Deals and Financings
WuXi PharmaTech (NYSE:WX), the China-US CRO/CMO, paid $65 million in cash to acquire NextCODE Health, a genomic analysis and bioinformatics company with operations in the US and Iceland (see story). One year ago, NextCODE was spun out of deCODE Genetics with a five-year exclusive license to deCODE's sequence-based clinical diagnostic applications. The acquisition involves WuXi in the clinical diagnostic market for the first time. The company says the transaction lays the groundwork for the creation of an integrated global enterprise for applying genomics to medicine.
Fosun Pharma (SHA: 600196; HK: 02196) will invest $35 million in Amerigen Pharma, a US-China maker of hard-to-manufacture generic drugs. Amerigen said it would use the capital to build its drug portfolio through internal R&D and business development. The two companies already have a relationship: in 2012, Amerigen partnered with Shanghai Fosun Omni Pharma to develop controlled-release oral generic products, which Amerigen planned to market in the US.
Hua Medicine Ltd. of Shanghai closed a $25 million Series B financing. With the new funds, the company will begin a Phase II clinical trial of its lead asset, HMS5552 (Sinogliatin), a novel 4th-generation glucokinase activator (GKA) for Type 2 diabetes. Hua in-licensed global rights to Sinogliatin from Roche (SIX: [ROG]) (OTCQX:RHHBY) three years ago. Hua will also begin a Phase I trial of the molecule in the US this year, with plans to complete the trial before year end. Hua was formed in 2011 with an initial Series A round of $50 million.
Sihuan Pharma (HK: 0460) (OTCPK:SHPHF), its Chairman and a Morgan Stanley (NYSE:MS) unit agreed to purchase a 69% stake in a Nanjing Jiangbei People's Hospital for $66.8 million, a privatization of a government-owned hospital (see story). The hospital stake will be acquired by a joint venture, Renfang Medical Holdings Ltd., which was formed by the three partners. Earlier last month, Renfang paid $133.5 million for a stake in another hospital, located in Huaiyin, Jiangsu Province.
Shenzhen Hybio Pharmaceutical out-licensed US rights for a generic version of Copaxone, Teva's (NYSE:TEVA) blockbuster multiple sclerosis treatment, to Akorn Inc. (NASDAQ:AKRX), a generic US drugmaker (see story). Copaxone recently lost its patent protection in the US. Akorn will pay an initial milestone of $5 million to Hybio when Hybio develops generic Copaxone to US standards and files for approval. The duration of the contract between the two companies is ten years.
China Medical System Holdings (HK: 0867) (OTC:CHSYF) of Shenzhen acquired China rights to two Novartis (NYSE:NVS) drugs: Lamisil, an antifungal medication used especially for fingernail and toenail infections, and Parlodel, a dopamine agonist that treats pituitary-caused disorders (see story). The agreement includes rights to manufacture the drugs and a joint marketing license for the Swiss market in addition to the China rights.
Phagelux, Inc., a Shanghai company that is developing phage-based anti-bacterial products, in-licensed several biodegradable polymer delivery systems from Iveria Technologies of the US. Mark Engel, Chairman of Phagelux, told ChinaBio Today, "The technologies acquired will primarily be used for human health although there are also some potential applications in animal health area, especially pets." Phages are potential alternatives to many uses of antibiotics, including drug-resistant bacteria strains. Engel said the Iveria deal contained provisions for upfront payments, milestones and royalties on sales.
Shanghai Fosun Pharma (SHA: 600196; HK: 2196) announced an $800 million budget for R&D during China's 13th Five-Year Plan (2016-2020), double its expenditure during the current five-year period. The largest investment will be a $240 million commitment for biosimilar drugs, centered on Shanghai Henlius Biotech Co., a subsidiary. Henlius will create a biopharma research center and build a GMP production facility for monoclonal antibodies. As a company, Fosun has long been an active M&A player, but the news makes clear the company is also increasing its internal development.
To make life easier for its CRO clients, WuXi PharmaTech announced a mobile app, WuXi V-Lab, to order chemical synthesis services (see website) (see story). Customers can make inquiries, get quotes, place orders, track progress or pay via mobile phones with either Android or iOS operating systems. WuXi wants to make its portfolio of CRO/CMO services available to the global market, and with the new app, placing a chemical synthesis order becomes a routine retail event, like paying for a Starbucks coffee.
Trials and Approvals
Ascentage Pharma Group, a China biopharma focused on cancer drugs with apoptosis mechanisms, received CFDA approval to begin clinical trials of a novel cancer drug candidate, APG-1387. As a new chemical entity, not previously approved in any country, APG-1387 was designated by the CFDA as a Class 1.1 drug and given priority review under the CFDA's Special Review Procedure. According to Ascentage, the drug is the first China-made molecule with an apoptosis mechanism to begin clinical trials in China.
Sirnaomics, a US-China biopharma, together with its partner Guangzhou Xiangxue Pharma (SHE: 300147), filed with the CFDA to begin human clinical trials of STP705, an anti-fibrosis small interfering RNA (siRNA) drug. The trial, which will be conducted simultaneously in the US and China, will test whether STP705 prevents and treats human skin hypertrophic scars. Sirnaomics said STP705 is the first siRNA product to file a China Class 1.1 IND, a class reserved for novel drugs not previously approved anywhere in the world.