<< Unigene Laboratories announces reduction in workforce and operating expenses | Key trends impacting the global Alzheimer's disease market >>
Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | עִבְרִית | Русский | Svenska | Polski

Osteologix to file an European Marketing Application for its NB S101 strontium therapy

Published on December 9, 2009 at 8:52 AM · No Comments

Osteologix Inc. (OLGX.OB) announced today that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis.

Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos® (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities. As a result of these discussions, Osteologix has determined that the company will be positioned to pursue a European Marketing Application for NB S101 as a treatment for post-menopausal osteoporosis. The company expects that it can complete the additional development work in 2010 and will be prepared to file a marketing application during the first half of 2011. This pathway is in keeping with the Company's overall strategy of developing its once-daily strontium tablet for the osteoporosis market. Osteologix has initiated discussion with potential regional and global partners and believes that the selected partner(s) will be able to begin marketing the novel product by 2012, providing them with at least 12 years of patent protection in the European Union.

Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.



  Country flag

biuquote
  • Comment
  • Preview
Loading