Remodulin Approvable For Pulmonary Hypertension

United Therapeutics (NASDAQ: UTHR) has received an approvable letter for Remodulin (treprostinil sodium) injection. The FDA has proposed drug labeling for the treatment of both primary and secondary pulmonary arterial hypertension (PAH) in patients with moderate-to-severe (NYHA Class II-IV) symptoms. United Therapeutics is planning to pursue several international regulatory approvals. Remodulin is administered subcutaneously via an infusion device developed by Medtronic (NASDAQ: MDT).

Upon approval, Remodulin will compete with GlaxoSmithKline's (NYSE: GSK) Flolan (epoprostenol) and Actelion (Swiss: ATLN) and Genentech's (NYSE: DNA) Tracleer (bosentan). Flolan is delivered intravenously. Remodulin is similar in structure to Flolan, but lasts longer in the body.

Remodulin will be the first FDA-approved therapy for NYHA Class II pulmonary arterial hypertension patients. Tracleer, an endothelin receptor antagonist approved for PAH treatment last November, is the first approved oral treatment for PAH patients as well as from a lower attributable cost profile compared to Flolan. Tracleer's risks are primarily from its adverse effect profile that includes liver damage and birth defects with patients requiring monthly blood tests to catch early signs of liver damage. Female patients on Tracleer need monthly pregnancy tests.

United Therapeutics is also developing a second agent to treat pulmonary hypertension called Beraprost, an oral formulation of prostacyclin presently in phase III clinical trials. Beraprost has demonstrated modest treatment effects in early-stage pulmonary arterial hypertension as well as early-stage peripheral vascular disease. However, mounting evidence shows that intermittent oral doses do not provide consistent levels of the drug in the blood necessary to treat the advanced pulmonary arterial hypertension. Moreover, the magnitude of its treatment effect in peripheral vascular disease is unlikely large enough to merit further study for that indication.

Pulmonary hypertension, in its primary form, strikes one or two people per million. Secondary forms, more frequently observed in the clinic, are seen as an adverse effect of the now-banned diet pills Redux and fen-phen and as a complication of lupus and other rheumatologic disorders. Pulmonary hypertension is high blood pressure in the pulmonary (lung and related) arteries and/or its branches, blood vessels normally under considerably lower pressures than those of the aorta and its branches that go to the rest of the body. Pulmonary hypertension can lead to irreparable and devastating
lung damage.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
February 12, 2002

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