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GSK (Human Genome Sciences, Inc.)

Partner : GSK

David P. Southwell, EVP, and Chief Financial Officer, responded to a question regarding the timing of data reads from the Darapladib clinical program. He stated, "On Darapladib there is apparently a rumor that data will come out in 2012, which you characterized as extremely far fetched, so let me address that. We don't have any inside information on that. What we have understood from GSK is that it is all about when 1500 people have either heart-attacks or strokes. We have not heard from GSK that they expect that to happen in 2012 and if you remember in the presentation I said that we have heard that it is more likely to happen in 2013. But it is event driven so GSK does not really know but htey probably have a better sense than anyone else and the word that we have heard is 2013. So, I would agree with you that 2012 seems a little on the early side. "
Source: Cowen & Co 32nd Health Care Conference, 3/5/12.

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David P. Southwell, EVP, and Chief Financial Officer, commented on the Darapladib clinical program. He stated, "The first of those studies should read out in about a year and a half or so. "
Source: Cowen & Co 32nd Health Care Conference, 3/5/12.

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David P. Southwell, EVP, and Chief Financial Officer, commented on the timing of results from the Darapladib phase III program with GSK. He stated, "We would expect that trial to read-out some time in late 2012 to late 2013, in that sort of time-frame."
Source: Goldman Sachs 32nd Annual Global Healthcare Conference, 6/6/11.

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David P. Southwell, EVP, and Chief Financial Officer, gave guidance for data from the Darapladib phase III trials. He stated, "They are expecting those trials to read-out some where around 2012, although because they are event driven you never quite know when 1500 people are going to have adverse cardiovascular events."
Source: JMP Securities Healthcare Conference, 9/27/10.

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ROCKVILLE, Maryland – December 18, 2008 – Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated the first pivotal trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with chronic coronary heart disease.
Source: press release, 12/18/08. http://www.hgsi.com/latest/fyi-from-human-genome-sciences-gsk-initiates-...

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STABILITY - A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
Enrollment: 15828
Study Start Date: December 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00799903?term=darapladib&rank=6

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Darapladib (SB-480848) CardiovascularAtherosclerosisLp-PLA2 inhibitorLp-PLA2

Mechanism of action: Darapladib (SB-480848), a SM-inhibitor, reduces vascular inflammation by inhibition of lipoprotein-associated phospholipase A2 (Lp-PLA2).

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-07-01 - 2013-10-31

Results: Pending