Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. The corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Synthélabo merged with Aventis and renamed to Sanofi-Aventis, which were each the product of several previous mergers. It changed its name back to Sanofi in May 2011. The company is a component of the Euro Stoxx 50stock market index.[2] In 2023, the company’s seat in Forbes Global 2000 was 89.[3]
Sanofi was founded in 15 February 1973[5] as a subsidiary of Elf Aquitaine (a French oil company subsequently acquired by Total), when Elf Aquitaine took control of the Labaz group, a pharmaceutical company formed in 1947 by Sociéte Belge de l'Azote et des Produits Chimiques du Marly;[6] Labaz developed benziodarone in 1957.[7]: 146 In 1993, Sanofi made a move into the Eastern Europe market by acquiring a controlling interest in Chinoin, a Hungarian drug company whose 1992, sales totaled about US$104 million.[8][9] In the same year, Sanofi made its first significant venture into the US, and strengthened its presence in Eastern Europe, by first partnering with Sterling Winthrop and then acquiring the prescription pharmaceuticals business in 1994.[8][10] Sanofi was incorporated under the laws of France in 1994, as a société anonyme, a form of limited liability company.[11]: 18
Synthélabo was founded in 1970, through the merger of two French pharmaceutical laboratories, Laboratoires Dausse (founded in 1834)б and Laboratoires Robert & Carrière (founded in 1899). In 1973, the French cosmetics group L'Oréal acquired the majority of its share capital.[11]: 19 In 1991, Synthelabo acquired Laboratories Delalande[12] and Laboratoires Delagrange, and through this deal picked up the product metoclopramide.[13][14]
Logo for Sanofi-Synthélabo (1999—2004)
Sanofi-Synthélabo was formed in 1999 when Sanofi merged with Synthélabo; at the time of the merger, Sanofi was the second largest pharmaceutical group in France in terms of sales and Synthélabo was the third largest. The merged company was based in Paris, France.[11]: 18–19 [15]
The merged companies focused on pharmaceuticals, divesting several businesses soon after the merger, including beauty, diagnostics, animal health and nutrition, custom chemicals, and two medical equipment businesses.[11]: 19
At the time of the merger, Rhône-Poulenc's business included the pharmaceutical businesses Rorer, Centeon (blood products), and Pasteur Merieux (vaccines), the plant and animal health businesses Rhône-Poulenc Agro, Rhône-Poulenc Animal Nutrition, and Merial, and a 67 percent share in Rhodia, a speciality chemicals company.[18]: 10 Hoechst, one of the companies that resulted from the post-WWII split of IG Farben, had seven primary businesses: Hoechst Marion Roussel (pharmaceuticals), AgrEvo (a joint venture with Schering in crop protection agents and pest control products), HR Vet (veterinary products), Dade Behring (diagnostics), Centeon, Celanese (chemicals), and Messer (chemicals).[18]: 9 Merieux has been in the business of selling blood products, and in the 1980s, during the AIDS epidemic, Merieux and other companies were involved in scandals related to HIV-contaminated haemophilia blood products that were sold to developing nations.[20]
In 2000, Aventis and Millennium Pharmaceuticals, a US biotechnology company formed to discover new drugs based on the then-new science of genomics, announced that Aventis would make a $250M investment in Millennium and would pay $200M to Millennium in research fees over five years, one of the largest such deals between a big pharmaceutical company and a biotech company at the time.[21]
In late 2000, in the midst of the recall of Starlink, its genetically modified maize product, Aventis announced that it had determined to sell off Aventis Cropscience, the seed and pesticide business unit it had created from the agriculture businesses of its predecessors.[22] In October 2001, Bayer and Aventis announced that Bayer would acquire the unit for about $6.6 billion; the unit became Bayer CropScience, making Bayer the world's second-largest agrochemical company behind Syngenta.[23]
In 2003, Aventis entered into a collaboration with Regeneron Pharmaceuticals, a New York biotechnology company, to develop Regeneron's VEGF-inhibiting drug, aflibercept, which was then in Phase I clinical trials. Aventis invested $45 million in Regeneron and made an upfront payment of $80 million in cash.[24] Regeneron partnered the use of the drug with Bayer Healthcare in the field of proliferative eye diseases, and under the name Eylea it was approved by the US Food and Drug Administration (FDA) in 2011;[25] after several setbacks in clinical trials,[26] Regeneron and Sanofi got the drug approved for metastatic colorectal cancer in combination with other agents, under the brand name Zaltrap in 2012.[27]
Sanofi-Aventis merger
