AZ stops making Pulmicort pMDI inhaler
pharmafile | March 8, 2011 | News story | Manufacturing and Production |Â Â AZ, AstraZeneca, Pulmicort, Pulmicort pMDI, Skyepharma, asthma, asthma inhaler, budesonideÂ
AstraZeneca has discontinued production of its Pulmicort pMDI asthma inhaler because of manufacturing issues, and looks set to exit from its agreement with SkyePharma for the product.
The decision to stop making the 100mcg and 200mcg/dose versions of the Pulmicort (budesonide) pMDI product is related to “complex manufacturing issues related to technical aspects of the device”, said SkyePharma in a statement.
The news had a big impact on SkyePharma’s share price, which closed down 12% yesterday at a little under 37 pence.
Other presentations of Pulmicort, including the Pulmicort Turbuhaler, Pulmicort Respules and Pulimicort Flexhaler, are unaffected by the announcement as they use different delivery devices. The decision also does not concern the firm’s big-selling asthma drug Symbicort/Vannair (budesonide and formoterol).
Pulmicort pMDI was developed to replace a prior version using environmentally-harmful CFCs, and is approved in more than 35 countries around the world.
The product accounted for around 5% of SkyePharma’s revenues of £29 million ($47m) in the first half of 2010, and the drug delivery specialist said it anticipates the decision “will lead to the termination of SkyePharma’s agreements with AstraZeneca for Pulmicort pMDI”. The UK-based company earns a 15% royalty on Pulmicort sales.
“We have exhausted all potential solutions in our efforts to continue supplying this medicine”, said David Smith, head of global manufacturing and supplies at AstraZeneca.
“It is in the patient’s best interest to find an alternative medication as soon as possible”, he added.
The Pulmicort pMDI device will remain on sale until existing supplies are exhausted, said SkyePharma.
Phil Taylor
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