Clinical trial data has confirmed the efficacy and safety of ZyComb™, a new combination nasal spray for the simultaneous treatment of the two major symptoms of common cold – nasal congestion and runny nose. ZyComb™ is currently under clinical development by Nycomed.
The completed trial was a double-blind, multi-country, phase III clinical study of almost 800 common cold patients randomized in parallel groups. The primary objective was to confirm the efficacy and safety of the combination product ZyComb™ (ipratropium bromide and xylometazoline hydrochloride) in comparison with the individual substances (ipratropium bromide, xylometazoline hydrochloride) and placebo in adults.
“The results were in line with our expectations and show that ZyComb™ is significantly more effective than current treatments. This could be the biggest step forward within products for treating common cold symptoms in the last 30 years,” said Thor-Björn Conradson, Senior Medical Advisor in Nycomed.
Nycomed has achieved a positive opinion under the International Patent Cooperation Treaty (PCT), and the patent application for ZyComb™ is now under regional and national evaluation. The first patents are expected to be granted within the next year.
The regulatory submission process in Europe is planned to start in second half of 2004.
The decongestant market has a total value of approximately € 200 million in Europe alone. Nycomed is considering partial or complete out-licensing of ZyComb™.
About ZyComb™
ZyComb™ contains two active ingredients, xylometazoline hydrochloride (for the treament of nasal congestion) and ipratropium bromide (for the treatment of nasal secretion). It is developed by Nycomed as a combination product for the simultaneous treatment of the two major symptoms of the common cold - nasal congestion and runny nose.
About Nycomed
Nycomed is a pharmaceutical company differentiating itself by its European focus. The company’s capabilities include product sourcing, late-stage clinical trials, registration, pricing and reimbursement negotiation and product life-cycle management. Dedicated sales teams target general practitioners, hospital specialists and pharmacists.
With 2,800 people, mostly in marketing & sales, Nycomed covers 19 European markets including the Russia/CIS. Products are also exported to other countries including Japan and the USA. Nycomed is a privately-owned company with 2003 revenue of € 635.5 million.
Further information is available on: www.nycomed.com
For further information:
Thor-Björn Conradson, Senior Medical Advisor
Phone: (+45) 46 77 11 11
Christoffer Jensen, VP Communications
Phone: (+45) 46 77 11 12
Mobile: (+45) 22 43 69 44