Sanofi's Shan5 overcomes manufacturing setback to score thumbs up from WHO

It's been four years since manufacturing problems cost Sanofi-owned Shantha Biotechnics a $340 million contract to supply pentavalent vaccine Shan5. But at long last, the jab has rewon the World Health Organization's (WHO) favor, nabbing a positive prequalification decision that opens the door for purchases by United Nations agencies.

Sanofi Pasteur CEO Olivier Charmeil--Courtesy of Sanofi

The 5-in-1 shot, which protects children against diphtheria, tetanus, pertussis, Hib and hepatitis B, earned the status based on a WHO review that included a site inspection to Shantha's facilities in Hyderabad, India. With the decision, more than 50 developing and low-income countries will gain access to the vaccine, while Sanofi ($SNY) will gain access to the emerging markets potential that drove it to pick up an 80% stake in Shantha back in 2009.

"Shan5 is the first product that puts together the best of Shantha and Sanofi Pasteur's assets and talents," Sanofi Pasteur CEO Olivier Charmeil said in a statement. "… By delivering large supplies of high-quality and affordable vaccines to emerging and low-income countries, Shantha will be contributing to filling this gap for the benefits of babies and their parents."

Shantha's comeback follows a tumultuous 2010, which saw UNICEF and WHO recall and destroy the vaccine still in stock--about 24 million doses--based on reports of white sediment in vials. The move affected vaccination programs in 7 countries, and when Shantha couldn't meet the organizations' deadline for nailing down the source of the problem and developing a corrective plan, they disqualified the Sanofi affiliate as a supplier.

But some tweaks to the manufacturing process, higher quality standards and Sanofi's oversight have put that all in the rearview mirror, Shantha CEO Harish Iyer said in a statement, and now the company has an eye on the revenues that come along with WHO's blessing. Last year, Iyer predicted that Shantha's expected $18.5 million in sales would quintuple with the return of Shan5, providing some meaningful returns on the French drugmaker's investment.

Shantha CEO Harish Iyer

"The development of Shan5 benefitted from Sanofi Pasteur's more than 50 years of experience with whole-cell pertussis and combination vaccines--ensuring robust processes and guaranteeing international quality standards," Iyer said. "Shantha's manufacturing platform in India will serve Indian needs and provide Sanofi Pasteur access to additional vaccine markets globally."

- read the release

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