On February 12, 2024, Gilead Sciences announced thatCymaBay Therapeutics Reaches Acquisition Agreement, GileadAt a price of $32.5 per share or a total equity value of $4.3 billionCymaBay。
Figure 1: Gilead announces the acquisition of CymaBay (Source: Gilead official website)
On the same day,CymaBay Announces Its Core PipelineThe NDA for Seladelpar submitted by CymaBay Therapeutics, Inc. has been accepted by the FDA.The PDUFA date is set for August 14, 2024.(This drug was granted Breakthrough Therapy Designation by the FDA in 2019 for the treatment ofPrimary Biliary Cholangitis）Affected by news,CymaBay's stock price surged 25.38% in after-hours trading, reaching $32.21 per share.
Figure 2: CymaBay's Stock Price (Data Source: Xueqiu)
This acquisition, Gilead aims to throughIncludeSeladelpar, SupplementLiver disease product portfolio to consolidate its leading position in the liver disease field.Seladelpar is an investigational "first-in-class"OralPPARδ Agonist for Second-Line TreatmentPrimary Biliary Cholangitis (PBC),First-line treatment drugs areUrsodeoxycholic Acid (UDCA)。
Figure 3: Current Status of PBC Diagnosis and Treatment (Data Source: CymaBay Therapeutics, Inc. Official Website)
EyeCurrently, the pathogenesis of PBC remains unclear, but more than 90% of patients test positive for anti-mitochondrial antibodies (AMA) and exhibit liver enzyme abnormalities primarily characterized by elevated alkaline phosphatase (ALP). Clinically, PBC patients often experience symptoms such as pruritus and fatigue, significantly impacting their quality of life. Intractable pruritus is also an important indication for liver transplantation.In the pivotal Phase III RESPONSE trial, seladelpar significantly reduced liver enzyme levels primarily characterized by ALP (61.7% in the seladelpar group vs. 20.0% in the placebo group).(See Figure 4); After 12 months of treatment, 25% of patients in the seladelpar group achieved normalization of ALP (0% in the placebo group); after 6 months of treatment, the least square mean reduction in pruritus NRS (n=49) for seladelpar-treated patients with baseline NRS≥4 (moderate to severe pruritus) was 3.2 points, compared to 1.7 points in the placebo group (n=23; p<0.005), indicating a statistically significant reduction in pruritus.(See Figure 5)。
Figure 4: Response rate of patients with ALP levels <1.67×ULN, ALP reduction ≥15%, and total bilirubin (TB) ≤1.0×ULN after 52 weeks
（Data Source:CymaBay Official Website）
Figure 5: Change in patient-reported itching severity from baseline (assessed by NRS with baseline ≥4) at 6 months
(Source: CymaBay official website)
The current treatment pathway for PBC can be summarized as a "wait-to-fail" strategy, which involves evaluating after one year of standardized UDCA treatment initiation, and providing second-line drug therapy to those with inadequate response.However, according to existing standards, even with a good response, if ALP does not fully return to normal, especially in young patients with liver fibrosis, the risk of adverse events remains relatively high.Therefore, for seladelpar, a therapy that not only improves liver composites but also normalizes liver function in some patients, it addresses an unmet clinical need.In recent years, Gilead Sciences, which has successfully joined the ranks of pharma with blockbuster drugs such as the HCV curative Sofosbuvir and the HIV product series Biktarvy, is undergoing a major transformation and aims to enter the oncology field through M&A.Acquired Kite for $17 billion, obtaining CAR-T cell therapies Yescarta, Tecartus, and other pipelines; acquired Immunomedics for $21 billion, obtaining Trop-2 ADC drug Trodelvy; acquired Forty Seven for $4.9 billion, obtaining potential first-in-class CD47 antibody Magrolimab……In 2023, the total sales of Gilead Sciences' oncology pipeline were$29.32 billion (an increase of 8% year-over-year). Among this,The sales revenues of Yescarta and Tecartus were respectively$3.70 billion and $14.98 billion,Trodelvy's sales reached $1.063 billion, and the substantial investment is gradually paying off.As for the field of liver disease where it once started, the revenue of the HCV pipeline in 2023$1.767 billion (Sofosbuvir/Velpatasvir Sales$1.57 billion）；In terms of Hepatitis B and D,Tenofovir disoproxil fumarate and tenofovir alafenamide had sales of $0.83 billion and $8.62 billion, respectively, in 2023. The antiviral field has significant limitations, and there is indeed a need for new products to strengthen the market.This time, Gilead Sciences spent $4.3 billion on the acquisitionDoes CymaBay imply a change in strategic layout? PharmaTimes will continue to follow.
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