UK-based SkyePharma developed the formulation for AstraZeneca's Pulmicort pMDI device using its proprietary particle engineering technology.
Speaking to in-PharmaTechnologist.com AstraZeneca spokesman Kristian Sjoholm stressed the company was quick to act the moment it became apparent there was a problem.
“The technical weaknesses of the Pulmicort pMDI device are mainly related to fine particle dose stability. AstraZeneca continuously monitors the performance of all marketed products to ensure high-quality medicines are delivered to the marketplace and have not manufactured any new product since we identified the manufacturing issue.
“We identified the manufacturing issue in late January. Right now we are focusing on working to ensure all patients continue to receive the appropriate alternative treatment.”
David Smith, executive vice president of global operations for AstraZeneca, said the company had explored ways to resolve the issue, but continued uncertainty over whether a solution to the manufacturing problem could be found, forced the company's hand.
“We have exhausted all potential solutions in our efforts to continue supplying this medicine,” he said, “the time required to fully resolve the technical issues is highly uncertain. We believe it is our responsibility to communicate our decision swiftly.”
Annabel Du Plessis, a spokesperson for SkyePharma told in-PharmaTechnologist the firm was informed of AstraZeneca's decision “at the end of last week,” but insisted the news will not affect any future dealings between the companies.
“Our relationship with AstraZeneca has not been affected by this matter, which is isolated to this unique combination of device components,” she said.
Earlier CEO, Axel Muller, described AstraZeneca's decision as “disappointing,” However,he remained upbeat about the company's future prospects with or without the drug.
“It [Pulmicort] 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,” he said.
SkyePharma claims it will retain certain rights for the pMDI and intends to explore whether a sub-licence of those rights may be of interest to “other parties.”
In other news, AstraZeneca announced yesterday that it has entered into a research and development agreement with US-based dermatology specialists, Galderma Pharma.
Under the agreement Galderma will gain exclusive access to a number of AstraZeneca's compounds in an effort to develop dermatological indications.
Commenting on the agreement, Alain Jacot, VP and CSO of Galderma said: “This unique and exclusive collaboration with one of the world's leading pharmaceutical companies will complement Galderma's internal R&D efforts and significantly enhance our ability to make important new discoveries that have the potential to treat serious dermatological disorders.”