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Merck Serono

Merck Serono was the division of Merck KGaA, a German science and technology company, formed in 2007 through the acquisition of the firm SA for $13.3 billion, marking one of the largest deals in the at the time. Headquartered in , , it specialized in the , development, and commercialization of innovative therapies targeting , , and , leveraging Serono's established expertise in biologics to expand Merck KGaA's global healthcare portfolio. Key products included Rebif () for the treatment of , Gonal-f () as a leading hormone therapy, and Erbitux () for colorectal and head-and-neck cancers, contributing to annual revenues approaching €5 billion by the early . The origins of Serono trace back to 1906, when Italian scientist Cesare Serono established the Istituto Farmacologico Serono in Rome, initially focusing on extracting and purifying natural active ingredients from animal glands for therapeutic use. The company relocated its headquarters to Geneva in 1977 and grew into Europe's largest biotech firm by the early 2000s, pioneering advancements in reproductive medicine—such as enabling the world's first in vitro fertilization (IVF) pregnancy in 1978—and building a strong pipeline in immunology and endocrinology. The 2007 acquisition by Merck KGaA, which secured an initial 66% stake from the founding Bertarelli family before increasing to over 84%, integrated Serono's approximately 8,000 employees and 20+ marketed products into a unified entity named Merck Serono International S.A., enhancing Merck's capabilities in biologics manufacturing and R&D with facilities in Switzerland and Germany. Under the Merck Serono banner, the division emphasized patient-centric innovation, investing heavily in clinical research and partnerships to address unmet needs in chronic diseases; for instance, it advanced Mavenclad (cladribine) for relapsing multiple sclerosis, approved in Europe in 2017 after years of development. By 2015, amid Merck KGaA's strategic restructuring to streamline its global identity, the Merck Serono name was discontinued outside the United States and Canada, where operations continued as EMD Serono to avoid confusion with the unrelated U.S.-based Merck & Co., Inc. The healthcare activities were fully absorbed into Merck KGaA's broader Healthcare sector, which as of November 2025 continues to drive growth in oncology (e.g., Bavencio for immuno-oncology), neurology, immunology, and fertility treatments, with ongoing R&D in precision medicine and digital health solutions. This evolution positioned the legacy of Merck Serono as a cornerstone of Merck KGaA's commitment to science-driven therapies, serving millions of patients worldwide.

History

Origins of Serono

Serono originated as an pharmaceutical company founded in 1906 by Cesare Serono in under the name Istituto Farmacologico Serono, initially producing biological extracts from animal sources for therapeutic use. The company's early research efforts in the 1950s, particularly at its Istituto Serono laboratories, focused on extracting human menopausal gonadotropin from postmenopausal urine, leading to the development of Pergonal, the first hormonal treatment for , approved in in 1950. This marked Serono's entry into , leveraging advancements in hormone isolation techniques pioneered by like Piero Donini. In response to political and economic instability in during the 1970s, the Bertarelli family, who had acquired control in the , relocated the headquarters to , , in 1977, renaming it Ares-Serono S.A. The company was formally incorporated in in 1987 as a biotechnology-focused entity, spinning off from its Italian research heritage to emphasize technology for fertility treatments. Under the leadership of Fabio Bertarelli, who became CEO in 1965, and later his son from 1996, prioritized biotech innovations, culminating in the 1985 development of Metrodin, the first highly purified (FSH) derived from urinary sources using purification, revolutionizing therapy by reducing LH contamination and improving injection tolerability. Serono's growth accelerated in the late with diversification beyond into , highlighted by the 1998 European approval of Rebif, a recombinant for relapsing , which became a cornerstone product after demonstrating efficacy in reducing relapse rates in clinical trials. By 2006, under the Bertarelli family's ownership—which held over 50% of shares—the company had achieved significant scale, with global revenues reaching approximately $2.5 billion, driven primarily by Rebif and products like Gonal-f, a recombinant FSH launched in 1995. This period solidified Serono's position as Europe's largest independent biotech firm before its acquisition by Merck KGaA.

