- Three late-stage products moving rapidly toward commercialization:
Albuferon(R) for hepatitis C, LymphoStat-B(R) for lupus and ABthrax(TM) for
inhalation anthrax -
- Accelerating development of novel targeted cancer therapies; TRAIL
receptor antibodies and small-molecule IAP inhibitors to be developed
separately and in combination -
- Products in GSK pipeline continue to advance -
ROCKVILLE, Md., Jan. 7 /PRNewswire/ -- Human Genome Sciences, Inc.
(Nasdaq: HGSI) will announce its priority goals for 2008 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 26th Annual JPMorgan Healthcare Conference in
San Francisco on Wednesday, January 9.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"We are performing on plan in every major respect. 2007 was a year of
great progress for HGS, as we executed well across all areas of our
business," said H. Thomas Watkins, President and Chief Executive Officer,
HGS. "We are poised for the market. In 2008, we expect to accomplish
additional key milestones in our transformation into a commercial
enterprise. Phase 3 trials of Albuferon for hepatitis C and LymphoStat-B
for lupus are well underway. We expect to have our first Phase 3 data for
Albuferon in late 2008. We expect to complete enrollment in the Phase 3
trials of LymphoStat-B by fall 2008. The pivotal efficacy studies of
ABthrax have demonstrated a dramatic and significant survival benefit in
the treatment of inhalation anthrax, and we are on track to begin delivery
of ABthrax to the Strategic National Stockpile by fall 2008. Our cash
position remains strong and we are making substantial progress toward
commercialization."
Mr. Watkins also pointed to the strategic importance of the promising
clinical pipeline that follows right behind the Company's three late-stage
products. "We are committed to building a company that achieves commercial
success and sustainable growth well into the future," he said. "We believe
that our future growth will be ensured by investing now in our mid- and
early- stage pipeline. With the licensing and collaboration agreement we
announced with Aegera Therapeutics in December 2007, we have significantly
enhanced the value of our oncology franchise. Both the TRAIL receptor
antibodies and the Aegera IAP inhibitors are highly targeted approaches
that selectively cause cancer cells to die through apoptosis, or programmed
cell death. We look forward to developing them in combination with one
another and in combination with other therapeutic agents."
During his presentation on January 9, Mr. Watkins will discuss the
following 2008 goals and updates on progress.
LATE-STAGE PRODUCTS
Albuferon(R): First Phase 3 Data Expected by Year-End 2008
In 2007, HGS completed enrollment ahead of schedule in both Phase 3
clinical trials of Albuferon (albinterferon alfa-2b) in combination with
ribavirin in treatment-naive patients with chronic hepatitis C - ACHIEVE 1
in genotype 1 patients and ACHIEVE 2/3 in genotypes 2 and 3 patients. HGS
expects to have data from ACHIEVE 2/3 available by the end of 2008, and all
Phase 3 data available by spring 2009 to support global marketing
authorization applications by fall 2009. Albuferon is being developed by
HGS and Novartis under an exclusive worldwide co-development and
commercialization agreement entered into in June 2006.
At the doses being studied in Phase 3, Albuferon requires half as many
injections as Pegasys (peginterferon alfa-2a). Final Phase 2b results in
treatment-naive patients, presented in November 2007 at the Annual Meeting
of the American Association for the Study of Liver Diseases (AASLD),
demonstrated that Albuferon provided efficacy at least comparable to
Pegasys, with comparable safety and the potential for less impairment of
health-related quality of life on treatment and fewer lost days of work.
"Market research tells us that the Albuferon product profile that has
emerged from Phase 2 results supports a leading share position in the
interferon segment of the hepatitis C market if these results are confirmed
in Phase 3," said Mr. Watkins. "In addition, we have a solid opportunity to
follow on with a monthly schedule at a higher dose after our initial launch
of Albuferon dosed every two weeks. We believe that Albuferon will become
the interferon of choice in combination regimens for the treatment of
chronic hepatitis C."
The key goals for Albuferon in 2008 are:
-- To have data available from ACHIEVE 2/3, the Phase 3 trial in genotypes
2 and 3 patients, by year-end 2008.
-- To continue progress in ACHIEVE 1, the Phase 3 trial in genotype 1
patients, with final data expected by spring 2009 to support filing of
global marketing authorization applications by fall 2009.
LymphoStat-B(R): Completion of Phase 3 Enrollment Expected by Fall
2008; Phase 3 Data Expected in 2009
Enrollment is progressing in both Phase 3 clinical trials of
LymphoStat-B (belimumab) in patients with active systemic lupus
erythematosus (SLE). HGS now expects to complete enrollment of BLISS-76 and
BLISS-52 by fall 2008 and to have Phase 3 data available in 2009.
