Fierce Competition in the $100B+ Autoimmune Arena: AbbVie Makes Four Moves in Six Months as Merck, Roche, Sanofi, and Pfizer Go on Global Acquisition Spree

Jul 04, 2024 18:37 CST Updated 18:37

AbbVie

Innovative Drug Developer

Celsius

Pharmaceutical R&D Developer

In the field of autoimmune diseases, the competition for布局 among multinational pharmaceutical companies (MNCs) has reached a fever pitch.

Recently, AbbVie announced the acquisition of Celsius Therapeutics for $250 million. The company focuses on developing novel drugs for the treatment of inflammatory diseases. Its core asset, CEL383, is a potential first-in-class TREM1-targeting antibody, which has completed Phase I clinical trials for the treatment of inflammatory bowel disease (IBD).

Industry insiders believe that AbbVie's outreach to innovative drug companies in the IBD field this time is already the fourth move in half a year focusing on niche areas. This not only reflects recognition of the clinical potential of IBD but also demonstrates an active response to the dynamics of the global pharmaceutical market. As competition in the IBD market becomes increasingly fierce, many companies are accelerating their layout in the autoimmune field, which will further intensify competition while expanding market capacity.

Four Actions in Half a Year
AbbVie Targets IBD Market

With the global aging population and changes in lifestyle, the incidence of IBD is increasing annually, becoming a focal point in the global healthcare field.

IBD mainly includes two types: Crohn's disease (CD) and ulcerative colitis (UC), both of which are characterized as chronic inflammatory bowel diseases. In recent years, with the medical community’s deeper research into the pathogenic mechanisms of IBD, pharmaceutical companies have increased their R&D investment in this field, leading to an unprecedented boom in the IBD treatment drug market.

Celsius Therapeutics, acquired by AbbVie in this deal, was founded in 2017. CEL383 is the company's only asset to have entered the clinical stage, functioning by targeting the TREM1 protein.

Celsius R&D Pipeline

TREM1 has been identified as a key disease-driving gene in IBD. It is expressed on inflammatory monocytes and neutrophils and acts as an upstream regulator of multiple inflammatory pathways, significantly enhancing inflammatory responses. CEL383 has demonstrated the ability to inhibit TREM1 signaling in preclinical studies, effectively reducing the levels of various inflammatory mediators that are clinically significant in inflammatory conditions.

In fact, this is already AbbVie's second boost to the IBD sector this month, and the fourth time in the past six months.

On March 20, 2024, AbbVie and Parvus Therapeutics announced a global exclusive licensing collaboration and option agreement. This collaboration will leverage Parvus' Navacim™ platform technology to develop regulatory T cell (Treg) immune tolerance therapies for the treatment of IBD. The Navacim™ technology presents multivalent peptide-major histocompatibility complexes (peptide-MHCs) to T cells, triggering the endogenous expansion and differentiation of T cells into antigen-specific Tregs, with the aim of restoring organ-specific immune tolerance and providing a new approach for the treatment of autoimmune diseases.

In the same month, AbbVie announced the acquisition of Landos Biopharma, gaining NX-13, an NLRX1 agonist in Phase II clinical trials for the treatment of IBD. The development of NX-13 aims to provide new therapeutic options for IBD patients, particularly those who do not respond well to existing treatments.

On June 13, AbbVie entered into a global licensing agreement with Mingji Biopharmaceutical (Beijing) Co., Ltd. to co-develop FG-M701, a next-generation TL1A antibody currently in preclinical development. FG-M701 aims to provide higher efficacy than existing treatments and reduce dosing frequency, with the potential to become the best-in-class drug. Mingji Biopharmaceutical will receive an upfront payment and near-term milestone payments totaling $150 million, along with subsequent clinical development, regulatory registration, and commercialization milestone payments of up to $1.56 billion.

In just half a year, AbbVie has made four strategic moves to solidify its market position in the IBD segment, drawing widespread attention from the industry.

AbbVie's position in the field of autoimmune diseases is highly prominent, with its product portfolio demonstrating strong performance in the global market, securing its leading place in the autoimmune sector. According to AbbVie's 2023 annual financial report, the company’s autoimmune segment generated revenue of $26.136 billion, surpassing the second-place competitor by nearly $8 billion and establishing its leadership in this field.

AbbVie's autoimmune segment consists of three major marketed products, with Humira being the flagship product. Despite facing the challenge of U.S. patent expiration, it still achieved revenue of $14.404 billion in 2023. Additionally, Skyrizi and Rinvoq, the other two key products in AbbVie’s autoimmune portfolio, have shown strong growth momentum in the market. Skyrizi generated $7.763 billion in revenue in 2023, while Rinvoq reached $3.969 billion, with both products seeing year-over-year increases exceeding 50%.

