New Marketing and Manufacturing Partner Appointed for Synthetic Heparin (Generic Fondaparinux Sodium)

SYDNEY, Australia, April 26 /PRNewswire-FirstCall/ -- Australian drug development company Alchemia Limited today announced the appointment of Dr Reddy's Laboratories Limited as its marketing partner for synthetic heparin (fondaparinux sodium).

Alchemia 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(R)'s market exclusivity expires in 2012. Dr Reddy's 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).

Alchemia Limited CEO, Dr Tracie Ramsdale, said Alchemia and Dr Reddy's would share profits equally from finished product sales, with Alchemia's share increasing to 60% if sales of Arixtra(R) exceed a certain level at the time of commercialization of its product.

"We had very strong interest from multiple potential partners for this product. We selected Dr. Reddy's Laboratories because of its marketing capabilities and rapidly growing sales in several important markets including the US."

In a separate agreement Alchemia has transferred the manufacturing rights from Dow Pharmaceuticals Inc under license to Dr Reddy's Laboratories in Hyderabad India. 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.

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," said Dr Ramsdale. "In addition, we foresee significant financial and regulatory benefits by having a vertically integrated partner."

Dr Reddy's is recognised as a leader in the generic drug market in the US where it has 31 approved ANDAs (generic drug approvals) and has 58 pending final approval. For the nine months ended December 31, 2006, Dr. Reddy's recorded revenues of US$ 408 million from the sales of generic drugs in the U.S.

"Reddy's also has a marketing presence in India, Germany, Russia and China which are important future markets. In addition, Reddy's is a highly experienced manufacturer of API (Active Pharmaceutical Ingredients) with over 100 Drug Master Filings (DMFs) in the U.S." said Dr Ramsdale.

For further information: Dr. Tracie Ramsdale Chief Executive Officer Alchemia Limited Tel: +61-7-3340-0200 Media enquiries: Ms Anna Whybird Manager, Finance & Investor Relations Phillips Group Tel: +61-7-3230 5000 Mbl: +61 400 611 155 About Alchemia Limited - http://www.alchemia.com.au/

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(R) and other heparin-related drugs, providing Alchemia with a potentially significant market share of the $US3.7 billion worldwide heparin market.

About Synthetic Heparin (Fondaparinux).

Alchemia has used its proprietary carbohydrate technology to develop a generic version of the antithrombotic drug Arixtra(R), via a more efficient manufacturing process. The branded version of fondaparinux, Arixtra(R) 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. Due to the complexity of the synthesis and the intellectual property that Alchemia has around its process, it is believed to be unlikely that there will be other generic versions of fondaparinux for a considerable period of time. The multi billion Dollar heparin market (estimated at US$3.7 billion in 2005) is presently dominated by Lovenox(R), which recorded sales of US$2.7 billion during 2005. Arixtra(R) has demonstrated superiority over Lovenox(R) and unfractionated heparins in a number of clinical trials. Arixtra(R) had already received approvals for the treatment and prevention of deep vein thrombosis and pulmonary embolism with acute coronary syndrome (ACS) the last remaining indication pending approval. Arixtra(R)'s sales are starting to gain traction following an initially slow start with 2006 sales figures of US$107M (+143%) worldwide and US$58M (+123%) in the US.