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Shorted this today at $25.48. Details: http://shortscreen.com/message-board/85-new-short-hgsi-human-genome-sciences-inc-hgsi
http://www.otcstockreview.com/cpbm.htm
Cyplasin Biomedical Ltd. (OTCBB: CPBM)Human Genome Sciences (NASDAQ: HGSI)Idenix Pharmaceuticals (NASDAQ: IDIX)Intermune (NASDAQ: ITMN)Schering-Plough (NYSE: SGP)ViroPharma (NASDAQ: VPHM)Vertex Pharmaceuticals (NASDAQ: VRTX)
Human Genome HGSI RBC Capital Mkts started with an Outperform & $38 target
I was in and out for a double ! .48 to .98~~ LOL ! I WANT TO COMMIT SUICIDE !
are you still in this? that would be sick. way to go
All is not lost check out cpbm, you can find last weeks news release on Yahoo, great potential and a chance to get in early.
GLTA
This is one that my broker told me to hold onto and said he thought it would go to $30
and of course, I didn't believe him and sold way too early :(
I know. I was remembering when HGSI was .50
check out HNAB as a recovery play here
.Human Genome Sciences Reports Increasing Momentum toward Commercialization and Announces 2010 Goals at JPMorgan Healthcare Conference
- Marketing applications planned for BENLYSTA™ in U.S. and Europe in second quarter 2010; potential U.S. approval in fourth quarter 2010 -
- Marketing applications submitted in fourth quarter 2009 for ZALBIN™/JOULFERON® in U.S. and Europe; potential U.S. approval in late 2010 -
- HGS provides financial guidance: expects 2010 net cash burn of $300-350 million and year-end 2010 cash position of $840-890 million -
Buzz up! 0 Print..Companies:Human Genome Sciences Inc..Related Quotes
Symbol Price Change
HGSI 30.82 0.00
{"s" : "hgsi","k" : "c10,l10,p20,t10","o" : "","j" : ""} Press Release Source: Human Genome Sciences, Inc. On Monday January 11, 2010, 7:16 am
ROCKVILLE, Md.--(BUSINESS WIRE)--Human Genome Sciences, Inc. (Nasdaq: HGSI - News) 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.
“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.
Syncria® (albiglutide) for type 2 diabetes mellitus. In February 2009, GSK announced the initiation of a Phase 3 program to evaluate the efficacy, safety and tolerability of Syncria in the long-term treatment of type 2 diabetes mellitus. Six Phase 3 trials of Syncria are currently ongoing with the objective to demonstrate durable efficacy and cardiovascular safety of Syncria as mono- and add-on therapy. Syncria is a biological product generated from the fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood-sugar levels and to control appetite. Syncria was created by HGS using its proprietary albumin-fusion technology, and the product 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 million received to date – in addition to single-digit royalties on worldwide sales if Syncria is commercialized.
ONCOLOGY PROGRAM: TRAIL PATHWAY OFFERS THERAPEUTIC OPPORTUNITIES ACROSS BROAD RANGE OF CANCERS
Mapatumumab (HGS-ETR1), the Company’s human monoclonal antibody to TRAIL receptor 1, is the most advanced of any product in development that targets the TRAIL apoptosis pathway. Three randomized Phase 2 chemotherapy combination trials are currently underway to evaluate mapatumumab’s potential in the treatment of advanced multiple myeloma, non-small cell lung cancer, and hepatocellular cancer. HGS is investing strategically to expand and advance its oncology portfolio around its expertise in the apoptosis, or programmed cell death, pathway.
In November 2009, HGS and Aegera Therapeutics announced the initiation of a Phase 1 trial of HGS’ lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors. The study’s primary objectives include evaluation of safety and tolerability, and dose selection for Phase 2 trials. HGS1029 as monotherapy is also being studied in an ongoing Phase 1 study initiated in 2008 in patients with advanced solid tumors. The IAP inhibitors are a novel class of compounds that block the activity of IAP (inhibitor of apoptosis) proteins, 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. HGS plans to continue the study of HGS1029 both alone and in combination with other anti-cancer agents, including mapatumumab.
Key goals for the oncology program in 2010:
•Results of randomized trial of mapatumumab with carboplatin and paclitaxel for first-line treatment of advanced non-small cell lung cancer (Q1).
•Time-to-progression data from randomized trial of mapatumumab with bortezomib in advanced multiple myeloma (mid-2010).
