Alchemia Ltd, an Australian drug development company, has announced the appointment of Dr Reddy's Laboratories Ltd as its marketing partner for synthetic heparin (fondaparinux sodium).

The company has granted Dr Reddy's the exclusive rights to market its synthetic heparin in North America, with first right of refusal to market the product in the European Union once GlaxoSmithKline's branded product, Arixtra's market exclusivity expires in 2012. The latter will be responsible for the development of the API as well as finished product and all regulatory filings including the submission of an Abbreviated New Drug Application (ANDA).

In a separate agreement Alchemia has transferred the manufacturing rights from Dow Pharmaceuticals Inc under license to Dr Reddy's Labs in Hyderabad. The transfer of the manufacturing rights has occurred through a license of Dow's manufacturing rights and related intellectual property to Alchemia. Dow, which successfully produced batches of synthetic heparin at pilot scale, will receive a royalty on sales of bulk synthetic heparin by Dr Reddy's. Sources at Dr. Reddy's have confirmed the agreement which was announced in Australia.

Dr Tracie Ramsdale, Alchemia Limited CEO, said, that Alchemia and Dr Reddy's would share profits equally from finished product sales, with Alchemia's share increasing to 60 per cent if sales of Arixtra exceed a certain level at the time of commercialisation of its product. "We had very strong interest from multiple potential partners for this product. We selected Dr. Reddy's Labs because of its marketing capabilities and rapidly growing sales in several important markets including the US", a press statement by Alchemia said.

Dr Ramsdale said, the technology transfer is complete and the commercial development of synthetic heparin is underway in preparation for US market launch. Alchemia has been working with Dr Reddy's on a number of projects over a period of years and "we recognise its capabilities and excellent international reputation as a manufacturer of FDA approved pharmaceuticals," it said. In addition, the company look ahead at significant financial and regulatory benefits by having a vertically integrated partner.

Alchemia is a drug discovery company with a novel carbohydrate platform technology focused on the development of a generic Synthetic Heparin and on discovering a pipeline of oncology, eye disease, antibiotic and pain treatment therapeutics. Alchemia has leveraged its carbohydrate chemistry expertise to develop a more efficient, economical manufacturing process which Alchemia believes will ensure its generic Synthetic Heparin will be cost competitive with Arixtra and other heparin-related drugs.

The branded version of synthetic heparin (fondaparinux), Arixtra was introduced into the US market in 2002 by sanofi and the rights were sold to GlaxoSmithKline in 2004. The US patents on fondaparinux expired in 2003. The multi billion-dollar heparin market (estimated at US$3.7 billion in 2005) is presently dominated by Lovenox, which recorded sales of US$2.7 billion during 2005.