Acquisition and Integration with Merck KGaA

On September 21, 2006, Merck KGaA announced an agreement to acquire a majority stake in SA from the Bertarelli family, who held 64.5% of the company's shares, for approximately €10.3 billion, marking the largest acquisition in Merck's history at the time. The deal was completed on January 5, 2007, after Merck increased its ownership to over 84% through a subsequent , integrating Serono's operations into Merck's portfolio. The strategic rationale behind the acquisition focused on bolstering Merck's capabilities, particularly in high-growth areas such as (including treatments like Serono's Rebif), , and , to establish a stronger global competitive position against rivals like and . This move combined Merck's chemical and pharmaceutical expertise with Serono's prowess, creating a unified R&D budget of approximately €1 billion annually and sales of around €4 billion (equivalent to roughly USD 5 billion) for , enabling accelerated innovation and market expansion. Post-acquisition, the integration process established Merck Serono as a dedicated division within Merck KGaA, headquartered initially in to preserve Serono's biotech expertise while leveraging Merck's operational infrastructure in . A structured integration effort, overseen by a Merck board member and involving 25 cross-functional teams of integration managers, focused on harmonizing processes, retaining key talent, and minimizing disruptions to ongoing operations. Early challenges included securing regulatory approvals across multiple jurisdictions, such as unconditional clearance from the U.S. on October 30, 2006, and from the on December 18, 2006, alongside initial staff transitions to align Serono's Geneva-based workforce with Merck's Darmstadt-centric model. These steps ensured compliance and set the foundation for operational synergy without immediate major relocations.

Rebranding and Evolution

In 2012, following the integration with Merck KGaA, Merck Serono relocated its global headquarters from , , to , , to centralize operations and leverage synergies within the parent company's ecosystem. This move involved transferring key functions, including administrative and select research roles, while retaining some specialized activities in and other global sites. The relocation aimed to streamline decision-making and enhance collaboration across Merck's divisions, marking a pivotal step in the unit's post-acquisition alignment. By 2015, Merck KGaA undertook a comprehensive corporate to establish a unified global identity, phasing out the standalone Merck Serono brand in favor of a consolidated "Merck" umbrella for its operations. This shift emphasized the company's positioning as a science and technology leader, with the biopharma business fully integrated under the Merck banner outside . In the United States and Canada, however, the brand persisted as EMD Serono to maintain market familiarity and regulatory continuity, allowing targeted persistence of the legacy in these key regions. The rebranding facilitated a more cohesive corporate narrative without disrupting established product lines or regional operations. Entering the 2020s, Merck Serono evolved into a core component of Merck KGaA's Healthcare , fully integrated with the broader pharmaceutical portfolio to drive in areas like , , and . This integration enabled shared resources, cross-functional R&D, and expanded global reach, positioning it as a vital biopharma pillar under Merck KGaA with sustained operations as of 2025. The Healthcare segment, encompassing these efforts, generated projected net sales exceeding €20 billion annually in 2025, underscoring its scale and economic impact within the group.

Corporate Structure and Operations

Headquarters and Organizational Setup

The healthcare business sector of Merck KGaA (formerly known as Merck Serono), integrated as the arm of Merck KGaA's Healthcare business sector following the 2015 rebranding, maintains its primary at the Merck KGaA global site in , . This facility serves as the central operational and strategic hub, housing key functions including executive leadership, research coordination, and administrative oversight for the biopharma division. The relocation to occurred in , consolidating functions from the former base in Geneva, Switzerland. The legacy Serono site in , while no longer the after its closure in , contributes to the Lake region as a prominent biotech for Merck, with nearby facilities supporting and activities. The Healthcare sector operates as one of three primary business units under Merck KGaA's —a auf Aktien (KGaA)—alongside Life Science and , all governed by the Executive Board in . Leadership includes Danny Bar-Zohar as CEO of the Healthcare sector since June 2025, overseeing biopharma strategy and integration with R&D and manufacturing. The biopharma division, as part of Merck KGaA's approximately 62,000 global employees with Healthcare as the largest sector, emphasizes integrating research, development, and manufacturing capabilities to drive innovation in therapeutics. Key facilities include biotech production sites in , such as the Aubonne plant serving as the global center for fill-and-finish operations, and in , where hosts integrated R&D and manufacturing under stringent quality control standards compliant with (EMA) and U.S. (FDA) regulations. These sites ensure adherence to (GMP) guidelines, facilitating high-quality output.

