Human Genome Sciences

UK court slaps down HGS patent

Maureen Martino — Fri, 01 Aug 2008 10:59:09 -0400

Human Genome Sciences--and other biotechs that made claims to parts of the human genetic sequence--have been dealt a blow by the U.K. The High Court yesterday ruled on the first case to question the patentability of discoveries made through the use of bioinformatics. Back in the 1990s, as scientists came to better understand the human genome, biotech companies rushed to patent genes, proteins and human cells for future research work. HGS grabbed one such patent on a disease-linked protein known as neutrokine-alpha. But now the High Court has revoked that patent, saying that "the company had failed to identify any practical use at the time its application had been filed," according to the Financial Times.

That's bad news for HGS, which is working with GlaxoSmithKline to develop a neutrokine-alpha antibody drug called lymphostat. It's a boon for Eli Lilly, however, which is developing its own neutrokine-alpha antibody drug.

- read the Financial Times summary

C&L: Una Ryan leaves Avant

Wed, 14 May 2008 06:59:52 -0400

Avant Immunotherapeutics today announced the departure of Una Ryan, Ph.D, President and CEO, effective immediately.

Watson Pharmaceuticals announced that co-founder and Chairman Allen Chao has resigned from the board of directors to pursue other business activities. Board member Andrew Turner will become nonexecutive chairman.

Ardea Biosciences has named John Beck senior vice president, finance and operations and chief financial officer.

Encorium Group has appointed Philip Calamia as its interim chief financial officer.

PregLem has named Sven Zimmermann, a biotech analyst at UBS Investment Bank, as its new chief financial officer.

Nucryst Pharmaceuticals revealed the appointment of David Holtz as vice president and chief financial officer.

Kendle has appointed Patricia Williams to the position of vice president, commercial operations.

Adnavance Technologies has appointed Christian P. Valcke, Ph.D., to its scientific advisory board.

Gilead Sciences on Wednesday said that Chief Executive Officer John C. Martin was named chairman of the biotechnology company's board of directors.

Vyteris named John E. Burrows and Susan Guerin to the company's board of directors,

Nventa Biopharmaceuticals Corporation has named John Varian to the company's board of directors.

DOR BioPharma announced that its President and Chief Executive Officer Christopher Schaber, PhD, has joined the board of directors of the Alliance for Biosecurity.

Inovio Biomedical announced that Patrick Gan was elected as the company's eighth director at Inovio's annual general meeting.

Human Genome Sciences announced that John LaMattina, Ph.D., who retired in late 2007 as president of Pfizer Global Research and Development, has been appointed to the HGS board of directors.

Robert Hill has joined the Biothera board of directors.

Rituxan fails (again) in late-stage lupus trial

Tue, 29 Apr 2008 06:59:55 -0400

Genentech and Biogen Idec were taking it on the chin this morning after researchers announced that Rituxan had failed in a later-stage trial as a therapy for lupus. The failure won't harm the blockbuster's penetration of the markets for non-Hodgkin's lymphoma and rheumatoid arthritis. But the companies had high hopes for the drug's ability to treat a condition with few therapeutic options to pick from. Analyst estimated potential sales in that one category at more than a billion dollars.

Rituxan block B cells, which play a role in inflammation, and has already been put into use for lupus on an off-label basis. Rituxan also recently failed a late-stage trial for MS.

- here's the Rituxan release
- read the story in the Wall Street Journal

HGS, Xencor team up on antibody tech

Fri, 08 Feb 2008 06:59:58 -0500

In another display of monoclonal antibodies' appeal to drug developers, Maryland-based Humab Genome Sciences announced that it will team up with Xencor on drug development. Xencor uses its XmAb technologies--which humanizes antibodies--to enhance the pharmacologic properties of monoclonal antibodies developed by HGS that specifically target antigens discovered by HGS. Xencor gains an upfront payment and could earn additional payments including development and commercial milestones, and royalties. Further financial details were not disclosed. Xencor was a 2005 Fierce 15 company.

