Q3 2020 Sales Performance
Progressing our innovative new medicines
Building momentum with impactful programmes across the portfolio
GSK '836 in chronic Hepatitis B
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Programme in-licensed from lonis Pharmaceuticals in Q3 2019
Ph2a data presented at AASLD (Nov)1
HBsAg reduction seen in HBeAg positive and negative patients
with 300mg dose
Ph2b study started
GSK '609 ICOS agonist in HNSCC
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Demonstrated activity in both monotherapy and PD-1 combo
Ph 2/3 gated studies INDUCE-3 and INDUCE-4 in HNSCC
initiated
gepotidacin in uUTIs and gonorrhoea
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gsk
UUTI and GC not addressed by new oral antibiotics in 20 years
• ~40% of uUTI patients have antibiotic resistance infections²
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Emerging resistance to 1st line therapy for gonorrhea 3,4,5
Ph3 programme initiated to investigate gepo vs. ceftriaxone +
azithromycin (GC) and gepo vs. nitrofurantoin (uUTI)
Ph3 results expected 1H 2022
daprodustat in anaemia
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Futility analysis performed Dec 2019 on CV outcome studies,
which are continuing without modification
Approved in Japan for anaemia due to chronic kidney disease
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Design allows progression to pivotal if interim analysis positive
Further POC data expected 2021
CVOT data expected 2H 2021
UUTIS = uncomplicated urinary tract infections; GC = urogenital gonorrhea; HNSCC = head and neck squamous cell carcinoma; POC = proof of concept; PMDA = Pharmaceuticals and Medicines Device Agency
1. Yuen MF et al. Phase 2a, randomized, double-blind, placebo-controlled study of an antisense inhibitor (ISIS 505358) in treatment-naïve chronic hepatitis B (CHB) patients: safety and antiviral efficacy. Poster presented at AASLD, The Liver Meeting, November 8-12, 2019, Boston.
2. World Health Organization STD Fact Sheet 2016: https://www.who.int/en/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
3. Workowski KA, Berman SM, Douglas Jr. JM. Emerging antimicrobial resistance in Neisseria gonorrhoeae: urgent need to strengthen prevention strategies. Ann Intern Med. 2008;148(8):606-13
4. Antibiotic Resistance Threats in the United States. US CDC https://www.cdc.gov/drugresistance/biggest-threats.html
5. GSK US physician market research, 2019
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