Global Presence and Subsidiaries

The healthcare business sector of Merck KGaA (formerly ), headquartered in , , maintains a robust international footprint through its subsidiaries and affiliates, operating in over 60 countries to deliver solutions globally. The division's emphasizes regional hubs that integrate local market needs with centralized oversight from , enabling efficient distribution and across diverse geographies. In , EMD Serono serves as the primary subsidiary for the and , headquartered in Boston, Massachusetts, following a relocation from Rockland in 2024 to enhance innovation and collaboration in the . This entity oversees commercial operations, research, and patient access programs, representing a key pillar of the strategy. In , the division holds a strong presence centered in , , which functions as the global headquarters for healthcare operations after the 2013 closure and relocation of legacy functions from Geneva, Switzerland. European subsidiaries, such as Merck Serono entities in (UAB) and (SIA), support localized distribution and compliance under full ownership by Merck KGaA. The healthcare sector demonstrates leadership in the , particularly in and treatments, leveraging its established infrastructure for market penetration and regulatory approvals. In the region, the division expands through Merck affiliates and strategic partnerships, including deepened collaborations in for and , as well as operations in amid leadership enhancements in 2025. For emerging markets in , the healthcare sector employs joint ventures for distribution, such as the 2012 partnership with Supera Farma in to commercialize innovative and branded generic products, alongside agreements for portfolio expansion in countries including , , , , , , and . In 2025, EMD Serono advanced its U.S. operations through an unprecedented agreement with the U.S. government, announced on October 16, to expand access to fertilization therapies for over 10 million women via discounted pricing and sales, aligning with broader efforts to enhance affordability in . This initiative underscores the sector's commitment to inclusive healthcare delivery amid its global diversification, with and contributing approximately 40% of healthcare sales as of 2024.

Products and Pipeline

Neurology and Immunology Portfolio

The neurology and immunology portfolio developed under Merck Serono, now part of Merck KGaA's Healthcare sector, primarily focuses on treatments for (MS) and other autoimmune conditions, emphasizing disease-modifying therapies that modulate immune responses to reduce relapses and progression. The division's offerings have established the company as a key player in addressing relapsing forms of MS, with products designed for long-term management through targeted . A cornerstone of this portfolio is Rebif (interferon beta-1a), an injectable disease-modifying therapy approved by the in 1998 for the treatment of relapsing-remitting MS. It received U.S. (FDA) approval in 2002 and is indicated for reducing the frequency of clinical exacerbations and delaying disability progression in relapsing forms of MS. Rebif works by mimicking natural beta, which helps regulate immune cell activity and reduce in the . Historically, Rebif has been a flagship product, generating peak annual sales exceeding €1 billion in the early , though recent figures show a decline to approximately €600 million in 2024 amid competition from newer therapies. Another key product is Mavenclad (cladribine tablets), an oral short-course therapy approved by the in 2017 for highly active relapsing and by the FDA in 2019 for relapsing-remitting and active secondary progressive . , a synthetic analog, selectively depletes certain lymphocytes—primarily B and T cells—leading to a reset of the and reduced autoimmune attacks on . Administered in two annual treatment courses totaling 3.5 mg per kg body weight over two years, it offers a convenient regimen with no continuous dosing required. In 2024, Mavenclad achieved net sales of €1.1 billion, reflecting strong growth of 12.3% organically, driven by expanded access in and . In the broader immunology space, Merck Serono previously marketed Raptiva (efalizumab), a approved in 2003 for moderate-to-severe plaque , which inhibits T-cell activation to reduce skin inflammation. However, due to reports of (PML)—a rare and serious brain infection linked to JC virus reactivation—the product was voluntarily withdrawn from the market in 2009 following recommendations from regulatory agencies. Three confirmed PML cases, including fatalities, prompted the suspension in and full withdrawal globally, highlighting the challenges of long-term immunomodulatory safety. Merck Serono maintains an active pipeline in , with ongoing clinical trials exploring therapies for progressive forms of , including investigational agents aimed at and remyelination to address unmet needs in primary and secondary progressive disease. These efforts build on the company's expertise in immune modulation, with recent data from 2025 presentations underscoring durable benefits in relapsing that may inform progressive indications. The and portfolio, dominated by treatments like Rebif and Mavenclad, contributed €1.7 billion in net sales in 2024, accounting for a substantial portion—approximately 30-40%—of the healthcare division's through its in the market. This focus has positioned Merck Serono among the top global providers of therapies, with Mavenclad's expansion helping offset Rebif's decline and sustaining overall franchise growth of 2.3% organically.

