Shantha Biotechnics'Shan5 drug gets WHO nod

Shantha Biotechnics'Shan5 drug gets WHO nod

This status qualifies Shan5 vaccine for purchase by the United Nations agencies, mainly UNICEF.

Picture for representational purpose. Picture for representational purpose.

Shantha Biotechnics, part of the French health-care major Sanofi, has regained its pre-qualification status with the World Health Organization (WHO) for its pentavalent paediatric vaccine Shan5, the company announced on Monday (May 5). Four years ago, it had lost this pre-qualification after some white sediment was found in some of its Shan5 vials.

This status qualifies Shan5 vaccine for purchase by the United Nations agencies, mainly UNICEF. Speaking to Business Today after the announcement, Harish Iyer, Shantha's CEO said: "The company is hopeful of adding Rs 500 crore per annum to its top-line from the sales of Shan5 in less than five years from now." Without spelling out the current turnover of Shantha since the company is part of Sanofi and revenue numbers are consolidated at the global level, he said it would significantly add to the company's current sales.

There are unconfirmed estimates that Shanta's sales are in the region of Rs 100 crore or less, but the company would not discuss the matter. Iyer however pointed out that this vaccine and the vaccine pipeline across Shantha are important to Sanofi, which he says views vaccines and emerging market presence as its two clear growth platforms. In the last four years, he said Sanofi had invested around Rs 1,000 crore on Shantha's pipeline of drugs, including Shan5, upgrading facilities, expanding capacity, training people and on clinical trials. The total staff strength of Shantha in this period has increased from 550 people to 850 today, he said.

He added the company hoped to resume supplies of Shan5 to the United Nations agencies from the fourth quarter of the current year. The development, he says is not just important financially but also from a disease point of view since the vaccine covers important diseases that are major causes of infant mortality. Shan5 is a five-in-one liquid that protects children from six weeks of age against five diseases - diphtheria, tetanus, pertussis, Hib (Haemophilus influenza type B) and Hepatitis B.

Iyer says, technologically, Shan5 will help the company transition more easily into more complex products like Shan6, which covers these five antigens apart from polio. "We (as a country) have got rid of the polio virus but immunization has to still continue and we have to go through the polio endgame," says Iyer. Shan6, which is still some way off, will include injectable polio vaccine instead of oral drops. Shantha Biotechnics, which was acquired by Sanofi in 2009 was founded by K I Varaprasad Reddy in 1994 with an investment of Rs 15 crore and when Sanofi acquired, it was valued by Sanofi at Euro 550 million (Rs 3,700 crore) and the company's revenues then were close to Rs 300 crore.