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Last week's hard-hitting report on the FDA by the Institute of Medicine lays out several common-sense reforms that should be embraced wholeheartedly by the biotech industry--if for no other reason than avoiding the backlash over drug safety that …

UCB to acquire Schwarz in latest buyout deal

Belgium's UCB is buying Germany's Schwarz Pharma for about $5.6 billion, the third major drug company deal in Germany in five days. Together, the two companies will enjoy about €3.3 billion in revenue and an R&D budget of €770 million. The merger will position the company to play partner with others in drug development around the world. According to UCB, "the enlarged UCB would be a more attractive partner for licensing deals and R&D collaboration than either Schwarz …

Shares surge as satraplatin succeeds in Phase III

Shares of Pharmion and GPC Biotech surged after the drug developers announced that volunteers in a Phase III trial of satraplatin for prostate cancer demonstrated a 40 percent reduction in the risk of disease progression. The reduced risks were compared to disease progression among volunteers taking a placebo along with prednisone. Researchers say they will continue to treat volunteers whose cancer has not progressed and track their outcomes. Germany's GPC says it plans to push ahead with …

X Prize prepares $10M genomics contest

The X Prize Foundation is preparing to offer a $10 million prize to the research team which can slash the cost of mapping a human genome. The genomics prize is intended to make it feasible for someone to have their DNA sequenced to better understand their risk for disease. The X Prize Foundation, which plans to make the announcement on October 4, wants to reduce the cost of sequencing to thousands of dollars and just days of lab time. The exact details of the contest aren't known yet, and …

Acorda shares soar on late-stage MS data

Shares of Acorda skyrocketed after the company reported a successful outcome of its Phase III trial of Fampridine-SR for multiple sclerosis. Researchers found that a statistically significant number of patients in the trial reported improvements in walking speed, the primary endpoint in the trial. Hawthorne, NY-based Acorda plans to seek talks with the FDA on how to proceed with the drug.

The average increase in walking speed over the treatment period compared to baseline was 25.2 …

NovaCardia pockets $48M in second round

San Diego-based NovaCardia--which is developing drugs for cardiovascular disease--has raised $48 million in its second round. Skyline Ventures and InterWest Partners led the round with previous investors Domain Associates, Forward Ventures, Montreux Equity Partners, and Versant Ventures taking part as well. "This financing underscores the excitement around KW-3902 as a promising treatment for patients with CHF," added Randall E. Woods, president and CEO of NovaCardia.

- see the release on the round

SPOTLIGHT: Can Florida woo biotechs?

Florida's success in luring three major research institutions to the Sunshine State has triggered a heated argument over its prospects in attracting new biotech companies. Some say that the deals insure the state's biotech future while others argue that biotechnology has already past its boom stage. Article

ALSO NOTED: CEO pay riles investors; Can-Fite inks licensing deal; and much more...

> Some investors are unhappy about the pay packages of UK biotech execs. Report

> Israel's Can-Fite has inked a new licensing deal with Japan's Seikagaku for the development of CF-101 as a therapy for RA and other inflammatory diseases. Report

> Scottish entrepreneur Sir Tom Hunter has taken a 20 …

IOM slams FDA, calls for major reforms

In a long-awaited review, the Institute of Medicine has slammed the FDA, saying its drug safety monitoring systems are inadequate and in need of reform, hampered by bad management and subject to incessant internal disputes. A spokesperson at the FDA said that the agency had made significant progress over the two years since the Vioxx debacle rattled the agency, but also recognized that more work was needed.

The report outlines a series of suggested changes that would dramatically …

Takeda expands R&D budget, may look for buyout

Japan's Takeda plans to significantly raise the amount of money it is investing in R&D, according to a report in a Japanese newspaper. The drug developer says it will spend 20 percent of its revenue from drug sales, or about $8.6 billion, on research over the next five years. And it will consider an acquisition to help boost its pipeline. New drug candidates are essential for Takeda, which is facing the loss of patents for drugs that supply 60 percent of its revenue. Takeda recently …

