Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces...
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Human Genome Sciences Reports Substantial Progress Toward Commercialization
and Announces 2009 Goals at JPMorgan Healthcare Conference
- Albuferon(R) for hepatitis C, LymphoStat-B(R) for lupus and ABthrax(R) for
inhalation anthrax all progressing rapidly toward commercialization -
- GSK Phase 3 trial of darapladib underway in chronic coronary heart disease -
- HGS provides 2009 financial guidance; expects less than $25 million net cash
burn -
ROCKVILLE, Md., Jan. 12 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc.
(Nasdaq: HGSI) will announce its priority goals for 2009 and report on the
Company's progress toward commercialization during a presentation by H. Thomas
Watkins, President and Chief Executive Officer, to financial analysts and
investors at the 27th Annual JPMorgan Healthcare Conference in San Francisco
on Wednesday, January 14.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"2009 will be a pivotal year for HGS," said Mr. Watkins. "In December 2008,
we reported the positive results of Albuferon's first Phase 3 trial in chronic
hepatitis C. We will have the results of Albuferon's second Phase 3 trial in
March. Assuming the second trial is also successful, we expect that global
marketing applications will be filed in fall 2009. We will have the results
of our two Phase 3 trials of LymphoStat-B in systemic lupus erythematosus
(SLE) in July and November, respectively, and expect to file marketing
applications in the first half of 2010 if LymphoStat-B is successful in these
studies. We are confident that we will deliver 20,000 doses of ABthrax to the
U.S. Strategic National Stockpile early in the year and will receive at least
$150 million in revenues in 2009. We also expect major financial progress in
2009, with revenues of more than $250 million and net cash burn of less than
$25 million."
During his presentation, Mr. Watkins will discuss the following goals and
updates on progress.
LATE-STAGE PRODUCTS
Albuferon(R): Met Primary Endpoint in Phase 3 Trial in Genotypes 2 and 3
Chronic Hepatitis C; Phase 3 Results in Genotype 1 Patients Expected March
2009
In December 2008, HGS reported that the results of ACHIEVE 2/3 demonstrated
that Albuferon (albinterferon alfa-2b) met its primary endpoint of
non-inferiority to peginterferon alfa-2a (Pegasys) in this global Phase 3
trial in 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis
C (p=0.0086). The data showed that the rate of sustained virologic response
was comparable for the 900-mcg dose of Albuferon administered every two weeks,
vs. the standard 180-mcg dose of peginterferon alfa-2a administered once
weekly. Rates of serious adverse events, severe adverse events and
discontinuations due to adverse events were also comparable. The results of
ACHIEVE 1, the Phase 3 trial of Albuferon in genotype 1 chronic hepatitis C,
are expected in March 2009. Albuferon is being developed by HGS and Novartis
under an exclusive worldwide co-development and commercialization agreement
entered into in June 2006.
"The data from ACHIEVE 2/3 show that the efficacy of Albuferon was comparable
to Pegasys, with half the injections," said Mr. Watkins. "If Albuferon is
also successful in ACHIEVE 1, we expect that global marketing applications
will be filed in fall 2009 - and we believe Albuferon could become the
market-leading interferon for the treatment of chronic hepatitis C,"
In a separate press release issued this morning, HGS announced that Novartis
has initiated a Phase 2b trial to evaluate the safety and efficacy of
Albuferon dosed monthly in treatment-naive patients with genotypes 2 and 3
chronic hepatitis C.
Key goals for Albuferon in 2009:
-- Report final Phase 3 data from ACHIEVE 1 in March.
-- File global marketing applications in fall.
LymphoStat-B(R): On Track for Phase 3 Data in July and November 2009
In 2008, HGS completed the enrollment of both Phase 3 trials of LymphoStat-B
(belimumab) in patients with active systemic lupus erythematosus (SLE). The
Company expects to report the first Phase 3 data for LymphoStat-B in July 2009
from the BLISS-52 trial, with results from BLISS-76 anticipated in November
2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in
lupus patients - and the only Phase 3 trials in these patients whose design
was directly informed by randomized Phase 2 results. LymphoStat-B is being
developed by HGS and GlaxoSmithKline (GSK) under a co-development and
commercialization agreement entered into in August 2006.