•Initiation of randomization stage in trial of mapatumumab with sorafenib in hepatocellular cancer (in 2010).
•Phase 1 trials of HGS1029 ongoing in advanced solid tumors and lymphoid tumors.
•Initiation of trials of HGS1029 in combination with mapatumumab and other agents.
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 2009 and 2010.
•HGS expects cash and investments at year-end 2009 to total approximately $1.19 billion, compared with approximately $373 million at the end of 2008.
•This includes approximately $813 million in net proceeds from two public offerings of HGSI common stock completed in August and December 2009.
•In 2010, HGS expects:
•net cash burn to be between $300 million and $350 million;
•cash and investments at year-end to total $840-890 million;
•revenues of at least $150 million.
These figures do not include potential ZALBIN approval milestone payments.
“From a financial perspective, 2009 was another strong year for HGS,” said Mr. Watkins. “Our financial performance substantially exceeded the guidance we provided in January 2009, both for net cash burn and year-end cash. We expect year-end 2009 cash and investments to total approximately $1.2 billion.”
Presentation to Be Webcast
Mr. Watkins’ presentation to the 28th Annual JPMorgan Healthcare Conference will be webcast and may be accessed at www.hgsi.com. The presentation is scheduled to begin on January 11, 2010, at 10:00 AM Pacific or 1 PM 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 lupus, hepatitis C, inhalation anthrax and cancer.
The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA™ (belimumab) for lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. Phase 3 development has been completed successfully for both BENLYSTA and Zalbin. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the second quarter of 2010. A BLA has been submitted for ZALBIN to the FDA in the United States, and an MAA has been submitted under the brand name JOULFERON® to the EMEA in Europe.
In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the Stockpile over a three-year period beginning near the end of 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax.
The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of inhibitor-of-apoptosis proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.
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 medinfo@hgsi.com or by calling HGS at (877) 822-8472 (877) 822-8472.
Non-GAAP Financial Measures
Net cash burn is a non-GAAP financial measure that may be considered in addition to results prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flows that either excludes or includes amounts that are not normally included or excluded in the most directly comparable measure calculated and presented in accordance with GAAP. We define “net cash burn” as net loss, plus non-cash expenses, such as stock-based compensation, depreciation and other non-cash charges, and minus deferred revenue and capital expenditures. This non-GAAP measure should not be considered a substitute for, or superior to, GAAP results. The Company believes that net cash burn is relevant and useful information for the Company and our investors as it provides a simple method of determining net cash used by the Company. Net cash burn is also a measure used by our management, including our chief executive officer, who is our chief operating decision maker, in evaluating the performance of our business. Net cash burn, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies necessarily calculate net cash burn in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies. Due to the forward-looking nature of the net cash burn figures for 2010, a reconciliation of net cash burn to net loss cannot be made without unreasonable efforts.
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 Human Genome Sciences’ unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, Human Genome Sciences’ 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, Human Genome Sciences’ 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 SEC. 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.
Contact:
Human Genome Sciences, Inc.Media:Jerry Parrott, 301-315-2777 301-315-2777Vice President, Corporate CommunicationsorInvestors:Peter Vozzo, 301-251-6003 301-251-6003Senior Director, Investor Relations
Merry Christmas....Hope everyone has a Wonderful and safe Holiday
Are you any good with bios? how the hell can you detect a monster before it runs.
(i look back at HGSI and stratch my nuts, and saw to myself this bio has 3 drugs, each in phase 3, each has the potential to be a blockbuster hit, but i didnt buy the damn thing.)
Wow! $29.67! who would have thought?
but bios are soaring now! ANTHX was up huge yesterday!
Shit, ive owned all the bad boys over the years CEMJQ at .039 hit 1.48, APWR at 3.50 hit 20 bucks, ATSG at .27 hit 4, GSAT at .50 hit 2 too freaking bad I didn't do this shit right or else i'd be a millionaire, where is that rope at cause I need it!
What stock might that be?
Nice, Im in a similiar situation with another stock right now..think it could be the next hgsi :)
Check out the news around July........July 20th was the explosion. It worked its way up from .60. It closed Friday the 17th around $3.30......opened around ten I think on the 20th...
http://www.hgsi.com/quarterly-results/2.html
wow! you lucky @#$%! :) wtg man
Hey HGSI people. i have a question for the longs. when did this start running from .60 to multi dollars? what event caused this? was it the partnership and was the partnership announced before/during or after phase 3? tia
Human Genome Sciences increases stock offering
Human Genome Sciences says it expects to raise $397M after boosting size of stock offering
On 2:40 pm EST, Thursday December 3, 2009
Companies:Human Genome Sciences Inc.
