Aventis

Sanofi-Synthelabo

サノフイ アベンティス買収へ　７兆円で合意

Aventis Supervisory Board Recommends Substantially Improved Offer from Sanofi-Synthelabo

「サノフィ・アベンティス」　2004/8/20に正式発足 　　

Is Sanofi-Aventis After Bristol-Myers?

Sanofi Aventi　

Sanofi-aventis Announces Non-Binding Offer to Acquire Genzyme

2004/09/03 グラクソ・スミスクライン

グラクソ・スミスクライン、サノフィ・アベンティスより
抗血栓症剤　フラキシパリン、アリクストラおよび関連生産施設の買収を完了
http://release.nikkei.co.jp/detail.cfm?relID=80418

　２００４年９月１日　ロンドン発−グラクソ・スミスクライン（以下、ＧＳＫ）は、サノフィ・アベンティス社より注射剤の抗血栓症剤　フラキシパリンとアリクストラおよび関連資産（フランスのノートルダム・ド・ボンドビルにある製造施設を含む）について世界規模での買収が成功裏に完了したことを発表しました。

　この買収において、ＧＳＫは現在進行しているアリクストラの臨床試験の実施の責任も担います。

　サノフィ・サンテラボ社によるアベンティス社の買収は、統合における必須条件を処理し欧州委員会および米国連邦公正取引委員会からの承認を得て完了しました。この度の製品の買収はそれにともない成立に至ったものです。

（以下略）

BusinessWeek January 29, 2007

Is Sanofi-Aventis After Bristol-Myers?
http://www.businessweek.com/globalbiz/content/jan2007/gb20070129_973975.htm?chan=top+news_top+news+index_businessweek+exclusives

Word is the two major pharmaceuticals may soon merge and become the world's largest drugmaker ahead of some best-selling drugs coming off patent

Speculation is mounting that the long-rumored merger between Franco-German drugmaker Sanofi-Aventis and New York-based Bristol-Myers Squibb may soon be reality. If true, the deal will enable Sanofi to vault past Pfizer and Britain's GlaxoSmithKline to become the world's largest drugmaker, with combined annual revenues of nearly $55 billion. Neither company is commenting. But a recent report in French financial newsletter La Lettre de l'Expansion claims the two companies have already signed a pre-merger agreement.

December 15, 2015　

Sanofi and Boehringer Ingelheim Enter Exclusive Negotiations on Business Swap

Sanofi Would Become a Global Leader in Consumer Healthcare and Boehringer Ingelheim Would Become Second largest Animal Health Company

Sanofi and Boehringer Ingelheim today announced that the companies have entered into exclusive negotiations to swap businesses.
The proposed transaction would consist of an exchange of Sanofi animal health business ("Merial") with an enterprise value of €11.4 bn and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of €6.7 bn.
Boehringer Ingelheim CHC business in China would be excluded from the transaction.
The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of €4.7 bn.

The transaction would allow Sanofi to become the number one ranked player in consumer healthcare with expected pro forma sales of approximately €5.1 bn in 2015(e) and a global market share close to 4.6%1. Sales of Boehringer Ingelheim CHC business (excluding China) are estimated at about €1.6 bn for 2015 and are highly complementary with those of Sanofi CHC, both in terms of products and geographies.
Boehringer Ingelheim CHC would improve the position of Sanofi in Germany and Japan where Sanofi CHC presence is limited, and expand Sanofi presence in its Priority Categories. Sanofi would gain access to iconic brands in Antispasmodics, Gastrointestinal, VMS and Analgesics, and attain critical mass in Cough & Cold. Sanofi CHC business in the US, Europe, Latin America and Eurasia would also expand significantly, giving it multiple leadership postions in key countries and/or on key product categories.

