Sinobiomed Wins Patent Approval For Viper Venom As Anti-Bleeding Agent

Sinobiomed Inc. (SOBM.OB) received approval for a patent in China that covers its recombinant batroxobin. Naturally-occurring batroxobin is the world’s most often prescribed product to stop bleeding, particularly during and after surgery. Batroxobin is found in the venom of the pit viper. rBAT from Sinobiomed is the world's first batroxobin synthesized through gene recombination.

Sinobiomed says that the natural product is relatively expensive to produce and can sometimes cause side-effects. As a competitive advantage, Sinobiomed’s product is 98% pure, rendering neurotropic side-effects less likely, and the recombinant compound can be made for as little as 3.68 RMB per dose (around 50 cents).

Sinobiomed is currently conducting Phase II trials of its rBAT, which it expects to conclude in October of 2007. In Phase I trials, rBAT was well tolerated and effective. Sinobiomed hopes to launch the product as early as 2008.

In China , natural batroxobin is included in the drugs approved for payment by the national health service. The total revenue for anti-bleeding agents in China is 2 billion RMB ($261 million). Reptilase, produced by Pentapharm of Basel, Switzerland, is the leading product in the market. It was originally approved for use in China in 1992, and now owns 80% of the market with revenues of 1.2 billion RMB ($157 million).

Sinobiomed expects its rBAT product to ultimately achieve sales levels of 300 RMB ($39 million) to 500 RMB ($65 million) with a 50% profit margin. The patent was awarded to Shanghai Wanxing Biopharmaceuticals Co., Ltd, the Chinese subsidiary of Sinobiomed, which discovered the compound and in which Sinobiomed holds an 80% stake. The patent also covers the synthesis of the batroxobin gene, and well as the expression, purification and characterization of batroxobin.

Through Shanghai Wanxing Biopharmaceuticals, Sinobiomed is already marketing two other drugs in China : Wanferon/Wanferin, a recombinant human interferon for hepatitis B, hepatitis C, viral infections and other conditions, and Leflunomide, a rheumatoid arthritis drug. It has a total of 10 drugs in development, including rBAT.

Disclosure: none.