- see this release for more

Related Articles:
HGS stock dives on drug safety concerns. Report
Xencor adds $15M to fifth VC round. Report

HGS stock dives on drug safety concerns

Wed, 23 Jan 2008 06:59:57 -0500

Human Genome Sciences watched its stock take a dive this morning after an independent data monitoring committee noted lung-related side effects in patients receiving 1200-microgram injections of the hep C drug Albuferon every two weeks. Patients at that dosage level in the Phase III trial are being shifted to a 900-mcg injection every two weeks. HGS says it still expects to have late-stage data on the drug in the spring of 2009, with a marketing application to follow in late 2009. But that was no comfort to investors, who took a 22 percent bite out of its stock as Wall Street in general got off to another rocky start.

- see this release
- read the AP report for more

Related Articles:
HGS pockets $40M for Albuferon, preps Phase III. Report
HGS marks success of Albuferon in IIb. Report

PharmAthene finds backers for research pact

Mon, 14 Jan 2008 06:59:56 -0500

PharmAthene has gained some powerful support in Washington for its plans to expand a herd of genetically modified goats used in drug research by housing the animals at a USDA facility in Maryland. One of the state's senators, Benjamin Cardin, has introduced a measure in the farm bill that would permit just that in a public-private partnership. PharmAthene has been developing Protexia--a therapy produced in goats' milk and used to protect people from nerve agents--under Project BioShield. PharmAthene is also in a race to produce a new anthrax vaccine, a field where Human Genome Sciences is widely considered the leader.

- read the report from The Washington Post

Related Articles:
PharmAthene to go public through merger. Report
Siga Technologies, PharmAthene to merge. Report
EMEA panel recommends goat-milk therapy. Report

HGS, Aegera ink $315M cancer deal

Thu, 20 Dec 2007 06:59:57 -0500

Aegera Therapeutics has pocketed $20 million in a combined upfront fee and equity stake from Human Genome Sciences in exchange for the global rights (excluding Japan) to an experimental cancer drug and related compounds. Aegera also stands to earn up to $295 million in commercial and developmental milestones, including a $5 million payday for the FDA's clearance of an IND. AEG40826--a small-molecule inhibitor of multiple IAP (inhibitor of apoptosis) protein family members--is slated to hit the clinic in early '08.

"Today's announcement underscores HGS's commitment to develop novel targeted therapies for the treatment of cancer," said H. Thomas Watkins, President and CEO, HGS. "Our company has pioneered development of antibody therapies based on the TRAIL receptor apoptotic pathway, and we will now have the opportunity to work collaboratively with Aegera Therapeutics to develop and commercialize exciting small-molecule drugs that also enhance apoptosis in cancer cells.

- read the release on the deal

Related Articles:
Berendt tapped to run Aegera. Report
Aegera raises $21 million. Report

ALSO NOTED: Pfizer to buy CovX; Florida commits $94M to Max Planck; Affymetrix buys USB; HGS touts animal trial results for ant

Tue, 18 Dec 2007 06:59:50 -0500

> Aggressively looking to expand its role in biologics, Pfizer has struck a deal to buy CovX. No figures were given. Report

> Florida's governor has committed $94 million to bring the Max Planck Society to Palm Beach County, making it a neighbor of Scripps Florida. Report

> Affymetrix is buying USB, which makes molecular biology and biochemical reagent products, for $75 million. Release

> The FDA has approved Forest Laboratories' hypertension drug Bystolic, which it plans to launch next month. Release

> Human Genome Sciences says that animal studies of a new anthrax therapy have demonstrated marked results. Release

> Insmed has received the FDA's Orphan Drug Designation for IPLEX, a treatment of myotonic muscular dystrophy. Release

> Elixir set the terms for its IPO at $14 to $16 a share. Report

> Belgium's Ablynx is touting the results of a Phase I trial of its ALX-0081 nanobody for thrombosis. Release

