remember the start of relenza?

Hi guys,

Like Lani today bringing Relenza to the market was not easy either.

Just some refreshing of how Relenza went, read the snippets and the link gives you the whole story.

http://en.wikipedia.org/wiki/Zanamivir


We will get Lani to the market but Relenza has taught us a lesson to be expect it to be a smooth run.

The USA even tried to stop approval of Relenza which was later overruled.

As Biota was a small company, it did not have the resources to bring zanamivir to market by itself. In 1990, zanamivir patent rights were licensed to Glaxo, now GlaxoSmithKline (GSK). The license agreement entitled Biota to receive a 7% royalty on Glaxo's sales of zanamivir.

In 1999, the product was approved for marketing in the US and Europe for treatment of influenza A and B. The FDA advisory committee had recommended by a vote 13 to 4 that it should not be approved, because it lacked efficacy an was no more effective than placebo when the patients were on other drugs such as paracetamol. But the FDA leadership overruled the committee and criticised its reviewer, biostatistician Michael Elashoff. The review of oseltamivir, which was also in approval process at that time, was taken away from him, and reassigned to someone else.[20] In 2006 zanamivir was approved in the US and Europe for prevention of influenza A and B.[1]

Commercial issues[edit]

Although zanamivir was the first neuraminidase inhibitor to the market, it had only a few months lead over the second entrant, oseltamivir (Tamiflu), with an oral tablet formulation.

According to the CDC, Tamiflu, zanamivir’s main competitor, is not as effective at treating the influenza viruses as zanamivir, especially in H1N1 seasonal flu. In fact, tests showed 99.6% of the tested strains of seasonal H1N1 flu and 0.5% of 2009 pandemic flu were resistant to Tamiflu, while no flu samples, seasonal or pandemic, showed any resistance to zanamivir.[3] [21][22]

When first marketed in the US in 1999/2000, zanamivir captured only 25% of the influenza antiviral market, despite a huge promotional campaign. By the end of that season, Tamiflu was outselling zanamivir 3:1. During that season, zanamivir experienced worldwide safety warnings involving the risk of bronchospasm and death. Glaxo then reduced the marketing of zanamivir, and Tamiflu's dominance increased. More than US$20 million worth of zanamivir sold by Glaxo in the first US season was returned to the company in the next two seasons because its sales to patients were far less than expected.

Biota commenced legal proceedings in 2004 alleging Glaxo's reduced marketing of zanamivir to be a breach of contract. Biota claimed about A$700 million from Glaxo. After Biota spent four years trying to progress its case, and incurring A$50 million in legal costs, the company abandoned the claim in July 2008, recovering only A$20 million, including legal costs following settlement at mediation. Biota had refused an earlier tactical offer from Glaxo of A$75 million plus legal costs.

In August 2006, Germany announced it would buy 1.7 million doses of zanamivir, as part of its preparation strategy against bird flu. "Germany's purchase shows that countries are starting to take a balanced view of influenza preparedness," said Simon Tucker, head of research at Melbourne-based Biota, where zanamivir was originally developed.[13]

In April 2009, many cases of swine flu (H1N1-type virus) were reported in US and Mexico. Zanamivir is one of only two drugs prescribed to treat it. A study published in June 2009 emphasized the urgent need for augmentation of oseltamivir stockpiles, with additional antiviral drugs including zanamivir, based on an evaluation of the performance of these drugs in the scenario that the 2009 H1N1 swine flu neuraminidase (NA) were to acquire the Tamiflu-resistance (His274Tyr) mutation, which is currently widespread in 99.6% of all tested seasonal H1N1 strains.[23]

In January 2011, GSK announced it would commence phase III trials for intravenous zanamivir in a study that will span 20 countries in the Northern and Southern Hemispheres