UTHR, from twst newsletter
<<TWST: Could we start with a history and an overview of United Therapeutics Corporation (Nasdaq:UTHR), including the origins, markets and your own view of the future potential of the firm?
Mr. Hadeed: United Therapeutics Corporation is a pharmaceutical company with over 60 employees in three states working to develop drugs in the cardiovascular, inflammatory, and infectious disease areas. The company was initially formed to develop therapies for patients diagnosed with pulmonary hypertension but has expanded to pursue therapies for peripheral vascular disease, osteoarthritis, and hepatitis B and C. Our current pipeline of drugs includes three drugs currently in Phase III clinical development, the last stage prior to FDA approval. Uniprost has successfully completed Phase III studies for advanced pulmonary hypertension and will soon be submitted to the FDA for approval. Beraprost is in the middle of two Phase III studies, one for early stage pulmonary hypertension and one for early stage peripheral vascular disease. Beraprost is already approved in Japan, where it is selling very well, and is anticipated to be approved in Europe later this year by its European developer Aventis. Ketotop is in Phase III studies to treat osteoarthritis. This is a transdermal patch that delivers the already approved anti-inflammatory drug, Ketoprofen. It allows patients to apply the drug where it is needed instead of throughout the body. The company also has a suite of other drugs in earlier stages of development. The market for pulmonary hypertension is estimated at $2.5 billion for the US and Europe alone. United Therapeutics has worldwide rights to Uniprost and intends to vigorously distribute the drug internationally after approval in each country. The market for peripheral vascular disease is much larger, as there are an estimated six million people living with this disease in the US alone. The failure of other medications to adequately treat peripheral vascular disease is underscored by the fact that there are 400,000 amputations and other surgeries each year in the US alone relating to this disease. Osteoarthritis is estimated to afflict 12 million Americans, many of whom have bad side effects when taking anti-inflammatory medication internally. So each of these markets has great potential for the company to generate substantial revenues with its products, if approved. At present, the company is well funded with over $240 million in cash. For the first six months of 2000, the company spent approximately $10 million for research and development. So the company has ample cash to complete all its clinical development activities. We are very excited about our future.
TWST:What is Uniprost used for?
Mr. Hadeed: It is used to treat pulmonary hypertension, a disease afflicting approximately 50,000 people in North America and Europe. Pulmonary hypertension is a very deadly disease characterized by very high blood pressure in the pulmonary blood vessels (those between the heart and lungs) and reduced levels of prostacyclin in the blood. Prostacyclin is a natural molecule found in healthy blood that causes blood vessels to dilate and remain open. Our drug, Uniprost is a synthetic version of the native molecule prostacyclin.
TWST: When will this product come to market?
Mr. Hadeed: We expect to file our new drug application with the FDA very soon. All signs from the FDA have been that we should expect a very quick review. So, with approval, we should commence sales next year.
TWST: Is there anything else on the horizon to compete with this product?
Mr. Hadeed: There are no other prostacyclin therapies on the market at present that will compete with Uniprost, other than Flolan.
TWST: As we look out over the next two or three years, what kind of growth does Wall Street expect from the company?
Mr. Hadeed: Wall Street is projecting exponential growth.>>
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