> Biomarin announced today that it has re-acquired the Canadian rights for tetrahydrobiopterin, including Kuvan, from Merck Serono, The FDA has granted marketing approval for BioMarin Pharmaceutical's Kuvan tablets, a specific drug therapy for the treatment of phenylketonuria. Release

> Medarex will receive an undisclosed milestone payment from Amgen for advancing an antibody into human clinical trials. Release

> Merck and Schering-Plough have responded to public outcry over their plans to re-jig a study of Vytorin, a joint product that combines Merck's Zocor and Schering-Plough's Zetia. Report

> The Internet is buzzing about a Wall Street Journal op-ed piece in which ex-FDA deputy commissioner Scott Gottlieb (photo) championed the sort of off-label promotions that make regulators crazy. Report

> Counterfeit drugmakers have found some unlikely allies: free trade zones. Report

And Finally… A new DNA sequencing technique could dramatically lower the cost to read human genomes. Article

HGS pockets $40M for Albuferon, preps Phase III

Tue, 28 Aug 2007 06:59:56 -0400

Human Genome Sciences can bank a $40 million pay check from Novartis, its milestone for a successful Phase IIa trial of Albuferon for chronic hepatitis C. That makes $132.5 million in milestone payments on that single drug program. And HGS is clearly hoping for more--soon. Researchers also announced today that they had wrapped enrollment early for two Phase III trials of Albuferon with data scheduled to arrive in early 2009 and a marketing application later that same year.

- read the release for more information

Related Articles:
Novartis inks major licensing pact with HGS. Report
HGS marks success of Albuferon in IIb. Report
HGS signs $425M deal for BioMed Realty campus. Report

Developers testing new therapies for lupus

Mon, 22 Jan 2007 19:01:36 -0500

Human Genome Sciences is one of several developers working on a new advance for lupus. This Wall Street Journal piece looks at the pipeline for lupus, which includes programs at Bristol-Myers Squibb, Genentech and Biogen Idec. There hasn't been a new therapy approved for lupus in 50 years, but these new drugs--which include Orencia and Rituxan--are being tested as treatments for the disease rather than just the symptoms.

- read the The Wall Street Journal article on lupus

Related Articles:
New warning issued on Rituxan for lupus. Report
HGS adds positive data in extended lupus trial. Report

HGS adds positive data in extended lupus trial

Mon, 13 Nov 2006 19:01:37 -0500

An extended mid-stage trial of Human Genome Science's lymphostat for lupus has produced new positive data on the drug. The results come a year after HGS concluded that 24-week data on 449 patients did not show that lymphostat-B reduced symptoms in the disease. In June, though, HGS announced that 52 week data did demonstrate efficacy and this new data is from 76 weeks of results on 321 patients. HGS said the response rate to the drug jumped from 46 percent to 56 percent. A late-stage trial is expected to get underway by the end of the year.

- see the company's press release on the data
- read the AP report

Related Articles:
HGS signs $425M deal for BioMed Realty campus. Report
Lupus drug fails Phase 2, HGS sees positive effects. Report
Feds ink HGS contract. Report

Press Release: Human Genome Sciences Announces Positive Phase 2 Results

Maureen Martino — Mon, 13 Nov 2006 12:36:50 -0500

Human Genome Sciences Announces Positive 76-Week Resuplts of Phase 2 Clinical Trial of Lymphostat-B in Systemic Lupus Erythematosus

- LymphoStat-B™ reduces signs and symptoms of SLE disease and demonstrates durable biological activity at 76 weeks -

- Phase 3 clinical trials to begin before year-end 2006 -

ROCKVILLE, Maryland – November 14, 2006 – Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that the 76-week results of a Phase 2 clinical trial demonstrated that LymphoStat-B™ (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE), exhibited durable biological activity, and appeared safe and well tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase 3 trials of LymphoStat-B™ increased from 46% at Week 52 to 56% at Week 76, with no increase in infections or infectious events observed over time.

The results were presented today in two oral presentations in Washington , DC at the 70th Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). Additional LymphoStat-B results were reported in poster presentations throughout the meeting.

