Home' Australian Pharmacist : Australian Pharmacist February 2016 Contents Australian Pharmacist February 2016 I ©Pharmaceutical Society of Australia Ltd. 79
Merck, P zer and Syndax
Merck, Pfizer and Syndax Pharmaceuticals
have entered into a collaboration
agreement to evaluate avelumab*,
an investigational fully human anti-
PD-L1 IgG1 monoclonal antibody, in
combination with Syndax's entinostat,
an investigational oral small molecule
that targets immune regulatory cells
(myeloid-derived suppressor cells and
regulatory T-cells), in patients with heavily
pre-treated, recurrent ovarian cancer.
Avelumab is currently under clinical
investigation across a broad range of
tumour types by the Merck-Pfizer Alliance.
This is an exclusive agreement between
the alliance and Syndax to study the
combination of these two investigational
agents in ovarian cancer. Syndax will be
responsible for conducting the Phase Ib/II
clinical trial in ovarian cancer.
Dr Mace Rothenberg, Senior Vice
President of Clinical Development
and Medical Affairs and Chief Medical
Officer for Pfizer Oncology, said:
'This collaboration with Syndax adds a
new dimension to our quest to pursue
regimens based on compelling
preclinical rationale and the potential
to generate clinical results superior to
those achieved with either agent alone.
Dr Luciano Rossetti, Head of Global
Research & Development of the
biopharma business at Merck, said:
'Combination therapy is the next
frontier in immuno-oncology and a key
strategy for the alliance. Avelumab as
a monotherapy has already shown
promising early activity in ovarian cancer
in a Phase Ib trial, and through our
ongoing research and this collaboration
with Syndax, we will hopefully be able to
make a real difference to women fighting
this complex cancer.'
*Avelumab is the proposed International
Non-proprietary Name for the anti-PD-L1 IgG1
monoclonal antibody (MSB0010718C). Avelumab is
under clinical investigation and has not been proven
to be safe and effective. There is no guarantee
any product will be approved in the sought-after
indication by any health authority worldwide.
Infant nutrition formula
Blackmores has partnered with Bega to
develop a nutritional range of products.
The first of these are infant nutrition
formulas that went on sale in January.
Blackmores CEO, Christine Holgate said:
'We've developed three Australian made
products, formulated with the highest
quality, premium ingredients and based
on the combined expertise of Blackmores
and Bega's subsidiary Tatura. Together our
companies have more than 180 years of
combined experience in nutrition and
dairy manufacture which is one of the key
reasons our customers trust our quality
Australian pharmacies were the first to
receive delivery of the new formulas
and received more than 80% of the total
'Our initial focus is supplying Australian
pharmacies so mums have quality advice
from a trusted healthcare professional,'
Ms Holgate said.
Blackmores has also bolstered its healthcare
professional support in infant nutrition
including the addition of a breastfeeding
counsellor to their freecall advisory service.
'Blackmores supports breastfeeding as
optimal nutrition for babies, though it's also
important to have a high quality offering
for when breastfeeding is not possible,'
said Ms Holgate.
The partnership between Blackmores
and Bega will be an important additional
source of supply for the Australian infant
The products will supply the local market
and will also be sold through established
retailers in Asia including Alibaba Group's
The European Commission (EC) has
approved Benepali -- a biosimilar to
Enbrel (etanercept), also known as
SB4 -- for the treatment of rheumatoid
arthritis, psoriatic arthritis, axial
spondylitis and non-radiographic axial
spondyloarthritis) and plaque psoriasis.
The EC approval follows a positive
opinion on Benepali by the European
Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use
(CHMP), which was announced on
20 November, 2015.
Christopher Hansung Ko, President
& CEO of Samsung Bioepis said the
approval of Benepali and its subsequent
launches in Europe were major
milestones for the company.
'In just under four years, we successfully
developed, tested and obtained
regulatory approval for Benepali,
a high-quality biologic medicine
that will drive down healthcare costs
and increase patient access to one
of the most widely used treatment
options for immunological diseases
across Europe. In addition to Benepali,
we continue to advance one of the
industry's broadest biosimilar pipelines
with multiple biosimilar candidates in
Phase 3 clinical trials. Over the coming
months, a number of them will be filed
for regulatory approval in markets
across the world. We remain committed
to leveraging our strengths in product
development and quality assurance
to bring affordable, high-quality
medications to patients worldwide.'
Benepali will be gradually rolled out
across all 28 European Union (EU)
member states as well as the European
Economic Area (EEA) member states
of Norway, Iceland and Liechtenstein.
In accordance with a commercialisation
agreement signed in 2013 between
Samsung Bioepis and Biogen.
Biogen will lead the commercialisation
and distribution of Benepali in the EU
and EEA member states.
Links Archive Australian Pharmacist January 2016 Australian Pharmacist March 2016 Navigation Previous Page Next Page