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RTP Wrapup 9/11

Thursday, September 10, 2009, 9:39 pm By No Comments | Post a Comment

GlaxoSmithKline gets good news on its Cervarix vaccine and bad news on its blockbuster asthma treatment Advair, the N.C. Biotechnology Center prepares to build a $10.4 million expansion with the help of private donations and Quintiles Transnational gets ready for Clinical Research Education Day at N.C. Central University.

The FDA giveth and Wall Street taketh away

GlaxoSmithKline’s Cervarix got a boost from Food and Drug Administration staffers who said studies showed the vaccine successfully blocked the human papilloma virus, or HPV, nearly 93 percent of the times. HPV infection increases the risk of cervical cancer.

Cervarix ran into regulatory roadblocks in 2007 and a panel of experts has yet to approve the vaccine for sale in the U.S. Gardasil, a competitor made by Merck that generated about $1.5 billion in sales last year, has been on the market since 2006 and has the added benefit to thwart two kinds of HPV responsible for most genital warts.

GSK, which has its U.S. headquarters in Research Triangle Park, hopes Cervarix will be a big seller like Gardasil to help offset expected sales losses due to generic competition.

GSK’s best selling asthma treatment Advair could come under full pressure from generics by 2011, an analyst warned. Advair, which is filled at GSK’s plant in Zebulon, generated $7.6 billion in sales, more than any other GSK drug.

In other company news:

  • The FDA approved Metozolv, a fast dissolving treatment for a diabetic stomach disorder. Salix Pharmaceuticals, a Morrisville company that specializes in gastrointestinal treatments, owns the rights to market Metozolv. If taken for extended periods of time, Metozolv can cause muscle spasms and a movement disorder.
  • XinRay Systems, a nanotechnology startup in RTP, received a $1.13 million research contract to develop and test X-Ray equipment using carbon nanotubes for the Department of Homeland Security. The equipment will be designed to detect explosives in baggage and cargo.
  • Oxygen Biotherapeutics, a Durham company developing wound care treatments, announced it will ask shareholders for approval to reduce the number of its outstanding shares. The company hopes the reverse stock split will boost its share price, enable a switch to a major stock exchange and make it easier to raise cash.
  • Cempra Pharmaceuticals, a Chapel Hill drug development company, said it has begun testing an antibiotic treatment for drug-resistant infections in patients. Cempra recently raised $46 million in venture capital.

NC Biotech Center gets ready for expansion

The N.C. Biotechnology Center has raised the money needed to build a $10.4 million expansion on its RTP campus.

The expansion has been planned for at least a year and private donors provided much of the cash needed to complete construction next year.

Donors included the Duke Energy Foundation and Biogen Idec. The Boston-based drugmaker, which has a production plant in the Triangle, provided $1 million.

Clinical Research Education Day

Free health screenings, food and a raffle promise to draw a crowd Sept. 12 at North Carolina Central University.

There’s a reason for all the goodies. Organizers want people to stay and listen - to speakers like Dr. Robert Califf, who heads Duke University’s Clinical Research Institute; Dr. Wendy Brewster, director of women’s health research at the University of North Carolina at Chapel Hill; and executives from Quintiles Transnational and PPD, two North Carolina companies that help drugmakers test new medicines.

Hosted by the Center for Information and Study of Clinical Research Participation, the public education workshops at NCCU are part of an East Coast campaign aimed at getting more people, particularly more minorities, interested in participating in clinical trials.

More about the Clinical Research Education Day here and a Q&A with Sandy Kennedy, whose job duties at Quintiles Transnational will be a topic at one of the workshops, here.

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