“The data that have emerged from the 24-week extension of the Phase 2 trial of LymphoStat-B show continued improvement beyond the first 52 weeks of treatment,” said Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, UCLA (based at Cedars-Sinai Medical Center , Los Angeles ). “ The reductions we see in SLE biomarkers, as well as the improvements observed in health-related quality of life, appear to correlate with therapeutic response. In serologically active patients, LymphoStat-B significantly r educed SLE disease activity, as evidenced by changes in multiple biomarkers and clinical indicators, including the combined response rate chosen as the primary efficacy endpoint of the Phase 3 trials. We look forward to continuing its evaluation as a potential treatment for SLE.”

“The results presented at this year’s ACR/ARHP meeting confirm and extend the growing body of evidence that LymphoStat-B has the potential to help meet the significant unmet need that we see in the SLE patient population,” said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research – Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences. “We are encouraged that 96% of the patients who completed the 52-week Phase 2 study chose to participate in the 24-week extension phase. Many of these patients were first randomized into the trial as long as three years ago and continue on treatment today. This provides us with a substantial longitudinal safety data base as we prepare to initiate Phase 3 trials before the end of 2006.”

About the Phase 2 Trial Results

The Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. Serologically active patients accounted for 72% (323/449) of the total Phase 2 study population. 86% (386/449) of the patients were receiving background prednisone therapy, either alone or in combination. At Week 52, patients were offered the opportunity to participate in an optional 24-week extension phase. In the extension phase, all placebo patients received LymphoStat-B at a dose of 10 mg/kg, while patients in the LymphoStat-B 10 mg/kg treatment arm continued on the 10 mg/kg dose, and patients in the 1 mg/kg and 4 mg/kg LymphoStat-B treatment arms were offered the choice of continuing on the same dose or receiving LymphoStat-B at a dose of 10 mg/kg.

Of the patients who completed 52 weeks of treatment, 96% (351/364) elected to enter the 24-week extension phase of the trial, and 92% (321/351) of those who entered completed it. Of those completing the extension phase, 83% (265/321) continue to receive LymphoStat-B. The study began in October 2003.

In June 2006, HGS reported the full presentation of 52-week data from the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity in patients with serologically active SLE, exhibited clinically relevant biological activity, and appeared safe and well tolerated. Among the Phase 2 study findings was a significantly improved response rate among serologically active patients at Week 52, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no BILAG worsening, and no worsening in Physician’s Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). This combination of measures is the primary efficacy endpoint in the Phase 3 program design.

The data presented at the ACR/ARHP annual meeting demonstrated that LymphoStat-B continued to reduce the signs and symptoms of SLE disease activity throughout the 24-week extension phase of the study, demonstrated durable biological activity at Week 76, and appeared safe and well tolerated, with frequency and severity of adverse events similar to placebo and with no increase at higher doses. The evidence of continuing improvement from Week 52 to Week 76 includes:

An increase from 46% to 56% in the response rate among serologically active patients, as d efined by an improvement in SELENA SLEDAI score of 4 points or greater, no worsening in Physician’s Global Assessment (with worsening defined as an increase in PGA of more than 0.30 points), no new BILAG A organ domain score and no more than 1 new BILAG B organ domain score from baseline. This combination of measures at 52 weeks is the primary efficacy endpoint of the Phase 3 trials.
An increase from 29% to 38% in the reduction in SLE disease activity among serologically active patients, as measured by SELENA SLEDAI.
An increase from 33% to 41% among serologically active patients who showed no worsening in the Physician’s Global Assessment.
An increase in the mean improvement in health-related quality of life from 3.0 points to 3.4 points among serologically active patients, as measured by the SF-36 Physical Component Summary score.
A durable reduction in anti-dsDNA autoantibodies (at least 50% or negative) among patients who were positive for anti-dsDNA at baseline (27% at Week 52; 28% at Week 76).
Durable or increased reductions from Week 52 to Week 76 in B-cell subsets including total CD20+, naïve (CD20+/CD27-), activated (CD20+/CD69+), and plasmacytoid (CD20+/CD138+).
An increase in C4 complement among patients with low C4 complement at baseline (33% at Week 52; 46% at Week 76).
Stable reductions in immunoglobulins, with no increase in infections or infectious events over time.
In addition, the 52-Week data showed that, in serologically active SLE patients, LymphoStat-B:

