07.14.15
Headquarters: Paris, France
twitter.com/sanofi
www.sanofi.com
TOP SELLING DRUGS
Sanofi recorded good sales performance across its various businesses in 2014. The French pharma giant has seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Group sales were up 3% to $41,047 million. The Pharmaceuticals segment grew 4.4%, driven by Diabetes and Genzyme. Vaccines increased 7.2% and Animal Health grew 6.7%. Emerging markets sales delivered 9.3% growth.
New Wave of Innovation
Sanofi reported a lot of progress on multiple new product launches. It said during the year it expects to launch high-potential new medicines and vaccines at an accelerated pace beginning in 2014. As many as 18 new launches are expected during the next 7 years with the potential to generate cumulatively more than €30 billion within the first five years of sales, confirming the strong momentum of the company’s R&D pipeline and ability to deliver new therapies across a range of therapeutic categories.
This year Sanofi says it has the potential to launch six new medicines in 2015 and approximately one new medicine every six months between 2016 and 2018. These new medicines have the potential to help address areas of need in rare diseases, cardiovascular care, diabetes, immunology and public health.
Nine new medicines and vaccines are being touted. For rare diseases Cerdelga (eliglustat) is the only FDA-approved, first-line oral therapy for certain adult Gaucher Disease Type 1 patients. For multiple sclerosis Lemtrada (alemtuzumab) is an FDA-approved treatment for adult patients with active relapsing remitting multiple sclerosis who have had an inadequate response to two or more MS therapies. For cardiovascular disease Praluent 3 (alirocumab) is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) with the potential to transform LDL-cholesterol management and was developed in collaboration with Regeneron.
For diabetes Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) is a new investigational basal insulin currently under review by the US and EU regulatory agencies; Afrezza (insulin human) is a new, FDA-approved, rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes; and Lixilan is an investigational fixed-ratio combination of insulin glargine, the leading basal insulin, with lixisenatide, a GLP-1 receptor agonist, in a single daily injection for the treatment of adults with type 2 diabetes.
In Diabetes, despite the potential impact of the U.S. basal insulin market dynamics on Lantus sales, Sanofi expects its global Diabetes sales to be flat to slightly growing from 2015-2018. This assumes a substantial conversion of patients from Lantus to Toujeo in the U.S. and Europe, continued growth of its diabetes products in Emerging Markets, the U.S. launches of Affreza, Lyxumia and LixiLan.
On the new vaccines front, Dengue Vaccine is Sanofi Pasteur’s dengue vaccine candidate with demonstrated efficacy across all dengue serotypes and a favorable safety profile in two Phase III studies, after 25 months active surveillance period. Regulatory submissions are planned in 2015.
For immunology and inflammation, Sarilumab is an investigational fully human monoclonal antibody targeting the IL-6 receptor (IL-6R) that was developed in collaboration with Regeneron and is currently being studied in patients with rheumatoid arthritis (RA). Dupilumab is an investigational fully human monoclonal antibody that blocks IL-4 and IL-13 signaling and was also developed in collaboration with Regeneron. It entered into Phase III in adults with moderate-to-severe atopic dermatitis. Positive results were also recently announced with dupilumab in a Phase IIb trial in adult patients with uncontrolled, moderate-to-severe asthma, and in Phase IIa trial in chronic sinusitis with nasal polyps.
Other new advances in the R&D pipeline include Revusiran, for the treatment of familial amyloidotic cardiomyopathy, which entered Phase III development during the year. The company says the launch of new medicines and vaccines in these therapeutic areas and the sustained performance of Sanofi’s other growth platforms is expected to continue to further reduce the relative contribution of Lantus to the group’s overall performance.
Key Events
Sanofi recorded several notable transactions during the year. Sanofi and Eli Lilly entered an agreement to pursue regulatory approval of OTC Cialis (tadalafil) for the treatment of men with erectile dysfunction (ED). Sanofi will gain exclusive filing and marketing rights to Cialis OTC in the U.S., Europe, Canada and Australia upon approval. Cialis had worldwide sales of $2.16 billion in 2013.
Sanofi and Transgene SA have begun construction of the manufacturing platform for the production of a new class of APIs called viral vectors, including Transgene’s MUC1 targeted cancer immunotherapy, TG4010. In March 2013, the companies entered a long-term collaboration to build the unit, which will be located at Genzyme’s Polyclonals site in Lyon, France. The companies will invest approximately €10 million in the production unit during a two-year period. This dedicated platform will be Sanofi’s exclusive property. Sanofi, through its Genzyme Polyclonals site, will act as Transgene’s contract manufacturer and Transgene will be considered a preferred customer of the platform through 2028.
