ONIVYDE® Receives Positive CHMP Opinion for Treatment of Patients with Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Following Gemcitabine Based Therapy

Zug, Switzerland (ots/PRNewswire) -

The positive opinion is based on a pivotal Phase 3 study showing
that ONIVYDE combined with chemotherapy significantly increased
overall survival (OS) in patients with metastatic pancreatic cancer
after previous gemcitabine based therapy

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) adopted a positive opinion recommending the
marketing authorization for the use of ONIVYDE® (irinotecan pegylated
liposomal formulation) also known as nal-IRI or MM-398, for the
treatment of metastatic adenocarcinoma of the pancreas, in
combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult
patients who have progressed following gemcitabine based therapy.

"There has been little improvement in the prognosis for patients
with metastatic pancreatic cancer in over 20 years. We therefore
welcome the CHMP positive opinion for ONIVYDE, a regulatory milestone
which brings us a step closer to helping patients with this
devastating disease." said Philip J. Vickers, Ph.D., Head of R&D,
Shire. "At Shire, we are committed to research and development
through innovation in order to identify unique methodologies for
treating patients with high unmet needs."

Pancreatic cancer is the third leading cause of cancer death in
the region and there are limited treatment options available. In
September 2015, the European Society of Medical Oncology (ESMO)
stated that use of MM-398 (ONIVYDE) when available in all countries,
may be the best option for second-line treatment of these patients
following gemcitabine-based therapy. Gemcitabine-based therapy is
commonly used as a first-line treatment for patients with metastatic
disease or locally advanced disease who cannot be treated with
surgery, or as adjuvant therapy.

"Guidance from ESMO indicates the use of ONIVYDE for the treatment
of metastatic pancreatic cancer in patients who have progressed
following gemcitabine-based treatment," said Volker Heinemann, M.D.,
Ph.D., a professor of medical oncology at the University of Munich,
Germany. "The CHMP positive opinion for ONIVYDE is an important step
for patients with this devastating disease."

The CHMP positive opinion is based on pivotal, Phase 3 NAPOLI-1
data that demonstrated nal-IRI combined with 5-FU and LV improved
overall survival (OS) (primary endpoint), as well as progression-free
survival (PFS) and objective response rate (ORR) relative to the 5-FU