[Ip-health] AstraZeneca sues US drug regulator to halt generic copies of its big seller Seroquel

Riaz K Tayob riaz.tayob at gmail.com
Wed Mar 14 04:09:18 PDT 2012

AstraZeneca sues US drug regulator to halt generic copies of its big 
seller Seroquel

Nick Goodway

Wednesday 14 March 2012

AstraZeneca is taking the United States Food and Drug Administration 
(FDA) to court, in an attempt to overturn last week's ruling that rivals 
can start selling generic copies of the pharmaceutical giant's second 
best-selling drug Seroquel in the country by the end of this month.

Click HERE to view graphic

Seroquel, which is used to treat schizophrenia and bipolar disorders, is 
the fifth-largest selling drug in the world, and last year accounted for 
17 per cent of all AstraZeneca's revenues.

Analysts reckon that every extra month which AstraZeneca manages to hold 
on to to its exclusive patent in the US would add 2 per cent to its 
earnings per share. Keeping the patent until the end of this year could 
boost its earnings by 15 per cent.

Last week the US drugs regulator refused AstraZeneca's call for generic 
copies of the drug to have to carry similar health warnings to Seroquel. 
These advise doctors and patients that the drug can affect blood sugar 
levels and heighten suicidal tendencies.

In its case, lodged with the District Court of Columbia, AstraZeneca 
challenged the FDA's ruling, claiming it "raised important issues 
regarding labelling requirements for generic copies of innovative 
medicines, as well as data exclusivity rights granted to innovative 
companies that conduct new clinical trials".

The company asked the court to bar the FDA from granting final marketing 
approval to the generic manufacturers until early December, or until a 
federal court "has a meaningful opportunity to review imminent FDA 
action regarding the pending generic marketing applications".

Last year Seroquel and its slow-release version, Seroquel XR, had global 
sales of $5.8bn (£3.69bn), of which $4.1bn were in the US.

The original Seroquel first won its patent in 1997 and the slow-release 
version was launched in 2007. Although not licensed for it, many doctors 
now prescribe the drug as part of the treatment for Alzheimer's disease.

Savvas Neophytou, an analyst at Panmure Gordon, said the challenge to 
the FDA was unexpected and ultimately had little likelihood of success. 
But he calculates that every extra month the generic launch is staved 
off adds 11-15 cents to AstraZeneca's earnings. He said this should not 
be regarded as a windfall but is positive for the group's cashflow.

With its acid reflux treatment Nexium also facing generics in the US in 
2014 and top-selling cholesterol fighter Crestor losing patent 
protection in 2016, AstraZeneca is stepping up the drive to buy in 
replacement products through a series of acquisitions.

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