The news flow from the China biomedical sector took a nose dive during the last week, probably the summer slowdown that seems to affect countries on both sides of the Pacific. One of our articles during the last week, covering patent law changes in China, noted that any further movement on the patent law initiative will be put off until after the Olympics conclude. So perhaps a focus on the Olympics has had a hand in dampening news flow as well. We have seen reports that China visas are becoming difficult for business people to get, and there have been anecdotal stories from CROs that chemicals and biomedical samples are being delayed by authorities, all because of the Olympics. Normally, news flow wouldn’t seem subject to those kinds of difficulties, but the Olympics could be putting a more indirect damper – hopefully, just a temporary one – on the China biomedical world.
On the patent front, we published the second part of our guest article that updates proposed patent law changes (see article). Because of the complicated nature of the issue, it has necessitated a detailed review. In early 2008, we published a series of four articles written by Dr. Charles C. Liu and Jeanne Liu that discussed the major areas of change under consideration at that time. Now, in July, we have published two updates to those earlier articles that detail the most recent proposals for change. This week, the subjects of inventions made in China and empowerment of patent administration were the focus. Earlier, the authors updated us on the subject of willful infringement and the subject of misuse of patent rights and unfaithful accusation.
Despite the generally low level of news last week, a few deals were announced. GlaxoSmithKline (NYSE: GSK) completed an unusual arrangement with Aspen PharmaCare, a generic drug manufacturer located in South Africa (see article). According to GSK, the deal will allow GSK to use generic drugs as a means of participating more fully in emerging markets for biopharma, such as China, where much of the growth is expected in the next decade. The arrangement with Aspen is part of a switch for GSK away from its former focus on high-cost patented drugs. GSK was granted the right to promote and sell various drugs from Aspen’s portfolio outside of Aspen’s core territory of sub-Saharan Africa. It will be GSK’s responsibility to obtain regulatory approval for the drugs in each country. Aspen will receive an upfront payment for each drug that GSK chooses to develop, but no upfront payment for the overall relationship. Aspen will also be paid royalties on revenues as GSK begins to sell
MedMira Inc. (TSX Venture: MIR) (NSDQ: MMIRF) of Canada received a patent in China for its diagnostic device and assay (see article). MedMira’s rapid flow-through technology (RFT) platform allows three-minutes tests for HIV, hepatitis and other diseases. MedMira, which is seeking partners to extend its growth, is an approved supplier to the US Agency for International Development (USAID) and the Pan American Health Organization (PAHO).
GNI Ltd. (TOKYO: 2160) of Japan in-licensed a late-stage hepatitis drug from EpiCept (NSDQ: EPCT) (see article). GNI now owns the rights for EP1013 in Asia, Australia and New Zealand, while EpiCept retains control of the drug in the rest of the world. Shanghai Genomics, the wholly-owned China subsidiary of GNI since their merger in 2005, will perform the China development of EP1013. GNI is already developing another hepatitis drug: F351 was given China IND approval in November 2007 for liver fibrosis.
And finally, Genelabs Technologies (NSDQ: GNLB) announced that it will collaborate with Taiwan’s National Health Research Institutes (NHRI), a governmental non-profit foundation, and Genovate Biotechnology of Taiwan to research and develop compounds that target the hepatitis C virus (HCV) (see article). According to Genelabs, the collaboration will combine Genelabs’ lead compounds on an existing target with NHRI’s chemistry and drug discovery abilities. Genelabs lists five R&D programs for HCV currently underway. With Novartis (NYSE: NVS), Genelabs is working on a non-nucleoside program called NS5b. The other four drugs being developed by Genelabs are all nucleosides. Earlier this week, Gilead (NSDQ: GILD) terminated an HCV collaboration with Genelabs, returning the rights to all compounds to Genelabs.