Anesiva, Inc. (ANSV), headquartered in South San Francisco, formed a joint venture with Wanbang Biopharma, a subsidiary of Shanghai Fosun Pharmaceuticals, to produce its topical pain killer Zingo. Zingo is a needle-free intradermal delivery of lidocaine powder that is indicated for children who are about to undergo a needlestick procedure. Its analgesic effect begins to work in one to three minutes.
Zingo was granted FDA approval in August, and Anesiva announced its marketing plans for the new product Friday, along with the manufacturing joint venture. Anesiva said Zingo will become widely available in Q2 of 2008.
Although Anesiva already has an approved facility for producing Zingo, it wanted to establish a second source because it expects large demand. Anesiva also wanted to lower its manufacturing costs and to add the production capacity without incurring a large capital expense. Anesiva will own 49% of the joint venture, which will be located in an existing Wanbang facility in XuZhou, Jiangsu province. The official name for the joint venture is Wanbang/Anesiva (Jiangsu) Pharmaceuticals Ltd. Anesiva is currently conducting a Phase III trial of Zingo in adults, over the age of 18.
In other China drug news last week, Zhejiang Huahai Pharmaceutical received an FDA OK to produce a generic form of Viramune, an AIDS drug developed by Boehringer Ingelheim (see story). Unfortunately, Zhejiang Huahai must wait until the patent expires in May 2012 to begin marketing the drug. It was the first time a China-based pharmaceutical company received FDA approval to market finished pills in the US.
Aida Pharmaceuticals (OTCBB:AIDA) said Chinese officials have lightened their previous restrictions on Etimicin Sulfate, the company’s new generation of aminoglycoside antibiotic (see story). Etimicin Sulfate, the first antibiotic to be developed in China, provides all of Aida’s revenues. Regulators had put restrictions on the drug because of fear that it would prove harmful in patients with kidney problems.
AMDL (ADL) found a distributor, Heze Mudan Medicals Co., that has promised to increase sales of a product from AMDL’s China subsidiary, Jade Pharmaceuticals (see story). The product is Domperidone tablets, a drug used to treat nausea and vomiting. AMDL expects the arrangement to add at least $2.3 million annually to sales.
Sinobiomed (OTC:SOBM.OB) said its 82% owned subsidiary, Shanghai Wanxing Biopharmaceuticals, received a patent for manufacturing technology used to create a compound that stimulates the re-growth of liver cells. Sinobiomed used the technology to produce a liver therapeutic that has completed its preclinical tests.
In news on clinical trials, Pharmaceutical Product Development, Inc. (NASDAQ:PPDI), the large CRO (contract research organization) headquartered in Wilmington, NC, appointed Simon J. Britton as vice president of clinical operations for Asia (see story). The new position and the realignment of PPD’s operations, elevating Asia into one of four general geographic areas for clinical trials, indicate the growing importance of Asia for CROs and in the plans for PPD’s Phase II-IV clinical trial services.
Generex Biotechnology Corporation (OTCPK:GNBT) will conduct the Phase I trial of its cancer immunotherapy in collaboration with Dr. Daopei Lu and the Beijing Daopei Hospital in Beijing, China (see story). The immunotherapy, which uses an RNAi approach, was effective in preclinical models of tumors.
And finally, WuXi PharmaTech (NYSE:WX), the Shanghai contract research organization, began construction of a GLP center in Suzhou that will provide preclinical toxicology services (see story). The anticipated completion date is 2009.