Notably, Skyrizi has been approved by the FDA for the treatment of moderate to severe UC in adults, which is one of the two main forms of IBD, marking an important step for AbbVie in the field of IBD treatment. Rinvoq, as an oral JAK1 inhibitor, has been approved globally for the treatment of various autoimmune diseases, including IBD.

In the past six months, AbbVie has made strategic moves in the IBD field, not only solidifying its existing advantages in autoimmune diseases but also laying a solid foundation for future development. The industry generally believes that with in-depth research and active investment in the IBD treatment area, AbbVie will continue to lead innovation and progress in autoimmune disease treatment.

R&D Race Accelerates
MNC Giants Sweep the Globe

According to a report by Mordor Intelligence, the market size for IBD treatments is expected to grow from USD 24.46 billion in 2024 to USD 31.43 billion in 2029, showing a compound annual growth rate (CAGR) of 5.15%.

Some of the key companies currently dominating the IBD treatment market include AbbVie, Takeda Pharmaceutical, Bristol-Myers Squibb (BMS), Johnson & Johnson, and others. These companies hold significant market shares and maintain their market positions through continuous product innovation and research and development.

Despite the availability of various treatment options, such as biologics like anti-tumor necrosis factor (TNF) drugs, many IBD patients still fail to achieve optimal therapeutic outcomes. In particular, prolonged use of these medications may lead to secondary loss of response, where patients' reaction to the drugs diminishes over time. Additionally, these treatments can increase the risk of infections and malignancies in patients. Moreover, mucosal healing, a critical goal in IBD treatment, remains difficult to achieve in all patients with existing therapies.

To address these unmet clinical needs, the field of IBD treatment is actively exploring new therapeutic approaches. This includes the development of novel biologics, such as drugs targeting different immune pathways, and disease-modifying therapies aimed at repairing the intestinal mucosa, maintaining barrier function, and restoring gut microbiota balance.

Facing the vast market prospects in the IBD field, pharmaceutical giants such as Pfizer, Merck, Roche, and Sanofi are also stepping up their efforts, increasing their presence in the IBD sector.

In December 2022, Pfizer and Roivant announced the establishment of a joint venture to co-develop the TL1A antibody RVT-3101. Pfizer holds the commercial rights to the drug outside the United States and Japan, while Telavant, a subsidiary of Roivant, is fully responsible for the subsequent development of RVT-3101 and holds the commercial rights in the United States and Japan. Through its collaboration with Roivant, Pfizer aims to further expand its influence in the IBD treatment field via RVT-3101 and provide patients with a potential new treatment option.

In April 2023, Merck acquired Prometheus Biosciences for $10.8 billion, gaining access to PRA023, a TL1A antibody in development for the treatment of IBD. The TL1A target of this drug plays a key role in the inflammation and fibrosis processes of IBD. This acquisition marks Merck's deepened commitment to the IBD treatment field, with PRA023 providing a potential "first-in-class" (FIC) drug that could address unmet clinical needs in current treatments.

Merck's "big move" acquisition has brought the TL1A target into the spotlight and spurred competition among other pharmaceutical companies targeting TL1A.

In October 2023, Roche announced that it had reached a definitive agreement with Roivant. Roche acquired Telavant, a subsidiary of Roivant, and its TL1A antibody RVT-3101 for $7.1 billion. The deal includes a $7.1 billion upfront payment and a $150 million near-term milestone payment. Roche will obtain the rights to develop, manufacture, and commercialize RVT-3101 in the United States and Japan for the treatment of IBD and potentially various other diseases. Additionally, Roche will also gain the option to collaborate globally with Pfizer on next-generation p40/TL1A-directed bispecific antibodies.

In the same month, Sanofi reached a cooperation agreement with Teva Pharmaceuticals to jointly develop TL1A monoclonal antibody TEV-48574 for the treatment of IBD. According to the agreement, Teva will receive an upfront payment of 460 million euros (approximately 500 million US dollars) and milestone payments of up to 940 million euros (approximately 1 billion US dollars). Sanofi's move demonstrates its strategic layout in the IBD treatment field and its pursuit of drugs with new mechanisms. Through the collaboration with Teva, Sanofi not only strengthens its R&D pipeline in the IBD field but also may provide patients with new treatment options through TEV-48574.

In the past two years, MNCs such as Pfizer, Merck, Roche, and Sanofi have all made moves to bolster their presence in the IBD field, inevitably stirring AbbVie's nerves. Continuously enriching its IBD pipeline through acquisitions or collaborations might be the best way for AbbVie to ease its anxiety.

The IBD treatment drug market is showing a booming trend, indicating that there will be more breakthroughs and innovations in IBD treatment in the future. At the same time, it also faces multiple challenges such as fierce market competition, high R&D costs and risks, diverse patient needs, drug side effect management, treatment resistance, and global market access. Companies need to think from multiple perspectives in terms of innovative R&D, market strategy, patient support, and international cooperation.

Editor: Allen