LymphoStat-B is being developed by HGS and GlaxoSmithKline (GSK) under a
definitive co-development and commercialization agreement entered into in
August 2006.
In November 2007, Phase 2 results were presented at the Annual
Scientific Meeting of the American College of Rheumatology (ACR), which
demonstrated that LymphoStat-B achieved a sustained improvement in disease
activity across multiple clinical measures, decreased the frequency of
disease flares over time, and was generally well tolerated through 2.5
years on treatment in combination with standard of care in patients with
active SLE. The results through 2.5 years confirm and extend the data
presented at previous scientific meetings at earlier time points, including
a significant reduction in SLE disease activity as measured by the response
rate chosen as the primary efficacy endpoint of the Phase 3 trials.
"If the Phase 2 results are confirmed in our ongoing Phase 3 trials,
LymphoStat-B will represent a breakthrough for patients with SLE," said Mr.
Watkins. "LymphoStat-B has the potential to offer a significant and durable
reduction in disease activity beyond that achievable with current standard
of care alone. Patients with SLE are in great need of newer and better
treatment options, and demand for LymphoStat-B should be high if it becomes
available commercially."
The key goals for LymphoStat-B in 2008 are:
-- To complete the enrollment of both Phase 3 trials, BLISS-76 and
BLISS-52, by fall 2008 with Phase 3 data expected in 2009.
-- To present results through four years of LymphoStat-B therapy in the
ongoing Phase 2 continuation trial at appropriate scientific meetings
in 2008.
-- To initiate a Phase 2 trial of LymphoStat-B with subcutaneous
administration by summer 2008.
-- To complete the production of cGMP conformance lots.
ABthrax(TM): Submission of Final Data Package Expected by Mid-2008 to
Support Authorization of Delivery to Strategic National Stockpile; Delivery
to Begin by Fall 2008
HGS reported in December 2007 that it has demonstrated a statistically
significant survival benefit for ABthrax (raxibacumab) in the treatment of
inhalation anthrax in two animal species, which is the requirement for
establishing the efficacy of new drugs used to counter bioterrorism.
ABthrax, a human monoclonal antibody that specifically targets and blocks
the deadly effects of anthrax toxins after they are released by the
bacteria into the blood, is being developed under contract with the
Biomedical Advanced Research and Development Authority (BARDA) of the U.S.
Department of Health and Human Services (HHS).
In June 2006, the U.S. Government exercised its option to purchase
20,000 doses of ABthrax for the Strategic National Stockpile. The purchase
award was made under the Project BioShield Act of 2004, which is designed
to accelerate the development, purchase and availability of medical
countermeasures for the Stockpile. HGS expects to receive $165 million in
revenue from the award, with approximately 70% to come in 2008, as the
Company begins to deliver ABthrax. HGS is also working closely with HHS,
FDA and CDC to complete the additional laboratory and clinical testing
required to support the filing of a Biologics License Application (BLA) in
2009.
"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.
"The most challenging scientific work is now behind us. We have
demonstrated the efficacy of ABthrax in multiple therapeutic and
prophylactic animal models of inhalation anthrax. We have demonstrated that
it was generally safe and well tolerated in two clinical trials to date in
healthy adults. We have completed conformance lots and are currently
manufacturing ABthrax on schedule to begin delivery to the Stockpile by
fall 2008."
The key goals for ABthrax in 2008 are:
-- To submit the final data package to FDA and BARDA by mid-2008, to
support authorization of delivery to the Stockpile.
-- To complete cGMP production of ABthrax for delivery to the Stockpile
beginning fall 2008.
-- To initiate the larger confirmatory human safety study by spring 2008,
to support the filing of a BLA in 2009.
ONCOLOGY PRODUCTS
HGS has pioneered the development of highly targeted antibody therapies
for cancer based on the TRAIL receptor apoptotic pathway. HGS-ETR1
(mapatumumab) and HGS-ETR2 (lexatumumab) specifically bind to the TRAIL
receptor-1 and TRAIL receptor-2 proteins, respectively, and cause them to
induce programmed cell death, or apoptosis, in cancer cells. HGS-ETR1 is
the most advanced of all the products in development that target the TRAIL
pathway.
