Mylan Inc. today announced that it has entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer’s generic equivalent to GlaxoSmithKline’s Advair Diskus and Seretide Diskus incorporating Pfizer’s proprietary dry powder inhaler delivery platform. Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol delivered via a dry powder inhaler and are used to treat asthma and COPD (chronic obstructive pulmonary disorder).
In addition, Pfizer will 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 existing Pfizer compounds currently in various stages of development.
In connection with the transaction, Mylan will employ select key members of the former Pfizer respiratory inhalation development team based at Discovery Park in Sandwich, U.K., where Mylan will establish a respiratory development division. Some employees also will be based in Cambridge, U.K.
Mylan Chairman and CEO Robert J. Coury said: “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. 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.” Mylan President Heather Bresch commented: “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. 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.” Mylan’s specialty division, Dey Pharma, has respiratory expertise in the development of unit-dose oral inhalation products for nebulization for the treatment of COPD. It currently markets Perforomist@ Inhalation Solution and is currently developing a combination product.
Dey also has expertise in the treatment of severe allergic reactions through its EPIPEN@ auto-injector product. Mylan believes there is the potential to leverage Dey’s experience and success as it develops and commercializes this expanded respiratory franchise.
According to IMS Health, the global respiratory asthma and COPD prescription market is valued at more than $34 billion and is averaging 7% growth per year. More than 50% of this market is expected to lose patent protection by the end of 2016, including several blockbuster products, many of which are inhaler based.
As part of the agreement, Mylan will pay for remaining development and capital expenditures to bring products to market. Pfizer will be due a payment of $17.5 million at closing of the transaction and will be eligible for additional payments, contingent upon regulatory and commercial success, including profit sharing. Mylan will have exclusive commercialization rights for the generic equivalent to GlaxoSmithKline’s Advair@ Diskus and Seretide@ Diskus in the U.S., Canada, Australia, New Zealand and in the European Union and European Free Trade Association countries. In the rest of the world, Mylan and Pfizer will have co-promotion rights to the product. All other financial terms and product details remain confidential.
Mylan expects to finance the costs of the program with available liquidity and does not expect the program to have any impact on Mylan’s guidance for 2011 or its financial targets through 2013. The transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and is expected to close by year-end.
