Frontage Laboratories hired by local Chinese pharmaceuticals to develop drugs overseas

Seeking additional financing to expand facilities this year -exec

2012-04-26   BioPharm Insight

 

Shanghai-based Frontage Laboratories China [Fang Da Yi Yao] has been hired by a few Chinese pharmaceutical firms to help new drug development overseas, and is also seeking additional financing to expand development facilities this year, according to senior vice-president Nick Zhang.

 

Founded in 2001, Frontage has helped Hisun Pharma file an Investigational New Drug (IND) for a cholesterol-lowering drug in the US in April 2012, and it will initiate clinical trials for Hisun in the US as well. Under a USD 10m framework agreement with Fanghui Pharma, Frontage will be responsible for drug development efforts, including clinical trials conducted in China and the US, regulatory guidance and facility construction consultation. Zhang said Frontage and Fanghui are going to sign the product development contract for a solid dosage form of a generic drug in early May. The drug was recommended and introduced to Fanghui by Frontage, but Zhang declined to give details on specific therapeutic indication.

 

The company recently closed a deal with Sihuan Pharma starting with consultation services, said Zhang. For large pharma companies such as Sihuan, with a capability of conducting internal research and development, Frontage mainly provides consulting services and is involved in clinical trials when it reaches a specific development stage.

Frontage has also been working with Janssen for a long term globally, such as clinical analysis, but Zhang emphasized that the company will be seeing more local collaborations with Xi'an Janssen in near future.

 

Founded in 1985, Xian-Janssen Pharmaceutical has since grown into one of China's largest pharmaceutical joint-ventures, becoming Johnson & Johnson's (NYSE:JNJ) largest branch on the Mainland. Its production facilities are located in Xi'an, with offices in 28 cities, with over 3000 employees.

Currently half of Frontage's clients are China-based pharmaceutical firms, while the other half are Western companies, but there is an expectation that an increasing number of clients will be from China, he noted. Chinese companies are now launching parallel studies in China and the US as a trend, and the companies will look for good quality CRO services when they aim to go global, Zhang explained.

 

Frontage has a few locations in China, which include Shanghai, Beijing, Zhengzhou, Jilin and Nanjing. The company is set on expansion this year, and will move its current CMC services from Beijing to Zhangjiang, Shanghai in a 10,000 m2 integrated facility with additional capacity and more equipment. The facility is almost ready to be renovated and is expected to fully online in 2013.

At the same time, the company is constructing a new clinical center in Nanjing, Jiangsu Province -- a collaboration project with Nanjing First Hospital -- that focuses on R&D of early-stage clinical cardiovascular medicines in China, Zhang said. The clinical center is expected to be fully operational later this year, he added.

 

Pharmaceutical innovation and improving generic drug safety is a focus in China's new 12th five year plan. China's SFDA recently issued a notice requiring the re-evaluation of a generic drug's safety, and companies have to redo clinical equivalence studies for both generic and brand-name drugs.

 

Zhang said these moves could be good opportunities for CRO development in the country. Even though the SFDA has not yet released a definite timeframe and detailed regulations for the re-evaluation, Frontage is actively in discussions with SFDA, who are willing to work together and get involved in implementation in order to help more Chinese companies by providing services such as bioequivalence testing.

 

So far, there are seven Abbreviated New Drug Application (ANDA) applications approved by the US FDA from Chinese companies, and Frontage participated in five of them, including nevirapine tablets and donepezil HCL of Huahai Pharma, amlodipine besylate of Beijing Second Pharmaceutical, irinotecan of Hengrui Pharma, zidovudine of HEC Pharma and quetiapine fumarate of Handa Pharmaceuticals from Fosun Group.

 

According to Zhang, the company has a two-pronged approach to its financial strategy. For new facility development, Frontage is considering a financing option of lending operation, and for organic growth it will consider venture capital funds. Frontage has already hired China Renaissance as its financial adviser, he added.

 

By Ying Huang in Shanghai