john steed schreef op 24 augustus 2018 16:54:
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The FDA wasted no time in stamping their quick approval on Shire’s marketing application for lanadelumab — one of the year’s top likely blockbusters in the industry pipeline. And that’s a critical endorsement for Takeda, which wants to provide some compelling reasons behind its $62 billion deal to buy Shire to help satisfy its critics.
The drug will now hit the market as Takhzyro. A spokesperson for the company says that is pronounced “Tek-zye-roe.” And you can find out what it will be priced at in the next week.
There wasn’t much drama behind this OK. Shire had provided stellar data to support the use of lanadelumab in treating hereditary angioedema — or HAE — a rare and life threatening genetic condition.
In what could well prove a chief part of Flemming Ornskov’s legacy as the last Shire CEO, the company acquired this drug in a $6.5 billion buyout of Dyax in 2015. Then the research team steered it through a pivotal stage study, where a 300 mg dose of the drug twice a month delivered an 87% reduction in mean HAE attack frequency, compared to 0% in the placebo group. It hit the primary endpoint with “highly” statistically significant results as well as all the secondaries.
Now analysts expect the drug will push ahead to around $1.3 billion in peak sales, protecting a key franchise for the company as Takeda works to complete the takeover deal in 2019.
“Looking to the future, we continue to work towards our goal of a world in which those living with HAE can aim for zero attacks,” noted the recently named Shire R&D chief Andreas Busch.
GlobalData highlighted the drug’s dominance in a chart related to future sales estimates for Shire’s pipeline therapies, where it easily overshadowed everything else in R&D. And Clarivate pegged the drug as number 9 on its list of 12 blockbusters up for an FDA decision this year.
Dyax shareholders will be cheering the news this evening. They will get $4 per share they owned under the contingent value right deal they struck at the time of the acquisition.