Transgene is an innovative biopharmaceutical company developing new drugs. The state-of-the art industrial platform will be dedicated to production of viral vectors through a broad range of technologies including mammalian cell culture up to 1m3 using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur, and Transgene in Lyon area. Sanofi will bring to Transgene its know-how in bioproduction and experience to launch biologics.
Sanofi and MannKind Corp. entered into a worldwide exclusive licensing agreement for the development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies planned to launch the drug in the U.S. in 1Q15. Sanofi is responsible for global commercial, regulatory and development activities and MannKind will manufacture Afrezza at its facility in Danbury, CT. The companies are also planning to expand global manufacturing capacity as needed.
MannKind received an upfront payment of $150 million and potential regulatory and development milestones of as much as $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%.
Sanofi and MyoKardia formed a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease. The collaboration builds upon MyoKardia’s pioneering science, which hopes to correct the disruptive effects that disease mutations have on heart muscle contraction.
The collaboration, representing one of the largest research and development commitments to genetic forms of cardiomyopathy, encompasses three MyoKardia programs. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and the other is focused on dilated cardiomyopathy (DCM). The collaboration provides up to $200 million in equity investments, milestone payments and research and development services through 2018, of which $45 million has already been received in an upfront licensing fee and an initial equity investment. In addition, Sanofi and MyoKardia will equally share development costs on the HCM programs following initial demonstration of efficacy in patients, with Sanofi fully covering the development costs of the DCM program.
The collaboration is an outgrowth of Sanofi’s Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi’s expert development and commercialization abilities.
Evotec AG and Sanofi entered negotiations for a five-year strategic alliance comprised of three major initiatives focused on improving innovation effectiveness in drug discovery and preclinical development. Sanofi will commit €250 million under the alliance. A pipeline-building collaboration will initially focus on oncology, where Evotec will accelerate drug discovery projects to the point of preclinical development candidates, at which point Sanofi may take over development. Evotec will license a portfolio of projects from Sanofi, including five well-advanced preclinical projects in oncology that will jointly be progressed to IND.
Also, under a French academic bridge program, Evotec will continue to expand its Cure X/Target X business model to leverage scientific expertise and a portfolio of drug development services to capitalize on the most promising science. Sanofi will fund this initiative and may support individual projects through this program.
Furthermore, an outsourcing alliance will include the acquisition of Sanofi’s drug discovery operations in Toulouse to build a European center of excellence for compound management and drug discovery services. To meet capacity needs, Evotec will expand its capabilities by integrating a scientific and technological facility with more than 200 experienced scientists from Sanofi’s Toulouse research site, which is a small molecule discovery site, into its global drug discovery platform that would cover early-stage discovery and preclinical process from screening to medicinal chemistry.
Evotec will manage Sanofi’s global screening compound library as well as provide a range of drug discovery services for Sanofi for the period of the contracts. Lastly, an open innovation initiative will offer combined libraries, which will be made available for screening to Evotec’s partners. The Sanofi library, with more than 1,000,000 compounds, will expand Evotec’s library of more than 400,000 compounds, creating a large drug discovery source. Evotec will screen the libraries against collaborators’ targets under pre-agreed terms from which Sanofi will receive a contribution if a product is developed from a library hit.
twitter.com/sanofi
www.sanofi.com
Headcount: | 110,000 | |
Year Established: | 2004 | |
Revenues | $41,047 | (+3%) |
Net Income: | $8,322 | (+2%) |
R&D: | $5,863 | (+1%) |
TOP SELLING DRUGS
Drug | Indication | 2014 Sales | (+/-%) |
Lantus | diabetes | $7,711 | 11% |
Plavix | heart attack, stroke | $2,263 | 0% |
Lovenox | thrombosis | $2,065 | 0% |
Polio/Pertussis/Hib Vaccines | vaccines | $1,403 | 1% |
Influenza Vaccines | vaccines | $1,432 | 27% |
Aprovel/Avapro | hypertention | $884 | -18% |
Cerezyme | Gaucher disease | $869 | 4% |
Renvela/Renagel | hypocalcemia | $831 | -9% |
Myozyme/Lumizyme | Pompe disease | $659 | 8% |
Meningitis/Pneumonia Vaccines | vaccines | $553 | -8% |
Sanofi recorded good sales performance across its various businesses in 2014. The French pharma giant has seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Group sales were up 3% to $41,047 million. The Pharmaceuticals segment grew 4.4%, driven by Diabetes and Genzyme. Vaccines increased 7.2% and Animal Health grew 6.7%. Emerging markets sales delivered 9.3% growth.
New Wave of Innovation
Sanofi reported a lot of progress on multiple new product launches. It said during the year it expects to launch high-potential new medicines and vaccines at an accelerated pace beginning in 2014. As many as 18 new launches are expected during the next 7 years with the potential to generate cumulatively more than €30 billion within the first five years of sales, confirming the strong momentum of the company’s R&D pipeline and ability to deliver new therapies across a range of therapeutic categories.