"If LymphoStat-B is successful in Phase 3, we expect to file marketing
applications in the United States and Europe in the first half of 2010, and we
believe it could become the first new drug approved by the FDA for the
treatment of lupus in 50 years," said Mr. Watkins. "Patients with SLE need new
treatment options; we hope to be able to help meet that need with
LymphoStat-B."
Key goals for LymphoStat-B in 2009:
-- Report Phase 3 data from BLISS-52 in July.
-- Report Phase 3 data from BLISS-76 in November.
ABthrax(TM): Delivery of 20,000 Doses to U.S. Strategic National Stockpile
Expected Early in Year; HGS Confident of Receiving $150 Million in 2009
HGS has met every milestone to date under its contract with the U.S.
Government and is currently awaiting authorization to begin delivery of 20,000
doses of ABthrax (raxibacumab) to the U.S. Strategic National Stockpile for
emergency use in treating inhalation anthrax. The Company has completed the
animal studies necessary to demonstrate the efficacy of ABthrax, the human
safety studies necessary for approval, and the manufacture of all bulk drug
necessary to supply 20,000 doses of ABthrax to the Stockpile. In May 2008,
HGS submitted the final data package to the FDA to support authorization of
delivery. ABthrax is being developed under a contract with the Biomedical
Advanced Research and Development Authority (BARDA) of the U.S. Department of
Health and Human Services (HHS).
"We believe that ABthrax offers a significant step forward in the treatment of
inhalation anthrax and could play an important role in strengthening America's
arsenal against bioterrorism," said Mr. Watkins. "We expect to receive
authorization to begin delivery to the Strategic National Stockpile early this
year. We are confident that we will receive at least $150 million in 2009
from our $165 million contract with the U.S. Government."
Key goals for ABthrax in 2009:
-- Deliver 20,000 doses of ABthrax to the Strategic National Stockpile
early in 2009.
-- Receive at least $150 million in revenue.
-- File a Biologics License Application with the FDA in the second
quarter.
Darapladib: GSK Phase 3 Development Program Underway
In December 2008, GSK announced initiation of the first pivotal Phase 3
clinical 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. Darapladib was discovered by GSK based on HGS
technology. HGS will receive 10% royalties on worldwide sales if darapladib
is commercialized, and has a 20% co-promotion option in North America and
Europe.
In its announcement, GSK said, "Despite major advances in medical treatment,
coronary heart disease remains the leading cause of death worldwide and new
approaches are needed to help reduce this burden to society. GSK is
initiating the large STABILITY trial with darapladib as part of a Phase 3
program to determine if this novel medication could improve people's lives by
reducing the risk of cardiovascular events." GSK also indicated that it plans
to initiate another large event-driven trial with darapladib in late 2009 in a
post-ACS (acute coronary syndrome) patient population.
MID- AND EARLY-STAGE PIPELINE
Syncria(R): GSK Update on Phase 3 Development Expected in the First Quarter
GSK is developing Syncria (albiglutide) as a treatment for type 2 diabetes
mellitus, and has completed a number of clinical studies of Syncria, including
a randomized Phase 2b dose-ranging trial of Syncria in patients with type 2
diabetes, which included a comparator arm of patients receiving Byetta
(exenatide). HGS expects an update from GSK in the first quarter of 2009
regarding Phase 3 development of Syncria.
Syncria is a novel long-acting form of GLP-1 (glucagon-like peptide 1) created
by HGS using its proprietary albumin-fusion technology, and licensed to GSK in
2004. Syncria is generated from the genetic fusion of human albumin and
GLP-1, a peptide hormone that acts throughout the body to help maintain normal
blood-sugar levels and to control appetite. HGS is entitled to fees and
milestone payments, some of which have already been received, that could
amount to as much as $183 million, in addition to single-digit royalties on
worldwide sales if Syncria is commercialized.
Oncology Portfolio: A Key Driver of Future Growth
HGS is investing strategically to expand and advance its oncology portfolio
around its leading expertise in the apoptosis, or programmed cell death,
pathway. HGS-ETR1 (mapatumumab) is the most advanced of any product in
development that targets the TRAIL apoptosis pathway, and three randomized
chemotherapy combination trials are currently underway to evaluate its
potential in the treatment of advanced multiple myeloma, non-small cell lung
cancer, and hepatocellular cancer.