ROCKVILLE, Md. (AP) -- Human Genome Sciences Inc. expanded the size of a planned stock offering Thursday, and said it expects to raise $397 million from the sale.
The company priced a sale of 15.5 million shares of stock at $26.75 per share, and said the underwriters of its offering will have the option to buy another 2.3 million shares if demand exceeds initial supply. Human Genome Sciences on Monday had said it would sell up to 14.4 million shares, including potential over-allotments.
The company plans to use proceeds from the sale to fund development of its lupus drug candidate Benlysta, including researching potential other uses for the product, among other purposes.
In afternoon trading, the stock rose $1.15, or 4.2 percent, to $28.61.
Human Genome Sciences had 165 million shares on the market at the end of the third quarter. If it sells all 17.8 million shares by the time the offering closes on Tuesday, that will increase its share count by 10.8 percent.
Hope they do it for AMGN stock.
Just a little worried about that gap in the chart.
December 3, 2009, 9:58 AM ET Human Genome Sciences Shows Public Offerings Work, Too
Article Comments Health Blog
By Jacob Goldstein
With big pharma eager to throw hundreds of millions of dollars at companies with promising experimental drugs, it’s easy to forget that there’s another route for up-and-coming drug makers: Selling shares to the public.
We were reminded of this fact by Human Genome Sciences, which said that a public offering expected to close next week will bring the company nearly $400 million. That’s on top of more than $350 million the company made in an August offering.
Of course, the markets aren’t throwing money at just anyone these days. Human Genome has several promising drugs in advanced stages of development, including a lupus drug called Benlysta. Lupus, an autoimmune disorder, has proved very tough to treat, so a new drug could be a big deal.
And that tendency of big drug makers to buy their way into new drugs could also be fueling investors’ interest in the company; there’s been some speculation that GlaxoSmithKline, which partners with Human Genome on Benlysta, could swoop in to buy the company outright.
Here is the link....
http://blogs.wsj.com/health/2009/12/03/human-genome-sciences-shows-public-offerings-work-too/?mod=msn_money_ticker
News report today / Amgen "interested" in HGSI. Think this is causing the sweet spike today.
Thanks for the chart loridans.......last Friday I liked the low 27's and picked some up....
7:03AM Human Genome receives complete response letter from FDA for Raxibacumab biologics license application (HGSI) 27.89 : Co announces it has received a Complete Response Letter from the FDA relating to the Company's Biologics License Application requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA. "We have responded to all of FDA's previous questions. We plan to address the current questions as well, In certain respects, the Complete Response Letter appears to be inconsistent with the FDA's published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible... It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA."
Wow King Kong huge. This dwarfs vrml. The next stock to do this will be hdvy. I cannot belive this monster is still on the rampage.
Iagree, just like last time around, HGSI pps kept creeping upwards where it finally settled in the 18-20 range.
LOL......and I don't think we're done yet. I still think we see $34
and here I'm crying about selling @ $25 from $19
if I had @ $2, I'd be looking for a rope lol
i had 100 grand in at 2.50 and sold just before it hit the sky.
I'd have 800 freakin grand if i held. shit.
yeah, i owned a whole bunch at 1.50 as well. Didn't see this train coming.
bobnagor-Oh-FETTUCINE / Shouldn't have sold at .96 ! LOL ~ BE WORTH $100 Grand Now ~ Ooooopppppsssss ~~~
lol...nope !
You in on this one too? LOL
Human Genome Sciences and GlaxoSmithKline Announce Positive Results in Second of Two Phase 3 Trials of BENLYSTA(TM) in Systemic Lupus Erythematosus
Nov 2, 2009 7:00:00 AM
Copyright Business Wire 2009
Email Story Discuss on ZenoBank
View Additional Profiles
- BENLYSTA (belimumab) 10 mg/kg plus standard of care met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo plus standard of care at Week 52 in BLISS-76 -
- Primary efficacy endpoint met in two pivotal Phase 3 trials, as specified by Special Protocol Assessment agreement with FDA -
ROCKVILLE, Md. & LONDON--(BUSINESS WIRE)-- Human Genome Sciences, Inc. (Nasdaq:HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.
