Dragon Pharmaceuticals Inc. (OTC BB: DRUG) is pleased to announce that it has entered into an agreement related to a novel, slow-release formulation for Erythropoietin (EPO) with Transworld Pharmaceuticals Corp. of Portugal and Renapharm AB of Sweden. EPO has been the most effective drug for the treatment of severe anemia since its introduction in 1989 and is ranked by IMS Health as the world’s fastest growing drug by annual sales, with estimated worldwide sales of $4.8 billion in 2000.
The agreement provides Dragon with sole worldwide manufacturing rights as well as exclusive marketing rights to Asia, including China, Japan, Korea, and SE Asia. Transworld Pharmaceuticals, a leading international distributor of blood related products and biotechnology drugs, will have exclusive marketing rights to all markets outside Asia.
“We are extremely pleased to have completed this agreement,” said Dr. Longbin Liu, President and Chief Executive Officer of Dragon. “We are one of only two companies worldwide developing a sustained release formulation for EPO. This agreement is a key development which will support our goal of developing a leading competitive position in the worldwide EPO market by offering premium quality generic product at significantly lower prices than branded product.”
A pilot clinical trial conducted in 101 patients at the University Hospital, Uppsala University of Sweden, assessed the monthly administration of EPO in this slow release formulation compared to the four times per week administration of conventional EPO. The total dose of each form of EPO was identical. The results of the study showed that monthly administration of the slow release formulation had the same therapeutic effect as four times per week conventional EPO with the added advantage of requiring less frequent injections.
According to the agreement, each partner will participate in the final development of this formulation. Dr. Bo Danielson MD PhD, Managing Director of Renapharm and developer of the slow-release formulation, will serve as lead clinical and technical advisor to the project. Dr. Danielson is recognized as a world expert on EPO, having participated in over 75 published clinical studies involving EPO.
The potential market for slow-release EPO is estimated at US$5 billion per year, with application in the treatment of anemia in patients with kidney failure and cancer patients undergoing chemotherapy.
Prior to the 2004 expiry of the EPO gene patent, generic forms of EPO may only be sold in developing world markets outside of North America, the European Union, Japan, Australia, and New Zealand. Given that Dragon’s slow release formulation includes the Company’s generic form of EPO, initial sales will focus on those markets not protected by the EPO gene patent. After 2004, Dragon’s new formulation would not be restricted by any existing patents and would be eligible for marketing throughout the world.
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