Epix anxiety drug fails in late-stage trial

Shares of Epix Pharmaceuticals slipped after the developer announced that a late stage trial of its experimental long-acting drug for general anxiety disorder failed to achieve a statistically significant response compared to a placebo. PRX-00023 was tested in a Phase III trial that enrolled 310 patients. "Based on these top-line results, we plan to refocus our efforts away from anxiety to evaluate the benefit in depression more closely and assess opportunities for initiating a Phase II …

Scientists use dead embryos to create cell lines

A Serbian scientific team has come up with a way to develop new embryonic stem cell lines without deliberately destroying an embryo. Taking 13 "arrested," or dead embryos in which cells have stopped dividing, the researchers were able to create one new embryonic stem cell line. Their work is published in the journal Stem Cell.

In vitro fertilization clinics typically dispose of the arrested embryos once the cells stop dividing. The hope of the scientific team is that …

Jerini drug for HAE produces mixed results

Germany's Jerini is touting half of the results from two pivotal Phase III trials for Icatibant, an experimental subcutaneous treatment of hereditary angioedema (HAE). In one study, the primary endpoint was reached, showing a significant reduction in the time to onset of symptom relief. A second Phase III study, though, failed to hit its primary endpoint. The primary endpoint of median time to onset of symptom relief in the second trial was 2.5 hours for Icatibant versus 4.6 hours for …

SPOTLIGHT: New cancer research consortium

The Starr Foundation is putting up $100 million to create a new consortium of cancer research groups. The consortium will coordinate their work mapping cancer genes and researching new ways to interfere with the development of cancer. Report 

ALSO NOTED: Oscient gains approvable letter; Achillion sets IPO terms; and much more...

> The FDA has issued an approvable letter to Oscient Pharmaceuticals for Factive as a five-day treatment for community-acquired pneumonia. The developer says that the agency is looking for additional analysis of existing data and some clarifications, but isn't looking for a new trial. Oscient says it should be able to satisfy the FDA's requests in a few weeks. Oscient has already received approval for Factive as a seven-day therapy and is also seeking approval of Factive for acute …

Merck KGaA buying control of Serono

Germany's Merck KGaA is buying the Bertarelli family's 64.5 percent interest in Switzerland's Serono. The $13.3 billion deal gives the family a 20 percent premium over yesterday's stock price. Serono also announced that its oral cladribine for multiple sclerosis had been fast tracked by the FDA. The family had long signaled its interest in finding a buyer for its stake in the biotech company, but recently had appeared to back off that strategy after failing to put a deal together. Goldman …

Hospira to buy Mayne Pharma in $2.6B deal

Yesterday's hot rumors about Australia's Mayne Pharma have been replaced by the news that Hospira is buying the generic drug company for $2.63 billion. The Lake Forest, IL-based Hospira said it expects to benefit from about $50 million in "synergies" between the two companies. Mayne shares soared on the news, which includes a 34 percent premium on yesterday's stock price. …

Altana sells drug unit to Nycomed

Germany-based Altana is selling its pharmaceutical business to Denmark's Nycomed for €4.5 billion. Last year Altana hired Goldman Sachs to find a buyer. The company said it would sell the unit due to slow business, high development costs and an inability to compete in the worldwide pharmaceutical market. Altana "has been under pressure ever since mid-2005, when...Pfizer terminated a cooperation to jointly develop respiratory drug Daxas, which Altana hopes will replace sales of its …

Medivation shares jump on Alzheimer's data

Shares of Medivation jumped 29 percent after the drug developer announced that its Alzheimer's therapy Dimebon showed significant efficacy in a mid-stage trial. Researchers announced that the Phase II trial in Russia hit all five primary endpoints for efficacy. The drug also appeared to be safe and well tolerated. The company has extended the trial for 12 months of dosing and will release that data in the second quarter of next year.

"We believe that these results are important, in …

Axcan abandons drug after trial failure

Shares of Canada's Axcan were taking a hit today after the company announced it will halt development of Itopride for indigestion after analyzing disappointing data gathered in a recent Phase III clinical trial. Researchers were studying the therapy as a treatment for functional dyspepsia, which is characterized by upper abdominal pain. The study did not find a statistically significant effect from the drug. Axcan noted that the decision to shutter the program would reduce its R&D …