In December 2007, HGS and Aegera Therapeutics Inc. completed a
licensing and collaboration agreement under which HGS has acquired
exclusive worldwide rights (excluding Japan) to develop and commercialize
AEG40826 and other small-molecule inhibitors of IAP (inhibitor of
apoptosis) proteins in oncology. When IAP proteins are over-expressed in
cancer cells, they can help cancer cells resist apoptosis and resume growth
and proliferation. The IAP inhibitors are a novel class of compounds that
block the activity of IAP proteins, thus allowing apoptosis to proceed and
causing the cancer cells to die.
HGS plans to develop its TRAIL receptor antibodies and IAP inhibitors
in combination with one another and in combination with other therapeutic
agents.
TRAIL Receptor Antibodies: Data from Phase 2 Combination Trial of HGS-
ETR1 in Multiple Myeloma Expected by Mid-2008
HGS-ETR1 has moved to a critical proof-of-concept phase in which HGS is
conducting randomized Phase 2 chemotherapy combination trials. The first of
these trials is evaluating HGS-ETR1 in combination with Velcade
(bortezomib) in advanced multiple myeloma. Multiple myeloma is a cancer of
the plasma cells in bone marrow and accounts for about 10 percent of all
hematologic cancers. HGS expects to have data available from the multiple
myeloma trial by mid-2008. GSK has exercised its option under a June 1996
agreement to develop and commercialize HGS-ETR1 jointly with HGS.
In December 2007, HGS initiated dosing of patients in a randomized
Phase 2 trial of HGS-ETR1 in combination with paclitaxel and carboplatin as
first-line therapy in patients with advanced non-small cell lung cancer
(NSCLC). NSCLC accounts for approximately 75-80% of all lung cancers and is
currently the leading cause of cancer death in developed countries in both
men and women. The NSCLC trial will continue the enrollment and
randomization of patients throughout 2008.
AEG40826 and Small-Molecule IAP Inhibitors: AEG40826 to Enter Clinical
Development Early in 2008
The HGS TRAIL receptor antibodies and small-molecule IAP inhibitors
represent two different highly targeted approaches targeting different
points in the apoptosis pathway. Each is able to cause cancer cells to die
selectively.
In the months leading up to the agreement with Aegera Therapeutics at
the end of 2007, HGS scientists conducted preclinical studies of AEG40826
in combination with the Company's TRAIL receptor antibodies. The results
demonstrated dramatic synergistic activity against a number of cancer
types, including prostate, breast, esophageal, colorectal and non-small
cell lung cancer. Preclinical studies also show that AEG40826 has
significant anti- tumor activity alone and in combination with other
anti-cancer agents in a broad range of cancers.
HGS expects to initiate a Phase 1 clinical trial of AEG40826 early in
2008. In addition, HGS will work collaboratively with Aegera to develop
additional IAP inhibitors as backup compounds to AEG40826 to ensure that
the optimal product candidates in this new class of compounds are advanced
to development.
Key goals for the HGS oncology pipeline in 2008 are:
-- To have data available by mid-2008 from the randomized Phase 2
chemotherapy combination trial of HGS-ETR1 in multiple myeloma.
-- To continue, throughout 2008, the enrollment and randomization of
patients in the Phase 2 chemotherapy combination trial of HGS-ETR1 in
non-small cell lung cancer, with completion of enrollment expected by
spring 2009.
-- To initiate a Phase 1 clinical trial of the IAP inhibitor AEG40826
early in 2008.
PRODUCTS IN GSK PIPELINE
HGS believes that 2008 will be a pivotal year for products in the GSK
clinical development pipeline to which HGS has certain rights: darapladib,
an Lp-PLA2 inhibitor for atherosclerosis; and Syncria(R) (albiglutide) an
albumin-fusion protein for diabetes. Darapladib is a small-molecule drug
discovered by GSK based on HGS technology. HGS will receive a 10% royalty
on worldwide sales if darapladib is commercialized, and also has a 20% co-
promotion option in North America and Europe. Syncria was created by HGS
and licensed to GSK in late 2004. 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 royalties on worldwide sales if
Syncria is commercialized. The third product in the GSK clinical pipeline
is GSK 649868, a small-molecule orexin antagonist for sleep disorders. Like
darapladib, it was discovered by GSK based on HGS technology.
Darapladib: Presentation of Phase 2 Results Expected in 2008; Phase 3
Decision Possible in 2008
Darapladib is a small-molecule inhibitor of lipoprotein-associated
phospholipase-A2 (Lp-PLA2), an enzyme associated with the formation of
atherosclerotic plaques and identified in clinical trials as an independent
risk factor for coronary heart disease and ischemic stroke. GSK is
developing darapladib as a treatment for atherosclerosis. Darapladib has
the potential to be an important treatment for the prevention of
cardiovascular risk.
