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Pfizer completed the acquisition
of Hospira in September 2015.
Since then Pfizer Australia has
been planning for the integration
of various functions across the two
legacy businesses -- Pfizer Australia
According to Pfizer, as a result,
the Australian legacy Hospira
pharmaceutical operations will be
integrated within Pfizer's current
operating model on 3 October 2016.
As such community pharmacies will
purchase legacy Hospira medicines
directly from Pfizer only through its
existing Direct to Pharmacy (Pfizer
Direct) distribution channel, as they
do now with all Pfizer medicines.
Pfizer said it is important to note
that there will be no change to
the current ordering process until
3 October 2016 and over coming
weeks pharmacies will receive
information from Pfizer detailing
the range of products that will
be added to Pfizer portfolio and
corresponding PDE numbers
effective 3 October, 2016.
Until 3 October, Pfizer and Hospira
purchase orders should be kept
separate as pharmacies will continue
to receive separate product
shipments and invoices.
For further information contact
Customer Service at: 1800 999 543.
Takeda has announced that it has vaccinated the first subject in the
Tetravalent Immunization against Dengue Efficacy Study (TIDES),
a Phase 3 double-blind, randomized and placebo-controlled trial of its
live-attenuated tetravalent dengue vaccine candidate (TAK-003).
The TIDES trial will enrol approximately
20,000 healthy children between the
ages of four and 16 years living in
dengue-endemic countries in Latin
America and Asia. The study will
evaluate the efficacy of the vaccine
candidate to protect subjects against
symptomatic dengue fever caused by
any of the four dengue virus serotypes,
regardless of age and whether the
individual has previously been exposed
to the virus. The study will also evaluate
vaccine safety and immunogenicity and
will involve two doses of the vaccine
candidate or placebo administered 90
President of the Global Vaccine Business
Unit at Takeda, Rajeev Venkayya said:
'The initiation of Phase 3 trials for
our dengue vaccine candidate is a
critical milestone, bringing us closer
to delivering a vaccine that can
address important unmet needs in
dengue prevention. This is a significant
achievement for Takeda's vaccine
program and underscores our ongoing
commitment to addressing critical
global health threats.'
TIDES will build on previous studies
which have assessed the tolerability,
safety and immunogenicity of the
vaccine against all four dengue
serotypes in multiple age groups to
determine whether the vaccine helps
prevent symptomatic dengue.2--4
Takeda's tetravalent dengue vaccine
candidate (TAK-003) is based on a live-
attenuated dengue serotype 2 virus
(DENV-2), which provides the genetic
'backbone' for all four vaccine viruses.
1. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent
Dengue Vaccine (TDV) in Healthy Children (TIDES) (2016).
ClinicalTrials.gov. Accessed May 2016 at: https://clinicaltrials.
2. Osorio JE, Velez ID, Thomson C, et al. Safety and
immunogenicity of a recombinant live attenuated
tetravalent dengue vaccine (DENVax) in flavivirus-naive
healthy adults in Colombia: a randomised, placebo-
controlled, phase 1 study. The Lancet Infectious diseases
3. Wallace D. Persistence of neutralizing antibodies one year
after two doses of a candidate recombinant tetravalent
dengue vaccine in subjects aged from 1.5 to 45 years.
Presented at 6th Annual Meeting, American Society of
Tropical Medicine and Hygiene, 2015.
4. Saez-Llorens X, et al. Phase II, double-blind, controlled
trial to assess the safety and immunogenicity of different
schedules of Takeda's Tetravalent Dengue Vaccine
Candidate (TDV) in healthy subjects aged between 2 and
<18 years and living in dengue endemic countries in Asia
and Latin America. Presented at 5th Pan-American Dengue
Research Network Meeting, 2016.
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