Home' Australian Pharmacist : Australian Pharmacist September 2012 Contents 690 Australian Pharmacist September 2012 I ©Pharmaceutical Society of Australia Ltd.
Biologics are the cutting edge
Biologic medicines are the next frontier of
treatment for many previously untreatable
illnesses and conditions, according to
Medicines Australia (MA).
Speaking at the launch last month of
an eight page booklet highlighting the
value of biologic medicines, Dr Brendan
Shaw said, 'More than 350 million patients
worldwide are leading healthier lives thanks
to biologic medicines.'
the New Generation
is published by
Manufacturers & Associations, and
highlights the dramatic increase in
treatment options resulting from the
development of biological medicines.
Dr Shaw said that Biologic medicines are
derived from proteins and other substances
produced by living organisms, such as
mammalian cells, viruses and bacteria.
'These medicines are being used for the
e ective treatment of illnesses that were
not previously treatable with simpler
chemical entities. Biologic medicines and
vaccines represent the cutting edge of
medicine and have the potential to deliver
the most e ective means of treating and
diagnosing some of humanity's most
'Over 250 innovative human-use biologics
have been approved since 1990 and more
than 900 are currently under development
globally, targeting diseases such as cancer,
AIDS, arthritis, Alzheimer's and Parkinson's,'
Dr Shaw said the increasing prevalence
of biological treatments required sound
intellectual property policy and speci c
'Biologics are more complex and costly
to produce than chemical medicines. The
level of testing and clinical studies required
to compare the e ectiveness of di erent
biologic medicines presents regulators in
Australia and elsewhere with a new set
'Biologic medicines and their generic
copies -- biosimilars -- are often not
interchangeable with each other in the
same way that chemical-based medicines
are, so regulatory approval systems
need to evolve to cope with evaluating
'Intellectual property protection is another
crucial policy element as it underpins
further research and development of
biologic medicines and ensures Australians
have access to these medicines as soon
as they become available. This includes
assurances that policies on things like
patents and clinical trial data are up-to-
date with the requirements of biologics
medicines,' he said.
Biotherapeutic Medicines: Grasping the new
generation of treatments is available at:
GSK o -loads classics
GlaxoSmithKline (GSK) has sold most of its
Classic Brands range in Australia to South
African based Aspen.
The sale came only months after it sold the
rights to its over-the-counter (OTC) drugs in
North America and Europe.
The agreement will see Aspen pay GSK
approximately $256.7 million in cash for 25
non-promoted and genericised products
including Valtrex, Lamictal, Timentin, Amoxil
and Aropax. Last year these ve generated
total sales of approximately approx$123.8
million, as well as an estimated $46.2 million
in the rst half of 2012.
According to GSK, revenues for these
products have gradually declined over
recent years due to local market price
reductions and generic competition.
Moving forward GSK has said that rather
than the Classic Brands, it sees its future
growth coming from patent protected
brands and new products in its pipeline.
In March, the GSK announced the sale of
its European consumer drugs -- including
Zantac -- to Omega Pharma in a deal valued
at US$612 million. Three months earlier it
sold its North American OTC portfolio of 17
products to Prestige Brands Holdings for a
US$660 million in cash.
In all Glaxo netted more than US$1.4 billion,
which will assist it to pay for its US$3 billion
acquisition of Human Genome Sciences.
'The Australian Government's mandatory
16% price cuts on medicines when they are
genericised as well as further annual price
cuts based on competitive discounting to
pharmacies are likely to continue,' GSK said
in a statement.
'This has made the continued distribution
of non-promoted and genericised products
from GSK Australia Pharmaceuticals
unsuitable for planned future growth.'
GSK General Manager Pharmaceuticals
Australia, Geo McDonald said the
company's pipeline of new drugs has the
'the potential to transform GSK's future and
as such the divestment of these brands
allows us to focus more on bringing these
new medicines to Australian patients.
US CMI trial
A new one sheet consumer medicines
information sheet is being trialled in the
With FDA support, three pharmaceutical
companies are testing a new one-page
sheet expressly created so that patients
would read and bene t from it, rather than
just cover the bases.
The single-page documents are being
tested in California and Michigan through
the Rite Aid drugstore chain. The sheets
are accompanying prescriptions of P zer's
Celebrex, GlaxoSmithKline's Ventolin and
Johnson & Johnson's HIV medication
Prezista, according to Medical Marketing
The sheets were created by
communications rm Catalina Health
with input from the drug companies and
consultants The Brookings Group. The
e ort began when Catalina and seven drug
companies led a citizen's petition with the
FDA in 2008 about the need for a change,
Catalina General Counsel, Claire DeMatteis,
told the publication. After reviewing a four-
page sheet for Celebrex with its hard-to-read
type, the FDA agreed there was a problem
and allowed the group to seek a solution.
The result, was a simpler, more consumer
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