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"Pharma in China Being Held to Higher Standard, Says Greg Scott, ChinaBio"
The Week in Review: Tasly Pharma to Build US Manufacturing Facility
Transactions and Deals
Tianjin Tasly Pharma (SHA: 600535) announced it will invest $40 million into a US facility to support its TCM-based treatment for coronary disease, known as Compound Danshen Dripping Pills (see story). The company will build a 430,000 square foot production facility and training center near Washington DC, in a life sciences park located in Maryland. CDDP successfully completed a Phase II trial in early 2010. The company is planning a 2,000 patient Phase III trial that is expected to begin this year.
Livzon Pharma (SHE: 200513) will spend $154 million to build two new fabrication facilities in a Ningxia Hui Autonomous Region industrial park (see story). As a first step, Livzon will allocate 90 million RMB apiece to form two JVs, each of which will be formed with one of its subsidiaries. The JVs will increase production of each subsidiary’s APIs. First phase work in the park will cost $46 million.
Pfizer (NYSE: PFE) and Zhejiang Hisun Pharma (SHA: 600267) are in the process of forming a branded generics JV, a potentially significant initiative for gaining a larger position in China’s pharmaceutical market (see story). About 60% of China’s drug spending goes to generics. Both companies would contribute products or other capabilities into the new JV, which is seen initially as a manufacturing venture. It will also commercialize and market drugs and conduct R&D on off-patent medicines. So far, the two companies have signed a Memorandum of Understanding.
Zhejiang Huahai Pharma (SHE: 600521) received FDA approval of a generic Alzheimer’s treatment, donepezil (see story). Donepezil, marketed as Aricept by Eisai (TYO: 4523) and Pfizer (NYSE: PFE), treats the symptoms of mild to moderate forms of Alzheimer’s, though whether the drug slows the progression of the disease remains controversial. Donepezil was the second FDA approval for a Huahai finished product.
KingMed Diagnostics, a China medical diagnostic laboratory, signed a three-year deal under which the University of Pennsylvania Medical Center will provide KingMed with second-opinion pathology consultations (see story). KingMed will transmit scanned glass pathology slides to UPMC. Using a Web-based telepathology portal, UPMC will render the opinions to KingMed. The service is expected to begin later this summer.
First China Pharmaceutical Group (OTCBB: FCPG) reported that due diligence has begun on its proposed acquisition of Shenzhen Ming He Tang Pharmaceutical Co., a drug distributor whose South China business will open new territory for First China (see story). First China announced a MOU to buy Ming He Tang in March. First China also said its acquisition of Shandong Run Kang Pharma has now been put on hold.
D-Pharm (TASE: DPRM), an Israeli biopharma, signed a deal giving Jiangsu Nhwa Pharma (SHE: 2262) exclusive rights to develop its epilepsy treatment, DP-VPA, for China (see story). Nhwa will be responsible for conducting the China clinical trials for the drug, which will be conducted following US FDA guidelines so D-Pharm can use the data to gain approval of DP-VPA in global markets. D-Pharm received $1 million up front, and it is due $1.4 million in milestone payments and 5% royalties on any sales over a specified threshold.
Government and Regulatory
In the case trying eleven individuals for selling fake versions of the drug Avastin, all the defendants have pled guilty (see story). They could face a sentence of death, which was the punishment administered to six people who exported fake malaria drugs to Nigeria. To protect its image as a safe place to manufacture drugs, China is interested in stiff punishments to discourage counterfeiting. Sentences have not yet been handed down by the Luwan District People's Court, where the case is being tried.