Onivyde gains EU approval

12:39 EDT 18 Oct 2016 | BioCentury

Shire plc (LSE:SHP; NASDAQ:SHPG) said the European Commission approved Onivyde irinotecan in combination with 5-fluorouracil (5-FU) and leucovorin to treat metastatic pancreatic cancer in patients who progressed following gemcitabine-based therapy.

Onivyde is approved in the U.S. and Taiwan in the indication (see BioCentury Extra, Oct. 22, 2015).

In June, Shire gained rights to Onivyde outside the U.S. and Taiwan via its acquisition of Baxalta Inc. Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) has U.S. rights to the drug from PharmaEngine Inc. (TPEx:4162), which retains Taiwanese rights.

On Tuesday, Shire rose 67p to 5,146p in London and gained $4.91 to $190.70 on NASDAQ. Shire announced the approval after market close in Taiwan.

Original Article: Onivyde gains EU approval


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