HGS expects that the results of two GSK clinical trials of darapladib
will be presented in 2008:
-- A Phase 2 multi-center, randomized, double-blind, placebo-controlled,
dose-ranging study was conducted in 920 patients with coronary artery
disease to evaluate whether darapladib produces sustained inhibition of
plasma Lp-PLA2 activity, to explore its effects on other circulating
biomarkers associated with cardiovascular risk, and to evaluate
darapladib's pharmacokinetics, safety and tolerability over 12 weeks of
once-daily oral dosing.
-- A Phase 2/3 imaging trial of darapladib known as IBIS-2 (Integrated
Biomarker and Imaging Study 2) was conducted in 330 patients with
angiographically-documented coronary artery disease who were receiving
standard care. IBIS-2 was an international, multi-center, randomized,
double-blind, placebo-controlled exploratory study with a treatment
period of one year. The study was designed to assess the impact of
darapladib on arterial plaque composition. IBIS-2 also measured
endothelial plaque volume and circulating biomarkers, as well as
evaluating safety and tolerability. HGS believes it is possible that GSK will reach a decision regarding
whether to advance darapladib to Phase 3 development in 2008.
Syncria(R): Presentation of Phase 2b Results Expected in 2008; Phase 3
Decision Possible in 2008
Syncria (albiglutide) is a novel long-acting form of GLP-1
(glucagon-like peptide 1) created by HGS using its proprietary
albumin-fusion technology. 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. GSK is
developing Syncria as a treatment for type 2 diabetes mellitus. It is
estimated that more than 20 million adults and children in the United
States have type 2 diabetes, approximately 30% of them undiagnosed.
In May 2007, GSK initiated a Phase 2b multi-center, randomized, double-
blind, placebo-controlled, dose-ranging clinical trial to evaluate the
efficacy, safety and tolerability of multiple doses and treatment regimens
of Syncria in patients with type 2 diabetes who are either taking no
diabetes medication or taking metformin only. The treatment period is 16
weeks with an additional 10 weeks of follow-up. As a comparison, one group
of patients is receiving Byetta (exenatide).
HGS believes that the results of the Phase 2b trial of Syncria will be
presented in 2008, and that it is possible that GSK will reach a decision
regarding whether to advance Syncria to Phase 3 development in 2008.
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 year 2007 and for 2008:
-- Excluding the impact of the recently announced transaction with Aegera
Therapeutics Inc., 2007 net cash burn will be approximately $160
million, in line with previous guidance. Including payments of $20
million made to Aegera Therapeutics Inc., total 2007 net cash burn will
be approximately $180 million.
-- HGS expects 2008 net cash burn of $180-200 million, including an
estimated $10 million related to development of the IAP inhibitor
AEG40826.
-- Revenue is expected to increase from $40 million in 2007 to $160
million or higher in 2008, including $100-120 million from ABthrax
product sales in late 2008.
-- HGS expects cash and investments at year-end 2008 to total $400-420
million, compared with approximately $600 million at the end of 2007.
PRESENTATION TO BE WEBCAST
Mr. Watkins' presentation to the 26th Annual JPMorgan Healthcare
Conference will be webcast and may be accessed at http://www.hgsi.com. The
presentation is scheduled to begin on January 9, 2007, 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 in order to download
any software required. The archive of the presentation will be available
for several days.
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, anthrax disease, 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- 2a) 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 anthrax disease, and the Company is on track to begin the
delivery in 2008 of 20,000 doses of ABthrax to the Strategic National
Stockpile under a contract entered into with the U.S. Government in June
2006. Other HGS drugs in clinical development include two TRAIL receptor
antibodies for the treatment of cancer. AEG40826, a small-molecule
antagonist of IAP (inhibitor of apoptosis) proteins, is expected to enter
Phase 1 clinical trials for the treatment of cancer in early 2008.
For more information about HGS, please visit the Company's web site at
http://www.hgsi.com. Health professionals or patients interested in Albuferon
clinical trials or other studies involving HGS products may inquire via the
"Contact Us" section of the Company's web site,
http://www.hgsi.com/products/request.html, or by calling (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.
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Related links:
http://www.hgsi.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/121115.html /
CONTACT:
Jerry Parrott, Vice President, Corporate
Communications, +1-301-315-2777, or Kate de Santis, Director,
Investor Relations, +1-301-251-6003, both of Human Genome
Sciences, Inc.
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