Sanofi-Aventis was formed in 2004, when Sanofi-Synthélabo acquired Aventis. In early 2004, Sanofi-Synthélabo made a hostile takeover bid for Aventis worth €47.8 billion. Initially, Aventis rejected the bid because it felt that the bid offered inferior value based on the company's share value, and the board of Aventis went so far as to enact poison pill provisions and to invite Novartis to enter merger negotiations.[28] The three-month takeover battle concluded when Sanofi-Synthélabo launched a friendly bid of €54.5 billion in place of the previously rejected hostile bid. The French government played a strong role, desiring what it called a "local solution", by putting heavy pressure on Sanofi-Synthélabo to raise its bid for Aventis and for Aventis to accept the offer[29] and by rejecting Aventis's poison pill proposal.[30] One of the largest risks in the deal for both sides was the fate of the patents protecting Clopidogrel (Plavix), which was one of the top-selling drugs in the world at the time and the major source of Sanofi's revenue.[31]
Post-merger activities
In 2006, Iraqis infected with HIV sued Sanofi and Baxter over HIV-contaminated haemophilia blood products sold by Merieux in the 1980s.[32] In 2006, the US patents on clopidogrel (Plavix) were challenged when a Canadian generics company, Apotex, filed an Abbreviated New Drug Application under the Hatch-Waxman Act, received FDA approval, and started marketing a generic formulation of clopidogrel. While Sanofi-Aventis and its partner in the drug, Bristol Myers Squibb (BMS), were able to get an injunction to stop Apotex from selling it,[33] the case became complicated when settlement negotiations fell apart twice – the second time because of an oral agreement made by BMS CEO Peter Dolan that BMS failed to disclose to the Federal Trade Commission during the review of the settlement agreement to ensure that it did not violate antitrust law. When Apotex disclosed the oral agreement to the FTC, the FTC launched an investigation that led to Dolan's dismissal by BMS.[34] Apotex finally lost on the patent litigation issues after its third appeal was decided in favor of BMS/Sanofi in November 2011; Apotex had to pay ~$442 million in damages and ~$108 million in interest for infringing the patent,[35] which it paid in full by February 2012.[36] Apotex also sued BMS and Sanofi for $3.4 billion for allegedly breaching the settlement agreement; Apotex lost a jury trial in March 2013.[37]
In 2007, Sanofi-Aventis expanded on Aventis's prior relationship with Regeneron Pharmaceuticals; in the new deal Sanofi-Aventis agreed to pay Regeneron $100 million per year for five years, under which Regeneron would use its monoclonal antibodydiscovery platform to create new biopharmaceuticals, to which Sanofi-Aventis gained the exclusive right to co-develop.[38] In 2009, the companies expanded the deal to $160 million per year and extended it to 2017.[38][39] As of 2009[update], the collaboration had four antibodies in clinical development and had filed an IND for a fifth. Two were against undisclosed targets, one targeted the interleukin-6receptor as a treatment for rheumatoid arthritis, another targeted nerve growth factor for the treatment of pain, and another targeted delta-like ligand 4 as a cancer treatment.[39]
Between 2008, when Chris Viehbacher was hired as CEO, and 2010, the company spent more than $17 billion in mergers and acquisitions to strengthen its consumer healthcare and generics platforms, especially in emerging markets, in the face of looming patent cliffs and the growth of the consumer healthcare segment.[40][41][42] In September, Zentiva was acquired for €1.8 billion, expanding the group's presence in eastern European markets.[43]
In 2009, Medley Farma, the third largest pharmaceutical company in Brazil and a leading generics company there, was acquired for about $635 million.[44] Sanofi outbid Teva Pharmaceuticals.[45] The deal was approved by Brazil's antitrust authorities in May 2010.[44] Later that year, Indian vaccine manufacturer Shantha Biotechnics was acquired for $784 million.[46] In October Sanofi-Aventis announced that it would lay off about 1700 US employees (about 25% of its US workforce) because of restructuring triggered by growing generic competition and other factors, and that the company would focus its US operations on diabetes, atrial fibrillation, and oncology.[47]
In 2010, US consumer healthcare company Chattem, Inc. was acquired for around $1.9 billion.[42] In the same year, Nepentes Pharma was acquired for $130 million and BMP Sunstone Corporation for $520.6 million.[48]
Name change, acquisitions and investments
The company dropped the -Aventis suffix of its name on May 6, 2011, after receiving approval at its annual general meeting. The reason given by the company for the change was to make its name easier to pronounce in countries such as China.[49]
