WHO delists Shantha bestseller

NEW DELHI/HYDERABAD: Shantha Biotech’s bread-winner vaccine has fallen out of favour with the World Health Organisation, or WHO, dealing the company a crippling blow and opening up opportunities for rivals such as Panacea Biotech, Serum Institute and Novartis.

The WHO said on July 28 that Shantha’s Shan5 vaccine is no longer on its list of pre-qualified medicines, in effect terminating what was a contract worth $340 million over three years. The WHO order last week sealed the fate of Shan5, whose future has been in doubt for months now, after a white sediment was found sticking to glass vials containing the vaccine.

Hyderabad-based Shantha is 80% owned by France’s Sanofi Aventis, which bought the company in July 2009.

“This is a vaccine version of Ranbaxy’s regulatory problems in the US. Since Shantha’s main revenue stream will be cut off, it may run into losses until it resumes sales of Shan5,” a pharmaceutical industry expert said.

Shan5 is estimated to account for more than three-fourths of the revenues of Shantha. The vaccine maker reported revenues of e17 million for the four months to December 2009, a Sanofi Aventis spokeswoman said. She did not say how much Shan5 earned.

Shan5 is a ‘five-in-one’ vaccine to protect infants against diphtheria, whooping cough, tetanus, hepatitis-B as well as a bacterium that causes diseases such as pneumonia and meningitis.

The WHO said it disqualified the vaccines after coming to the conclusion that the corrective action plan suggested by Shantha for dissolving the sediments detected in Shan5 vials would require a revised manufacturing procedure and hence new approvals. In April, the organisation had suspended the supply of Shan5 vaccines to Unicef following discovery of the sediments. The Indian company had recalled $72 million worth of vaccines and discontinued sale in the domestic retail market.

The WHO has also delisted Shantha’s tetravalent (DTwP-hepatitis B) vaccine and terminated ongoing prequalification evaluation process for a DTwP vaccine Shantrip as the two vaccines also use the pertussis component, the root cause that is linked with flaws in Shan5.

“The financial impact will depend on the ramp-up (of its) production. We are confident that Shantha will be able to resume production and supply of Shan5 and Shantetra in compliance with WHO requirements," the Shantha spokeswoman said. She added the decision to withdraw the prequalification for Shan5 is a precautionary measure and none of the information available so far suggests a safety problem.

The WHO has asked Shantha to reapply for prequalification, so that it can become eligible to resume supply of Shan5 and other vaccines to Unicef and other global health organisations. But the process of obtaining these approvals may take 2-3 years, industry executives said.

Shantha had started executing the supply order last year and it may have to reimburse Unicef and other buyers for transportation and storage charges for the vaccines. “We are working with Unicef to define the best way to compensate for the recall of Shan5 in the interest of public health," the company spokeswoman said.

The WHO had in October last year probed a similar vaccine manufactured by Delhi-based Panacea Biotech after four infants who had reportedly taken this vaccine died in Bhutan. The Indian company was given a clean chit.

The development with Shantha opens up an opportunity for other makers of five-in-one vaccines that have already been qualified by the WHO. Panacea Biotech, Serum Institute and Novartis are seen as potential gainers.

Several Indian drugmakers such as Ranbaxy and Sun Pharma have been pulled up by the American drug regulator for lapses in manufacturing standards in the past 2-3 years. But Shantha’s problems are a “company issue” and have nothing to do with the Indian vaccine industry, industry experts and executives with rival firms said.