The animal health industry is a very attractive industry in terms of innovation, growth potential and profitability. Combining Merial's and Boehringer Ingelheim's complementary strengths would create the second largest player in the global animal health market with pro forma sales of approximately € 3.8 bn in 2015(e) with the ability to compete for global market leadership. The combined portfolios and technology platforms in anti-parasitics, vaccines and pharmaceutical specialities would place the combined company in the key growth segments of the industry. The species portfolios are highly complementary building on Merial's expertise in companion animals and poultry and BI's expertise in swine.

"In entering into exclusive negotiations with Boehringer Ingelheim, we have acted swiftly to meet one of the key strategic objectives of our roadmap 2020, namely to build competitive positions in areas where we can achieve leadership. This transaction would allow Sanofi to become a world leader in the attractive non-prescription medicines market and would bring a complementary portfolio with highly recognized brands, allowing for mid and long term value creation," said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "I am confident that Boehringer Ingelheim will enable Merial to fully express and develop its potential in the attractive but competitive animal health market."

Germany would become a key center of Sanofi CHC business, including in particular for Gastro-Intestinal and Cough & Cold categories that will benefit from the strong capabilities of Boehringer Ingelheim teams. Sanofi will pay particular attention to social matters as well as skills and people retention sensitivities.

"Boehringer Ingelheim's strategic priority is to focus on the company's core areas of expertise and businesses with an established global scale, or where a pathway to a global scale can be achieved and prioritized among Boehringer Ingelheim's portfolio opportunities," said Prof. Dr Andreas Barner, Chairman of the Board, Boehringer Ingelheim. "Boehringer Ingelheim Animal Health is and will stay strongly committed to bringing novel, innovation driven solutions to veterinarians and animal owners. Our combined Animal Health business would be well positioned for growth and emergence as a leader globally. I am confident that Sanofi will enable our CHC business to fully live its potential supported by highly professional and committed teams."

Lyon would be a key operational center of Boehringer Ingelheim's Animal Health business. Boehringer Ingelheim will commit to maintain business operations, R&D and Manufacturing Centers in France. As the U.S. market is an important part of Merial's business, Boehringer Ingelheim would pay particular attention to sustain the momentum of the U.S. operations. Boehringer Ingelheim will give particular attention to social matters as well as skills and retention sensitivities.

The execution of definitive agreements is expected in the coming months following consultations with the relevant social bodies. Boehringer Ingelheim and Sanofi's goal currently is to close the potential transaction in Q4 2016, subject to appropriate regulatory approvals.

Sanofi intends to use a portion of the net proceeds of the transaction to repurchase shares. Taking into account the anticipated CHC results, share buybacks and potential synergies, the overall transaction is expected to be business EPS neutral in 2017 and accretive in subsequent years.

About Boehringer Ingelheim's CHC activities
Boehringer Ingelheim Consumer Healthcare is the 8th largest Consumer Healthcare business in the world. Sales of Boehringer Ingelheim's CHC business were €1.4 bn in 2014, contributing 11 per cent to Boehringer Ingelheim's net sales. It aims to create and drive inspiring and sustainable solutions that will efficiently develop compelling and true global brands for consumers.The leading brands of Boehringer Ingelheim's CHC business are the antispasmodic Buscopan® (2014 sales of €219 million; mainly sold in Europe and Latin America), the laxative Dulcolax® (2014 sales of €204 million; sold in more than 40 countries with a strong presence in the U.S.), the multivitamins Pharmaton® (2014 sales of €133 million, with majority of sales in Latin America), the cough treatments Mucosolvan® (2014 sales of €165 million, mainly in China, Germany and Russia) and Bisolvon® (2014 sales of €101 million with a fragmented worldwide presence with largest countries being Spain and Italy) and the cold treatment Mucoangin®/Lysopaine® (2014 sales of €48 million).

