Testing Tysabri’s risks

The scientist who was instrumental in developing Tysabri has come up with a test to identify patients at risk of getting a potentially deadly brain infection known as progressive multifocal leukoencephalopathy, or PML.

Since 2005, Tysabri has been linked to 23 PML cases worldwide, that’s about 1 in 400 patients who received the drug. Four patients have died.

Elan, an Irish company that developed the drug, and Boston-based Biogen Idec, which makes it at its Research Triangle Park plant, maintain PML is rare. But patients and investors are getting worried – particularly after it became known recently that the caseload in Europe is much higher than initially thought.

Only eight of the PML cases occurred in the U.S., where doctors must follow strict guidelines of who may get Tysabri and regulators closely monitor adverse event reports for the drug. Most of the 16 cases reported in Europe were in Germany, where regulatory oversight was less strict.

Elan projects Tysabri sales of about $1 billion this year. But more patients could get the drug if a test became available to sort out those at risk of developing PML.

GSK’s need for a new Advair

GlaxoSmithKline will advance efforts to develop a next-generation treatment for chronic obstructive pulmonary disease, or COPD, but the British drugmaker stopped short of updating patients and investors about its next-generation asthma treatment.

GSK’s Advair is currently the top seller to treat asthma and COPD. But Advair, which generated about $8 billion in sales last year, could get competition from cheaper generic copycats starting next year. GSK, which has its U.S. headquarters in Research Triangle Park, fills the Advair disk at its RTP-area plant in Zebulon.

A next-generation Advair is in the works. GSK has a partnership with Theravance, a Bay Area drug development company, to develop a once-daily treatment that is a combination of a new long-acting beta agonist and a corticosteroid GSK already uses in another product.

On Tuesday, GSK said both partners “remain committed to the progression of the … program for the treatment of asthma. ” But for now, the new combination treatment will only go on to late-stage testing in COPD.

In other company news:

• Aldagen made its second attempt in two years to raise $80.5 million in an initial public offering of stock. The Durham biotech company filed for an IPO in May 2008 and withdrew its filing five months later.
• Metabolon, a Durham biotech company, completed a $12.3 million fund raiser. One of the investors in the round is Syngenta, a Swiss agricultural products company that has its research center for genetically modified crop seeds in RTP. Metabolon, which identifies biochemical biomarkers associated with disease and medicines, already had a partnership with Syngenta.

Oil from sticks and grasses

The RTP area is already a hot spot for biofuels research. Researchers, economists and economic developers at universities, companies and government organizations have been working on efficient ways to make ethanol from biomass such as wood chips, corn stover and switch grass.

Now, researchers at RTI International in RTP have received a $3.1 million contract from the U.S. Department of Energy to develop a one-step process that turns biomass in a type of bio crude. The biomass “oil” is an effort at finding a replacement for petroleum, the world’s most important source of energy since the 1950s.

Patients grow wary of Tysabri

Concerns are on the rise about Tysabri’s side effects. The multiple sclerosis therapy, which Biogen Idec makes at its plant near Research Triangle Park, has been linked to more than a dozen cases of a potentially deadly brain infection called progressive multifocal leukoencephalopathy, or PML.

A few months ago, Biogen stopped reporting new PML cases, but during his third-quarter earnings call with analysts, Biogen’s chief executive acknowledged that the risk of developing PML seems to increase the longer a patient takes the drug.

The risk of coming down with PML has had an effect on patients and doctors. The number of new patients starting on the drug every week decreased slightly in the third quarter compared to the second quarter.

Biogen temporarily withdrew Tysabri from the market in 2005 and reintroduced the drug a year later with closer patient monitoring in place and with approval from the Food and Drug Administration.

BDSI goes on publicity blitz

BioDelivery Sciences International has been on a publicity blitz to appeal to institutional investors as Onsolis, a pain patch that is the Raleigh drug development company’s first product, hits the market.

Mark Sirgo, BDSI’s chief executive, rang the bell at the NASDAQ stock market’s opening and sat for interviews with TheStreet.com TV and The Wall Street Transcript in the past two weeks.

The effort hasn’t helped the stock – it’s down below $5 per share from a high of near $7 per share in June. But at least one analyst says he’s impressed. Matthew Kaplan, managing director of the health care group at Ladenburg Thalmann, told The Wall Street Transcript that he liked BDSI.

In other company news:

• Shareholders of Oxygen Biotherapeutics approve a 15-1 reverse stock split. The Durham drug development company hopes to get listed on a major exchange now that it boosted its stock price.
• A Korean company offered about $80 million to buy Trimeris, a Durham company that has shut down its lab and laid off all but a handful of employees. Sales of Trimeris’ AIDS drug Fuzeon continued to drop in the third quarter.
• Quintiles Transnational, a Durham company that helps drugmakers test and sell new medicines, launched a Web site, ClinicalResearch.com, to make it easier for patients to find a clinical trial.