UPDATE 2-Indevus testosterone drug hits safety snag, shrs crash
(Adds detail, comment; updates share movement)
By Aradhana Aravindan
BANGALORE, June 4 (Reuters) - Indevus Pharmaceuticals Inc's IDEV.O injectable testosterone drug's approval may be delayed by two years, as U.S. health regulators are expected to ask for more safety data, wiping out more than two-thirds of the company's market value.
The decision on approval of the drug Nebido was set to be taken later this month, but will now be delayed as Indevus plans to conduct another safety study and re-apply for approval in around 18 months, which would be followed by six months of review.
This means the company may have to use its available cash of about $60.8 million at March 31 for the added study. The cash could have been used for the previously anticipated launch of Nebido.
Indevus Chief Executive Glenn Cooper said the company will allocate resources to conduct the additional safety study.
However, UBS analyst Annabel Samimy said with lesser than $65 million in cash and a burn rate in the high teens, "operations may be stretched to conduct final studies for Nebido and continue to develop Octreotide."
Indevus, which focuses on treating urology and hormone-related conditions, planned to start a late-stage trial for its octreotide implant for acromegaly, a disorder that results from excessive growth hormone, in the first half of this year.
The company has a number of drugs on the market, including Sanctura for overactive bladder, and several others in the pipeline, but Nebido was considered to be the product with the most market opportunity and the one investors were focused on. Continua...