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Re: jq1234 post# 165213

Sunday, 08/11/2013 2:59:59 PM

Sunday, August 11, 2013 2:59:59 PM

Post# of 252254
Re: Generic Advair and 3M’s technology

In ADMP’s PR you posted, it says the exclusive license to 3M’s technology runs only through 12/31/13 unless ADMP makes an additional payment to acquire the technology outright.

MYL’s licensed technology from 3M concerns the MDI rather than the DPI formulation of Advair, so that’s the answer to the apparent conflict with ADMP’s license. From MYL’s recent Investor Day webcast (http://seekingalpha.com/article/1602252-mylan-inc-analyst-investor-day ):

We've acquired the scientific expertise and technology in dry powder inhalation. We've married our strong science with an excellent partner in the MDI space…in 3M.

With respect to generic Advair DPI, MYL is guiding for an ANDA submission to the FDA in 1H15 following a bioequivalence trial (see page 81 of the slide deck in #msg-90654516) and for an EU submission in 2H14 based on clinical data already in hand. MYL also plans an EU submission for the MDI formulation of Advair in 2H13, according to the Investor Day webcast.

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