This year Sanofi says it has the potential to launch six new medicines in 2015 and approximately one new medicine every six months between 2016 and 2018. These new medicines have the potential to help address areas of need in rare diseases, cardiovascular care, diabetes, immunology and public health.
Nine new medicines and vaccines are being touted. For rare diseases Cerdelga (eliglustat) is the only FDA-approved, first-line oral therapy for certain adult Gaucher Disease Type 1 patients. For multiple sclerosis Lemtrada (alemtuzumab) is an FDA-approved treatment for adult patients with active relapsing remitting multiple sclerosis who have had an inadequate response to two or more MS therapies. For cardiovascular disease Praluent 3 (alirocumab) is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) with the potential to transform LDL-cholesterol management and was developed in collaboration with Regeneron.
For diabetes Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) is a new investigational basal insulin currently under review by the US and EU regulatory agencies; Afrezza (insulin human) is a new, FDA-approved, rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes; and Lixilan is an investigational fixed-ratio combination of insulin glargine, the leading basal insulin, with lixisenatide, a GLP-1 receptor agonist, in a single daily injection for the treatment of adults with type 2 diabetes.
In Diabetes, despite the potential impact of the U.S. basal insulin market dynamics on Lantus sales, Sanofi expects its global Diabetes sales to be flat to slightly growing from 2015-2018. This assumes a substantial conversion of patients from Lantus to Toujeo in the U.S. and Europe, continued growth of its diabetes products in Emerging Markets, the U.S. launches of Affreza, Lyxumia and LixiLan.
On the new vaccines front, Dengue Vaccine is Sanofi Pasteur’s dengue vaccine candidate with demonstrated efficacy across all dengue serotypes and a favorable safety profile in two Phase III studies, after 25 months active surveillance period. Regulatory submissions are planned in 2015.
For immunology and inflammation, Sarilumab is an investigational fully human monoclonal antibody targeting the IL-6 receptor (IL-6R) that was developed in collaboration with Regeneron and is currently being studied in patients with rheumatoid arthritis (RA). Dupilumab is an investigational fully human monoclonal antibody that blocks IL-4 and IL-13 signaling and was also developed in collaboration with Regeneron. It entered into Phase III in adults with moderate-to-severe atopic dermatitis. Positive results were also recently announced with dupilumab in a Phase IIb trial in adult patients with uncontrolled, moderate-to-severe asthma, and in Phase IIa trial in chronic sinusitis with nasal polyps.
Other new advances in the R&D pipeline include Revusiran, for the treatment of familial amyloidotic cardiomyopathy, which entered Phase III development during the year. The company says the launch of new medicines and vaccines in these therapeutic areas and the sustained performance of Sanofi’s other growth platforms is expected to continue to further reduce the relative contribution of Lantus to the group’s overall performance.
Key Events
Sanofi recorded several notable transactions during the year. Sanofi and Eli Lilly entered an agreement to pursue regulatory approval of OTC Cialis (tadalafil) for the treatment of men with erectile dysfunction (ED). Sanofi will gain exclusive filing and marketing rights to Cialis OTC in the U.S., Europe, Canada and Australia upon approval. Cialis had worldwide sales of $2.16 billion in 2013.
Sanofi and Transgene SA have begun construction of the manufacturing platform for the production of a new class of APIs called viral vectors, including Transgene’s MUC1 targeted cancer immunotherapy, TG4010. In March 2013, the companies entered a long-term collaboration to build the unit, which will be located at Genzyme’s Polyclonals site in Lyon, France. The companies will invest approximately €10 million in the production unit during a two-year period. This dedicated platform will be Sanofi’s exclusive property. Sanofi, through its Genzyme Polyclonals site, will act as Transgene’s contract manufacturer and Transgene will be considered a preferred customer of the platform through 2028.
Transgene is an innovative biopharmaceutical company developing new drugs. The state-of-the art industrial platform will be dedicated to production of viral vectors through a broad range of technologies including mammalian cell culture up to 1m3 using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur, and Transgene in Lyon area. Sanofi will bring to Transgene its know-how in bioproduction and experience to launch biologics.
Sanofi and MannKind Corp. entered into a worldwide exclusive licensing agreement for the development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. The companies planned to launch the drug in the U.S. in 1Q15. Sanofi is responsible for global commercial, regulatory and development activities and MannKind will manufacture Afrezza at its facility in Danbury, CT. The companies are also planning to expand global manufacturing capacity as needed.
MannKind received an upfront payment of $150 million and potential regulatory and development milestones of as much as $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%.
