT for $750 million. The principal product of Protein Sciences is Flublok, the only recombinant protein-based influenza vaccine approved by the FDA in the U.S. Protein Sciences received approval for Flublok from the FDA in October 2016.
Sanofi also divested its ACAM2000 small pox business to Emergent BioSolutions for $125 million. ACAM2000 (Smallpox Vaccine, Live) is the only vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. The deal includes a cGMP bulk manufacturing facility and a lease to a cGMP fill/finish facility, both U.S.-based, along with the existing staff of approximately 100 employees.
Lastly, another major transaction took place as this issue went to press when Sanofi sold off its European generics business for $2 billion. It made the deal with Advent International in order to focus on core areas of global medicines and emerging markets, specialty care and diabetes and cardiovascular. The deal is expected to close in the fourth quarter this year and the new business will be called Zentiva. Sanofi’s chief executive officer, Olivier Brandicourt, had planned to sell the business back in 2015 as part of a refocusing effort. Since then, Sanofi also sold its animal health business Merial, purchased Boehringer Ingelheim’s consumer health assets, and acquired the aforementioned Ablynx and Bioverativ.
Biologics pacts
In March of 2017 Sanofi and Lonza entered into a partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the biologics development pipeline of Sanofi with Lonza’s capability to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be approximately $285 million to be split equally between each company.
The initial phase of the facility construction began in 2017 and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.
Each party will share the available capacity in line with their equity shareholding in the joint venture. Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it. Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available. Lonza will construct the facility and will support the joint venture in its operations.
According to the companies, the strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.
In other biologics news, Sanofi Pasteur entered an agreement with MedImmune, the biologics R&D arm of AstraZeneca, to develop and commercialize monoclonal antibody MEDI8897 for the prevention of respiratory syncytial virus (RSV) in infants. According to the CDC, RSV is the most common cause of lower respiratory tract infections in children younger than 1 year in the U.S. and worldwide.
MEDI8897 is a highly potent monoclonal antibody (mAb) that neutralizes RSV by binding the RSV fusion (F) protein expressed on virions and infected cells; it has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season. It is being developed for the passive immunization of the infant population. MEDI8897 is currently being investigated in a Phase IIb study in preterm infants with plans for a Phase III trial in healthy full-term infants. MEDI8897 received fast-track designation from the U.S. FDA in 2015.
Sanofi Pasteur made an upfront payment of $140 million and will pay as much as $575 million in milestones. The two companies will share all costs and profits. MedImmune will continue to lead development up to the first approval, and AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi-Pasteur will lead commercialization activities.
AI-driven drug discovery
Pushing the innovation envelope, Sanofi penned a nearly $300 million deal with Exscientia, a company at the forefront of artificial intelligence (AI)-driven drug discovery. The research collaboration will focus on the area of metabolic disease.
According to Exscientia, delivery of new therapies for metabolic disease, such as diabetes, is hampered by a paucity of single targets that are amenable to drug discovery. To address this challenge, it says it will apply its platform to identify and validate combinations of drug targets that could work synergistically and be amenable to its bispecific-small-molecule design strategy—where a small molecule is designed to be compatible with two distinct drug targets.
Starting with over a thousand disease-relevant target combinations, Exscientia will triage opportunities and prioritize those with promising bispecific binding potential. Target pairs fulfilling these initial tractability criteria will pass through to Exscientia’s lead-finding platform in order to generate bispecific-small-molecule compounds that can further validate the biological hypothesis. Bispecific small molecules passing all these quality gates may progress to full candidate delivery projects for Sanofi.
As part of this agreement, Exscientia will be responsible for all compound design, while chemistry synthesis will be delivered by Sanofi. Further assays, preclinical experiments and subsequent trials for compounds progressing to the clinic will be managed by Sanofi, where Sanofi exercises the license option.
Portfolio update
At the beginning of February 2018, Sanofi’s R&D pipeline contained 70 projects including 36 new molecular entities and novel vaccines in clinical development. Twenty-five projects are in Phase III or have been submitted to the regulatory authorities for approval.
In January 2018, Sanofi and Regeneron announced that they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases.
In the same month Sanofi and Alnylam announced a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. Sanofi will obtain global development and commercialization rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B. Alnylam will obtain global development and commercialization rights to its investigational RNAi therapeutics programs for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02.
Sanofi recently signed a clinical collaboration agreement with Roche to explore the role of atezolizumab in combination with isatuximab in certain solid tumors, reflecting scientific evidence that checkpoint inhibition by CD38 may reverse resistance to PD-L1.
In December a supplemental biologics license application for dupilumab (partnership with Regeneron) was submitted to the U.S. FDA for uncontrolled, persistent asthma for patients aged 12 and over.
At the end of 2017, the Phase III program evaluating efpeglenatide (partnership with Hanmi), a weekly GLP-1 agonist, in type 2 diabetes was initiated.
In December 2017, the FDA lifted the hold on clinical studies with fitusiran (an investigational RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B; partnership with Alnylam), including the Phase II open-label extension (OLE) study and the ATLAS Phase III program.