Alchemia's synthetic heparin on track

Alchemia (ASX: ACL) has completed the scale-up of its manufacturing process for synthetic heparin on schedule.

It is a significant milestone for the company, which with partners Dow Chemical Company and American Pharmaceutical Partners (APP), plans to be ready with its generic product when the market exclusivity period expires for the only synthetic heparin currently on the market, Arixtra, which was recently acquired by GlaxoSmithKline from Sanofi.

"The completion of large scale synthesis at Alchemia gives confidence in the cGMP manufacture currently underway at Dow Chemical, due to be completed in June 2005," said CEO Dr Tracie Ramsdale.

"This material will be used by APP for its formulation and stability studies in preparation for filing with the FDA at the end of 2006. Dow needs to produce a minimum of three batches for FDA approval."

Ramsdale said APP would have plenty of time to get ready for its FDA submission, as the exclusivity period would not allow the company to access data on Arixtra before the end of 2006.

But because the product is to be marketed as a generic, the companies only have to show that the drug is identical to Arixtra -- clinical trials will not be required.