Member of Farmavita.Net, the Australian pharmaceutical company is wishing to license Fexofenadine dossier to interested parties. Dossier is in CTD format acceptable to Australian TGA. Reference BE was done against Australian innovator.
The older antihistaminic agent terfenadine was found to metabolize into the related carboxylic acid, fexofenadine. Fexofenadine was found to retain all of the biological activity of its parent while giving fewer adverse reactions in patients, so terfenadine was replaced in the market by its metabolite. Fexofenadine was developed by Hoechst Marion Roussel (now part of Sanofi-Aventis) and approved by the Food and Drug Administration (FDA) in 1996. AMRI holds the patents to the intermediates and production of fexofenadine HCl along with Roussel. Since that time, it has achieved blockbuster drug status with global sales of $1.87B USD in 2004 (with $1.49B USD coming from the United States). AMRI received royalty payments from Aventis that enabled the growth of AMRI.
Almost all regulatory authorities worldwide accept BE against Australian innovators. Product is from facility that is TGA approved, UK MHRA approved and sth African MCC approved. Facility is also approved by Singapore and Malaysian authorities.
EXTREMELY competitive unit pricing on offer. Full stability, validation and BE against Australian innovator.
Offer is valid subject to confirmation, country by country. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights. Farmavita.Net is not owner of offered products/licenses and do not take any liability related to them. However, as the licensing agent we do our the best to facilitate that closed licensing agreements are made on mutual benefit of contracting parties and without infringement of intellectual property of third parties.
|Pharma licensing||Out-licensing (offer)|