Significantly delayed the time to SLE flare after six months (p<0.04);
Reduced the frequency of SLE flares after six months;
Significantly reduced the frequency of patients transitioning from low-dose prednisone ( <7.5 mg/day) to high-dose prednisone (>7.5 mg/day) (p<0.05 over multiple time-points);
Significantly reduced the number of patients experiencing BILAG Neurological and Musculoskeletal organ domain flares at Week 52 (Neurological p=0.04; Musculoskeletal p<0.01; and Cardiovascular-Respiratory (p=0.06); and
Produced significant and clinically meaningful improvements in health-related quality of life in serologically active SLE patients.
The 76-week results of the LymphoStat-B Phase 2 trial, as well as the results of other studies presented at the ACR/ARHP meeting, demonstrated that therapeutic responses in patients with active SLE, as measured by the combined response index selected as the primary efficacy endpoint of the LymphoStat-B Phase 3 trials, correlated well with changes in SLE biomarkers and improvements observed in health-related quality of life. In the Phase 2 study, relative to baseline, responders across all groups (LymphoStat-B and placebo) exhibited greater changes in biomarkers for SLE disease and reported more improvement in health-related quality of life than was observed in non-responders.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the LymphoStat-B 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 agreement.

About LymphoStat-B

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS™. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection. In lupus, rheumatoid arthritis, and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrated that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.

LymphoStat-B is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. It has received a Fast Track Product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA’s Continuous Marketing Application Pilot 2 Program.

For links to scientific presentations and posters referenced, or for more information about LymphoStat-B, visit www.hgsi.com/products/LSB.html.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease. The Lupus Foundation of America estimates that approximately 1.5 million Americans suffer from various forms of lupus, including SLE. More than 300,000 people are afflicted with SLE in the United States alone. Lupus can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. About 90 percent of the individuals diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov.

About Human Genome Sciences

The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

The HGS clinical development pipeline includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company’s primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon™ for hepatitis C, and LymphoStat-B™ for lupus. Both compounds are expected to advance to Phase 3 clinical trials in 2006.

In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax™ for the treatment of anthrax disease. Other HGS compounds in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.

For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals or patients interested in inquiring about LymphoStat-B clinical trials or any other study involving HGS products in development are encouraged to inquire via the Contact Us section of the company’s web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.

HGS, Human Genome Sciences, ABthrax, Albuferon, BLyS and LymphoStat-B are trademarks of Human Genome Sciences, Inc.

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 the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s 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 planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s 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 Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. 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.

ALSO NOTED: Adolor to give back pain patch; Dynavax pursues universal flu vaccine; Charles River buys Northwest Kinetics; and m

Mon, 30 Oct 2006 19:01:30 -0500

> Adolor has decided to stop its work on a pain patch licensed three years ago and will hand it back to EpiCept. Adolor says it wants to devote its resources to other development projects. Report

> The San Jose Mercury News profiles Dynavax's work in developing a universal flu vaccine. Article

> Charles River Laboratories has acquired Northwest Kinetics, a 150-bed facility engaged in branded drug studies, for $29.5 million. Report

> Regeneron Pharmaceuticals' IL-1 Trap hit its primary endpoints in a Phase III trial for CIAS1-related autoinflammatory periodic syndromes, or CAPS Regeneron says its will ask the FDA for approval in the second quarter of next year. Report

> The European Commission has granted CytRx's ALS drug arimoclomol orphan drug status. Release

> Sigma Pharmaceuticals has increased its bid for Australian Pharmaceutical Industries. Report

> Human Genome Sciences is touting positive data from a mid-stage trial of its hepatitis drug Albuferon with ribavarin. Report

And Finally… Harvard biologist Marc D. Hauser believes that evolution has programmed our essential views of morality into our neural circuits. Article

ALSO NOTED: Titan discontinues Phase II; Poniard lines up $15M; and much more...