Oncology and Hematology Offerings

The and portfolio developed under Merck Serono, now part of Merck KGaA's Healthcare sector, centers on targeted biologics that address solid tumors, with a focus on monoclonal antibodies and inhibitors. Integrated into Merck KGaA following the 2007 acquisition of , this division has emphasized immuno-oncology advancements through strategic licensing and co-development agreements. While hematology-specific offerings remain limited, the portfolio's key products demonstrate clinical utility in improving survival outcomes for patients with advanced cancers. Erbitux (cetuximab), a recombinant human/mouse chimeric monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is a cornerstone of Merck Serono's oncology lineup. Licensed from ImClone Systems (now part of Eli Lilly), it was first approved by the FDA in 2004 for use in combination with irinotecan for EGFR-expressing metastatic colorectal cancer after failure of irinotecan-based chemotherapy, and later expanded to head and neck squamous cell carcinoma. The pivotal phase III NCIC CTG CO.17 study established its efficacy in extending median overall survival to 6.1 months versus 4.6 months with best supportive care in patients with irinotecan-refractory, EGFR-expressing metastatic colorectal cancer. As of Q2 2025, Erbitux continues to drive growth, with net sales increasing 10.9% organically due to sustained demand in metastatic colorectal and head/neck indications. Bavencio (avelumab), a fully anti-PD-L1 IgG1 , represents Merck Serono's entry into immuno-oncology. Co-developed with , it received accelerated FDA approval in 2017 for metastatic , the first therapy for this rare , and full approval in 2018 for locally advanced or metastatic urothelial carcinoma maintenance treatment following platinum-based . The JAVELIN Merkel 200 trial demonstrated an objective response rate of 33.2% in chemotherapy-refractory patients, highlighting its role in unleashing T-cell responses against PD-L1-expressing tumors. Despite facing increased competition, Bavencio generated €157 million in net sales in Q1 2025, underscoring its ongoing clinical significance in these indications. Merck Serono's oncology pipeline builds on these foundations, featuring investigational agents in immuno-oncology and antibody-drug conjugates aimed at expanding options for solid tumors. Post-2010s expansions, including the partnership for Bavencio, have bolstered this portfolio through collaborative trials exploring combination therapies in diverse cancer types. As of 2025, efforts focus on next-generation modalities like DNA damage response inhibitors and ADCs, with data presented at major congresses such as ASCO and ESMO to advance precision approaches in .

Fertility and Endocrinology Treatments

The and portfolio developed under Merck Serono, now part of Merck KGaA's Healthcare sector, is anchored in recombinant hormone technologies developed by , emphasizing therapies for reproductive health and growth disorders. These products have become cornerstones in assisted reproductive technologies () and endocrine management, leveraging to mimic natural hormones with high purity and consistency. Gonal-f (follitropin alfa) is a recombinant follicle-stimulating hormone (r-hFSH) used to stimulate follicular development in women undergoing treatments, such as fertilization (IVF). It was first approved in in 1995 and in the United States in 1997, marking a significant advancement as the first recombinant FSH therapy, which offered improved safety and efficacy over urinary-derived alternatives by reducing risks. Gonal-f has since become a leading treatment in ART, available in various formulations including prefilled pens for easier self-administration, with ongoing innovations like the 150 IU pen approved in in 2020. In , Saizen (somatropin) is a recombinant human indicated for the long-term treatment of growth failure in children due to inadequate endogenous secretion. Approved by the FDA in 1996, Saizen has been utilized for over 30 years globally, supporting growth in pediatric patients and available in user-friendly devices like the easypod™ injection system approved in the in 2007. Its recombinant formulation ensures consistent dosing and has been approved in more than 80 countries for various growth-related indications. Serostim (somatropin), another recombinant from the portfolio, is specifically approved for treating HIV-associated wasting or to increase and body weight, thereby improving physical endurance. It received accelerated FDA approval in 1996 under Serono's development, addressing a critical need in HIV management during the 1990s epidemic, and remains indicated for adult patients with this condition. Ovidrel (choriogonadotropin alfa in the ) or Ovitrelle (in ) is a recombinant (r-hCG) analog used for final follicular maturation and early luteinization in women undergoing in , such as IVF. Approved by the FDA in 2000, it mimics the natural LH surge to trigger , demonstrating comparable efficacy to urinary hCG in clinical outcomes like ongoing rates, with the added benefit of reduced batch-to-batch variability. As of 2025, EMD Serono, Merck KGaA's US affiliate, has expanded access to treatments through a with the , agreeing in October to participate in the TrumpRx.gov direct purchasing launching in 2026, aimed at improving affordability for IVF patients via negotiated pricing. This initiative builds on Gonal-f and Ovidrel's established roles in , enhancing equity in access to these therapies.

