TAIPEI, Taiwan, Oct. 18, 2016 /PRNewswire/ -- PharmaEngine, Inc.
(TWO: 4162) announced that the European Commission (EC) has granted
Shire plc (PharmaEngine's sublicensee, LSE: SHP, NASDAQ: SHPG) a
marketing authorization (MA) for ONIVYDE®
(pegylated liposomal irinotecan hydrochloride trihydrate, nal-IRI)
in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for
the treatment of metastatic adenocarcinoma of the pancreas in
patients who have progressed following gemcitabine based
therapy.
With this approval, Shire (formerly Baxalta) is authorized to
market ONIVYDE in the 28 Member States of the European Union (EU),
as well as in Iceland,
Liechtenstein and Norway. The approved dose of ONIVYDE in
combination with 5-FU/LV is 80 mg/m2 irinotecan
hydrochloride trihydrate every two weeks, which is also the
FDA-approved dose regimen for pancreatic cancer in Taiwan.
The approval follows on the positive opinions from the Committee
for Medicinal Products for Human Use (CHMP) and the Committee for
Orphan Medicinal Products (COMP) and is based on data from the
phase 3 NAPOLI-1 study. The NAPOLI-1 study demonstrated that ONIVYDE in
combination with 5-FU/LV extended overall survival and
progression-free survival and increased tumor response rate,
without compromising quality of life as compared to 5-FU/LV alone
in metastatic pancreatic cancer patients who have progressed after
gemcitabine-based therapy. It is the first and only therapy
approved by the US FDA and the European Medicines Agency (EMA) in
this setting. In September 2015, the
European Society of Medical Oncology (ESMO) stated that the use of
MM-398 (ONIVYDE) when available in all countries, may be the best
option for patients following gemcitabine-based therapy.
"We appreciate the joint team efforts from Merrimack (NASDAQ:
MACK) and their licensee, Shire, for having submitted the Marketing
Authorization Application (MAA) to the EMA in May 2015, and successfully obtained the marketing
approval," said C. Grace Yeh, Ph.D.,
President and CEO of PharmaEngine. "We are excited that ONIVYDE
will now be available to treat the post-gemcitabine pancreatic
cancer patients in the EU which is one of the major markets that we
licensed to Merrimack."
About Pancreatic Cancer
According to GLOBOCAN, pancreatic cancer prognosis is typically
poor, with an estimated 337,900 new cases and 330,400 deaths each
year. However, the early stages of pancreatic cancer do not usually
produce symptoms, so the disease is generally advanced when it is
diagnosed. Metastatic pancreatic cancer is a highly fatal disease.
Therapies are designed to control disease and extend survival.
Gemcitabine, both as monotherapy as well as in combination, is
commonly used in the first-line treatment of locally advanced
and/or metastatic pancreatic adenocarcinoma, as well as in the
adjuvant (treatment after surgery) and neo-adjuvant (treatment
before surgery) settings.
About ONIVYDE® (irinotecan liposome
injection, pegylated liposomal irinotecan hydrochloride trihydrate,
nal-IRI)
ONIVYDE®, also known as MM-398 or PEP02, is a
novel encapsulation of irinotecan in a liposomal formulation. In
May 2011, PharmaEngine licensed its
Asian and European rights except Taiwan to Merrimack. Following the
announcement of positive top line phase 3 data in May 2014, Merrimack licensed the rights to
ONIVYDE outside of the US and Taiwan to Baxalta Incorporated (now Shire) in
September 2014. ONIVYDE has received
regulatory approvals from the Taiwan FDA (TFDA) and the US FDA in
October 2015, and the Marketing
Authorization by the EC in October
2016. PharmaEngine received the Product License from the
TFDA in March 2016. ONIVYDE has
orphan drug designations in the US, EU and elsewhere.
About PharmaEngine (TWO: 4162)
PharmaEngine, Inc. is a publicly traded commercial stage
oncology company headquartered in Taipei,
Taiwan, with a wholly owned subsidiary, PharmaEngine Europe
Sarl in Paris, France.
PharmaEngine focuses on the development of new medications for the
treatment of cancer and Asian prevalent diseases. PharmaEngine has
three ongoing projects: ONIVYDE® has received
regulatory approvals by the TFDA, the US FDA and the EMA; PEP503
(NBTXR3) is in a global pivotal trial of soft tissue sarcoma, a
phase 1b/2 study of rectal cancer, and a phase 1/2 study of head
and neck cancer in Taiwan; and
PEP06 is in lead optimization. For further information, please
visit PharmaEngine's website at http://www.pharmaengine.com.
Contact
Chihsing Chang, Vice President,
Finance and Administration
Telephone No.: (+886)-2-2515-8228, ext. 700
Email: chihsing.chang@pharmaengine.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/pharmaengine-announces-onivyder-receives-european-marketing-authorization-for-the-treatment-of-metastatic-adenocarcinoma-of-the-pancreas-following-gemcitabine-based-therapy-300346572.html
SOURCE PharmaEngine, Inc.