Wed, 25 Oct 2006 20:01:30 -0400

> Titan Pharmaceuticals announced it was launching a Phase III trial for opioid independence but discontinued a Phase II trial of an experimental therapy for CHF without explanation. Report

> South San Francisco-based Poniard has secured a $15 million loan. Release

> Bilcare has acquired DHP, a UK-based clinical trials service provider. Report

> Insert Therapeutics has completed a $10 million private placement. Release

> Evolutec has raised 2.8 million stg in a private placement. Report

> Millennium Pharmaceuticals discussed plans to focus on Velcade and pipeline development in its latest quarterly report. Report

> The FDA has signed off on Human Genome Sciences Phase III trial of LymphoStat-B. Report

And Finally... Researchers are studying the use of fat stem cells for breast reconstruction. Release

ALSO NOTED: Wall Street waits on new Pfizer CEO; HGS touts Phase II hep C trial; and much more...

Sun, 15 Oct 2006 20:01:30 -0400

> Wall Street is waiting to see how Jeff Kindler, the new CEO at Pfizer, will handle his role on Thursday as he announces the company's third quarter performance. Analysts want some idea of what new directions he has in mind for Pfizer. Report (WSJ sub. req.)

> Omrix Biopharmaceuticals says that its Phase III non-inferiority study of human thrombin compared to bovine thrombin met its primary endpoints. Both thrombins had similar results in stemming bleeding. Report

> Human Genome Sciences is touting positive data from Phase IIb trials of Albuferon for hepatitis C. Report

> Germany's Evotec will collaborate with Japan's Daiichi for medicinal chemistry and compound profiling. Report

> A Chinese antibiotic maker had its license revoked after an antibiotic it makes was blamed for the death of six people and multiple injuries. Report

> Cambridge Antibody Technology and The Debiopharm Group have entered into an exclusive worldwide licensing agreement to develop and commercialize SC-1. SC-1 is a fully human monoclonal IgM antibody SC-1 that targets CD55SC-1, a cell surface receptor that is specifically expressed on gastric carcinoma cells. Release

> J&J has won a round in federal court in its patent fight against a generic version of Risperdal. A judge has ordered that sales of the generic be held up to the end of 2007. Report

> Hana Biosciences has acquired the rights to develop Menadione, a preclinical therapy intended to prevent skin rash associated with epidermal growth factor receptor inhibitors in certain cancer treatments. Report

> Vical is selling $12.5 million in stock to fund operations. Report

> India's Wanbury will buy the generic drug business of Spain's industrial Farmaceutica Cantabria. Report

And Finally… The U.S. government is creating a new cord blood bank to provide life-saving stem cells needed for therapies. Cord blood contains the same stem cells as bone marrow, but doesn't need the same kind of genetic match to be effective in patients. Article

ALSO NOTED: FDA fast tracks Nexavar; ImClone, Merck KGaA amend pact; and much more...

Wed, 19 Jul 2006 20:00:50 -0400

> U.S. Sen. Charles Grassley (R-IA) has alleged that an FDA official collaborated with Merck to discredit FDA safety expert Dr. David Graham after he publicized health risks linked to Vioxx. Report

> Bayer Pharmaceuticals and Onyx reported that the FDA has provided fast-track status for Nexavar as a therapy for advanced melanoma. Nexavar was approved last year as a therapy for advanced renal-cell carcinoma. Report

> The FDA has approved a generic version of Boehringer Ingelheim's Mobic osteoarthritis therapy. Report

> ImClone Systems and Merck KGaA have amended their '98 development and licensing pact for Erbitux. Report

> Human Genome Sciences has initiated dosing of patients in a randomized Phase II clinical trial of HGS-ETR1--mapatumumab--in combination with bortezomib, Velcade, in advanced multiple myeloma. Release

