#Japan #Tokyo #Gilead Sciences #Kaken Pharmaceutical #Seladelpar

Kaken Pharmaceutical and Gilead's New Contract

In a strategic move aimed at enhancing treatment options for patients suffering from Primary Biliary Cholangitis (PBC), Kaken Pharmaceutical Co., Ltd. and Gilead Sciences, Inc. have officially signed a domestic sales contract concerning the treatment drug Seladelpar. This agreement reflects both companies' commitment to addressing the significant unmet medical needs faced by PBC patients in Japan.

Background on the Partnership

This collaboration builds upon their established partnership concerning existing licensing agreements with Cymabay Therapeutics, which was acquired by Gilead. The expansion of this partnership signifies both companies' intentions to accelerate patient access to innovative treatments for rare liver diseases, particularly PBC, within the Japanese market.

Kaken's President Hiroyuki Horiuchi commented on the collaboration, stating, "This contract marks a crucial step forward in responding to the substantial unmet medical needs of patients living with PBC in Japan. By combining our expertise in the Japanese market with Gilead's profound specialization and experience in liver disease, we aim to ensure that patients can quickly benefit from new treatment options."

Details of the Collaboration

Under the framework of this sales partnership, both Kaken and Gilead will leverage their complementary expertise and established presence in the liver disease domain to jointly work towards the commercialization of Seladelpar in Japan. Specifically, Kaken will continue to lead development, regulatory affairs, and marketing efforts, while both companies will collaborate on activities aimed at promoting appropriate use and providing scientific information. Together, they strive to enhance understanding of PBC as a disease and support patients in a meaningful way.

Andrew Hexter, President of Gilead's Japan branch, also expressed the significance of the partnership, citing, "Patients with PBC in Japan are still facing major unmet medical needs. Through our expanded partnership with Kaken, we hope to improve treatment outcomes for these patients by providing access to new treatment options, working alongside healthcare professionals to help alleviate these challenges."

Understanding Primary Biliary Cholangitis (PBC)

PBC is a chronic, progressive autoimmune disease affecting the bile ducts, with an estimated 37,000 patients in Japan. It predominantly affects women and can lead to liver damage. If untreated, it may progress to liver failure and require transplantation. The most common symptoms of PBC include chronic itching (pruritus) and fatigue, significantly impairing patients' quality of life (QOL). Since PBC symptoms are often invisible to others, the path to diagnosis can be long and fraught with difficulties.

Currently, there is no cure for PBC, and the treatment objectives focus primarily on slowing the disease progression and alleviating symptoms associated with cholestasis, such as pruritus. Treatment efficacy is mainly assessed through improvements in liver biochemical markers, including alkaline phosphatase (ALP) levels, which are critical indicators of disease progression.

Introduction of Seladelpar

Seladelpar, a selective PPARδ agonist, is currently under development as a treatment for PBC in Japan. The PPARδ pathway has shown promise in modulating key metabolic processes and the pathogenesis of liver diseases. Data from prior nonclinical and clinical trials suggest that Seladelpar may offer anti-cholestatic, anti-inflammatory, anti-pruritic, and anti-fibrotic benefits.

Commercially available as Livdelzi in the US and UK and as Lyvdelzi in Europe and Canada, Seladelpar has demonstrated statistically significant improvements in biochemical response and normalization of ALP levels compared to placebo, potentially addressing the significant unmet needs of PBC patients. Given that pruritus is a prevalent symptom of PBC, its alleviation can substantially enhance patients' quality of life.

About Kaken Pharmaceutical

Kaken Pharmaceutical is a research-driven pharmaceutical company focused on improving patients' quality of life, particularly in the areas of orthopedics and dermatology. Their R&D efforts are concentrated on the immune system, neurological diseases, infectious diseases, and rare diseases with high unmet medical needs. The company strives to create and provide valuable pharmaceuticals that meet the needs of patients and healthcare professionals alike.

For more details, visit www.kaken.co.jp.

Gilead Sciences and Its Liver Disease Initiatives

For years, Gilead has been devoted to improving the quality of life for liver disease patients around the world. They have contributed to transforming chronic hepatitis C into a curable disease for millions and are actively working on new therapies for chronic hepatitis B, as well as providing advanced treatments for PBC patients. Through groundbreaking science and collaborative partnerships, Gilead is dedicated to creating a healthier future for all individuals living with liver diseases.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company devoted to advancing healthcare innovations for over 35 years, striving to create a healthier world for everyone. They develop innovative therapies for life-threatening diseases such as HIV, viral hepatitis, COVID-19, cancer, and inflammatory diseases. Headquartered in Foster City, California, Gilead operates in over 35 countries globally.