About Sanofi CHC activities
Sales of Sanofi CHC business were €3.3 bn in 2014. The leading brands of Sanofi's CHC business are the allergy products Allegra® (2014 sales of €350 million) and Nasacort® (2014 sales of €114 million), the pain killers Doliprane® (2014 sales of €310 million), No-Spa® (2014 sales of €109 million) and Dorflex® (2014 sales of €90 million), the digestive products Essentiale® (2014 sales of €235 million), Enterogermina® (2014 sales of €156 million) and Maalox® (2014 sales of €98 million), the feminine care product Lactacyd® (2014 sales of €104 million) and the vitamins, minerals and supplements Magné B6® (2014 sales of €88 million). In 2014, 52.6% of CHC sales were generated in emerging markets, 21.2% in the U.S. and 20.3% in Western Europe.

Sanofi and Boehringer Ingelheim combined worldwide CHC businesses - Priority Categories
(pro forma)
Source: Nicholas Hall & Company, FY 2014
　

About Merial
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health and well-being of a wide range of animals. Merial employs 6,600 people and operates in more than 150 countries worldwide with €2.5 billion of sales expected in 2015.
Merial has three main business areas: pets, farm animals, and veterinary public health. Our pharmaceuticals and vaccines focus on disease prevention and overall health and wellness in animals, and target more than 200 diseases and conditions across a variety of species.
The main Merial brands in the field of pet health include Frontline®, Heartgard®, NexGard® and Purevax®; and in farm animals Vaxxitek®, Eprinex®, Ivomec®, Longrange®, Circovac® and GastroGard®. Merial is a strategic partner for veterinary public health (VPH), providing governments with vaccines to control foot and mouth disease (FMD), Rabies and Blue Tongue Virus (BTV).
As part of our commitment to innovation and excellence, Merial has a global footprint with 13 R&D centers and 18 production sites. Working with global trends in mind, such as population growth, increased demand for animal proteins, needs of emerging markets, growing middle classes, resource constraints, and sustainability concerns, we aim to consciously and constantly innovate and provide solutions to our customers' and animals' needs.
For more information, please see www.merial.com

About Boehringer Ingelheim Animal Health
Boehringer Ingelheim Animal Health is the 6th largest animal health business in the world and is committed to providing leading innovative solutions to prevent, treat and cure animal diseases. With approximately 4,000 employees worldwide, Boehringer Ingelheim Animal Health achieved net sales of about € 1.13 billion in 2014. Main brands of Boehringer Ingelheim's Animal Health portfolio are Ingelvac Circoflex® (2014 sales of € 260 million), Metacam® (2014 sales of € 93 million), Ingelvac PRRS® (2014 sales of € 74 million), Duramune® (2014 sales of € 69 million) and Vetmedin® (2014 sales of € 57 million), representing 8% of the corporation's revenue base. From a regional perspective, Boehringer Ingelheim has its legacy as an Animal Health company in the US with most of its R&D and manufacturing infrastructure located there. Significant investments have been made recently in Hannover, Germany and are underway in China. The Boehringer Ingelheim Animal Health Business is currently holding strong positions in swine and cattle vaccines as well as in pharmaceutical specialties for animal use. In its research-driven Animal Health business, Boehringer Ingelheim continually invests more than 12% of net sales of the Animal Health business in R&D.

Boehringer Ingelheim and Merial combined businesses - priority categories (pro forma)

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

June 23 2020

Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas

The two companies will build upon their existing collaboration to pursue novel mRNA vaccines aimed at broadly addressing current and future infectious diseases

Translate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccines

Sanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technology

The expanded collaboration brings together Translate Bio’s leading mRNA technology and manufacturing with Sanofi’s world class vaccine development and distribution

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.

The expansion of this agreement will further unite Translate Bio’s expertise and knowledge from more than 10 years of mRNA research and development with Sanofi’s leadership in vaccine research and development.
Under the expansion agreement, Translate Bio will receive a total upfront payment of $425 million, consisting of a $300 million cash payment and a private placement common stock investment of $125 million at $25.59 per share representing a 50 percent premium to the 20-day moving average share price prior to signing.

