Human Genome Sciences, Inc. (Nasdaq: HGSI) today will announce its
priority goals for 2010 and report on the Company’s increasing momentum
toward commercialization of late-stage products for systemic lupus and
chronic hepatitis C in a presentation by H. Thomas Watkins, President
and Chief Executive Officer, to financial analysts and investors at the
28th Annual JPMorgan Healthcare Conference in San Francisco.
“Based on the Phase 3 results, BENLYSTA could become the first new
approved drug in more than fifty years for people living with systemic
lupus”
“2010 will be another pivotal year for HGS,” said Mr. Watkins. “In 2009,
we and our partners successfully completed Phase 3 development of
BENLYSTA for systemic lupus and ZALBIN for chronic hepatitis C. In the
fourth quarter of 2009, we submitted a Biologics License Application
(BLA) for ZALBIN in the United States, and Novartis submitted a
Marketing Authorization Application (MAA) under the brand name JOULFERON
in Europe. We and GSK plan to submit marketing applications for BENLYSTA
in the U.S. and Europe in the second quarter of 2010. We have the
potential for regulatory approval of two major products in the U.S.
before the end of this year, both directed to large and growing markets
that represent significant medical need. We greatly strengthened our
cash position in 2009 with two successful public offerings of common
stock. Even with our expected ramp of investment in commercial build-out
and pre-launch manufacturing, we expect to end 2010 with between $840
million and $890 million in cash and investments.”
During his presentation, Mr. Watkins will discuss the following goals
and updates on progress:
LATE-STAGE PRODUCTS
BENLYSTA™: First Drug for Lupus to Succeed in Phase 3 Trials; On
Track for Second Quarter 2010 Submission of U.S. and European Marketing
Applications; Potential U.S. Approval Fourth Quarter 2010
In July and November 2009, HGS and GSK announced that BENLYSTA
(belimumab) met the primary efficacy endpoints in BLISS-52 and BLISS-76
– thus becoming the first drug for lupus to achieve positive results in
Phase 3 trials. BENLYSTA is being developed by HGS and GSK under a
co-development and commercialization agreement entered into in August
2006.
“Based on the Phase 3 results, BENLYSTA could become the first new
approved drug in more than fifty years for people living with systemic
lupus,” said Mr. Watkins. “We and GSK plan to submit marketing
applications in the second quarter of 2010, following discussions with
regulatory authorities in the United States and Europe.”
The data showed that BENLYSTA plus standard of care achieved a
clinically and statistically significant improvement in patient response
rate, compared with placebo plus standard of care. BLISS study results
also showed that belimumab was generally well tolerated, with rates of
overall adverse events and discontinuations due to adverse events
comparable between belimumab and placebo treatment groups.
With nearly 1700 patients participating, the BLISS studies comprise the
largest clinical trial program ever conducted in lupus. In October 2009,
HGS provided a full presentation of BLISS-52 results at the Annual
Scientific Meeting of the American College of Rheumatology. The BLISS-76
study was analyzed after 52 weeks in support of a potential Biologics
License Application (BLA) in the United States and Marketing
Authorization Applications (MAA’s) in Europe and other regions.
Additional data from BLISS-76 will be available in the second quarter of
2010 following completion of the full 76-week study period.
Key goals for BENLYSTA in 2010:
-
Pre-submission meetings with regulators (Q1).
-
Submission of BLA in the U.S. and MAA in Europe (Q2).
-
Top-line 76-week results from BLISS-76 (Q2).
-
Scientific disclosure of BLISS-76 52-week results (Q2).
-
Potential U.S. regulatory approval (Q4).
ZALBIN™: Phase 3 Development Successfully Completed; Marketing
Applications Filed in United States and Europe; Potential Approval
Second Half 2010
HGS submitted a BLA to FDA for ZALBIN (albinterferon alfa-2b) in the
United States in November 2009, and Novartis submitted an MAA under the
brand name JOULFERON® to the EMEA in Europe in December 2009.
Albinterferon alfa-2b is being developed by HGS and Novartis under an
exclusive worldwide co-development and commercialization agreement
entered into in June 2006.
”Assuming licensure by regulatory agencies in the United States, Europe
and other regions, HGS believes ZALBIN could become an important
treatment for chronic hepatitis C,” said Mr. Watkins. “We look forward
to continuing to work closely with Novartis to advance albinterferon
alfa-2b to the market under the brand name ZALBIN in the United States.”
The regulatory submissions include the results of two pivotal Phase 3
clinical trials, known as ACHIEVE 1 and ACHIEVE 2/3, showing that
900-mcg ZALBIN dosed every two weeks met its primary endpoint of
non-inferiority to Pegasys (peginterferon alfa-2a) dosed once each week.
Patients also received oral ribavirin. In both studies, ZALBIN, with
half the injections, achieved sustained virologic response comparable to
that achieved by Pegasys. The rates of serious and/or severe adverse
events were also comparable in these studies. ACHIEVE 1 was conducted in
patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted
in patients with genotypes 2 or 3 virus. The two studies treated a total
of 2255 patients.
ZALBIN will be the brand name for albinterferon alfa-2b in the United
States, and JOULFERON® will be the brand name in the rest of the world.
These brand names will be subject to confirmation by health authorities
at the time of product approval.
Key goals for ZALBIN in 2010:
-
Results of Phase 2b monthly dosing trial (H1)
-
Potential U.S. regulatory approval (H2)
Raxibacumab: $163 Million in Revenue Recognized from First 20,000
Doses Delivered to Strategic National Stockpile; Approximately $151
Million Expected from Second Order for 45,000 Doses to Be Delivered Over
Three Years
In April 2009, HGS completed its first product sales with the delivery
of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile
for emergency use in treating inhalation anthrax. In July 2009, the U.S.
Government exercised its option to purchase an additional 45,000 doses
for the Strategic National Stockpile, to be delivered over a three-year
period. HGS expects to receive approximately $142 million from this
award as deliveries are completed. The first delivery under the second
order, approximately 5600 doses, was completed in November 2009.
Raxibacumab is being developed under a contract entered into in 2006
with the Biomedical Advanced Research and Development Authority (BARDA)
of the Office of the Assistant Secretary for Preparedness and Response
(ASPR), U.S. Department of Health and Human Services (HHS). HGS
submitted a Biologics License Application to the FDA for raxibacumab in
May 2009. The BLA submission included safety and efficacy data published
in the July 9, 2009, edition of The New England Journal of Medicine.
The Company received a Complete Response Letter from FDA in November
2009 and discussions with FDA are planned. HGS will receive $20 million
from the U.S. Government upon FDA licensure of raxibacumab.
Key goals for raxibacumab in 2010:
-
Deliveries to the Stockpile of approximately 15,000 doses in partial
fulfillment of the follow-on order for 45,000 doses over three years,
with payment received as deliveries are made and accepted.
-
Discussions with FDA regarding Complete Response Letter.
GSK Pipeline: Two Phase 3 Trials of Darapladib Now Underway
for Treatment of Cardiovascular Disease; Six Phase 3 Trials of Syncria®
Ongoing for Treatment of Type 2 Diabetes Mellitus
Darapladib for cardiovascular disease.
In December 2009, GSK announced the initiation of its second pivotal
Phase 3 trial to evaluate whether darapladib can reduce the risk of
adverse cardiovascular events such as a heart attack or stroke. This
second Phase 3 trial will enroll and randomize approximately 11,500 men
and women with acute coronary syndrome. GSK initiated its first pivotal
Phase 3 trial of darapladib in December 2008. The first trial completed
enrollment ahead of schedule of approximately 15,000 men and women with
chronic artery 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.