In 2011, Genzyme Corporation was acquired for around $20.1 billion. This biotechnology company, headquartered in Cambridge, Massachusetts, specializes in the treatment of orphan diseases, renal diseases, endocrinology, oncology, and biosurgery.[50]
In January 2012, Sanofi co-invested in the $125 million Series A financing of Warp Drive Bio. Sanofi sought support for its internal cancer research program and also took on an obligation to acquire Warp Drive if certain milestones were met.[51]
In January 2014, Genzyme and Alnylam Pharmaceuticals, a US biotechnology company developing RNAi therapeutics, announced that Genyzme would invest $700 million in Alnylam. Under the deal, Genzyme obtained further rights to patisiran, an RNAi treatment for transthyretin-mediated amyloidosis – a condition that can result in familial amyloidotic polyneuropathy and familial amyloidotic cardiomyopathy[52] and obtained rights to other compounds in Alnylam's pipeline.[53]
In March 2014, Sanofi joined the bidding for Merck & Co.'s over-the-counter health-products unit, the maker of Coppertone sunblock and the antihistamine Claritin; bids were expected to range between $10 billion and $12 billion.[54]
In October 2014, Sanofi's directors fired US-resident chief executive Chris Viehbacher, blaming his alleged lack of communication with the board and poor execution of his strategy.[55] Board chairperson Serge Weinberg took over as interim CEO until 2 April 2015 when Bayer Healthcare board chairman Olivier Brandicourt (appointed by Sanofi on 19 February 2015[56]) took over. Before Brandicourt even started his new job, French government ministers Stéphane Le Foll and Ségolène Royal attacked the $4.5 million golden handshake he was getting from Sanofi – and his pay of about $4.7 million a year.[57] Furthermore, in 2014, the business took a 66% stake in Globalpharma, a Dubai-based generics manufacturer.[58]
In July 2015, Genzyme announced that it would acquire the cancer drug Caprelsa (vandetanib) from AstraZeneca for up to $300 million.[59] In the same month, the company announced a new global collaboration with Regeneron Pharmaceuticals to discover, develop, and commercialize new immuno-oncology drugs, which could generate more than $2 billion for Regeneron,[60] with $640 million upfront, $750 million for proof of concept data, and $650 million from the development of REGN2810.[61]
In June 2016, the company announced that it had struck an asset-swap deal with Boehringer Ingelheim. Sanofi would sell its Merial animal health division (valuing it at €11.4 billion), while acquiring Boehringer's consumer health division (valuing it at €6.7 billion) and €4.7 billion in cash. The deal meant that Sanofi was now one of the global consumer healthcare leaders by market share.[62]
In July 2017, the company announced its intention to acquire Protein Sciences, a privately held Connecticut-based vaccines biotechnology company, for $650 million and with up to $100 million in milestone achievements.[63]
In January 2018, Sanofi announced that it would acquire Bioverativ for $11.6 billion[64] and days later announced that it would acquire Ablynx for €3.9 billion ($4.8 billion).[65]
In December 2019, the company announced that it would acquire Synthorx for $2.5 billion ($68 per share), adding the lead product candidate THOR-707 (SAR444245), a form of interleukin-2 (IL-2) being developed for use against multiple solid tumors.[66][67] In October 2022, Sanofi announced that it had stopped Phase 2 studies of THOR-707 (SAR444245) because the drug's efficacy “was lower than projected”.[68] Sanofi would take a roughly $1.6 billion impairment charge because of delays to the program.[69][70]
In May 2020, Regeneron announced that it would repurchase around $5 billion of its shares held directly by Sanofi. Before the transaction, Sanofi had held 23.2 million Regeneron shares.[71] In June, the company announced that it had agreed a potential $2 billion deal with Translate Bio, expanding an already existing collaboration for COVID-19 treatments.[72] The company agreed to produce 60 million doses of a coronavirus vaccine for the United Kingdom government in July 2020. It used recombinant protein-based technology for Sanofi's flu vaccine along with GSK's pandemic technology and was seeking regulatory approval by the first half of 2021.[73] Sanofi also agreed to a $2.1 billion deal with the United States for 100 million doses.[74] In August, Sanofi announced that it would acquire Principia Biopharma for $3.7 billion, acquiring its BTK inhibitor program.[75][76][77] The acquisition was completed in September 2020.[78] In November, Sanofi announced that it would acquire Kiadis Pharma for €308 million (around $359 million, or €5.45 per share), expanding its immuno-oncology pipeline with the acquisition of Kiadis's three clinical compounds: K-NK002 in Phase II trials for hematopoietic stem cell transplants in blood cancer, K-NK003 for relapsed or refractory acute myeloid leukemia, and K-NK-ID101 for COVID-19.[79]
