Human Genome Sciences Gains FDA Recommendation for Benlysta. Shares Soar 10% in Afterhours Trading

Image representing Human Genome Sciences as de...

Good news today for Human Genome Sciences and those who suffer from Lupus.  FDA voted in favor of Benlysta with a strong vote of 13-2.  Although the FDA doesn't always approve drugs that are recommended by the panel, many times they do, and more so with an Approval Recommendation than without one.  Shares of Human Genome Sciences were up 10.51% to 28.60 in afterhours trading. 

Trading was halted throughout the day and will resume normal trading tomorrow.  I expect a strong day tomorrow and it should be watched closely tomorrow.  It's partner Glaxo SmithKline was trading slightly higher at 39.45 +0.91 a 2.36% gain.  This is really good news for investors who have watched HGSI drop from a high of  30.18 in September to a low of 23.60 this past Friday from a Doctor scandal, a CRL for Zalbin, and safety concerns from their Phase III clinical trial results for Benlysta. 

It did report positive 3Q 2010 results in the following press release,  Human Genome Sciences Announces Third Quarter 2010 Financial Results and Key Developments.  I see HGSI stock to rise towards the 32-35 mark with possible Full Approval coming December 9th.  

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FDA panel favors lupus drug from Human Genome Sciences despite mixed results in studies

Associated Press

11/16/10 7:00 PM EST ADELPHI, MD. — Federal health experts on Tuesday voted in favor of the first new drug to treat Lupus in over 50 years, setting aside concerns that the experimental therapy does not work in some key patient groups, including African-Americans.

The recommendation from a panel of Food and Drug Administration advisers brings the biotech drug from Human Genome Sciences one step closer to market. The drug was co-developed with GlaxoSmithKline PLC.

Known as Benlysta, the drug is designed to treat flare-ups and pain caused by lupus, a little-understood and potentially fatal ailment in which the body attacks its own tissue and organs. Ninety percent of lupus patients are women. The disease causes skin rashes, joint pain and inflammation of the kidneys and the fibrous tissue surrounding the heart.

The FDA panel voted 13-2 in favor of approving the drug. The agency is not required to follow the advice of its panelists, though it often does.

The FDA is scheduled to make a decision on Benlysta by Dec. 9, and company executives suggested the drug could be available in the first quarter 2011.

Shares of Human Genome Sciences rose $2.41, or 9.3 percent, to $28.29 in after-hours trading, while GlaxoSmithKline stock gained 94 cents, or 2.4 percent, to $39.48.

Throughout Tuesday's meeting, FDA's experts stressed that Benlysta will not work for all patients and that more effective therapies are still needed.

"I think it's very exciting that this is the first new drug in five decades, but it's not magic bullet," said Dr. Maria Suarez-Almazor of the MD Anderson Cancer Center in Houston.

Panelists who voted against the drug's approval said the studies submitted by Human Genome Sciences did not show that patients taking Benlysta fared significantly better than those taking older therapies.

"I have all the hopes and dreams that we have heard expressed today, and I know my lupus patients want a medicine that is more effective, but I have not seen data that says this drug is it," said Dr. David Blumenthal of Case Western Reserve University.

Only 30 percent of patients studied by Human Genome Sciences responded to the drug, as measured by a comprehensive list of lupus symptoms. The drug did not help African-Americans — who are three times more likely to have lupus than Caucasians. Additionally, studies conducted in Latin America and Eastern Europe showed significantly better results than those conducted in the U.S. and Canada, leading some panelists to question the accuracy of the results.

Despite such concerns, panelists appeared swayed by more than 30 lupus patients — several of whom currently take Benlysta — who urged the FDA to approve the drug during a public comment session. Many of the patients said the side effects of current drugs are as debilitating as the disease itself. Current treatments include steroids, which can cause bone fractures, and chemotherapy drugs, which cause hair loss, anemia and diarrhea.

The drugs help keep the immune system in check, but aren't designed to treat lupus itself.

"Living with lupus is a daily fight simply to see another day, and often survival means letting go of things you love and wanted to do," said Wendy Rogers, a spokeswoman for the Lupus Foundation of America.

In separate votes the panel voted 10-5 in favor of the drug's effectiveness and 14-1 in favor of its safety.

"I found the personal stories today particularly compelling, and I see this as an important opportunity to advance a challenging area of medicine and serve a previously underserved population," said Dr. Robert Kerns of the Veterans Affairs Connecticut Healthcare System.

An estimated 1.5 million people in the U.S. have lupus. Benlysta, known chemically as belimumab, is a once-a-month infusion that works by blocking the antibodies that cause the disease in a subset of patients.

If approved, analysts estimate Benlysta could eventually post sales of over $2 billion annually. Human Genome Sciences Inc., of Rockville, Md., and GlaxoSmithKline PLC, of Britain, which would split the profits, are also seeking approval to market the injectable drug in Europe.

Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of BENLYSTA(R) for Systemic Lupus Erythematosus

ROCKVILLE, Md., & LONDON, Nov 16, 2010 (BUSINESS WIRE) -- Human Genome Sciences, Inc. (HGSI 28.60, +2.72, +10.51%) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA(R) (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).

The FDA Arthritis Advisory Committee is convened to provide the FDA with independent expert advice on a broad range of issues related to rheumatology drug products. The committee provides non-binding recommendations for consideration by FDA, with the final decision on approval made by FDA. The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of December 9, 2010.

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006. Under the agreement, 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.


GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.


The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

For more information about HGS, please visit the Company's web site at http://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.

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