AbbVie and FutureGen Announce License Agreement to Develop Next-Generation Therapy for Inflammatory Bowel Disease

Rhea-AI Summary

AbbVie and FutureGen Biopharmaceutical announced a global license agreement to develop FG-M701, a next-generation TL1A antibody for treating inflammatory bowel disease (IBD). FG-M701 is in preclinical development and aims to offer improved efficacy and less frequent dosing compared to first-generation therapies. AbbVie will receive exclusive rights to develop, manufacture, and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments, with the potential for up to $1.56 billion in additional payments and tiered royalties up to low-double digits on net sales. The collaboration aims to advance treatment options for patients with IBD.

Positive

• AbbVie will receive an exclusive global license to develop, manufacture, and commercialize FG-M701.
• FutureGen will receive $150 million in upfront and near-term milestone payments.
• FutureGen is eligible to receive up to $1.56 billion in clinical development, regulatory, and commercial milestones.
• FG-M701 targets TL1A, a clinically validated target in IBD, with potential best-in-class functional characteristics.
• The collaboration aims to offer greater efficacy and less frequent dosing for IBD treatment.
• Partnership highlights FutureGen's Structure-based Targeted Evolution Platform (STEP) technology.

Negative

• FG-M701 is still in preclinical development, adding uncertainty to its future success.
• FutureGen's revenue is dependent on milestone achievements and successful commercialization.

Insights

Financial Analyst

AbbVie's license agreement with FutureGen indicates noteworthy strategic movement in the biopharmaceutical sector. The total potential payment framework, which includes $150 million upfront and up to $1.56 billion in future milestones, highlights AbbVie's confidence in the prospective market size and efficacy of FG-M701. Upfront payments ensure FutureGen's immediate funding needs are met, while the milestone-based payments reduce AbbVie’s risk by tying future payments to the successful achievement of key development and commercialization stages. This structure is typical for biopharmaceutical partnerships, aiming to align the interests of both parties while managing financial exposure.

For retail investors, this deal showcases AbbVie’s ongoing commitment to expanding its autoimmune disease portfolio, a key revenue driver. The exclusive global license accords AbbVie complete control over the development and marketing of FG-M701, potentially heralding significant future market share if the therapy proves successful. The tiered royalties up to low-double digits on net sales ensure FutureGen benefits from commercial success, providing a continuous revenue stream.

Medical Research Analyst

FG-M701's focus on TL1A as a target in IBD treatment is noteworthy. TL1A is a well-validated immunological target implicated in inflammatory mechanisms of diseases like ulcerative colitis and Crohn's disease. Antibodies targeting TL1A have shown potential in prior studies, but the unique engineering of FG-M701 aims to enhance efficacy and reduce dosing frequency. This could be a significant advancement for patients, potentially translating into better compliance and outcomes.

The collaboration between AbbVie and FutureGen leverages FutureGen’s Structure-based Targeted Evolution Platform (STEP) technology. This platform allows for precise engineering of antibodies, which can lead to the creation of more effective and safer therapies. Investors should monitor the progress of FG-M701 through clinical trials to evaluate its therapeutic advantages over existing treatments.

Market Research Analyst

The global market for Inflammatory Bowel Disease (IBD) therapies is expanding, driven by the increasing prevalence of IBD conditions like Crohn’s disease and ulcerative colitis. Current treatments can be insufficient, with many patients not achieving remission. FG-M701, with its potential for greater efficacy and less frequent dosing, could capture a substantial market share if it proves superior to existing therapies. AbbVie’s entry into a partnership with FutureGen underscores its strategy to strengthen its position in the IBD therapeutic space, competing with other major players like Johnson & Johnson and Takeda.

Investors should note the high competitive barrier in the biopharma sector where innovation in treatment methodologies often leads to substantial long-term gains. Monitoring the advancement of FG-M701's clinical trials and regulatory approvals will be important to gauge the partnership’s success and its impact on AbbVie’s market position.

-   Global license agreement to focus on the development of FG-M701, a TL1A antibody, for the treatment of inflammatory bowel disease (IBD)

NORTH CHICAGO, Ill. and BEIJING, June 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. today announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development.

FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

"The prevalence of IBD continues to increase, and many people living with ulcerative colitis and Crohn's disease do not respond to current therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "AbbVie's mission to raise the standard of care includes the pursuit of transformative therapies that help more patients living with autoimmune diseases achieve remission. We look forward to our collaboration with FutureGen in advancing development of FG-M701 for the treatment of IBD."

"We are very pleased to partner with AbbVie, a world-leader in the development and commercialization of innovative inflammation and autoimmune therapies," said Zhaoyu Jin, Ph.D., founder and chief executive officer, FutureGen Biopharmaceutical (Beijing) Co., Ltd. "We believe that AbbVie is a great partner, with the ability to apply their expertise and global scale to realizing FG-M701's therapeutic potential and rapidly advancing this therapy for patients suffering from IBD. The collaboration with AbbVie also highlights FutureGen's ability to generate potential best-in-class product candidates with our proprietary Structure-based Targeted Evolution Platform (STEP) technology platform."

Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments and will be eligible to receive up to an additional $1.56 billion in clinical development, regulatory and commercial milestones, as well as tiered royalties up to low-double digits on net sales.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About FutureGen

FutureGen Biopharmaceutical (Beijing) Co., Ltd. is an innovative biopharmaceutical company committed to providing high-quality innovative biologics for patients with cancer, immune diseases and other diseases. FutureGen has developed the proprietary STEP by integrating structural biology, advanced antibody engineering, and AI technologies to enable highly efficient, rapid and high-throughput drug screening and optimization. FutureGen has utilized STEP to develop CLDN18.2 antibody-dependent cellular cytotoxicity (ADCC) enhanced antibody (FG-M108), a potential best-in-class product with excellent efficacy and superior safety in the first-line treatment of advanced G/GEJ and pancreatic cancer, currently in Phase 3. Additionally, FutureGen possesses several innovative multi-specific antibodies and antibody-drug conjugates (ADC) for immuno-oncology therapy, including a CD40-PDL1 bi-specific antibody in clinical stage. For more information, please visit www.futuregenbiopharm.com. 

AbbVie Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

 

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SOURCE AbbVie

FAQ

What is FG-M701?

FG-M701 is a next-generation TL1A antibody for treating inflammatory bowel disease, currently in preclinical development.

What companies are involved in the FG-M701 agreement?

AbbVie and FutureGen Biopharmaceutical are involved in the global license agreement for FG-M701.

What are the terms of the AbbVie and FutureGen agreement for FG-M701?

FutureGen will receive $150 million in upfront and near-term milestone payments, with potential additional payments up to $1.56 billion and tiered royalties up to low-double digits on net sales.

Why is FG-M701 significant?

FG-M701 targets TL1A, a clinically validated target in IBD, and is engineered for greater efficacy and less frequent dosing compared to first-generation therapies.

What is the financial impact of the FG-M701 agreement on FutureGen?

FutureGen could receive up to $1.56 billion in additional payments and tiered royalties, dependent on clinical development, regulatory, and commercial milestones.