In January 2021, Sanofi announced that it would buy the British biotech Kymab Ltd and its potential first-in-class drug candidate – KY1005 –- for $1.45 billion.[80][81][82] In April, the business announced that it would acquire Tidal Therapeutics for up to $470m.[83] in August the company announced that it would acquire Translate Bio and its mRNA vaccine technology for $3.2 billion.[84] On 8 September 2021, Sanofi announced that it would acquire US biotech company Kadmon Corporation for $1.9 billion[85] On 18 November 2021, it was reported that Sanofi would be investing $180 million in French startup Owkin, whose predictive algorithms aim to improve the research and development of new cures against cancer.[86] In December, the company announced that it would acquire Origimm Biotechnology GmbH and its acne vaccine candidate (ORI-001),[87][88] as well as Amunix Pharmaceuticals, for an initial $1 billion plus potentially $200 million in additional milestones.[89]
In April 2022, Sanofi broke ground on its biggest industrial investment, a $638m vaccine and enzymes production facility in Tuas, Singapore, targeted for completion in 2025.[90]
In March 2023, the company announced it would acquire Provention Bio and its type 1 diabetes therapy pipeline.[91]
In the fall of 2023, Sanofi announced plans to separate the OTC and focus on its key prescription production, increasing investment and reducing costs. The most likely way to separate a non-prescription division (about 11,000 employees, 2023 revenue — over $4 billion) is to create a public company headquartered in France. The division is planned for the fourth quarter of 2024.[92]
In December 2023, the company has signed a 140 million dollars partnership with Aqemia, a company that solves a mathematical equation that eliminates the need for heavy computing facilities with large computing power.[93]
In January 2024, Sanofi announced that it had agreed to buy a U.S. biotech firm Inhibrx for up to $2.2 billion, with a focus on obtaining Inhibrx's INBRX-101, an experimental treatment for Alpha-1 Antitrypsin Deficiency (AATD), an inherited rare disease that causes progressive deterioration of the lung tissue.[94]
In October 2024, Sanofi and CD&R entered exclusive negotiations to transfer a 50% controlling stake in Opella with Sanofi to remain a significant shareholder.[95]
Product recall and effects: The epinephrine (adrenaline) auto-injection devices made by Sanofi SA currently on the market in the US and Canada were voluntarily recalled on 28 October 2015.[107][108] The reason given by Sanofi was that the products had been found to potentially have inaccurate dosage delivery systems, which might include failure to deliver the drugs.[109][110]
Sanofi US also added the following warning: If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death, because anaphylaxis is a potentially life‑threatening condition.[109]
In its news release on 28 October 2015, Sanofi Canada stated that it was "actively working with suppliers of alternative epinephrine auto-injectors to have a full stock available in Canada as soon as possible. Canadian customers were asked to immediately return the Allerject product to their local pharmacy to obtain an alternate epinephrine auto-injector."[111]
The US Food and Drug Administration (FDA) also filed a news release,[110] confirming that the recall involved all Auvi-Q currently on the market in the United States. The FDA release went on to provide information for consumers re: exchanging the device for another brand of product, also provided on the Auvi-Q web site. Sanofi US would provide reimbursement for out of pocket costs incurred for the purchase of new, alternate epinephrine auto-injectors with proof of purchase.[112]
The alternate products expected to most commonly replace the recalled Sanofi devices were the EpiPens made by Mylan in the US and by Pfizer—under license from Mylan—in Canada.[113] Mylan already had an 85% market share of the auto-injectors in the USA[114] in the first half of 2015. Maylan was expected to benefit from the recall by its competitor Sanofi, according to a report published in the Fierce Pharma newsletter of 2 November 2015. As Bernstein analyst Ronny Gal wrote in a note to clients,"....it is very hard to see Auvi-Q returning to the market, as it will need to be redesigned and face uphill battle to recapture patient trust after the recall."[115] Gal also believed that the company would eventually have 95% of the epinephrine auto-injector market, according to another Fierce Pharma report on 3 November 2015.[116]
Mozobil (Plerixafor), for macrocycle, approved by the FDA for peripheral blood stem cell mobilizer for non-Hodgkin's lymphoma and multiple myeloma in December 2008.[120]
Libtayo (Cemiplimab), for squamous cell skin cancer, marketed by Regeneron.
