Indication intelligence, analysis and sector perception

Kite Pharma (KITE) EMA recommends EU orphan drug designation for KTE-C19

October 15, 2015 9:47am

In 3 hematological indications: ALL, CLL/SLL, and FL - jumps 1.5% or +$0.92 - HOLD

The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions recommending KTE-C19 for designation as an orphan medicinal product for the treatment of ALL, CLL/SLL, and FL.

Kite previously received orphan drug designation for KTE-C19 for the treatment of diffuse large B-cell lymphoma (:DLBCL) in both the US and the EU, as well as COMP positive opinions for orphan drug designation in the EU for primary mediastinal B-cell lymphoma (:PMBCL) and mantle cell lymphoma (:MCL)

The Bottom Line: The orphan drug designation is always an important regulatory milestone where there are limited treatment options.

Kite closed at $60.40 and is UP at the open +$0.61 to $1.00 and slipping to $0.92 – it will “dance” on strength.

The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission (EC) for endorsement of the opinion. Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.

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