"The BLISS-76 results confirm our view that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We take great pride in the innovation and scientific rigor that has made it possible to bring BENLYSTA to this point. We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the United States, Europe and other regions. We will continue to work with GSK to advance this drug to the market where it may benefit patients with significant need."
Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, "The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in fifty years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients."
The data from the BLISS-76 study were analyzed after 52 weeks, in accord with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. However, the BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
Key Findings from BLISS-76
"We are delighted that the efficacy of treatment with belimumab plus standard of care was superior to placebo plus standard of care in both BLISS-52 and BLISS-76, with overall adverse event rates comparable to placebo plus standard of care," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Belimumab met the primary endpoint in both pivotal Phase 3 trials, as specified by the Special Protocol Assessment Agreement with FDA. We look forward to the full presentation of the BLISS-76 52-week results at an appropriate scientific meeting, hopefully in the first half of 2010."
Topline BLISS-76 results include:
-- Based on an intention-to-treat (ITT) analysis, belimumab 10 mg/kg met
its primary efficacy endpoint of superiority versus placebo at Week 52.
A statistically significant improvement was shown in patient response
rate for belimumab 10 mg/kg plus standard of care, vs. placebo plus
standard of care, as measured by the SLE Responder Index at Week 52:
43.2% for 10 mg/kg belimumab, 40.6% for 1 mg/kg belimumab, and 33.8% for
placebo (p=0.021 and p=0.10 for 10 mg/kg and 1 mg/kg belimumab,
respectively vs. placebo). The 1 mg/kg dose plus standard of care did
not achieve statistically significant improvement in the current study.
The SLE Responder Index defines patient response as an improvement in
SELENA SLEDAI score of 4 points or greater, with no clinically
significant BILAG worsening and no clinically significant worsening in
Physician's Global Assessment.
-- Results for prespecified major secondary efficacy endpoints were:
o The proportion of patients with a reduction in SELENA SLEDAI score of
at least 4 points by Week 52, was 46.9% for belimumab 10 mg/kg, 42.8%
for belimumab 1 mg/kg, and 35.6% for placebo (p=0.0062 and p=0.087 for
belimumab 10 mg/kg and 1 mg/kg, respectively vs. placebo).
o Improvement from baseline in Physician's Global Assessment (PGA) at
Week 24 was not statistically different between the belimumab and
placebo treatment groups. Mean improvement in PGA at Week 52, a
prespecified although not a major secondary endpoint, was 0.49 for
belimumab 10 mg/kg, 0.55 for belimumab 1 mg/kg, and 0.46 for placebo
(p=0.12 for belimumab 10 mg/kg and p=0.022 for 1 mg/kg, respectively
vs. placebo).
o At entry into the BLISS-76 study, approximately 46% of patients were
receiving steroids at a prednisone-equivalent dose of at least 7.5 mg
per day. Among these patients, the percentage of patients who had
their average steroid dose reduced by at least 25% from baseline to
7.5 mg per day or less during the last 12 weeks of study was 16.7% for
belimumab 10 mg/kg, 19.2% for belimumab 1 mg/kg, and 12.7% for placebo
(not statistically significant vs. placebo).
o Improvement in health-related quality of life at Week 24 as measured
by the SF-36 Physical Component Summary (PCS) score was not
significantly different among treatment groups. Mean improvement in
the SF-36 PCS score at Week 52, a prespecified although not a major
secondary endpoint, was 3.41 for belimumab 10 mg/kg, 4.37 for
belimumab 1 mg/kg, and 2.85 for placebo (p=0.51 for belimumab 10 mg/kg
and p=0.012 for 1 mg/kg, respectively vs. placebo).
-- In BLISS-76, belimumab was generally well tolerated, with rates of
overall adverse events, serious and/or severe adverse events, all
infections, serious and/or severe infections, and discontinuations due
to adverse events comparable between treatment groups receiving
belimumab plus standard of care and the treatment group receiving
placebo plus standard of care. Serious and/or severe adverse events were
reported in 26.8% of patients on belimumab and 24.0% of patients on
placebo. Infections were reported in 72.1% of patients on belimumab and
67.3% of patients on placebo. Serious and/or severe infections were
reported in 7.2% of patients on belimumab and 8.0% of patients on
placebo. Serious and/or severe infusion reactions were reported in 1.1%
of patients on belimumab and 0.7% of patients on placebo.
