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Gilead Sciences Clinical Development Profile

  • March 2014
  • -
  • Industry Standard Research
  • -
  • 76 pages

With a market capitalization greater than $100B, Gilead is fast becoming one of the most influential pharmaceutical companies in the world. ISR’s report provides a thorough analysis of Gilead Sciences’ R&D pipeline, clinical trial activity, patents, FDA submissions, and includes profiles of Gilead’s key products.

How you can use this report:
- Pharmaceutical Companies: Identify the clinical and commercial status of competing compounds and understand how these will affect the launch of similar/ competing
products.
- For Service Providers: Better prepare your business development activities focused on Gilead. Understand their strategic direction, current and potential clinical development pipeline, and historic trial metrics.

Background and strategy
Gilead Sciences Inc. (NASDAQ:GILD) is considered the world’s largest pure-play biotech with a market capitalization over $125 billion as of March 3rd 2014. Yes, $125 billion, with a “b.” Just to put Gilead’s $125B market capitalization into context, AstraZeneca’s (LON: AZN) market cap is around $50B, Ford’s (NYSE: F) is roughly $60B, Coke’s (NYSE: KO) market cap is $168B, and Bank of America’s (NYSE: BAC) is approximately $170B.

During the Gilead Sciences Q4 2013 earnings conference call on February 4, 2014, chairman and CEO, John Martin called 2013 a very productive year for Gilead. Their marketed products achieved record product sales of $10.8 billion, an increase of 15% year over year. He went on to say that the research and development organization also executed a record number of clinical studies across all therapeutic areas, as well as submitted marketing authorization applications in both hepatitis C and oncology. Also during the Q4 2013 call, Martin announced that top line data from three Phase III studies on ledipasvir/sofosbuvir showed positive results and that they expect to file FDA and European applications this quarter. The FDA previously assigned breakthrough designation to this combination and the European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment, a designation that is granted to new therapies and medicines of major public health interest.

Table Of Contents

Gilead Sciences Clinical Development Profile
Table of Contents

Methodology and sources ...5
Background and strategy .6
Financial condition ..9
Drug sales ..10
Stock performance 11
RandD pipeline overview ..12
Clinical trial activity 17
Number of clinical trials, by phase 19
Study type distribution (e.g. interventional) .19
Interventional trials, by phase ..20
Observational trials, by phase ...20
Industry-funded study type distribution ...21
Industry-funded interventional trials, by phase ...21
Industry-funded observational trials, by phase 22
Average trial length, by phase ..23
Average interventional trial length, by phase ...24
Average observational trial length, by phase ...24
Average industry-sponsored interventional trial length, by phase ..25
Average industry-sponsored observational trial length, by phase ...25
Projected vs. actual ongoing trial length, by phase ..26
Projected vs. actual ongoing interventional trial length, by phase ...26
Projected vs. actual ongoing observational trial length, by phase ...27
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase ..27
Projected vs. actual ongoing industry-sponsored observational trial length, by phase ...28
Average enrollment by phase ...29
Interventional enrollment, by phase 29
Average enrollment by phase - outlier removed .30
Interventional enrollment, by phase - outlier removed ...30
Observational enrollment, by phase .31
Industry-sponsored, interventional trial enrollment, by phase 31
Industry-sponsored, observational trial enrollment, by phase .32
Patents ...33
Drug patent expirations 55
FDA submissions 57
Approved drugs .57
Key product profiles ...58
Sovaldi ...59
Atripla 60
Truvada ..61
Viread 62
Complera/Eviplera .63
Stribild 64
Hepsera ..65
Emtriva ..66
Letairis ...67
Ranexa ..68
AmBisome .69
Summary 70
RandD spending ...71
Clinical development summary .72
Key compound MOA and trial overview ...75
About Industry Standard Research 76

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