New mktg, mfg partner appointed for synthetic heparin

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Australian drug development company Alchemia Limited (ASX: ACL) today announced the appointment of Dr Reddy's Laboratories Limited (NYSE: RDY) 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®'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® 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.

 

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