Venticute® granted “Fast Track” designation in the US


Nycomed’s investigational surfactant product Venticute® (rSP-C- Surfactant) has been granted “Fast Track” designation by the United States Food and Drug Administration for reduction of mortality in patients with severe acute pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation and severe oxygenation impairment.

Currently, there is no approved treatment for acute respiratory failure which causes death in approximately 30% of affected patients. For those affected, hospital and intensive care costs are high as patients often remain on mechanical ventilation for weeks.

Venticute® is currently being studied in the VALID trial, a multi-national clinical phase III investigation of mortality reduction in 1,200 patients. The trial is being conducted in selected sites throughout Europe, North America and other regions. In addition to clinical outcome data, the trial will collect other relevant clinical and health economics information such as quality of life, resource use and associated costs.

“We are optimistic that in this population of critically ill patients Venticute® has the potential to demonstrate reduced mortality and other clinically important effects,” said Anders Ullman, Executive Vice President R&D.

Fast Track designation is received when a product is intended for a serious or life threatening condition and has the potential to address an unmet medical need. Fast track designation is also intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

In September 2006, Venticute® received Orphan Drug Designation from the FDA for use in patients with severe acute pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation and severe oxygen impairment. Orphan drug status is designed to encourage the development of drugs which treat rare diseases and would be prohibitively expensive/unprofitable to develop under normal circumstances. Companies that develop and obtain approval for an Orphan Drug are granted tax incentives and seven years marketing exclusivity.

About Nycomed

Nycomed provides products for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.
The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.
Privately owned, the combined group had non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).

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