Anesiva Forms Joint Venture With Wanbang Biological

SHANGHAI – Anesiva entered into a joint venture Oct. 14 with Jiangsu Wanbang Biological Pharmaceutical Corp., a subsidiary of Shanghai Fosun Pharmaceuticals, to establish additional manufacturing capacity for the worldwide supply of its fast-acting topical local analgesia Zingo (lidocaine hydrochloride monohydrate).

Under the agreement, San Francisco-based Anesiva will own 49 percent of the company, which will be renamed Wanbang-Anesiva Jiangsu Pharmaceutical Ltd.

The production area will be located at an existing Wanbang facility in the city of XuZhou in Jiangsu province. Following completion of a new assembly facility, Anesiva will seek U.S. FDA certification for the plant.

Zingo is a needle-free system that delivers 0.5 mg sterile lidocaine powder into the epidermis of the skin and provides topical, local analgesia one to three minutes after administration. It was approved by the U.S. FDA to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children three to 18 years on Aug. 16, and is set to enter the U.S. market in the second quarter of 2008.

"With the strong commercial success we expect from Zingo, we believe it is important to add production capacity beyond what we are building here in the U.S.," Anesiva CEO John McLaughlin said in a statement. "Our new joint venture will create significant additional capacity that will also help us drive down our manufacturing costs, all with only a modest up-front capital investment."

At present, Anesiva views China as a manufacturing base, and is not yet looking to the Chinese market for product sales.

“We haven’t filed for regulatory approval of Zingo in China, and do not have a timeline for a launch there at this time,” Anesiva Spokeswoman Daryl Messinger told PharmAsia News. “We don’t foresee conducting any additional trials of Zingo beyond the registrational Phase III trials that are already completed and upon which the U.S. approval is based.”

“Anesiva has no current plans to market it in China and we do not have any market data for the Chinese market,” Messinger said. “However, we are investigating marketing approvals throughout the world.” 

Messinger also added that for the time being, the manufacturing agreement with Wanbang pertains solely to Zingo, Anesiva’s only approved product. The company is also studying Zingo for adult use; positive top-line results from a pivotal Phase III study were released earlier this month. In addition, Anesiva is studying another pain product, Adlea, currently in Phase II studies.

“Zingo is not yet commercially available,” said Messinger, on the issue of manufacturing capacity. “We are still bringing up automated manufacturing in the U.S. and we will gain an additional manufacturing capacity in China with the agreement with Wanbang.”

“Wanbang could expand its foreign business by the joint venture,” Xia Qian, an analyst with Beijing-based Orient Health Ecommerce, told PharmAsia News. “It will also help them raise their quality control management to U.S. FDA standards.”

“For Anesiva, the joint venture means reduced manufacturing costs, as a result of the lower business operating costs in China,” added Xia.

Wanbang is one of China’s leading biopharmaceutical enterprises and the largest manufacturer of insulin in China. Its products include insulin injections, meglumine adenosine cyclophosphate for the prevention of arrhythmia, and nateglinide tablets for treatment of diabetes.

In addition to R&D and contract manufacturing, parent company Fosun Pharma commands a leading market share in China pharmaceutical distribution, diagnostic products and medical equipment. The company is also well known for its anti-malarial medication Artesunate (artesunic acid), which is listed on the World Health Organization’s prequalified medicinal products list.

In 2005, Fosun Pharma entered into an agreement with LEO Pharma, a Danish company, to manufacture LEO’s antibiotic cream Fucidin (fusidic acid) – the first time a Chinese company entered a contract manufacturing agreement to manufacture a finished drug product for a Western company.

– Dai Jialing

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