Tracleer and PPH News New Treatment, Significant Improvement for HIV-related Heart Condition
(Ivanhoe Newswire) - December 8, 2004 - Treatment with the oral drug bosentan (Tracleer) led to significant improvements in an often fatal disease, pulmonary arterial hypertension, according to a new study. PAH is usually linked with human immunodeficiency virus infection. HIV infection is believed to cause the overproduction of endothelin, which increases the chance for small pulmonary arteries to become obstructed. This chronic obstruction leads to PAH, a condition that in most cases is the direct cause of death. Bosentan mediates the effects of excess endothelin production. Researchers in France evaluated 16 HIV-positive patients suffering from PAH who were treated with bosetan for 16 weeks. In the past three months, patients had to be in stable condition in terms of their HIV infection. Results show there was significant improvement in survival indicators of the disease, such as six-minute walk distance and cardiac index, following bosetan treatment. All patients suffered at least one adverse side effect of the drug including peripheral edema, headache, abnormal liver function, muscle cramps, fluid retention, and vomiting. SOURCE: American Journal of Respiratory and Critical Care Medicine, 2004;170:1212-1217
Accredo Health 2Q Earnings Up Slightly
01.31.2005 - Accredo Health Inc., a provider of contract pharmacy services for chronic diseases, said Monday that earnings rose 2 percent in the second quarter, and raised profit estimates for fiscal 2005. Net income grew to $20.2 million, or 41 cents per share, from $19.9 million, or 41 cents per share, a year ago. Revenue increased 29 percent to $503.9 million from $389.8 million last year. Analysts surveyed by Thomson First Call were looking for the company to post earnings of 40 cents per share on sales of $488.5 million in the latest quarter. Chief Financial Officer Joel R. Kimbrough said, "We are pleased with the breadth of our continued revenue growth across our product lines, as evidenced by exceeding the current quarter growth rate for two of our pulmonary hypertension products - Remodulin and Tracleer - and several of our more established core product lines such as growth hormone, Avonex and hemophilia." The company said second-quarter gross profit margins decreased to 17.8 percent from 20.5 percent a year ago, due to lower reimbursement levels from government and commercial payors. Accredo expects its overall gross profit margin percentage to be in the 17 percent to 18 percent range in the third quarter of fiscal 2005. The company raised fiscal year earnings projections to between $1.56 and $1.61 per share, from prior estimates of $1.53 to $1.60. Revenue is still expected to range between $1.85 billion and $1.90 billion. In addition, Accredo Health estimates that for the fiscal year ending June 30, 2006, the company will post profit of $1.78 to $1.84 per share on revenue of $2.15 billion to $2.225 billion. Analysts currently expect the company to post fiscal 2005 earnings of $1.61 per share on sales of $1.88 billion, and fiscal 2006 profit of $1.81 per share on revenue of $2.13 billion.
Long-term treatment with bosentan improves outcomes in pulmonary arterial hypertension, European Respiratory Journal
26 Jan 2005 - 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. This is a press release from the European Respiratory Journal (ERJ), Vol. 25, No 2
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