Gilead Acquires Global Royalty Rights to Seladelpar from Johnson & Johnson for $320 Million

Aug 09, 2024 11:58 CST Updated 11:58

Gilead Sciences

Innovative Drug Developer, Distributor

Johnson & Johnson

Medical Device R&D and Manufacturer

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丨Medicine Hunter Club Research Team Compiled

Today, according to the well-known media Endpoints News,Gilead Sciences Acquires Global Royalty Rights for Primary Biliary Cholangitis (PBC) Drug Seladelpar from Johnson & Johnson for $320 Million

There are a few important timelines to review:

--June 2006, CymaBayTherapeutics (Formerly Known AsMetabolex）Comprehensive Development and Commercialization Agreement Signed with Johnson & Johnson for Metabolic Disease Drugs, Johnson & Johnson ObtainsCymaBay Licenses Three Drugs Including Seladelpar。

-- On February 12, 2024, Gilead Sciences announced a merger agreement with CymaBay Therapeutics. Gilead will acquire CymaBay at $32.5 per share, or a total equity value of $4.3 billion, gaining access to the company’s core pipeline drug, seladelpar.

--On February 12, 2024, the U.S. FDA accepted the New Drug Application (NDA) for seladelpar for the treatment of PBC and granted it Priority Review, with a PDUFA date of August 14, 2024.

According to the agreement between CymaBay and Johnson & Johnson, if this PBC drug is approved, Johnson & Johnson will receive royalties from the drug's sales. A week before the FDA's PDUFA date, Gilead Sciences made a timely move.

Cracking the PBC Code: Seladelpar

Primary Biliary Cholangitis (PBC) is a lifelong chronic cholestatic liver disease. The pathogenesis is still unclear, but the currently more accepted cause may be the interaction between immunogenetic and environmental factors.Currently, there is no cure for PBC.Although lifelong medication can slow liver damage and halt its progression, approximately 40% of patients do not respond to currently approved therapies.Many patients still have abnormal liver function tests after receiving current treatment regimens, and these therapies do not improve pruritus, one of the main ongoing symptoms affecting the quality of life for PBC patients.

According to a report by Coherent Market Insights,The global PBC treatment market size was US$526 million in 2017 and is expected to maintain a compound annual growth rate of 36.3% over the next decade, reaching an astonishing US$8.593 billion by 2026.

Seladelpar is a potent, selective, oral PPARδ agonist for the second-line treatment of primary biliary cholangitis (PBC).Seladelpar was granted Breakthrough Therapy Designation by the U.S. FDA in February 2019. The U.S. FDA has accepted the new drug application for seladelpar for the treatment of patients with primary biliary cholangitis, including its pruritus symptoms, and has awarded it Priority Review status.The PDUFA date for this drug is August 14, 2024.In addition, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have also accepted the marketing review of seladelpar.

The therapy was originally developed by CymaBay. On February 12 this year, Gilead Sciences acquired CymaBay Therapeutics for $4.3 billion, thereby obtaining the therapy.

Seladelpar Molecular Formula

Gilead Sciences presented interim two-year analysis data of the investigational drug seladelpar for the treatment of primary biliary cholangitis (PBC) at the 2024 European Association for the Study of the Liver (EASL) Congress. The analysis included PBC participants from previous seladelpar conventional clinical studies and the pivotal Phase 3 RESPONSE registration study, showing that:After treatment with seladelpar, the indicators of cholestasis improved and inflammation was also alleviated;Other study results suggest that seladelpar helps alleviate pruritus symptoms in PBC patients.

ASSURE is an open-label, long-term Phase 3 study designed to evaluate the long-term safety and tolerability of seladelpar in PBC patients who have previously participated in other clinical studies of seladelpar; additionally, ASSURE will assess the impact of seladelpar on the quality of life of PBC patients, including key indicators such as pruritus in cholestatic liver disease.

Results:

-- Among the 99 subjects who had participated in prior conventional studies and received 24 months of seladelpar treatment,70% reached the comprehensive response endpoint,Including alkaline phosphatase (ALP) levels below 1.67 times the upper limit of normal (ULN), a reduction in ALP levels by at least 15%, and total bilirubin (TB) levels equal to or below the ULN. At 24 months, 42% of participants achieved normalization of ALP.

-- Among the 164 subjects who had participated in previous traditional studies and received 12 months of seladelpar treatment,73% achieved a clinically meaningful composite response endpoint, with 42% achieving ALP normalization.。

--Among participants who continued into the ASSURE study after 12 months in the RESPONSE study, receiving continuous seladelpar treatment for a total of 18 months, 62% reached the composite response endpoint and 33% achieved ALP normalization; for participants continuously receiving seladelpar treatment for 24 months (n=29), 72% and 17% reached the composite response endpoint and ALP normalization, respectively.

-- Among the 52 subjects who were previously randomized to receive placebo treatment in the RESPONSE study, 75% reached the composite response endpoint, and 27% of the subjects achieved ALP normalization after six months of cross-over treatment with seladelpar. After 12 months of treatment, 94% of the cross-over subjects reached the composite response endpoint, and 50% achieved ALP normalization (n=16).

--The drug was well tolerated with long-term use, and no serious adverse events related to the treatment occurred.

-- In addition, the patient-reported itching was collected using a numerical rating scale (NRS; 0-10).In subjects with a baseline NRS ≥4, sustained improvement in pruritus was observed. In the ASSURE study, subjects experienced an average reduction of 3.8 points at 12 months and 3.1 points at 24 months.

Seladelpar was previously developed for NASH treatment. However, its Phase 2 study results showed less benefit than placebo and potential safety issues, leading CymaBay to halt further development of this compound in the NASH field. Currently, the compound is showing excellent performance in the PBC field and is highly anticipated.

Gilead Sciences' Layout in the Field of Liver Diseases

Gilead Sciences announced its financial results for the second quarter of 2024 on August 8, with total revenue of $6.954 billion.Liver disease product revenue was $8.32 billion (+17% YoY), accounting for 12% of total revenue.Moreover, revenue in the hepatology field has been gradually increasing, from US$6.91 billion in 2023Q4 to US$8.32 billion in 2024Q2.

According to incomplete statistics, Gilead Sciences currently has a pipeline of approximately 50 drugs in the liver disease field.

In recent years, the company has frequently strengthened its drug layout in the field of liver disease through transactions.

Data SourceSource:

1. endpoint news

2. Gilead Sciences Official Website

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