How Tamiflu became a global blockbuster

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When senior executives from Roche host a briefing for journalists on Monday in Basel, their chosen topic will be unusual for a drug company that focuses on oncology and other hospital-prescribed niche medicines.

William Burns, head of pharmaceuticals, will instead discuss Tamiflu, the antiviral drug that has become an unexpected “blockbuster”: with projected sales this year of SFr2bn ($1.9bn, €1.3bn, £1.1bn), it has become Roche’s fourth-biggest selling product. For a drug that was almost stillborn when it was launched in 1999, it provides a case study in how to create a commercial success.

With seasonal flu long dismissed as a relatively minor threat, in spite of killing up to 500,000 people globally a year, Japan had been the only large country to widely adopt Tamiflu to treat it.

What changed for other governments was the growing fear of a pandemic. In 2003, the H5N1 bird flu virus, which killed millions of animals and dozens of people, raised concerns that there could be a repeat of the 1918 Spanish flu outbreak.

Politicians were under pressure to avoid repeating previous failures to prepare and respond to emergencies such as Hurricane Katrina in 2005, the 2003 heatwave in France that killed thousands, or the foot and mouth outbreaks in the UK.

Tamiflu became a key part of their response. First, it met a clinical need. While far from a cure, clinical studies show that it can reduce the severity and duration of infection, especially if taken within two days of the onset of symptoms.

Second, it offered an advantage over the alternatives. Flu strains including H5N1 are resistant to older antiviral drugs. Only one other drug exists in the same class: GlaxoSmithKline’s Relenza, which was launched just ahead of Tamiflu. But Relenza has to be inhaled, making it more difficult for patients to take than Tamiflu, a capsule that is swallowed.

Third, Tamiflu filled a psychological gap. With no vaccine able to protect against flu until after the specific pandemic variant of the evolving virus emerged, stockpiling the drug allowed politicians and policymakers to show that they were doing something to prepare.

Moreover, its brand name – snappier than oseltamavir, its generic prescribing name, and more clearly linked to the name of the virus it was designed to treat than Relenza – helped raise its public profile. Searches on Google for Tamiflu even briefly surged ahead of those for Viagra in 2005 and again this year.

Fourth, by supporting and circulating studies that compared the widely varying levels of stockpiles purchased by different governments, Roche added pressure for the laggards to purchase more.

Fifth, the company has extended its franchise. It has supported sales to private doctors and to companies concerned that supplies through national health systems would not be sufficient to meet demand. It has funded research on whether the drug can be used in combination with others, in higher doses and over longer periods, to further boost efficacy – and sales.

Roche has sold bulk versions of the drug’s ingredients to governments prolonging its shelf-life even beyond the seven years regulators have allowed. And it is now proposing ways for governments to send back older stock of the drug for reprocessing and reuse – at a price.

Finally, Roche has attempted to deflate criticism that while it makes profits from richer countries, poorer ones cannot afford the medicine. It has made donations to the World Health Organisation, and introduced discounts in the developing world.

Not everyone is impressed. Generic drug companies claim Roche’s discounting has kept them out of the market. Some doctors are sceptical of Tamiflu’s efficacy and concerned about side effects.

The expanding market has also spurred its rivals to accelerate research on at least two new experimental antiviral drugs, and GSK has made improvements to Relenza.

By the time of the next pandemic, Tamiflu’s patent may have expired, its efficacy been reduced and it will face greater competition.

But fear, need and a clever marketing strategy have helped it far exceed Roche’s expectations.

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