Discontinuations due to adverse events were 7.2% in the belimumab
treatment groups and 7.6% in the placebo treatment group. Malignancies
were reported by 2, 3, and 1 subjects in the belimumab 10 mg/kg,
belimumab 1 mg/kg and placebo groups, respectively. There were three
deaths in the study, with 1, 2, and 0 reported in the belimumab 10
mg/kg, belimumab 1 mg/kg and placebo groups, respectively.
"The lupus community has waited for decades for one positive Phase 3 trial of an investigative drug developed for lupus. Now we have two. Based on the data we now have in hand, we have cause for hope that belimumab may emerge as a significant new treatment for lupus," said Joan T. Merrill, M.D., a study investigator, Program Chair, Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, and Professor, Department of Medicine, University of Oklahoma Health Sciences Center.
About the Belimumab Phase 3 Development Program
The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in seropositive (HEp-2 ANA >= 1:80 and/or anti-dsDNA >= 30 IU/mL) patients with SLE. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 randomized and treated 819 patients at 136 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. Data from BLISS-76 were analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.
The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52 as measured by the SLE Responder Index, which is defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which indicates a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.
In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290; BLISS-76, n=273), 1 mg/kg belimumab (BLISS-52, n=288; BLISS-76, n=271), or placebo (BLISS-52, n=287; BLISS-76, n=275). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All patients receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.
About Belimumab
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, suggest that belimumab can reduce SLE disease activity.
About the HGS/GSK Collaboration
In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. No new drug for lupus has been approved by regulatory authorities in more than 50 years. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.
Conference Call
HGS management will hold a conference call to discuss this announcement today at 8:15 AM Eastern. Investors may listen to the call by dialing 800-753-9057 or 913-312-0718, passcode 9331404, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 9331404. Today's conference call also will be webcast and can be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.
About GlaxoSmithKline
GlaxoSmithKline's collaboration with HGS is led by its GSK Biopharm R&D division, which employs novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease. This innovative research is one way GSK - one of the world's leading research-based pharmaceutical and healthcare companies - can deliver on its commitment to improve the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
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 lupus, hepatitis C, inhalation anthrax and cancer.
The Company's primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA(TM) (belimumab) for lupus and ZALBIN(TM) (albinterferon alfa-2b) for hepatitis C. BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in systemic lupus erythematosus, and the submission of marketing applications in the U.S., Europe and other regions is planned in the first half of 2010. ZALBIN has completed Phase 3 development, and the submission of global marketing applications is planned in fourth quarter 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria(R) (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.
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 medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS 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 Human Genome Sciences' unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, Human Genome Sciences' 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, Human Genome Sciences' 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 SEC. 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.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US 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 GSK's Annual Report on Form 20-F for 2008.
Source: Human Genome Sciences, Inc.
----------------------------------------------
HGS CONTACTS:
Media
Jerry Parrott
Vice President
301-315-2777
Corporate Communications
or
Investors
Peter Vozzo
301-251-6003
Senior Director
Investor Relations
or
GSK CONTACTS:
U.K. Media Inquiries --
Philip Thomson
(020) 8047-5502
Gwenan White
(020) 8047-5502
Claire Brough
(020) 8047-5502
Stephen Rea
(020) 8047-5502
or
U.S. Media Inquiries --
Holly Russell
919-483-2839
Mary Anne Rhyne
919-483-2839
or
European Analyst/Investor Inquiries -
David Mawdsley
(020) 8047-5564
Sally Ferguson
(020) 8047-5543
Gary Davies
(020) 8047-5503
or
U.S. Analyst/Investor Inquiries -
Tom Curry
215-751-5419
Jen Hill Baxter
215-751-7002
We should be seeing some really nice green soon IMO :)
positive results announced.the lupus drug works faster than first thought.
Human Genome Sciences Announces $75 Million Milestone Payment for ZALBIN(TM) Progress
Oct 19, 2009 7:00:00 AM
Copyright Business Wire 2009
View Additional Profiles- Two pivotal Phase 3 clinical trials completed successfully in patients with chronic hepatitis C -
- Regulatory submissions planned for fourth quarter 2009 -
ROCKVILLE, Md.--(BUSINESS WIRE)-- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has earned a $75 million milestone payment from Novartis, related to successful completion of the Phase 3 development program and the decision to submit applications seeking regulatory approval to market ZALBIN(TM) (albinterferon alfa-2b) for the treatment of chronic hepatitis C.
