Healthcare Industry News:  Leucovorin 

Biopharmaceuticals Oncology Regulatory

 News Release - July 25, 2016

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

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

ZUG, Switzerland, July 25, 2016 -- (Healthcare Sales & Marketing Network) -- 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 ONIVYDEŽ (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 and LV control arm (secondary endpoints). The most common Grade 3 or higher adverse events with greater than five percent difference in patients receiving nal-IRI and 5-FU and LV were neutropenia, fatigue and diarrhoea, and vomiting.

"The CHMP positive opinion confirms the strength of the Phase 3 NAPOLI-1 data for the use of ONIVYDE to treat metastatic pancreatic cancer patients in the post-gemcitabine setting." said Professor Thomas Seufferlein, M.D., University of Ulm, Germany. "This data will allow physicians to better evaluate options for extending overall survival of patients diagnosed with a very difficult-to-treat cancer."

The CHMP's positive opinion will be submitted to the European Commission (EC), which is responsible for granting marketing authorizations for medicines in the European Union (EU). We anticipate a final decision later this year.

J. Marc Pipas, M.D., Senior Medical Director at Merrimack Pharmaceuticals Inc. commented: "We applaud the CHMP's positive opinion on ONIVYDE as it acknowledges the clinical significance of this therapy for a patient population with few treatment options. We look forward to continuing our work with Shire to expand the global availability of this important therapy to patients facing metastatic pancreatic cancer."

About Pancreatic Cancer

Pancreatic cancer is a significantly underserved disease in Europe and almost always fatal. Half of people diagnosed with pancreatic cancer are diagnosed at Stage 4, which is advanced metastatic disease and no longer curable. The disease has a five-year overall survival (OS) rate of three percent, and a median OS typically less than a year, as supported by real-world European systematic review. The only curative treatment for pancreatic cancer is surgical resection in the primary stage, which can improve five-year survival to 10 percent.

Source: Shire plc

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