And Finally... Columbia University Medical Center researchers say they have found an "off switch" for chronic pain. They've applied for a patent to develop a new class of drugs based on their findings. Report

New spinoff set to begin first human trial

Wed, 12 Jul 2006 20:01:35 -0400

CoGenesys, the new spinoff from Human Genome Sciences, is expected to announce today that the FDA has OK'd its first human trials--in this case a therapy for chronic heart failure. The biotech has an unusual approach to drug development. Its executives plan to advance drug candidates through early-stage trials and then sell them to bigger pharma companies. CoGenesys will try that with Cardeva, a therapy designed to provide longer protection from a drug that currently works for only a short period.

- see the report on CoGenesys from The Washington Post

C&L: Craig Tuttle tapped to run Transgenomic

Tue, 11 Jul 2006 20:01:32 -0400

Transgenomic has named Craig Tuttle as its new CEO. He succeeds Mike Summers, the current interim CEO, who will stay on as CFO.

Biogen Idec announced today that Cecil B. Pickett, Ph.D., has been named president, research & development. Dr. Pickett will join the Biogen Idec board of directors.

Manhattan Pharmaceuticals has named Michael G. McGuinness CFO.

LTKfarma announced its formation and the executive team that will run the company: Alain Clergeot, Tamara Joseph, David Klatzmann, Jean-Francois Labbe, Laurent de Narbonne and Leo van Wersch.

Timothy C. Barabe has joined Human Genome Sciences as senior vice president and chief financial officer.

Angiotech Pharmaceuticals named Jeffrey P. Walker, MD as senior vice president, research and development.

Savient Pharmaceuticals has named Brian Hayden as senior vice president, CFO and treasurer.

Jonathan Burgin has left his position as CFO of XTL Biopharmaceuticals. Bill Kessler, the company's finance director, will become principal financial and accounting officer for financial and compliance reporting purposes.

The Perrigo Company has named Judy Brown executive vice president, CFO and chief accounting officer effective July 1, 2006. She succeeds Douglas Schrank, who retired June 30.

ARCA Discovery has named Ann Lenich Hards, Ph.D., as executive vice president, regulatory affairs.

AtheroGenics has named Joseph M. Gaynor, Jr. senior vice president and general counsel.

Oculus Innovative Sciences has named Michael Wokasch as COO.

Anadys Pharmaceuticals has named James L. Freddo, M.D., as chief medical officer.

Depomed appointed Matthew Gosling as vice president, legal and general counsel.

Gene Network Sciences has appointed Zach Pitluk, Ph.D., as vice president of business development.

SkinMedica announced that Theodore Ebel has joined the company as vice president, corporate development

Alexion has named David Hallal as vice president of US commercial operations.

Metabolix has named Robert C. Findlen as vice president, sales and marketing.

Eisai has appointed Alex Scott as vice president of business development.

Michael Pinto has joined Model N as vice president of sales.

Clinical Data has appointed Robert Bondaryk, Ph.D, to the position of general manager and unit head, Cogenics.

MTM Laboratories has made two new clinical research appointments: Lisa Kaufman is heading clinical operations in the U.S. while Petra Klement is leading clinical operations in Europe.

Lux Biosciences has named David R. Guyer, MD, venture partner, SV Life Sciences Advisers, to its board of directors.

Jim Brown has resigned from the board at Iomai, citing his duties as head of R&D at MedImmune.

INNOVIVE Pharmaceuticals has named Antony Pfaffle, M.D. and J. Jay Lobell to its board.

Pheromone Sciences has appointed Charles Allard, LLB of Edmonton, Alberta, to its board of directors.

Chromos Molecular Systems announced that Ron MacKenzie has been appointed to its board of directors.

PeriCor Therapeutics, has elected Robert L. Engler, M.D. to its board.

