Working to Improve the Worlds Best Selling Anesthetic
We're building a diverse pharmaceutical product pipeline that addresses serious chronic and acute neurodegenerative disorders. AQUAVAN® Injection is an important addition to this franchise, which may offer advantages over traditional anesthetic agents.
Propofol is an intravenous drug widely used to anesthetize or sedate patients undergoing surgery or other diagnostic or medical procedures. Sales of propofol in 1999 were in excess of $750 million -- making it the world's best selling anesthetic agent. Despite its commercial success, propofol has been associated with various side effects. These include: cardiovascular side effects (such as reduced heart rate and decreased blood pressure), depressed respiration, elevated blood lipid levels, pain at the site of injection, and a potential for bacterial contamination that could lead to infection. Many of these side effects result from the product's formulation, which is an oil-based emulsion.
The newest addition to Guilfords pharmaceutical pipeline, AQUAVAN® Injection is a novel, water-soluble pro-drug of propofol that is rapidly converted in the body into propofol after intravenous administration. Because of its solubility in water, Guilford believes that AQUAVAN® Injection could have significant advantages over a lipid-based formulation. These may include potentially fewer side effects such as: cardiovascular side effects, elevated blood lipid levels (hyperlipidemia), increased ease of use, improved stability, reduced risk of bacterial contamination and pain upon injection.
AQUAVAN® Injection is formulated in a clear aqueous solution that does not require a lipid (oil-based) emulsion for its administration. In preclinical studies, AQUAVAN® Injection produced rapid and effective anesthesia and sedation at doses that were not associated with cardiovascular or other side effects.
AQUAVAN® Injection is an important addition to Guilford's neurological product pipeline. Under the terms of an agreement with ProQuest Pharmaceuticals Inc., Guilford acquired exclusive worldwide rights to develop and commercialize AQUAVAN® Injection, as well as rights to other potential pro-drugs of propofol for other indications. Under the agreement, Guilford acquired an equity position in ProQuest. In exchange, ProQuest received $1 million in cash and will be eligible for milestone payments - if the product progresses through clinical development, and royalty payments on any future product sales.
The Development Strategy:
Since AQUAVAN® Injection is a pro-drug of a successful commercial product, Guilford believes that the development timeline for AQUAVAN® Injection may be shorter than with a new chemical entity.
In 2002, Guilford began a U.S. Phase II clinical trial of AQUAVAN® Injection in approximately 200 patients undergoing colonoscopy procedures. A second phase II clinical trial was begun in Europe in patients undergoing coronary artery bypass surgery. The goal of these studies is to assess the safety and efficacy AQUAVAN® Injection in the conscious sedation and cardiac surgery setting. Results from these studies should be available in late 2003.
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