Deals and Financings

Kinex Pharma of New York State extended its relationship with South Korea’s Hanmi Pharma by gaining the right to lead Hanmi’s Orascovery program development in China (see story). The Orascovery program is developing oral treatments for cancer from known infused chemotherapies. In 2011, Kinex licensed rights to Orascovery for many countries, though not China, an agreement that included $34 million of upfront and milestone payments to Hanmi.

Tianjin Weikai obtained exclusive China rights to manufacture and distribute TissueFlex® from Zyoxel Limited of Oxford, UK (see story). TissueFlex® is a microbioreactor for 3D perfused cell culture. Zyoxel will receive royalties for each system sold. Zyoxel and Weikai both focus on stem cell technologies. Weikai offers stem cell CRO services and products.

SciClone Pharma (NSDQ: SCLN) formed a collaboration with Soligenix (OTCQB: SNGX), a New Jersey clinical-stage biopharma, to develop a personal medicine treatment for oral mucositis (see story). SciClone will grant Soligenix access to its own oral mucositis clinical and regulatory data in return for China rights to SGX942, Soligenix’ novel treatment for the disorder. SciClone is a US company that distributes western drugs in China. Financial details of the pact were not disclosed.

Luqa Pharma partnered with BMG Pharma S.r.l. of Italy to bring BMG’s products to China (see story). Luqa will be responsible for registering and commercializing BMG’s dermatology, oral care and cancer support therapy products in mainland China and Hong Kong. Luqa, headquartered in Hong Kong, acquires innovative niche products for unmet needs in the China market.

DelMar Pharma (OTCQB: DMPI), a Canada-US startup, reported that its partner, Guangxi Wuzhou Pharma (SHA: 600252), received government support for its collaboration with DelMar (see story). The grant came from the Chinese Bureau of Foreign Experts. In 2012, DelMar and Wuzhou formed an unusual partnership for developing VAL-083 (DAG for Injection).

Government and Regulatory

Because of scandals in China – first a retraction of a scientific article, then the bribery accusations – GlaxoSmithKline’s (NYSE: GSK) China operations have cast a pall over the entire company’s reputation. An even larger question is whether the company’s problems will spill over to affect other multinational pharmas that are also operating in China (see story). In particular, will Glaxo’s misfortunes deal a blow to R&D in China? According to Greg B. Scott, CEO of ChinaBio®, "If something like the scientific retraction had occurred in the US or Europe, the company involved would just have said that a researcher made an error,” Scott said. “But it happened in China, so it affects the perception of the whole country."

GlaxoSmithKline executives in China have reportedly confessed to bribing government officials, hospitals and doctors, a scheme that has been in place for “years” (see story). The executives used travel agencies to make and conceal the transactions. With faked invoices from the travel agencies, GSK effectively avoiding paying taxes on the bribes, according to China’s Ministry of Public Safety, which released the first details of the two-week-old scandal on its website.

About a week after China officials raided three major GlaxoSmithKline offices in China, looking for evidence of “economic crimes,” more of the story has been revealed. It is alleged that GSK’s sales force in Chengdu hatched a scheme to pay doctors to prescribe Botox, the wrinkle treatment, offering payments up to $490 (see story).  

China promotes itself as a great place to conduct global clinical trials. It features low costs and the world’s largest population, most of whom are treatment naïve. But according to documents recently released by the US FDA, the China arm of a global trial caused a nine-month delay in the approval process of Eliquis, a major new product (see story). The reason? There were errors in the data, the wrong drugs may have been administered and adverse events were covered up.

Disclosure: none.