Translate Bio will also be eligible for potential future milestones and other payments up to $1.9 billion, including $450 million of milestones under the 2018 agreement. Of these potential milestones and other payments, approximately $360 million are anticipated over the next several years, inclusive of COVID-19 vaccine development milestones. In addition, Translate Bio is also eligible to receive tiered royalty payments based upon worldwide sales of the developed vaccines. Sanofi Pasteur will pay for all costs during the collaboration term. Under this agreement Sanofi Pasteur will receive exclusive worldwide rights for infectious disease vaccines.

“As all eyes are on prevention of infectious disease through vaccines, this is a pointed moment in time where we are called upon to seek innovative ways to protect public health,” said Thomas Triomphe, Executive Vice President, Sanofi Pasteur. “We are excited by the novel technology and expertise Translate Bio brings, and we believe that adding this mRNA platform to our vaccines development capabilities will help us advance prevention against current and future infectious diseases.”

“The expansion of our collaboration with Sanofi Pasteur validates the progress we’ve made in the development of mRNA vaccines for infectious diseases since our work together began in 2018 and also speaks to the potential of our mRNA platform. We are excited to work with Sanofi in this broadened capacity with the goal of ultimately delivering vaccines on a global scale, a need underscored by the current pandemic,” said Ronald Renaud, Chief Executive Officer of Translate Bio. “Translate Bio will also be well positioned financially to continue to build upon our internal capabilities with a focus on advancing innovations in platform discovery and on the development of ongoing and additional preclinical therapeutic programs as we aim to bring multiple programs towards clinical development.”

Under the collaboration, Translate Bio is using its mRNA platform to discover, design and manufacture vaccine candidates and Sanofi Pasteur is providing its deep vaccine expertise to advance vaccine candidates into and through further development. Translate Bio will also transfer technology and processes to allow Sanofi Pasteur to develop and manufacture mRNA vaccines for infectious diseases.

The teams are currently evaluating multiple COVID-19 vaccine candidates in vivo for immunogenicity and neutralizing antibody activity to support lead candidate selection and the companies have the goal of initiating a first-in-human clinical trial in the fourth quarter of 2020.

The companies are also advancing an mRNA vaccine development candidate against influenza through preclinical studies with clinical trial initiation anticipated in mid-year 2021. Additional mRNA vaccine development programs under the collaboration include another viral pathogen and a bacterial pathogen.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. For more information regarding the financial and other terms of the agreement, please refer to the Current Report on Form 8-K which will be filed by Translate Bio with the U.S. Securities & Exchange Commission on June 23, 2020.

Evercore acted as financial advisor to Translate Bio for the expansion of the collaboration agreement.

About mRNA Vaccines
Vaccines work by mimicking disease agents to stimulate the immune system; building up a defense mechanism that remains active in the body to fight future infections. mRNA vaccines offer an innovative approach by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential to induce a protective immune response. mRNA vaccines also represent a potentially innovative alternative to conventional vaccine approaches for several reasons - their high potency, ability to initiate protein production without the need for nuclear entry, capacity for rapid development and potential for low-cost manufacture and safe administration using non-viral delivery. This approach potentially enables the development of vaccines for disease areas where vaccination is not a viable option today. Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process offering maximum flexibility and efficiency in development.

About the Sanofi Pasteur and Translate Bio collaboration
In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens. This agreement was first expanded in March 2020 to include the collaborative development of a novel mRNA vaccine for COVID-19. This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018. Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs including screening, optimization and production of mRNA and LNP formulations across multiple targets.

