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Author Topic: Lupus drug headed to FDA  (Read 6144 times)
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« on: November 03, 2009, 11:37:57 am »

Lupus drug headed to FDA
HGS to seek approval after higher dose met target in final tests


Tuesday, November 3, 2009


Rockville-based Human Genome Sciences announced Monday that its experimental lupus drug has completed its final round of testing at a higher dose and will be headed to the Food and Drug Administration for approval.

The latest round of studies on the experimental drug Benlysta showed that a sufficient number of lupus patients given a higher dosage of the drug showed improvement after a year, which enabled the drug to meet its target. A lower dosage of the drug did not meet that target.

The next step is to submit the drug to the FDA. If approved, Benlysta could be on the market in late 2010.

"We believe that likelihood of approval is high and that commercial potential is substantial," Barclays Capital analyst Jim Birchenough wrote in a note to investors.

Many industry analysts and lupus experts have questioned whether a new medication for treating the disease would ever come; it has been more than 50 years since a lupus drug has been approved.

HGS would share any profit from the drug with pharmaceutical giant GlaxoSmithKline, a partner that contributed to the drug's development and testing expenses.

"We've got a good chance to redefine the standard of care for patients living with lupus," said H. Thomas Watkins, chief executive of HGS. Lupus, an autoimmune disease, manifests itself differently in every patient, making the development of treatments particularly difficult.

Before July 20, the day HGS revealed that its experimental drug had performed well in a near-final round of testing, the company's shares had been trading at under $3. Ever since, the company's stock has been rising. Monday's announcement sent shares surging again to over $25 in morning trading.

The stock also has risen in recent months as a result of periodic rumors that GlaxoSmithKline will acquire HGS.

Watkins said his company is "no small start-up" and, therefore, doesn't need to be bought out by a larger firm in order to bring its lupus drug to the market. "HGS has the wherewithal to fully realize this opportunity as an independent company," he said. "Our business plans call for us to go forward as an independent company."

Benlysta attempts to control the actions of a protein that becomes overactive in lupus patients. In test results, 43.2 percent of patients responded to the drug at the higher dose and 40.6 percent responded at the lower dose. That compares with a placebo response rate of 33.8 percent.

Analyst Joseph P. Schwartz, of Leerink Swann, reiterated his "outperform" rating on HGS stock, and wrote that the test results "provide us with increased confidence in Benlysta's approvability and uptake."

The Lupus Foundation of America estimates that about 1.5 million Americans have some form of the disease, which has typically been treated with chemotherapy and steroids.

"Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease," Sandra C. Raymond, the organization's president and chief executive, said in a statement. "We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires."

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« Reply #1 on: October 28, 2010, 12:34:55 pm »

Here we are a year later...
watch video...
FDA approved it since this post was made! WHoo Hoo!

http://www.youtube.com/watch?v=t0yxEupJPjA&feature=share


Lupus drug headed to FDA
HGS to seek approval after higher dose met target in final tests


Tuesday, November 3, 2009


Rockville-based Human Genome Sciences announced Monday that its experimental lupus drug has completed its final round of testing at a higher dose and will be headed to the Food and Drug Administration for approval.

The latest round of studies on the experimental drug Benlysta showed that a sufficient number of lupus patients given a higher dosage of the drug showed improvement after a year, which enabled the drug to meet its target. A lower dosage of the drug did not meet that target.

The next step is to submit the drug to the FDA. If approved, Benlysta could be on the market in late 2010.

"We believe that likelihood of approval is high and that commercial potential is substantial," Barclays Capital analyst Jim Birchenough wrote in a note to investors.

Many industry analysts and lupus experts have questioned whether a new medication for treating the disease would ever come; it has been more than 50 years since a lupus drug has been approved.

HGS would share any profit from the drug with pharmaceutical giant GlaxoSmithKline, a partner that contributed to the drug's development and testing expenses.

"We've got a good chance to redefine the standard of care for patients living with lupus," said H. Thomas Watkins, chief executive of HGS. Lupus, an autoimmune disease, manifests itself differently in every patient, making the development of treatments particularly difficult.

Before July 20, the day HGS revealed that its experimental drug had performed well in a near-final round of testing, the company's shares had been trading at under $3. Ever since, the company's stock has been rising. Monday's announcement sent shares surging again to over $25 in morning trading.

The stock also has risen in recent months as a result of periodic rumors that GlaxoSmithKline will acquire HGS.

Watkins said his company is "no small start-up" and, therefore, doesn't need to be bought out by a larger firm in order to bring its lupus drug to the market. "HGS has the wherewithal to fully realize this opportunity as an independent company," he said. "Our business plans call for us to go forward as an independent company."

Benlysta attempts to control the actions of a protein that becomes overactive in lupus patients. In test results, 43.2 percent of patients responded to the drug at the higher dose and 40.6 percent responded at the lower dose. That compares with a placebo response rate of 33.8 percent.