HGS and Novartis have completed pre-submission meetings with the FDA and European regulatory agencies, and plan to submit marketing authorization applications for albinterferon alfa-2b, an investigational treatment for chronic hepatitis C, in the fourth quarter of 2009. HGS and Novartis have selected ZALBIN as the brand name for albinterferon-alfa 2b (formerly Albuferon(R)) in the United States. JOULFERON(R) has been selected as 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.
"We are pleased with the progress of this program and look forward to continuing to work closely with Novartis to advance ZALBIN to the market," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Submission of global marketing authorization applications for ZALBIN and JOULFERON is planned for later this quarter. Assuming licensure by the FDA and other regulatory agencies, HGS believes ZALBIN could become a market-leading treatment for chronic hepatitis C."
About the Collaboration with Novartis
Under an exclusive worldwide co-development and commercialization agreement entered into in 2006, HGS and Novartis will co-commercialize albinterferon alfa-2b in the United States under the brand name ZALBIN(TM), and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization of albinterferon alfa-2b in the rest of the world under the brand name JOULFERON(R), and will pay HGS a royalty on those sales. HGS has primary responsibility for the bulk manufacture of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $132.5 million received previously and a $75 million payment expected in fourth quarter 2009. The remaining payments to HGS under the agreement relate to the achievement of certain regulatory approval and commercial milestones.
About ZALBIN (albinterferon alfa-2b)
ZALBIN (also known as JOULFERON) is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins.
ZALBIN dosed once every two weeks has completed Phase 3 development. In April 2009, positive Phase 3 results of ZALBIN in patients with chronic hepatitis C were presented at the 44th annual meeting of the European Association for the Study of the Liver in Copenhagen. Data from two pivotal Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, showed that ZALBIN met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a). With half the injections, ZALBIN achieved a rate of sustained virologic response comparable to Pegasys in these studies; rates of serious and/or severe adverse events were also comparable.
In addition, Novartis is currently conducting a Phase 2b trial to evaluate ZALBIN/JOULFERON dosed once every four weeks.
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 and cancer.
The Company's primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA(TM) (belimumab) for lupus and ZALBIN(TM) (albinterferon alfa-2b) for hepatitis C. BENLYSTA has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus erythematosus, and results of the second BENLYSTA Phase 3 trial are expected in November 2009. ZALBIN has now completed Phase 3 development, and the submission of global marketing applications is expected in fourth quarter 2009.
In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. In July 2009, the Company secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the U.S. Strategic National Stockpile over a three-year period, beginning near the end of 2009. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody HGS-ETR1 (mapatumumab) 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 pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria(R) (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.
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 medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences, Albuferon, BENLYSTA, and ZALBIN 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 Human Genome Sciences' unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, Human Genome Sciences' 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, Human Genome Sciences' 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 SEC. 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.
----------------------------------------------
Human Genome Sciences
Inc.
Media:
Jerry Parrott
Vice President
Corporate Communications
301-315-2777
or
Investors:
Peter Vozzo
Senior Director
Investor Relations
301-251-6003
results on Monday, Nov. 2nd ?
we are in play again should see 22.00 by end of next week
let me know if you think you find something
HGSI news after hours today:
Human Genome Sciences to Host November 2nd Conference Call to Discuss Top-Line Results from Second Phase 3 Trial of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus
* Press Release
* Source: Human Genome Sciences, Inc.
* On 4:05 pm EDT, Thursday October 15, 2009
ROCKVILLE, Md.--(BUSINESS WIRE)--Human Genome Sciences, Inc. (Nasdaq:HGSI - News) today announced that it expects to have top-line 52-week results available on Monday, November 2nd, from BLISS-76, the second of two pivotal Phase 3 clinical trials of BENLYSTA™ (belimumab) in systemic lupus erythematosus (SLE).
Senior management will host a conference call to discuss the results on November 2, 2009 at 8:15 AM Eastern. The BLISS-76 data will later be submitted for full presentation at an appropriate scientific meeting.
Investors may listen to the call by dialing 800-753-9057 or 913-312-0718, passcode 9331404, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 9331404.
This conference call also will be webcast and may be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. The archive of the conference call will remain available for several days.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
HGS, Human Genome Sciences, and BENLYSTA are trademarks of Human Genome Sciences, Inc.
