Jan 21, 2012

China - Double boost for Novartis in China as Lucentis approved and Galvus launched



Two Novartis drugs have seen positive developments in the rapidly emerging Chinese healthcare market.

The pharma company’s vision loss disorder treatment Lucentis has received approval from the state drug regular, while its type 2 diabetes treatment Galvus has now been launched onto the market.

Lucentis' approval makes the drug the first in its class to be available on the Chinese market, where this is a “huge unmet need” for wet age-related macular degeneration (AMD) treatments, according to Professor Xiaoxin Li, Chairman of the China Fundus Society.

It is estimated that there are 300,000 new wet AMD patients per year, with the condition a major cause of blindness and severe vision loss in people over 50.

Lucentis, co-developed with Genentech/Roche, was first approved in the US in 2006 and is now seen as a standard first-line treatment for wet AMD in many markets.

The company achieved sales of $1.5bn for the drug during the first nine months of 2011, with Genentech/Roche recording sales of $1.2bn in the US. But it now faces competition from Regeneron's Eylea (aflibercept), whose less frequent dosing regime could give it an advantage over Lucentis.

Galvus launched in China

The Chinese launch of diabetes drug Galvus (vildagliptin), approved as an add-on treatment to metformin, will also be a boost for Novartis.

The country's diabetic population has quadrupled over the last four years to 92.4m adults, due to the adoption of western lifestyles and an ageing population. Despite the growing number of people affected by the condition rates of awareness and treatment, and consequently control of the condition, remain low.

"Uncontrolled diabetes is threatening to overwhelm our healthcare system," said Professor Ning Guang, an endocrinologist at the Shanghai Jiatong University affiliated Ruijing Hospital. "It is important that new treatments continue to be made available to help physicians address the growing healthcare need."

Galvus, which is approved in over 90 countries across Europe, Asia Pacific, Africa and Latin America had revenues of $478m for Novartis over the first nine months of 2011. But it failed to reach the US market after Novartis withdrew the drug’s marketing application in 2008 following FDA requests for additional clinical trials.

"Today's announcement demonstrates our continued commitment to providing patients in emerging markets access to innovative treatments where there is significant unmet need," said David Epstein, head of Novartis’ pharmaceutical division.

"We are proud to bring Lucentis and Galvus to patients and physicians in China and support the achievement of the Chinese government's public health goals."

China is one of the company’s top emerging markets according to Novartis CEO Joseph Jimenez. The company has invested $1bn to build the largest pharmaceutical R&D institute in China, and is collaborating with the federal and local governments to improve healthcare infrastructure and access.

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