Research and Development

Core R&D Focus Areas

Merck Serono, as the biopharmaceutical division of Merck KGaA, allocates significant resources to research and development, with the healthcare sector's R&D expenditure projected at approximately 20% of its revenues in 2025, equating to around €1.7 billion based on expected net sales of €8.7-8.9 billion. This investment forms part of the broader Merck Group R&D budget exceeding €3 billion annually, emphasizing innovation in high-unmet-need therapeutic areas. The core R&D focus areas include biologics targeting , particularly (MS) progression; , with an emphasis on immunotherapies; and treatments. In , efforts center on advancing therapies to slow MS disease progression, building on established interferon-based treatments like Rebif. R&D prioritizes immuno-oncology approaches to enhance immune responses against tumors, while research aims to improve assisted reproductive technologies, including hormone therapies for in vitro fertilization (IVF). These domains align with Merck Serono's strategy to address chronic and reproductive health challenges through targeted biologic interventions. Key technologies underpinning these efforts include monoclonal antibodies for precise targeting in and , antibody-drug conjugates (ADCs) for delivering cytotoxic payloads to cancer cells, and -driven platforms to accelerate and optimize candidate selection. The AIDDISON™ platform, for instance, leverages generative to explore chemical spaces and design novel molecules rapidly, potentially reducing discovery timelines by up to 70%. Major R&D facilities in , , and , , support these initiatives, housing expertise in biologics development and . As of 2025, the pipeline comprises over 20 molecules across these focus areas, with more than five in Phase III trials, including candidates like pimicotinib for in . These milestones reflect a robust progression toward commercialization, with several programs leveraging and platforms to address unmet needs in and immuno-oncology.

Key Collaborations and Initiatives

Merck KGaA, through its healthcare division formerly known as Merck Serono, has actively participated in the InnoMed PredTox consortium, an EU Framework Programme 6-funded initiative launched in the mid-2000s to enhance predictive toxicology in drug development by integrating omics technologies with conventional safety assessments. This collaborative effort involved 14 pharmaceutical companies, academic institutions, and small enterprises, aiming to reduce animal testing and improve early detection of drug-induced toxicities through molecular profiling techniques like transcriptomics, proteomics, and metabolomics. The project generated valuable datasets on hepatotoxicity and nephrotoxicity, contributing to more efficient R&D pipelines across participating firms. In the realm of and broader drug safety, Merck KGaA engaged in the Innovative Medicines Initiative (IMI), Europe's largest public-private partnership for pharmaceutical innovation, including contributions to projects focused on advanced cancer modeling and predictive safety. For instance, the company is a key partner in the imSAVAR project under IMI2, which develops innovative tools for assessing immune-mediated adverse events in , funded by a €36 million grant to support safer treatments. Additionally, the 2014 strategic alliance with for the co-development and co-commercialization of (BAVENCIO), a inhibitor, accelerated its path to approval for and urothelial carcinoma, with shared costs and profits until Merck regained exclusive worldwide rights in 2023 to streamline ongoing development. Recent collaborations in neurodegeneration underscore Merck KGaA's commitment to external partnerships, such as its July 2024 participation in Asceneuron's $100 million Series C financing round as a later-stage investor, building on the spin-off from Merck Serono to advance O-GlcNAcase inhibitors like ASN51 for and other tauopathies into Phase 2 trials. In Parkinson's research, a June 2024 agreement with leverages Merck's SMC technology to explore biomarkers and cell dysfunction, aiming to identify therapies that slow disease progression. These deals align with broader R&D investments in novel targets for neurodegenerative disorders. Merck Serono has fostered alliances with (MS) patient advocacy groups to advance research and care, including a 2009 collaboration with LLC, the arm of the National Society, providing up to $15 million to fund innovative MS therapies targeting and remyelination. The MS in the 21st Century initiative, sponsored by Merck, unites MS experts, patients, and healthcare professionals to enhance communication and holistic management of the disease. Complementing these, the MS-LINK platform, launched in 2019, connects industry, academia, and patient stakeholders to drive scientific progress and improve patient outcomes through shared insights. On sustainability, Merck KGaA's initiatives in biotech include the , which coordinates R&D efforts to integrate environmental considerations, such as reducing use and waste in production processes. The Healthcare R&D evaluates the environmental impact of from to commercialization, prioritizing greener chemistry and principles in biologics . These efforts support the company's goal of by 2045, with specific focus on Scope 3 reductions in the biotech .

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