Alchemia partner applies to sell fondaparinux in EU

Alchemia (ASX:ACL) has announced its marketing partner has made a regulatory submission covering Alchemia's generic fondaparinux in Europe.

The partner, US-based Dr Reddy's Laboratories, has made a filing seeking marketing approval for the product in key European markets.

Alchemia CEO Dr Peter Smith said the submission is “consistent with Dr Reddy's strategy for the commercialisation of fondaparinux outside of the US.”

Fondaparinux is an anticoagulant medication marketed by GlaxoSmithCline as Arixtra. It has been off-patent in the US since 2002.

The generic version is manufactured using a method developed by Alchemia, and marketed by Dr Reddy's.

Alchemia last month was granted a US patent covering this manufacturing method, which involves synthesising fondaparinux sodium from monosaccharide building blocks.

A month earlier, Alchemia revealed it was selling more than $1.4 million per week worth of the drug in the US market since its launch in July 2011.

This represents a prescription market share of 18%, including 30% of the retail (non-hospital) segment.

Gaining approval to sell pharmaceuticals in the EU requires a marketing authorisation application to the European Medicines Authority. Applicants are required to follow guidelines on development, manufacturing and packaging, or justify why they are deviating from the guidelines.

Alchemia was founded in Brisbane in 1995. The company is developing a number of pharmaceutical products to add to its portfolio.

The company's oncology business has a drug delivery platform, HyAct, which it is using to develop anti-cancer treatments including HA-irinotecan. This unit is in the process of being spun off into a separately listed entity that will be wholly owned by Alchemia shareholders.

Alchemia (ASX:ACL) shares were trading 0.93% higher at $0.540 by 3pm on Tuesday.