This announcement, made on December 19, 2018, signifies a significant step in the fight against fibrosis, a condition characterized by tissue scarring that contributes to numerous serious health issues.
Under the agreement, Gilead gains exclusive options to license worldwide rights to potential drug candidates from three of Scholar Rock’s TGFβ programs. These programs are focused on:
- Inhibitors with high affinity and specificity for latent TGFβ1 activation.
- Inhibitors selectively targeting latent TGFβ1 activation within the extracellular matrix.
- A third TGFβ discovery program to be further defined.
Scholar Rock will handle antibody discovery and preclinical research up to the selection of a product candidate. Following option exercise by Gilead for a program, Gilead will then take over responsibility for preclinical and clinical development, as well as commercialization. Importantly, Scholar Rock retains all worldwide rights to develop and commercialize certain TGFβ inhibitors specifically for oncology and cancer immunotherapy applications.
“Gilead’s dedication to creating cutting-edge treatments for fibrotic diseases, including conditions like non-alcoholic steatohepatitis and diabetic kidney disease, aligns perfectly with this collaboration,” stated John McHutchison, MD, AO, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. “We are eager to partner with Scholar Rock and explore this innovative approach to TGFβ inhibition, which is a crucial component of our fibrotic disease research initiatives.”
In conjunction with the collaboration agreement, Scholar Rock received an initial payment of $80 million, consisting of $50 million in cash and a $30 million purchase of Scholar Rock Holding Corporation common stock. Additionally, Scholar Rock is eligible for a $25 million milestone payment upon successful completion of specific preclinical studies. The agreement also outlines potential further payments to Scholar Rock of up to $1.425 billion, contingent on achieving various research, development, regulatory, and commercial milestones across all three programs. Furthermore, Scholar Rock is set to receive tiered royalties, ranging from high single-digit to low double-digit percentages, on future product sales originating from this collaboration.
Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock, commented, “Gilead’s strong commitment to developing innovative therapies for fibrotic diseases makes them the ideal partner to maximize the potential of our TGFβ program candidates. This collaboration underscores our confidence in the broad potential of Scholar Rock’s pipeline of highly specific modulators targeting the TGFβ superfamily. These modulators have potential applications across a wide spectrum of serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia.”
Fibrosis, characterized by the excessive formation of fibrous connective tissue in an organ or tissue, is a significant factor in the progression of many diseases. It leads to tissue scarring and organ dysfunction, contributing significantly to illness and death. TGFβ signaling is recognized as a central driver of fibrosis. Scholar Rock’s proprietary platform has enabled the discovery of TGFβ signaling inhibitors that have demonstrated selective prevention of growth factor activation within the fibrotic matrix in laboratory settings and preclinical models. By specifically targeting the disease microenvironment, these inhibitors of TGFβ activation offer a promising novel strategy for suppressing pro-fibrotic signaling in various organs.
About Scholar Rock
Scholar Rock is a biopharmaceutical company at the clinical stage, dedicated to discovering and developing innovative medicines for serious diseases where protein growth factor signaling plays a critical role. Leveraging its deep understanding of growth factor activation mechanisms, Scholar Rock is building a pipeline of novel product candidates with the potential to transform the lives of patients with a wide range of serious conditions, including neuromuscular disorders, cancer, fibrosis, and anemia. Scholar Rock’s proprietary platform focuses on creating monoclonal antibodies that selectively target these signaling proteins at the cellular level. This targeted approach to biologically validated growth factors aims to streamline and enhance drug development efficiency. For further details, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).
Scholar Rock® is a registered trademark of Scholar Rock, Inc.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines to address unmet medical needs. Gilead aims to transform and simplify care for individuals with life-threatening diseases globally. With operations spanning over 35 countries, Gilead is headquartered in Foster City, California. More information about Gilead Sciences can be found on their website at www.gilead.com.
Forward-Looking Statements
Both Scholar Rock and Gilead Sciences’ press releases include forward-looking statements, which involve risks and uncertainties. These statements are based on current expectations and could differ materially from actual results due to various factors, including the risks associated with realizing the benefits of the collaboration and the development and commercialization of potential products. Readers are cautioned not to place undue reliance on these forward-looking statements, and both companies undertake no duty to update the information unless required by law. For detailed information on risks and uncertainties, refer to each company’s filings with the Securities and Exchange Commission.
