Recently, Human Genome Sciences Inc. (HGSI) announced that the U.S. Food and Drug Administration (FDA) delayed the approval of ABthrax (raxibacumab), the company’s candidate for anthrax treatment, asking for additional information pertaining to the drug.   The agency issued a complete response letter wherein it asked for additional information in response to the Biologics License Application (BLA) filed in May 2009. The company intends to provide the agency with the requested information shortly.   The agency’s decision comes weeks after an FDA advisory panel questioned the drug’s effectiveness when compared to existing anti-bacterial drugs since ABthrax was primarily tested in animals, not humans. Late last month, the panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment. Consequently, the decision to delay approval does not surprise us.   As ...

Human Genome Sciences, Inc. (HGSI) reported third quarter net loss of $49 million or 32 cents per share, in-line with the Zacks Consensus Estimate. The company reported a net loss of $74.2 million or 50 cents in the year ago quarter. The lower net loss for the quarter was primarily attributable to increased revenues from manufacturing and development services and lower operating expenses. Revenues for the quarter came in at $18.834 million which reflected an increase of 60.6%. Revenues were inclusive of $8.7 million from manufacturing and development services, $8.9 million recognized under the company’s agreement with Novartis (NVS) pertaining to hepatitis C drug Zalbin, and $1.0 million recognized under the agreement with GlaxoSmithKline plc (GSK) pertaining to the potential blockbuster lupus drug Benlysta. Research & development spend declined 36% to $34.8 million in the quarter. Selling general & administrative expenses declined 6.3% to ...

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Amylin (NasdaqGS:AMLN) based in San Diego, said late Sunday it will receive $75 million upfront from Takeda and said future payments for development and achieving commercial milestones could top $1 billion. The deal includes two potential weight-loss treatments, a pramlintide-metreleptin combination and davalintide. Both potential drugs are in midstage, or Phase II, clinical development. In July, Amylin said pramlintide-metreleptin prompted an average weight loss of 22 pounds, or 11 percent of patients’ body weight, during a midstage study.

Human Genome Sciences Inc (NasdaqGM:HGSI) and GlaxoSmithKline (NYSE: GSK) said Monday heir experimental

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A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs.  The panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment.  Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit of ABthrax. Furthermore, the drug appeared to be effective when used with antibiotics in rabbits and monkeys. The same panel also voted in favor of using data from the animal studies to predict how the drug will work in humans. However, more data is required for the purpose. Last week, the FDA expressed concerns regarding some ...

Recently, Human Genome Sciences Inc. (HGSI) suffered a setback when the US Food and Drug Administration (FDA) questioned the efficacy of its drug ABthrax (raxibacumab), meant for treating anthrax infection.  The FDA accepted that the medication was more effective than a placebo in treating anthrax exposure in animals. However, it was unsure as to how effective the treatment would be for humans since the reliability of human data is doubtful. Though the drug appeared to be effective when used with antibiotics in rabbits and monkeys, animal studies do not always predict success in humans.  Later today, an advisory panel from the FDA is scheduled to meet to decide whether the benefits of the drug outweigh the risks for treating deadly infections caused by anthrax inhalation.  As a reminder, Human Genome had filed a Biologics License Application with the FDA in May 2009. The company is ...

Earlier this week, Human Genome Sciences Inc. (HGSI) announced that its eagerly anticipated lupus drug Benlysta is expected to cost patients about $20,000 a year. The actual price might also be slightly more than the figure. Consequently, the drug could reach $1 billion in annual sales if taken by 50,000 patients, which represents a small fraction of those affected by the disease. In July 2009, Human Genome Sciences and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52 compared with standard of care alone. Study results also showed that Benlysta was generally well tolerated, with adverse ...

Human Genome Sciences Inc. (HGSI) announced that it plans to raise approximately $310 million as net proceeds by selling 23.2 million common shares at $14 per share. This reflects an expansion of the initial public offering where the company had planned to sell 18 million shares in public.   The Rockville, Maryland-based company further stated that the underwriters would be given a month to buy up to an additional 3.48 million common shares to cover any over-allotments. The offering, expected to close on August 3, will lead to considerable dilution in the shareholder base.   Human Genome intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.   As a reminder, Human Genome has a robust and diversified pipeline which includes drugs to treat hepatitis C, lupus, anthrax, cancer, ...

This week, biopharmaceutical company Human Genome Sciences Inc. (HGSI) announced the commencement of an underwritten public offering of up to 18 million shares of its common stock. The Maryland-based company stated that the underwriters would be given a month’s period to buy up to an additional 2.7 million common shares. While the company should be able to raise funds sufficient to finance operations through this operation, the issuance of shares will lead to considerable dilution in the shareholder base. The company intends to use the proceeds for general corporate and acquisition or investment purposes. Additionally, this funding arrangement is also expected to provide cash for further development of the pipeline.

As a reminder, Human Genome has a robust and diversified pipeline, which includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The company has recently filed a Biologics License Application (BLA) for ABthrax for

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Rockville, Maryland- based biopharmaceutical company Human Genome Sciences, Inc. (HGSI) announced today that that it will be selling 45,000 doses of raxibacumab or ABthrax to the U.S. Government for the Strategic National Stockpile. The delivery is to be made over a 36-month period, beginning the final quarter of 2009.The company expects to receive approximately $151 million from the completion of this order.

The company had delivered 20,000 doses of the drug, for emergency use in the treatment of inhalation anthrax, to the U.S. Strategic National Stockpile in the first quarter of this year and completed the delivery in the second quarter. It recognized $153.8 million in ABthrax revenue in the first quarter.

Human Genome is under contract to deliver doses of the drug to the U.S. Strategic National Stockpile, which stores huge quantities of medicine and medical supplies to be used in national emergencies like a flu outbreak, terrorist attacks or

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July 22, 2009

Dow 8,881.26 34.68 -0.39% Nasdaq 1,926.38 +10.18 +0.53% S&P 500 954.07 -0.51 -0.05%

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Shares of Human Genome Sciences Inc. rose Wednesday after the biotechnology company said the U.S. government placed an additional $151 million order for the inhaled anthrax treatment ABthrax.

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