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Mylan poised to enter generic inhalers market Posted 25/11/2011

The global market for respiratory asthma and chronic obstructive pulmonary disorder (COPD) inhalers, a specialist field, is valued at more than US$34 billion (Euros 25.1 billion) and is averaging 7% growth per year according to IMS Health. 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.

Just a few players currently dominate the COPD market, and GlaxoSmithKline (GSK) is doing rather well from Advair Diskus (fluticasone/salmeterol) and Seretide Diskus (fluticasone/salmeterol). These are still the biggest selling drugs for the treatment of asthma/COPD with sales of GBP 4,977 million (US$7,794 million) in 2009 [1]. These have been off-patent in the US since September 2010, and will expire in most European markets in 2013, but competition from generics relies on the same technology in order to compete. A Greek company won approval for its version of the drug, but its delivery technology is different enough to prevent automatic generics substitution, GSK believes.

A Pfizer–Mylan deal would give the latter the rights to develop and sell Pfizer’s generic version of Advair, which uses a proprietary dry powder inhaler, just as GSK’s Advair Diskus does. In a press release from 9 November 2011, Mylan explained, ‘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.’

Under the agreement, Mylan will employ select key members of the former Pfizer respiratory inhalation development team based at Discovery Park in Sandwich, UK, where Mylan will establish a respiratory development division. Some employees will also be based in Cambridge, UK. This will cost Mylan US$17.5 million (Euros 12.9 million) up front, plus milestone payments.

Mylan’s specialty division, Dey Pharma, has expertise in the development of unit dose oral inhalation products for nebulisation for the treatment of COPD. It currently markets Perforomist inhalation solution and is 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 build on Dey’s experience and success as it develops and commercialises this expanded respiratory franchise. Some Pfizer employees associated with the inhalation technology will join Mylan as well.

Mylan will have exclusive commercialisation rights for the generics equivalent to GSK’s Advair Diskus and Seretide Diskus in Australia, Canada, European Union and European Free Trade Association countries, New Zealand and the US. In the rest of the world, Mylan and Pfizer will have co-promotion rights to the product. Mylan can also use the delivery technology to develop some branded specialty products, the company said.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Opportunities in the COPD market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 25]. Available from: www.gabionline.net/Reports/Opportunities-in-the-COPD-market

Source: IMS Health, Mylan

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