AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again

By Dan Stanton contact

- Last updated on GMT

Crestor Manufacturing, photo c/o AstraZeneca
Crestor Manufacturing, photo c/o AstraZeneca

Related tags: Astrazeneca, Statin

An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.

2013 sales of AstraZeneca’s cardiovascular drug Crestor (rosuvastatin) decreased 8% on the previous year to $5.6bn due to erosion from patent expiration in certain markets. However, the encroaching loss of exclusivity in the US has led the firm to earmark its active pharmaceutical ingredient (API) plant in Avonmouth, Bristol, for closure.

“The decision to cease manufacturing at our Avlon site was made in 2008 and our plan is to close the site in late 2016 or early 2017,”​ a company spokesperson told in-Pharmatechnologist.com.

The spokesperson added that the move is "part of a broader strategy review looking across our global operations, but it’s true to say that the impending expiration of the Crestor patent was one factor.”

According to local paper the Bristol Post​, more than 250 jobs are set to be lost at the Avlon plant.

“Affected staff have been kept informed throughout and we continue to provide re-employment support to them ahead of the planned site closure,”​ AstraZeneca told us, adding the local MP and union representatives had been made aware of the situation.

Patent Problems

While Crestor’s patent is set to expire in the US in 2016, AstraZeneca is already losing sales to generic products in other markets. For example, in Canada a generic version of the statin launched in 2012 and made by Apotex had a negative impact on 2013 figures.

Meanwhile, Pfizer’s Lipitor (atorvastatin) – a major competitor to Crestor – lost its exclusivity in the US late 2011 and since May 2012 AstraZeneca has had to compete against several generic atorvastatin products.

And like this decision, the expiration of Lipitor led to the reduction of staff and closure of Pfizer production facilities in Ireland​. During the mid-2000s, Lipitor netted the pharma firm over $12bn annually​ but this has dramatically fallen in the face of generic competition.

The Avlon facility also makes the API for schizophrenia drug Seroquel which reported a 12% fall in sales in 2013 to $1.4bn, following its own patent expirations.

The news is another blow to AstraZeneca’s small molecule manufacturing network as in the past two weeks the firm has announced it will close​ the Westborough, Massachusetts facility that makes asthma drug Pulmicort (budesonide).

However, the Anglo-Swedish Pharma Giant is investing in its more complex biologics pipeline, as demonstrated with a $200m capacity expansion​ of a biomanufacturing plant in Frederick, Maryland.

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