Sanofi and MyoKardia formed a worldwide collaboration to discover and develop first-of-its-kind targeted therapeutics for heritable heart diseases known as cardiomyopathies, the most common forms of heart muscle disease. The collaboration builds upon MyoKardia’s pioneering science, which hopes to correct the disruptive effects that disease mutations have on heart muscle contraction.
The collaboration, representing one of the largest research and development commitments to genetic forms of cardiomyopathy, encompasses three MyoKardia programs. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and the other is focused on dilated cardiomyopathy (DCM). The collaboration provides up to $200 million in equity investments, milestone payments and research and development services through 2018, of which $45 million has already been received in an upfront licensing fee and an initial equity investment. In addition, Sanofi and MyoKardia will equally share development costs on the HCM programs following initial demonstration of efficacy in patients, with Sanofi fully covering the development costs of the DCM program.
The collaboration is an outgrowth of Sanofi’s Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi’s expert development and commercialization abilities.
Evotec AG and Sanofi entered negotiations for a five-year strategic alliance comprised of three major initiatives focused on improving innovation effectiveness in drug discovery and preclinical development. Sanofi will commit €250 million under the alliance. A pipeline-building collaboration will initially focus on oncology, where Evotec will accelerate drug discovery projects to the point of preclinical development candidates, at which point Sanofi may take over development. Evotec will license a portfolio of projects from Sanofi, including five well-advanced preclinical projects in oncology that will jointly be progressed to IND.
Also, under a French academic bridge program, Evotec will continue to expand its Cure X/Target X business model to leverage scientific expertise and a portfolio of drug development services to capitalize on the most promising science. Sanofi will fund this initiative and may support individual projects through this program.
Furthermore, an outsourcing alliance will include the acquisition of Sanofi’s drug discovery operations in Toulouse to build a European center of excellence for compound management and drug discovery services. To meet capacity needs, Evotec will expand its capabilities by integrating a scientific and technological facility with more than 200 experienced scientists from Sanofi’s Toulouse research site, which is a small molecule discovery site, into its global drug discovery platform that would cover early-stage discovery and preclinical process from screening to medicinal chemistry.
Evotec will manage Sanofi’s global screening compound library as well as provide a range of drug discovery services for Sanofi for the period of the contracts. Lastly, an open innovation initiative will offer combined libraries, which will be made available for screening to Evotec’s partners. The Sanofi library, with more than 1,000,000 compounds, will expand Evotec’s library of more than 400,000 compounds, creating a large drug discovery source. Evotec will screen the libraries against collaborators’ targets under pre-agreed terms from which Sanofi will receive a contribution if a product is developed from a library hit.
In February 2015 Olivier Brandicourt was appointed chief executive officer of Sanofi, effective April 2. Dr. Brandicourt succeeds Chris Viehbacher who was fired last October amidst whistleblower lawsuit claims that the company was involved in a kickback scheme directed through consultants for diabetes drug sales in the U.S. Dr. Brandicourt has 28 years of global experience in the pharmaceutical industry, most recently as chairman of the board of management of Bayer HealthCare AG and member of the executive council at Bayer AG. Previously, he held positions of increasing responsibility at global pharmaceutical groups, including Parke-Davis/Warner-Lambert and Pfizer. Dr. Brandicourt also served as a member of Pfizer’s global executive leadership team from 2010 to 2013. |
Although Sanofi’s financials have kept it afloat on the leader board this year, it’s having a tough old time of it. Lantus, the company’s basal insulin was set to slide off patent in the U.S. in February this year, but was rescued only at the last minute by a lawsuit against Eli Lilly and Boehringer Ingleheim under the Hatch-Waxman Act for patent infringement. This has spared them the hangman’s noose until June 2016, and although it is difficult to make, Lilly and Boehringer already have biosimilars approved in Europe and they will be waiting in the wings to take the U.S. by storm. Sanofi’s new basal insulin Toujeo launched in the U.S. in February, but will it be enough? Also, the re-assessment of the Cancer Development Fund (CDF) in the UK has sent shock waves throughout the industry and the company, as it had two of its cancer drugs for prostate and colorectal cancer de-listed, effectively taking the company out of the UK marketplace. The French giant is going to have to come up with something to fill in the gaps that have appeared in its portfolio. An alliance with Lead Pharma was announced in the first quarter of the year illustrating the company’s intentions to expand drug development efforts in autoimmune diseases such as rheumatoid arthritis, psoriasis and inflammatory bowel disease (IBD). Alongside this, agreements with Medtronic in the diabetes arena, Lilly in erectile dysfunction, and UCB in immune mediated diseases could mean it might be on the road to recovery. But if sales of inhaled insulin Afrezza don’t pick up, it will be relying on Toujeo more and more. —Adele Graham-King |