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 ...

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 ...

DrStockPick.com Stock Report!

Thursday August 27, 2009

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Fujitsu Microelectronics Limited and Taiwan Semiconductor Manufacturing Company, Ltd. (NYSE: TSM) today announced that they have agreed to collaborate on 28-nanometer (nm) process technology targeted for foundry production of Fujitsu Microelectronics’ 28nm logic ICs and to jointly develop an enhanced 28nm high-performance process technology by utilizing TSMC’s advanced technology platform. Previously, both companies announced that Fujitsu Microelectronics will collaborate with TSMC on 40nm production. This will extend Fujitsu Microelectronics’ 40nm collaboration with TSMC and covers joint development of an optimized 28nm high-performance process technology. Initial 28nm samples are expected to ship toward the end of 2010.

UCB and Immunomedics (Nasdaq:IMMU) announced

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HGSI’s Benlysta meets its endpoints in Bliss-52 phase III trial for lupus Earlier today, Human Genome Sciences, Inc. (HGSI) 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 event rates comparable between belimumab and placebo treatment groups. As a reminder, HGSI and GSK is co-developing Benlysta as a potential treatment for SLE. Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered ...

HGSI: NDA for Albuferon Expected to be Filed This FallWaiting for 2 Phase III Results for BenlystaNDA filing for Albuferon is expected in the fall for Hepatitis C      Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences Inc. (HGSI) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.HGSI has an exclusive worldwide agreement with Novartis (NVS) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for chronic hepatitis C (HCV). Under this agreement, ...

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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Highlights include BioMarin Pharmaceutical Inc. (BMRN) and Genzyme Corp. (GENZ).1Q09 revenue was in line with our expectation, but EPS fell shortOn April 30, 2009, BioMarin Pharmaceutical Inc. (BMRN) reported financial results for the first quarter ended March 31, 2009.Total revenue in 1Q09 came in at $74 million, up 22.5% from $60.4 million in the same quarter of 2008. Total revenue of $74 million was in line with our estimate of $74.9 million.Net product revenue in 1Q09 reached $71.9 million, up 24.8% from $57.6 million for the 1Q08. 1Q09 net product revenue was also in line with our estimate of $70.9 million. BioMarin currently markets three products.Net product revenue from Naglazyme was $39.4 million for the first quarter of 2009, an increase of 42.2 percent compared to Naglazyme net product revenue of $27.7 million for the first quarter ...

We downgrade BioMarin Pharmaceutical Inc. (BMRN) shares from Buy to Hold based on worse-than-expected 4th quarter financials and the not-rosy outlook for 2009. Fourth Quarter 2008 Results Fall Short of Expectations; Outlook Not RosyBioMarin continues to deliver strong results in 4Q08, but the outlook for 2009 and beyond is not rosy.  Total revenue in 4Q08 came in at $99.3 million, up 121.4% from $44.9 million in the same quarter of 2007. Fourth quarter total revenue included $15.2 million from Kuvan sales, which was not included in 4Q07. Total revenue of $99.3 million was short of our $109 million estimate. Net product revenue in 4Q08 reached $66 million, up 154.8% from $25.9 million for the 4Q07. Fourth quarter net product revenue was $8 million less than our estimate of $74 million. Naglazyme sales were $36.5 million for the 4th ...

Yesterday, very few investors even knew about Dynavax Technologies Corp., but today the company received much attention after announcing a worldwide strategic alliance with GlaxoSmithKline (NYSE: GSK) to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) to treat immuno-inflammatory diseases. As of Wednesday afternoon, the stock is up approximately 458% on 8.7 million traded shares.

Through the alliance, Dynavax will receive $10 million from GSK for the exchange of an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. According to the press release, Dynavax can receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK has the exclusive option to license each program upon achievement of proof-of-concept or earlier depending on certain circumstances.

Dino Dina, M.D., President and Chief Executive Officer of Dynavax, commented, “Our alliance with GSK provides an opportunity to create an entirely

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