Salix soars on rifaximin data

Shares of Salix Pharmaceuticals are up more than 50 percent since the Morrisville company, which specializes in gastrointestinal treatments, announced results from two late-stage studies.

The studies showed rifaximin works better than placebo in treating non-constipation irritable bowel syndrome. Salix already sells rifaximin for traveler’s diarrhea under the name Xifaxan.

Treatments for non-constipation IBS generate about $2.2 billion in annual sales, but patients and doctors are looking for more choices with fewer side effects.

Salix stock dropped below $6 a year ago as the company struggled with generic competition. The day the rifaximin study results came out, Salix shares soared as high as $21.34. Since then, they’ve been close to $20 and attracting the attention of Credit Suisse pharmaceuticals analyst Catherine Arnold, who has tagged Salix an appetizing acquisition target for large drugmakers looking to boost revenue.

Pozen hires executive to broaden its scope

Pozen, a Chapel Hill drug development company, hired a chief commercial officer to develop licensing and marketing strategies for its drugs in development. Elizabeth Cermack, a former Johnson & Johnson executive, specializes in sales and marketing.

Founded in 1996, Pozen has long relied on partnerships with large drugmaker to help develop and market its medicines. Migraine pill Treximet, its first drug to receive regulatory approval, is sold by GlaxoSmithKline, which also helped develop it. Pozen also has a partnership with AstraZeneca to develop and bring to market Vimovo, an experimental painkiller that is easy on the stomach.

But the company, which never ventured into sales and marketing before, recently announced plans to broaden its scope and fly solo bringing to market its family of aspirins that promise to be gentler on the stomach.

GSK waits while competition gets ahead

GlaxoSmithKline, which has its U.S. headquarters in Research Triangle Park, hopes to get approval for Cervarix, a vaccine that blocks a major risk factor for cervical cancer, before the end of the month.

A Food and Drug Administration panel recently recommended the vaccine get cleared for sale after a series of delays. If the FDA follows the recommendation, Cervarix would become available in the U.S. three years after Merck’s version Gardasil was approved.

GSK is also still awaiting FDA approval of its H1N1 vaccine. Four competitors already got the regulatory nod.

Investors rushed to trade the stock after Salix announced results from two late-stage studies Monday that showed rifaximin  works better than placebo in treating non-constipation irritable bowel syndrome. Salix sells rifaximin for traveler’s diarrhea under the name Xifaxan.

About 12 percent of Americans suffer from irritable bowel syndrome, which can cause abdominal pain, bloating, constipation and diarrhea. IBS is not considered life-threatening, but it is difficult to treat, making it one of the most expensive gastrointestinal diseases in the U.S., according to an analysis in Nature Reviews Drug Discovery.

A handful of IBS treatments are on the market, but patients and doctors have been looking for more choices with fewer side effect.

Rifaximin is an antibiotic with minor side effects, including headache and constipation, and has the potential to replace sales Salix has lost since the end of 2007, when generic competition started pummeling its biggest seller, Colazal.

The company expected it will request regulatory approval of rifaximin for non-constipation IBS, the most common form of the disease, by mid-2010. Salix projected that treatments for non-constipation IBS generate about $2.2 billion in annual sales.

Shares rose as high as $21.34 on Monday and started trading above $19 Wednesday. The stock dropped below $19 in  November 2005.

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.