Agreements with SkyePharma expected to be terminated
AstraZeneca is ending production of the pressurised metered dose inhaler (pMDI) for its asthma drug Pulmicort, due to technical problems.
SkyePharma developed the formulation for the drug and earns a mid-teens percentage royalty on AstraZeneca’s net sales of the product. Royalties from the product comprise around 5% of SkyePharma’s revenues.
AstraZeneca said ‘complex manufacturing issues related to technical aspects of the device’ had led to the decision to discontinue production of the 100 microgram per dose and 200 microgram per dose HFA pMDI forms of Pulmicort.
AstraZeneca said production would cease immediately although patients can continue using the formulation until their current supply is finished.
‘We have exhausted all potential solutions in our efforts to continue supplying this medicine. The time required to fully resolve the technical issues is highly uncertain,’ said David Smith, executive vice president, Global Operations and IS, AstraZeneca.
Pulmicort pMDI is manufactured using product-specific processes and components, the combination of which is not used with any other AstraZeneca respiratory products, which means that Pulmicort Turbuhaler, Pulmicort Respules and Pulmicort Flexhaler are not affected by the decision.
Symbicort budesonide/formoterol fumarate dihydrate) pMDI and Vannair (budesonide/formoterol) are also not affected.
It is expected that AstraZeneca will terminate its agreements with SkyePharma for Pulmocort pMDI. Following any termination of these agreements, certain rights for the product will revert or be licensed to SkyePharma and the company intends to explore whether a sub-licence of these rights may be of interest to other parties.
Axel Müller, chief executive of SkyePharma, said the decision to cease manufacture of Pulmicort pMDI was ‘disappointing’.
‘However, it is one of 12 approved and marketed products which use our technology and we anticipate continued progress in our pipeline of development products this year, including Flutiform, which is currently being assessed by European regulators,’ he said.