The deal, worth $17.5m upfront, will see Mylan use the dry-powder delivery platform to develop new respiratory drug products, including generic equivalents to GSK’s asthma and chronic obstructive pulmonary disorder treatments (COPD) Advair and Seretide Diskus inhalers.
Much of the work will be conducted at the R&D site in Sandwich, Kent that Pfizer has been exiting over the last 12-months as part of its global restructuring plan. Mylan said it will hire “key” members of staff from Pfizer’s respiratory drug team but did not specify how many.
The deal will be of interest to GSK CEO Andrew Witty who told Reuters last year that despite the loss of patent protection generic competition for the blockbuster Advair was unlikely given the complexity of developing inhaled drugs.
Novartis’ subsequent decision to halt development of a competitor drug and, more recently, Teva’s suggestion that US “regulatory hurdles for winning approval for an inhaled drug such as Advair…are so high it will not be possible to develop a generic copy” appeared to support Witty’s contention.
Additionally, while one generic version of Advair is currently approved – Greek drugmaker Elpen’s Rolenium – the product's delivery technology is deemed different enough from the GSK product that it is not considered directly substitutable.
Quite what impact Mylan’s acquisition of the Pfizer dry-powder platform will have on Advair is unclear, but the generics firm does have considerable experience in the area primarily as a result of its specialty division Dey Pharma.
Mylan President Heather Bresch commented: "We are particularly excited about the global potential of a generic Advair. Further, we intend to utilize this delivery platform and scientific expertise to develop additional branded specialty products, building upon the capabilities and assets we have in place at Dey Pharma.
“The addition of Pfizer's dry-powder inhaler platform to Dey's existing capabilities in nebulized medicines and allergies will create a powerful platform in this important therapeutic area."