DEALS: Deals Table headline

Wed, 21 Jun 2006 20:01:32 -0400

Schering, Celera ink $365M deal

DEALS
WHO	WITH	WHAT	SCOOP
Schering	Celera Genomics	$365M licensing deal	Schering has acquired Celera Genomics' cathepsin S inhibitor small molecule drug program for the treatment of autoimmune diseases.
Pfizer	Bayer Pharmaceuticals	Licensing deal	The companies have entered into an agreement granting Pfizer exclusive worldwide rights to Bayer's DGAT-1 inhibitors, a class of compounds that modify lipid metabolism.
PTC Therapeutics	CV Therapeutics	Research collaboration	The companies will work on development of orally bioavailable small molecules through the application of PTC's GEMS (Gene Expression Modulation by Small-Molecules) technology.
U.S. Government	Human Genome Sciences	$165M purchase	U.S. Government has exercised its option to purchase 20,000 treatment courses of ABthrax for the Strategic National Stockpile from HGS.
Discovery Partners International	Galapagos	$5.4M purchase agreement	All the drug discovery service operations of DPI will be transfered to Galapagos.
Novartis	Intercell	$37.86M marketing deal	Novartis has bought the rights to market IC51, a late-stage drug for the prevention of Japanese Encephalitis virus infections from Austrian biotech firm Intercell.
PRA International	Pharma Bio-Research	€85M acquisition	Pharma Bio-Research is a private early-phase clinical development company based in the Netherlands.
Nicholas Piramal	Pfizer	Acquisition	Nicholas Piramal has acquired one of Pfizer's plants in Britain. The deal includes a supply agreement until November 2011 totaling potential revenues of above $350M.
Nutra Pharma	ReceptoPharm	Merger	ReceptoPharm has signed a letter of intent to be fully acquired by Nutra Pharma, a biotech that is developing drugs for HIV and MS.
PharmAthene	SIGA	Merger	The company will operate under the "PharmAthene" name and focus on biodefense.

ALSO NOTED: GSK to submit bird flu vaccine in October; Serono touts Raptiva data; and much more...

Wed, 21 Jun 2006 20:00:50 -0400

> GlaxoSmithKline says it will apply for European marketing approval for a new vaccine to prevent bird flu in October. Glaxo started clinical trials in March. Report

> Serono announced that a 12-week study of Raptiva demonstrated a significant improvement among patients with psoriasis, even among patients who were resistant to other therapies. The drug was well tolerated among trial subjects. Psoriasis is a chronic skin condition that requires long-term therapy. Serono expects sales of Raptiva to grow from $33 million last year to $250 million in four years. Report

> Blaming unexpectedly low revenue from its genomics division, Gene Logic has withdrawn its advisory for 2006 and 2007, sending shares down. Report

> Human Genome Sciences says a Phase II trial of LymphoStat-B demonstrates it was effective in reducing the disease activity of systemic lupus erythematosus and was safe and well tolerated. A Phase III trial is planned. Release

> GenMab shares were buoyed by news that a small Phase II study of AMG 714 demonstrated efficacy against rheumatoid arthritis. Report

> Takeda's full pipeline of experimental therapies has turned analysts bullish about the company's future prospects. Report (WSJ sub. req.)

> Molecular Insight announced that the FDA has put its cancer drug Azedra on the regulator's fast track and begun a Phase I trial. Report

> Anticipation is growing for an FDA decision on Oxymorphone ER, a pain med from Penwest and Endo. Report

> Chutes & Ladders: Dr. Hamish Cameron has been appointed CEO of CAT Ltd. Release

> ISTA Pharmaceuticals will issue $40 million in notes. Report

> New studies show that Orencia and Rituxan both offer rheumatoid arthritis patients substantial benefits. Report

> A new study shows that the old cancer drug Cytoxan has some effect as a therapy for scleroderma, a disfiguring autoimmune disease. Article

> An independent panel has recommended that Neopharm continue a late-stage trial of its experimental therapy for brain tumors. Release

> And Finally… The FDA is developing a new Web-based reporting system for adverse events. Report