The European Commission (EC) marketing authorization (MA) that was granted in December to US biotech Atara Biotherapies (Nasdaq: ATRA) for Ebvallo (tabelecleucel) has been transferred to privately French drugmaker Pierre Fabre.
As a result, from today, Pierre Fabre will lead all commercialization, distribution, medical and regulatory activities in Europe, the Middle East, Africa and other selected markets. Pierre Fabre is planning to launch Ebvallo in the first European countries during the first quarter of this year.
Under a previously announced license agreement with Atara, Pierre Fabre would lead all commercialization and distribution activities in Europe and select other markets, in addition to medical and regulatory activities following the transfer of the MAA from Atara to Pierre Fabre. Atara became eligible for a $30 million milestone payment from Fabre due to the approval.
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