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PITTSBURGH — Mylan Inc. has entered into an agreement with Pfizer for the exclusive global rights to develop, manufacture and commercialize Pfizer’s generic equivalent to GlaxoSmithKline’s Advair Diskus and Seretide Diskus respiratory products, incorporating Pfizer’s proprietary dry-powder inhaler delivery platform.
Announcing the deal Wednesday, Mylan said Pfizer also has agreed to grant Mylan rights to its dry-powder delivery platform to develop and commercialize additional brand and generic pharmaceutical products, including rights of negotiation for certain current Pfizer compounds in various stages of development.
GSK’s Advair Diskus and Seretide Diskus are inhaled, fixed-dose combinations of fluticasone propionate and salmeterol delivered via a dry powder inhaler and used to treat asthma and chronic obstructive pulmonary disorder (COPD).
With the transaction, expected to close by the year’s end, Mylan said it will employ select key members of the former Pfizer respiratory inhalation development team based at Discovery Park in Sandwich, United Kingdom, where Mylan will establish a respiratory development division. Some employees also will be based in Cambridge, U.K.
"Mylan’s acquisition of rights to Pfizer’s inhalation technology platform delivers on yet another one of our key strategic objectives by filling an important gap in our product portfolio and builds a truly world-class respiratory franchise for Mylan," Mylan chairman and chief executive officer Robert Coury said in a statement. "I would like to personally welcome to Mylan the talented former Pfizer employees who will be joining us. This team’s core competency in respiratory brings Mylan deep knowledge and expertise that will allow us to fully leverage this exciting delivery platform. We will be establishing a ‘center of excellence’ in respiratory at Discovery Park in Sandwich and believe this franchise will serve as an additional contributor to Mylan’s long-term growth."
The worldwide respiratory asthma and COPD prescription market is valued at more than $34 billion and is averaging 7% growth per year, according to IMS Health data cited by Mylan. Over half of that market stands to lose patent protection by the end of 2016, including several blockbuster products, many of which are inhaler-based, Mylan added.
"We are extremely pleased to enter into this agreement with Pfizer, as we believe that inhaler-based products represent a significant opportunity for our generics business and expand our focus on difficult-to-produce, limited competition products," Mylan president Heather Bresch stated. "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."
Dey Pharma, Mylan’s specialty division, has respiratory expertise in the development of unit-dose oral inhalation products for nebulization in treating COPD. It currently markets Perforomist Inhalation Solution and is developing a combination product, Mylan said. Dey also has expertise in the treatment of severe allergic reactions through its EPIPEN auto-injector product.
