Collaborating with Chinese pharma: Inside one company's success story
Part 2 of a 2-part series on CleveXel, anti-malarials, and China's Guilin
You can read part 1 of this series, "How one Shanghai pharma became a model for malaria drug production," here.
French pharmaceutical CleveXel has a unique approach to developing therapies and working with other players in the industry. Its invest-in-kind business model focuses on providing development work in exchange for equity participation.
The company's overarching goal is to bridge the gap between academia, biotech, and big pharma. For this reason, CleveXel has found many opportunities in China, a country that -- despite having a great deal of manufacturing capacity and pharmaceutical activity -- still thirsts for development support. And CleveXel's current collaboration with Shanghai-based Guilin to develop artesunate-injection antimalarial treatments is a shining example of the potential such joint ventures have for industry and consumers alike.
“We have actively been working in China for eight years," said CleveXel CEO Christian Bloy (pictured above) in an interview with BioPharma Dive. "This deal with Guilin is very time sensitive. We are working to actualize phase I and phase II in Europe and then move production to China. By January 2015, our goal is to have the bioequivalence studies completed.”
The meteoric rise of Chinese markets
CleveXel’s longstanding relationships in China are likely to pay off. According to the Financial Times (FT), Asia has the highest rate of pharmaceutical sales growth in the world, with a 15% annualized growth rate between 2007 and 2012. Healthcare spending more than doubled between 2006 and 2011 to $357 billion. And by 2020, that figure is expected to balloon to the $11 billion mark.
Pharmaceutical sales have mirrored that same meteoric rise, growing from $21 billion in 2008 to just under $50 billion in 2012. FT analysts expect about $63 billion in Chinese pharma sales next year -- more than in Brazil, Russia, and India combined.
Beyond the sheer size of the Chinese populace, two key drivers of industry growth are an aging population and a growing middle class. So where might the best opportunities for pharma lie?
As the CleveXel-Guilin collaboration underscores, opportunity awaits when each partner has a well developed skill or expertise that complements the other and allows both to move into a market that would be hard to otherwise access. This may eventually require third-party organizations to get involved. CleveXel may do the heavy developmental lifting, but the not-for-profit group Medicines for Malaria Venture (MMV) has played a critical role in allowing Guilin to leverage its extensive artesiminin franchise and expand its marketing into other high-demand countries.
Artesunate moves to the front-line
The market potential for these anti-malarials was born in 2010, when researchers analyzed two large, randomized clinical trials and confirmed that injectable artesunate decreases malaria-related deaths more effectively than injectable quinine, the preferred treatment at the time. In fact, injectable artesunate offers a 35% reduction in mortality in adults and a 22% reduction in mortality for children compared with injectable quinine.
In response, the World Health Organization (WHO) quickly established artesunate-injection as first-line therapy for severe malaria -- and that's when Guilin struck, working with MMV to become the first Chinese company to produce WHO-prequalified artesunate.
How it all came together
China's pharma industry is known for its focus on generics, API, and manufacturing. But it's never exactly been considered an innovator. In fact, just four drugs have been approved in China in the last 10 years.
So for a company like CleveXel, refining product formulation and handling the preclinical and clinical stages of development before moving production to China makes sense. The end product of the collaboration -- WHO-qualified artesunate -- will go mainly to Africa, though some will be distributed domestically within China.
In order to facilitate distribution and marketing within Africa, Guilin opened a Côte d’Ivoire-based marketing and consulting subsidiary company named GPAF in June 2013. It serves many purposes, including distribution of artesunate-based antimalarials to French-speaking malaria-endemic countries.
Guilin also has subsidiaries in Myanmar, Kenya, and Uganda. Having an Ugandan location facilitates distribution to English-speaking countries with high rates of malaria. In addition, GPAF provides support with policy affairs, local marketing, and phase IV monitoring.
Severe malaria affects just 8% of infected individuals -- but it's a horrible death, beginning with anemia, searing pain, all-consuming weakness, and, eventually, devolving into a coma. It has taken the collaborative efforts of pharma companies in Asia and Europe, along with a Swiss not-for-profit, to ramp up artesunate production. But that collaboration has been a unbounded success. Between November 2010 and this past June, Guilin shipped more than 20 million vials of injectable artesunate.
Bloy emphasizes it's entirely possible for others in the industry to enter China's pharma market as collaborators -- as long as these companies have a strong business model and a desire to work together.
He also has one other piece of practical advice for the industry (and for our readers): “Make sure that someone in your company speaks Chinese and has a strong cultural connection.”
- Medicines for Malaria Venture Guilin Pharmaceutical ─ The world’s first producer of WHO prequalified artesunate for injection for severe malaria
- www.outsourcedpharma.com CleveXel And Guilin To Co-Develop 2 Anti-Malarial Products