Mozobil (Plerixafor), macrocycle, approved by the FDA for peripheral blood stem cell mobilizer for non-Hodgkin's lymphoma and multiple myeloma in December 2008.[121]
The company also produces a broad range of over-the-counter products, among them Allegra, IcyHot for muscle pain, Gold Bond for skin irritation, and Selsun Blue dandruff shampoo. These brands were acquired in 2010, when Sanofi-Aventis purchased Chattem.
In 2013, Sanofi announced that another candidate from its collaboration with Regeneron, a monoclonal antibody against the interleukin 6 receptor, sarilumab, had better efficacy than placebo in its first Phase III trial in rheumatoid arthritis.[128]
Head office 54 rue de la Boétie, Paris 8th arrondissementFormer head office 174 avenue de France, Paris 13th arrondissement
In January 2012, Sanofi moved its head office location to 54, Rue La Boétie in the 8th arrondissement of Paris. This former mansion designed by architect René-Patouillard had previously been the head office of Alcatel-Lucent.
Sanofi's previous head office was located in the 13th arrondissement of Paris, at 174 Avenue de France. The architecture of the head office is of the predominant style of the area surrounding the François Mitterrand Library. After Sanofi and Aventis merged, the employees at the former Aventis head office in Schiltigheim, Alsace, moved to Paris.[135]
In November 2022, Sanofi moved into its new global headquarters in the 17th arrondissement of Paris, at 46-48 Avenue de la Grande Armée.[136][137]
Collaborative research
In addition to internal research and development activities, Sanofi is also involved in publicly funded collaborative research projects, with other industrial and academic partners. One example in the area of non-clinical safety assessment is the InnoMed PredTox project[138][139] The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.[140]
In June 2010, Sanofi and the Charité University of Berlin signed a cooperation agreement for the research and development of medicines and therapies.[141]
On 25 October 2012, Sanofi said its earnings for the third quarter slumped, as generic competitors ate into profits from its Eloxatincancer treatment.[142]
In 2011, a Sanofi Pasteur plant flooded, causing it problems with mold.[144] The facility, located in Toronto, Ontario, Canada, produced BCG vaccine products, made with the Glaxo 1077 strain,[145] such as a tuberculosis vaccine ImmuCYST, a BCG Immunotherapeutic, a bladder cancer drug. By April 2012, the FDA had found dozens of documented problems with sterility at the plant, including mold, nesting birds, and rusted electrical conduits.[144] The plant was closed for over two years, resulting in shortages of bladder cancer and tuberculosis vaccines.[146] On 29 October 2014 Health Canada gave Sanofi permission to resume production of BCG.[147]
In 2020, Sanofi, together with GSK, signed a deal with the US government's Operation Warp Speed to provide 100 million doses of COVID-19 vaccine for up to US$2.1 billion, if the vaccine was approved.[148]
As of August 2020, COVID-19 vaccine development in Sanofi underscored its fundamental competitiveness weakness, with which management has been struggling and failed to deal with for many years, beyond cutting more costs. Unfortunately, even though the approach of Sanofi-GSK is based on pre-existing, approved platforms and technology (as with Flublok flu), without reinventing the wheel of the necessary infrastructure,[149] the company lagged behind many other rivals in delivering a working vaccine. Sanofi planned to start Phase 1 clinical testing only in September and expected emergency use approval in the first half of 2021.[150] Competitors such as Novavax had already completed Phase 1 studies, with promising results,[151] and Moderna-NIH had already initiated its Phase 3 trial.[152] According to CNBC reports,[153] as part of the $2.1 billion US government deal, more than 750 million went to supporting Sanofi-GSK in vaccine development and clinical trials. Sanofi turn-outs "accelerate" the development via a smaller biotech firm, Translate Bio, with a $425M partnership.[154]
At the end of September 2021, Sanofi announced that it would stop developing its mRNA COVID-19 vaccine. Despite promising results, the drug would not continue to Phase 3 trials, and the company stated that it would be 'too late to reach the market.'[155][156]
In June 2021, Sanofi partnered with Capgemini, Orange & Generali to launch Future4care, an all-European start-up accelerator centered on digital health.[161][162]
Aventis Foundation
The Aventis Foundation, a German charitable trust, was established in 1996, as the Hoechst Foundation, with an endowment of €50 million. In 2000, the foundation was renamed the Aventis Foundation. The foundation promotes cultural and scientific projects, specifically focused on the Frankfurt Rhine-Main area.[163]
^Innovative Medicines Initiative. "IMI Call Topics 2008". IMI-GB-018v2-24042008-CallTopics.pdf. European Commission. Archived from the original on 15 October 2009. Retrieved 25 August 2008.
^Palmer, Eric (10 September 2014), "Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years", FiercePharma
