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AZ withdraws asthma drug, bad news for SkyePharma

World News | March 07, 2011


Kevin Grogan

AZ withdraws asthma drug, bad news for SkyePharma

AstraZeneca is to discontinue production of the pressurised metered dose inhaler version of its asthma treatment Pulmicort as a result of manufacturing problems.

The Anglo-Swedish drugmaker says the decision has been taken to pull Pulmicort pMDI (budesonide) 100 and 200 microgram/dose HFA due to "complex manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product". This issue is not related to budesonide, or any other respiratory products, including Pumicort Turbuhaler, Pulmicort Respules and Pulmicort Flexhaler. AstraZeneca added that Symbicort ((budesonide/formoterol), also sold as Vannair, is not affected.

David Smith, head of global manufacturing and supplies at AstraZeneca, said "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". He added that "it is our responsibility to communicate our decision swiftly, as it is in the patient’s best interest to find an alternative medication as soon as possible".

An AstraZeneca spokesman told PharmaTimes World News that Pulmicort pMDI is on the market in 38 countries including the European Union, Mexico, Venezuela, Israel, Hong Kong, Singapore, Malaysia and others. However, it is not a big earner and brought in less than 0.1% of total group sales in 2010, ie $33.30 billion. He would not comment on what charges AstraZeneca will take as a result of the discontinuation.

This is particularly bad news for SkyePharma, the UK firm which developed the formulation for Pulmicort pMDI and earns a mid-teens percentage royalty on its sales. These comprise about 5% of SkyePharma's total revenues and the latter's shares were trading down 16.7% this morning at 35 pence.

Meantime AstraZeneca has linked up with Switzerland's Galderma Pharma to develop new treatments for conditions including psoriasis, acne and atopic dermatitis.

Under the terms of the five-year agreement, the financial details of which were not disclosed, Galderma will have exclusive access to a number of compounds from across AstraZeneca’s portfolio to develop in dermatological indications. Initial targets for collaboration "have already been identified from disease areas as diverse as oncology, inflammation and central nervous system," the firms said.

Clive Morris, head of the new opportunities innovative medicines unit at AstraZeneca, said the partnership is "an example of how we are leveraging our science in new and creative ways through collaborations with recognised experts outside of AstraZeneca’s core therapy areas". Linking up with Galderma, "a world-leader in dermatology, is the most efficient and effective way to unlock the potential of our compounds in this rapidly- evolving disease area," he concluded.

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