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Pulmonary arterial hypertension (PAH) is a devastating disease that carries a poor prognosis. Untreated, about half of patients die within two years.

Only recently have specific medicines for this disease become available. While effective, the first available therapy, epoprostenol, proved difficult for patients to use because it is delivered on a continuous intravenous basis rather than in a pill form.

Bosentan, a dual endothelin receptor antagonist, is the first approved oral treatment for PAH. In short-term (12-16 week) trials, bosentan has demonstrated improvements in how far patients can walk and how they feel.

This improvement, combined with the convenience of an oral therapy provides a valuable treatment option for patients.

In order to assess the long-term benefit of bosentan, a recent analysis of long-term data was performed. Vallerie McLaughlin (University of Michigan, Ann Arbor, USA) and her American and European colleagues compared the survival in bosentan-treated patients to the survival that would have been predicted based on past clinical experience.

Survival in the treated patients was 96% at one year and 89% at two years. In comparison, the expected survival without treatment was 67% at one year and 58% at two years.

After two years of follow-up, 70% of patients were still on bosentan alone, without the need for additional therapies. Although treatment with bosentan was well tolerated, it was associated with a 10% incidence of elevated liver enzymes thereby requiring monthly liver enzyme monitoring by a simple blood test.

In summary, bosentan, an oral treatment of pulmonary hypertension, improves how patients feel and how long they live.

Biotech halts production of dietary supplements

Neil Adler
Staff Reporter
January 26, 2006 - United Therapeutics has decided it didn't have the heart to continue making and selling its HeartBar product line.

The Silver Spring-based company (Nasdaq: UTHR) says Securities and Exchange Commission filing that its managers agreed to stop production, marketing and sales efforts for the HeartBar products, which are arginine-enriched dietary supplements.

The decision was made Jan. 19 by company executives after evaluating recently clinical trial results and market potential, among other considerations, the Jan. 25 SEC filing says. Silver Spring-based Unither Pharma, a subsidiary of United Therapeutics, marketed the HeartBar line. The supplements were used to treat and prevent cardiovascular disease.

United Therapeutics will recognize non-cash impairment charges of about $2 million from the write-off of the HeartBar trademarks. These charges will be recorded in the quarter ending March 31. The firm says it does not anticipate any other "significant expenses or future cash expenditures" relating to the discontinuance of HeartBar.

In 2003, Unither Pharma and United Therapeutics settled charges brought by the Federal Trade Commission that the companies made deceptive claims in advertising for the HeartBar products.

According to the FTC, the companies claimed that HeartBar, among other things, reduced the risk of developing heart disease and reversed damage to the heart.

The commission charged that these claims were not supported by scientific evidence. In its agreement with the FTC, the companies were prohibited from repeating these type of claims for HeartBar unless they had adequate scientific support.

Despite the decision to halt production and sales of HeartBar, United Therapeutics remains one of the most successful biotech firms in the Washington area -- and of several to actually be in the black. The company reported earnings of $15.8 million on revenue of $33 million for its quarter ended Sept. 30, representing increases of 152 percent and 65 percent, respectively, over the same period a year earlier.

The firm's lead marketed product, Remodulin, is for the treatment of pulmonary arterial hypertension, a disease caused by high blood pressure in the pulmonary artery that takes blood from the heart to the lungs. Analysts say Remodulin could eventually reach $300 million in annual sales.

Another product, Ovarex, is a monoclonal antibody in Phase III clinical trials for patients with stage III/IV advanced ovarian cancer. It could be ready for market approval by 2008, if late-stage data come back positive. United Therapeutics is building a new $32 million, 50,000-square-foot lab and manufacturing facility near its headquarters that will be ready to occupy in April.

The plant will produce materials used in both Remodulin and Ovarex. United Therapeutics is hiring about 25 new workers and transferring another 25 people from Chicago to staff the new facility.

Stock in United Therapeutics was trading at roughly $69 a share a week ago. The stock was trading at about $64 a share Thursday afternoon.