8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 16, 2011

HUMAN GENOME SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-14169	22-3178468
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

14200 Shady Grove Road, Rockville, Maryland	20850-7464
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (301) 309-8504

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD Disclosure.

On November 16, 2011, GlaxoSmithKline announced topline results from the first of eight Phase 3 studies of albiglutide in type 2 diabetes. A copy of the GSK press release is furnished herewith as Exhibit 99.

Albiglutide was created by Human Genome Sciences, Inc. using its proprietary albumin-fusion technology, and was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million — including $33.0 million received to date — in addition to single-digit net royalties on worldwide sales if albiglutide is commercialized.

Safe Harbor Statement

This Form 8-K and attached press release include statements regarding albiglutide that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this announcement, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

Some important factors that could cause actual results to differ from expectations in these forward-looking statements include: the inherent uncertainty of the timing, success of, and expense associated with, research, development, regulatory approval and commercialization of albiglutide; the occurrence of adverse safety events with albiglutide; substantial competition in our industry, including from branded and generic products; the highly regulated nature of our business; and uncertainty regarding our intellectual property rights and those of others. The foregoing list sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any of these forward-looking statements. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating these forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99 Press Release issued by GlaxoSmithKline, dated November 16, 2011.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

HUMAN GENOME SCIENCES, INC.
By:	/s/ James H. Davis, Ph.D.
	Name:	James H. Davis, Ph.D.
	Title:	Executive Vice President, General Counsel and Secretary

Date: November 16, 2011

INDEX TO EXHIBITS

Exhibit No.		Description
	99	Press Release issued by GlaxoSmithKline, dated November 16, 2011.

EX-99

Exhibit 99

Issued: Wednesday 16 November, London UK

GSK receives initial data from the first completed
phase III study of albiglutide in type 2 diabetes

- Head-to-head study primary end point did not meet non-
inferiority, but results support progression towards registration

GlaxoSmithKline (GSK) today announced that topline results have been received from the first of eight Phase III studies of albiglutide to complete in type 2 diabetes.

The study, known as Harmony 7, is a head-to-head study designed to compare albiglutide, an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist, to once-a-day liraglutide, an approved treatment for type 2 diabetes, in the same class. The primary endpoint of the study was reduction in HbA1c, a marker of the amount of glucose in the blood.

Results showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline (p<0.001), it did not meet the pre-specified primary endpoint of non-inferiority to liraglutide (95% CI: 0.08 — 0.34%).

The most common adverse events observed during this study were associated with gastrointestinal tolerability. Nausea and vomiting rates were lower in patients receiving albiglutide compared to those receiving liraglutide (9.9% versus 29.2% for nausea; 5% versus 9.3% for vomiting). While weight loss was observed for both treatments, the weight loss for patients receiving albiglutide (-0.62 kg) was lower than that observed with liraglutide (-2.21 kg).

“While the pre-specified margin of non-inferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for type 2 diabetes,” said Moncef Slaoui, Chairman of R&D at GSK. “This is the first of eight phase III studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in type 2 diabetes,” he added.

Detailed analysis of the full data set from this study will be conducted in the coming months and the data will be submitted for presentation at a scientific meeting in 2012. In addition, initial results from the remaining seven Phase III studies will become available over the course of the next several months. An update on the clinical development programme will be the subject of a future announcement when a more complete view of the programme is available, expected in mid 2012.

About the Harmony 7 study

Harmony 7 is one of eight Phase III studies investigating the efficacy and safety of albiglutide in men and women with type 2 diabetes.

This 32 week, head-to-head, open-label, non-inferiority study, enrolled 841 patients, on single, dual or triple oral antidiabetes medicines, from eight countries. The patients were randomised to receive, via titration, either albiglutide 50 mg weekly or the maximum approved dose of liraglutide, 1.8 mg once daily. The primary endpoint was reduction in HbA1c, while secondary endpoints included other parameters of glucose control, weight, and safety and tolerability.

About the Harmony Phase III programme

The Phase III clinical development programme for albiglutide, compromises eight individual studies, known as Harmony 1 to Harmony 8.

The programme is investigating the efficacy, tolerability and safety, including cardiovascular safety, of albiglutide as mono- and add-on therapy, in patients with type 2 diabetes. The primary efficacy endpoint for all studies is the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including sulphonylurea, thiazolidinedione (TZD), insulin and a dipeptidyl peptidase four inhibitor (DPP IV).

The individual phase III studies are due to complete from late 2011 through early 2013. In addition to Harmony 7 one other study is expected to complete in late 2011. One study will complete in 2012. The remaining five studies are expected to complete by early 2013; these studies have a primary efficacy endpoint set at between 26 weeks and two years, which is expected to be achieved by mid 2012 for all studies. As per the study protocols, these studies will remain blinded past the primary efficacy endpoint until completion, which for most studies is three years.

About albiglutide

Albiglutide is an investigational biological, injectable form of human GLP-1 — a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. Normally, GLP-1 levels rise during a meal to help the body utilise and control the elevation in blood sugar levels. However, GLP-1 is rapidly degraded, resulting in its short duration of action. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced. Albiglutide is an investigational medicine which fuses human GLP-1 to human albumin. It is designed to have the potential to extended duration of action and allow for weekly or less-frequent injections.

GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

GlaxoSmithKline Enquiries:

UK Media enquiries:	David Mawdsley	+44 (0) 20 8047 5502	(London)
	Stephen Rea	+44 (0) 20 8047 5502	(London)
	Sarah Spencer	+44 (0) 20 8047 5502	(London)
	David Daley	+44 (0) 20 8047 5502	(London)
US Media enquiries:	Kevin Colgan	+1 919 483 2839	(North Carolina)
	Mary Anne Rhyne	+1 919 483 2839	(North Carolina)
	Sarah Alspach	+1 919 483 2839	(Washington, DC)
	Jennifer Armstrong	+1 919 483 2839	(Philadelphia)
Analyst/Investor enquiries:	Sally Ferguson	+44 (0) 20 8047 5543	(London)
	Tom Curry	+ 1 215 751 5419	(Philadelphia)
	Gary Davies	+ 44 (0) 20 8047 5503	(London)
	Ziba Shamsi	+ 44 (0) 20 8047 3289	(London)
	Jeff McLaughlin	+ 1 215 751 7002	(Philadelphia)

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’ s Annual Report on Form 20-F for 2010.

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Registered Office:
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Brentford, Middlesex
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