Human Genome Sciences, Inc (HGSI)

[chevelle]

The company reported positive Phase II clinical data for its lupus drug candidate Benlysta, also known as belimumab.

Human Genome added it expects to have Phase III data available in July and November. The product is being co-developed with GlaxoSmithKline

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Three Products in Late-Stage Development
We now have three promising products in late-stage development, moving toward commercialization. We have reported the positive results of two Phase 3 trials of Albuferon®, and we plan to file global marketing applications in fall 2009. Two Phase 3 trials are ongoing for BENLYSTA™ (formerly LymphoStat-B®) in patients with lupus, with results expected in July and November 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. Also in late-stage development is ABthrax™, which offers a new way to address the threat of inhalation anthrax and is being developed under a contract with the U.S. Government.
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Also under the contract, HGS plans to file a Biologics License Application (BLA) with the FDA in the second quarter of 2009. The Company will receive an additional $10 million from the U.S. Government upon FDA licensure of ABthrax. ABthrax 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).

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Human Genome Sciences Files BLA with FDA for Anthrax Drug, Abthrax - Update
5/21/2009 1:35 PM ET
(RTTNews) - Thursday, 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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Call Volume Accelerates on Human Genome Sciences
6/3/2009 2:58 PM

Keywords: HGSI
Human Genome Sciences (HGSI) is attracting bullish option attention today, according to data from WhatsTrading.com. The stock has seen 6,969 calls change hands, which is more than five times its average daily volume. It appears that many of these options have been bought to open, with 74.4% of the contracts crossing at the ask price.

Traders today are favoring HGSI's July 5 call, where 2,037 contracts have traded on open interest of 2,781. Also popular are the June 2.50 call, with volume of 1,414 contracts on open interest of 3,864, and the June 5 call, with 1,155 contracts changing hands on open interest of just 268.

This upbeat attitude is nothing new for HGSI. During the past 10 days, traders on the International Securities Exchange (ISE) have bought to open nearly 34 times more calls than puts on the equity. This 10-day ISE call/put volume ratio ranks in the 80th annual percentile, revealing a notable skew toward bullish bets.

At last check, HGSI was up 10.7% at $2.91. No news in particular seems to have sparked the day's rally. (PRICE ON 6-3-09)

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