Analyst Joseph P. Schwartz, of Leerink Swann, reiterated his "outperform" rating on HGS stock, and wrote that the test results "provide us with increased confidence in Benlysta's approvability and uptake."

The Lupus Foundation of America estimates that about 1.5 million Americans have some form of the disease, which has typically been treated with chemotherapy and steroids.

"Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease," Sandra C. Raymond, the organization's president and chief executive, said in a statement. "We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires."


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I look normal, as I have an "Invisible Illness". You can not catch it, you can not see it. It's called Lupus.My body is attacking itself on the inside.
www.LupusMCTD.com Represents:
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2) Where HOPE is a WORK In Progress
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« Reply #2 on: October 28, 2010, 01:15:41 pm »

http://www.hgsi.com/benlysta-belimumab-3.html
The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010
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I look normal, as I have an "Invisible Illness". You can not catch it, you can not see it. It's called Lupus.My body is attacking itself on the inside.
www.LupusMCTD.com Represents:
1) We are patients helping researchers build a future for the lives of others...
2) Where HOPE is a WORK In Progress
3) Pay It Forward~Giving Back To The Future Lupus/MCTD Patients
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« Reply #3 on: November 16, 2010, 04:21:29 pm »

FDA Briefing Package

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM233579.pdf

« Last Edit: November 16, 2010, 04:23:29 pm by Adminஐﻬ » Logged


I look normal, as I have an "Invisible Illness". You can not catch it, you can not see it. It's called Lupus.My body is attacking itself on the inside.
www.LupusMCTD.com Represents:
1) We are patients helping researchers build a future for the lives of others...
2) Where HOPE is a WORK In Progress
3) Pay It Forward~Giving Back To The Future Lupus/MCTD Patients
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« Reply #4 on: April 15, 2011, 08:16:02 am »

Human Genome Sciences Updates Investors on Progress of Benlysta Launch and Future Priorities
U.S. launch of BENLYSTA for systemic lupus off to a good start; launch preparations in Europe on track
HGS expects to reach profitability in 2013


Apr 14, 2011 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today will report on the progress of its U.S. launch of BENLYSTA® (belimumab) and outline future strategic priorities at a meeting of financial analysts and investors in New York. (A webcast of today's HGS Analyst and Investor Meeting may be accessed at www.hgsi.com, beginning at 1:00 PM Eastern time.)

“The FDA's approval of BENLYSTA as the first new drug for systemic lupus in more than fifty years opens the door to a promising future for Human Genome Sciences,” said H. Thomas Watkins, President and Chief Executive Officer. “Our U.S. launch of BENLYSTA is off to a good start, our preparations for a European launch are on track, and our collaboration with GlaxoSmithKline is going well. HGS now expects to reach profitability in 2013.”

Mr. Watkins said that, as the Company moves forward, HGS has three over-arching strategic priorities: first, the successful global commercialization of BENLYSTA; second, achieving the full therapeutic and commercial potential of BENLYSTA through further development in SLE and other B-cell mediated diseases; and third, continuing to strengthen the HGS product pipeline.

2011 Financial Guidance

As previously indicated, HGS expects cash and investments at year-end 2011 to total between $550 million and $650 million. Cash and investments were $933.4 million at year-end 2010.

At today's Analyst and Investor Meeting, HGS said that it expects SG&A and R&D expense for 2011 to total between $330 million and $390 million. The anticipated SG&A increase to between $150 million and $170 million will primarily reflect the full-year impact of the U.S. commercial expansion begun in 2010, as well as continued growth of the HGS organization in Europe. The Company expects R&D spending for the year to total in the range of between $180 million and $220 million.

HGS Analyst and Investor Meeting Webcast

The presentations at the HGS Analyst and Investor Meeting today in New York will be webcast starting at 1:00 PM Eastern time and may be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the presentations begin in order to download any software required. The archive of the presentations will be available for several days following the meeting.

About Human Genome Sciences

Human Genome Sciences exists to place new therapies into the hands of those battling serious disease.

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 and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

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 and regulatory approvals, 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 Contacts:
Susannah Budington
Director, Corporate Public Relations
301-545-1062
or
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
or
Investor Contacts:
Claudine Prowse, Ph.D.
Executive Director, Investor Relations
301-315-1785
or
Peter Vozzo
Senior Director, Investor Relations
301-251-6003
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I look normal, as I have an "Invisible Illness". You can not catch it, you can not see it. It's called Lupus.My body is attacking itself on the inside.
www.LupusMCTD.com Represents:
1) We are patients helping researchers build a future for the lives of others...
2) Where HOPE is a WORK In Progress
3) Pay It Forward~Giving Back To The Future Lupus/MCTD Patients
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