In May 2008, HGS initiated dosing in a Phase 1 clinical trial to evaluate the
safety and tolerability of its lead IAP inhibitor, HGS1029, as monotherapy in
patients with advanced solid tumors. Results of this study will also help
identify the recommended dose for Phase 2 trials. The IAP inhibitors are a
novel class of compounds that block the activity of IAP (inhibitor of
apoptosis) proteins, thus allowing apoptosis to proceed and causing the cancer
cells to die. When IAP proteins are over-expressed in cancer cells, they can
help cancer cells resist apoptosis and resume growth and proliferation.
FINANCIAL GUIDANCE
During his presentation to the JPMorgan Healthcare Conference, Mr. Watkins
will present the following guidance regarding the financial results expected
by HGS for the full years 2008 and 2009:
-- HGS expects 2009 net cash burn of less than $25 million, compared with
approximately $245 million in 2008.
-- Revenue is expected to increase to $250 million or higher in 2009,
from
$48 million in 2008.
-- This includes at least $150 million from sale of 20,000 doses of
ABthrax.
-- HGS expects cash and investments at year-end 2009 to total
approximately
$340 million, compared with approximately $365 million at the end of
2008.
PRESENTATION TO BE WEBCAST
Mr. Watkins' presentation to the 27th Annual JPMorgan Healthcare Conference
will be webcast and may be accessed at www.hgsi.com. The presentation is
scheduled to begin on January 14, 2009 at 7:30 AM Pacific or 10:30 AM Eastern
time. Investors interested in listening to the live webcast should log on
before the presentation begins to download any software required. The archive
of the presentation will be available for several days following the event.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring
innovative drugs to patients with unmet medical needs. The HGS clinical
development pipeline includes novel drugs to treat hepatitis C, lupus,
inhalation anthrax, cancer and other immune-mediated diseases. The Company's
primary focus is rapid progress toward the commercialization of its two key
lead drugs, Albuferon(R) (albinterferon alfa-2b) for hepatitis C and
LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs
are ongoing.
ABthrax(TM) (raxibacumab) is in late-stage development for the treatment of
inhalation anthrax, and the Company is awaiting authorization to begin the
delivery of 20,000 doses of ABthrax to the Strategic National Stockpile under
a contract entered into with the U.S. Government in June 2006. HGS also has
three drugs in clinical development for the treatment of cancer, including two
TRAIL receptor antibodies and a small-molecule antagonist of IAP (inhibitor of
apoptosis) proteins. In addition, HGS has substantial financial rights to
certain products in the GSK clinical development pipeline.
For more information about HGS, please visit the Company's web site at
www.hgsi.com. Health professionals and patients interested in clinical trials
of HGS products may inquire via e-mail to clinical_trials@hgsi.com or by
calling HGS at (301) 610-5790, extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks
of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The forward-looking statements
are based on Human Genome Sciences' current intent, belief and expectations.
These statements are not guarantees of future performance and are subject to
certain risks and uncertainties that are difficult to predict. Actual results
may differ materially from these forward-looking statements because of the
Company's unproven business model, its dependence on new technologies, the
uncertainty and timing of clinical trials, the Company's ability to develop
and commercialize products, its dependence on collaborators for services and
revenue, its substantial indebtedness and lease obligations, its changing
requirements and costs associated with facilities, intense competition, the
uncertainty of patent and intellectual property protection, the Company's
dependence on key management and key suppliers, the uncertainty of regulation
of products, the impact of future alliances or transactions and other risks
described in the Company's filings with the Securities and Exchange
Commission. In addition, the Company will continue to face risks related to
animal and human testing, to the manufacture of ABthrax and to FDA concurrence
that ABthrax meets the requirements of the ABthrax contract. If the Company
is unable to meet the product requirements associated with the ABthrax
contract, the U.S. government will not be required to reimburse the Company
for the costs incurred or to purchase any ABthrax doses. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of today's date. Human Genome
Sciences undertakes no obligation to update or revise the information
contained in this announcement whether as a result of new information, future
events or circumstances or otherwise.
SOURCE Human Genome Sciences, Inc.
Media: Jerry Parrott, Vice President, Corporate Communications,
+1-301-315-2777, or Investors: Tim Barabe, Senior Vice President and Chief
Financial Officer, +1-301-315-1780, both of Human Genome Sciences
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