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July 20, 2009 3:31 PM ET
Human Genome Sciences (NASDAQ:HGSI) is a biopharmaceutical company with a pipeline of novel protein and antibody drugs directed toward large markets that have significant unmet medical need.
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HUMAN GENOME SCIENCES AND NOVOZYMES ANNOUNCE AMENDMENT TO ALBUMIN FUSION LICENSE AGREEMENT |
Rockville, Maryland and Nottingham, UK - May 7, 2009 - Human Genome Sciences, Inc. (NASDAQ: HGSI) and Novozymes Biopharma, a part of Novozymes (NASDAQ: NZYM B), today announced that they have amended an existing license agreement to allow both companies to expand application of their proprietary albumin fusion technology. Under the amended agreement, HGS and Novozymes each has the opportunity to exclusively license and/or sublicense a number of albumin fusion proteins in exchange for royalties and other consideration. No existing HGS or Novozymes products or product rights, including rights licensed to other companies, are affected by these amendments. Financial or other terms of the agreement were not disclosed. "Genetic fusion of therapeutic proteins to albumin can improve the pharmacology of the proteins, resulting in important benefits to patients," said Barry A. Labinger, Executive Vice President and Chief Commercial Officer, HGS. "For example, with certain therapeutic proteins, albumin fusion may make it possible to dose less frequently and reduce side effects associated with injections. We are pleased to work with Novozymes to broaden the application of albumin fusion technology to new classes of proteins and peptides." Thomas Videbæk, Executive Vice President, Novozymes, said, "We are delighted to expand this license agreement with HGS. We license both the fusion protein and the yeast expression systems, which have been optimised for producing albumin fusion proteins as the solution that provides an efficacious half-life in patients. Our strength lies in the fact that we focus on solutions and that is why Novozymes is an ideal partner for the pharmaceutical industry. This enables Novozymes to continue to further develop albufuse®, our proprietary albumin fusion technology, and advance our existing and new partnerships." 5/21/2009Human Genome Reports Positive Results For Long-Term Phase 2 Continuation Trial Of Benlysta In SLE Patients - Update Human Genome Sciences Reveals Positive Trial Results Of Lupus Drug, Shares Up - Update Human Genome Sciences Reveals Positive Long-Term Data For BENLYSTA In Patients With Active Systemic Lupus Erythematosus - Quick Facts Human Genome Sciences - Racing To Cure Lupus Human Genome Sciences Submits Biologics License Application For ABthrax To FDA - (RTTNews) - Thursday, (5-21-09) biotechnology company Human Genome Sciences, Inc. (HGSI: News ) announced the submission of a Biologics License Application or BLA with the U.S. Food and Drug Administration or FDA related to human monoclonal antibody drug Abthrax for the treatment of inhalation anthrax. Anthrax infection is caused by a spore-forming bacterium, Bacillus anthracis, which multiplies in the body and produces lethal toxins. The Rockville, Maryland-based company said the BLA was submitted on the results of the efficacy tests of raxibacumab carried out on rabbits and monkeys. The results exhibited a survival benefit in both rabbits and monkeys, which is needed for launching the efficacy of new drugs used to counter bioterrorism. The submission also includes the results of safety studies of raxibacumab conducted in healthy human volunteers. Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority or BARDA. In the first quarter of 2009, under the BARDA contract, HGS achieved its first product sales by initiating the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for emergency use in the treatment of inhalation anthrax. HGS said it generated revenue of $153.8 million in raxibacumab in the first quarter, including $127.8 million in product sales. The company has now completed delivery and expects to recognize at least $8.0 million in additional raxibacumab revenue in the second quarter of 2009. Commenting on the submission, HGS' senior vice president, development and regulatory affairs, Sally Bolmer said, "Based on the results of our efficacy and safety studies, we believe raxibacumab has the potential to be an important new treatment for inhalation anthrax. In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our company."
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Human Genome Sciences to Host July 20 Conference Call to Discuss Top-Line Phase 3 Results for Benlysta(TM) (Formerly Lymphostat-B(R)) in Systemic Lupus ErythematosusJuly 1, 2009 7:00 AM ET All PR Newswire news ROCKVILLE, Maryland, July 1 /PRNewswire-USNewswire/ -- Human Genome Sciences, Inc. HGSI today announced that it expects to have top-line results available on Monday, July 20, from BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) in systemic lupus erythematosus (SLE). |
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