About Translate Bio
Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Translate Bio is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease. Translate Bio’s lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad range of diseases, including diseases that affect the liver. Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio

・Further strengthens core R&D areas of autoimmune and allergic diseases
・Provides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), making commercialization more efficient and eliminating future royalty payments
・Allows expansion of SAR442168 development program into other central nervous system diseases and therapeutic areas
・Adds clinically advanced oral BTK inhibitor rilzabrutinib with potential across a range of immunology and inflammation indications, complementing Sanofi’s existing R&D pipeline

Principia Biopharma Inc.は臨床段階のバイオ医薬品会社である。
【事業内容】同社は免疫･腫瘍学分野において患者に対する経口療法の開発に焦点を当てる。同社はテーラード・コバレント・プラットフォームを使用して、可逆的な共有結合および不可逆的な共有結合性小分子阻害剤を設計･開発する。同社のパイプラインはPRN1008、PRN1371およびPRN2246を含む。PRN1008薬物候補は慢性免疫学的障害の治療に設計される。PRN2246は多発性硬化症（MS）および他の中枢神経系（CNS）疾患の治療用不可逆的共有結合BTK阻害剤である。PRN1008はまた、天疱瘡などの複数の自己免疫疾患の治療に開発される。PRN1371は、固形腫瘍の治療に設計された線維芽細胞増殖因子受容体（FGFR）の阻害剤である。同社はまた、炎症および自己免疫疾患の治療用経口免疫プロテアソーム阻害剤の開発に焦点を当てる。

2017/11

Principia Biopharma has signed a deal worth up to $765 million with Sanofi for the development of a multiple sclerosis drug candidate.
Sanofi will develop privately-held Principia’s Bruton's tyrosine kinase (BTK) inhibitor PRN2246(SAR442168), an experimental oral treatment for MS. The drug is designed to access the brain and spinal cord by crossing the blood-brain barrier and impact immune cell and brain cell signaling. Through this mechanism of action, the company believes it has the potential to treat MS as well as other diseases of the central nervous system. Principia said it has initiated a Phase I trial for PRN2246 in healthy volunteers.
　

2020/2  サノフィがPrincipiaから導入したBTK阻害剤SAR442168による多発性硬化症（MS）治療の第2相試験が、主要評価項目である脳のMRI病変減少を達成

今回、Principia Biopharmaを買収し、SAR442168 をfull control へ

Sanofi and Principia Biopharma Inc., a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68billion (on a fully diluted basis). The Sanofi and PrincipiaBoards of Directors unanimously approved the transaction.

“This acquisition advances our ongoing R&D transformation to accelerate development of the most promising medicines that will address significant patient needs,” said Paul Hudson, Sanofi Chief Executive Officer. “The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant  BTK inhibitor ‘168 removes complexities for this priority development program and simplifies future commercialization.” 

“The Phase 2b data in relapsing multiple sclerosis showed the strong potential of ‘168 to address disability and disease progression, and triggered the start of Phase 3 studies across the full spectrum of MS.  Through this acquisition, we will be able to expand and accelerate development of BTK inhibitors across multiple indications. Both‘168 and rilzabrutinib, have ‘pipeline in a product’ potential, and we look forward to unlocking their full treatment benefits across an array of diseases,” said John Reed, M.D., Ph.D., Global Head of Research & Development at Sanofi.

“Principia’s successful design and development of a whole portfolio of BTK inhibitors for immunology is aimed to transform the treatment for patients with immune-mediated diseases. By combining with Sanofi, we will bring significant resources to expand and accelerate the potential benefits of these therapies. The benefit of developing several BTK inhibitors will allow us to target specific organ systems for optimal patient benefit. The merger will provide global resources to get these novel therapies to patients faster,” said Martin Babler, President and CEO at Principia Biopharma.

Principia’s Bruton tyrosine kinase (BTK) inhibitors add to Sanofi’s efforts to accelerate and build a portfolio of the next generation of transformative treatments for auto immune diseases. BTK is present in the signaling pathways of key innate and adaptive cell types of the immune system. Being able to block or disrupt these signaling processes can help in stopping inflammation and tissue destruction related to autoimmune diseases and target some of the underlying pathophysiology.