Efforts by WuXi PharmaTech to set up clinical trial capacity in China have just begun but it expects to be operational in the “near future”. In recent years WuXi has consistently invested to add capabilities and views clinical trials as the next “natural extension” to its service offering.
“We get requests from clients who want us to have this capability”, Ge Li, CEO of WuXi, said in a call with investors. WuXi will “most likely” enter the sector by investing to develop its capabilities and through acquisitions.
A timeframe for the expansion is yet to emerge but David Windley, equity analyst at Jefferies & Company, expects things to move slowly. “Most new capabilities [at WuXi] have been in adjacent areas. Clinical is a little further outside of its core area”, Windley said.
It is also uncertain which stage of development WuXi wants capabilities. Asked if the expansion is focused on Phase I or later-stage development, Li declined to answer, citing competitive concerns.
Windley thinks WuXi to start small. “We expect the initial foray to be focused on smaller [clinical pharmacology] capabilities that could leverage the company’s regulatory expertise in China”, Windley said.
Li also touched on the need for China-focused regulatory services. “Clients need high quality clinical and regulatory work in China”, Li said. WuXi plans to target international clients seeking “high-quality and credible” clinical trial work to support marketing applications in China.
Clinical is one of several expansions underway at WuXi and Windley thinks other areas, notably toxicology, should be prioritised. “We believe toxicology needs to be successful for a long-term clinical strategy to make sense”, Windley said.
WuXi conducted seven GLP (good laboratory practice) toxicology studies in the quarter for a range of clients, from big pharma to biotech, and expects the business to grow strongly next year.
Expansion into clinical trial services follows addition of large-scale manufacturing and biologics capabilities at WuXi. Investments have been made to enter these sectors and now some of starting to payoff.
In particular, commercial scale manufacture has ramped up following Vertex gaining approval for Incivek (telaprevir). WuXi supplies an advanced intermediate for Incivek and, with the product outselling its rival, drove a big leap in year-on-year sales.
Vertex chose WuXi as commercial manufacturer of after working together on drug development. WuXi hopes other companies will follow similar paths, with production of clinical trial materials leading to commercial-scale deals, and this idea underpins several expansions at the company.