“Striving for a pain-free world” - Sanochemia

“Striving for a pain-free world”
Professor Helmut Schmidhammer is a
co-founder of AlcaSynn Pharmaceuticals
GmbH, a spin off of the University
of Innsbruck. His interests lie in
the investigation of new analgesic
substances. While conducting research
at the National Institute of Health in
Bethesda, USA, between 1980 and
1982, he discovered a new therapeutic
concept associated with opioids.
An interview
with Professor
Helmut Schmidhammer
The breakthrough for Professor
Schmidhammer and his colleagues
from the Institute for Pharmacy at the
University of Innsbruck came with the
discovery of AS006.
Dr. Holger Bengs, owner of Frankfurtbased
Biotech Consulting, spoke
to Professor Schmidhammer about
the development of AS006 from the
laboratory to use in patients.
Professor Schmidhammer, in June 2006
Sanochemia Pharmazeutika AG acquired a
majority shareholding in your company, AlcaSynn
Pharmaceuticals GmbH. What does this change
mean for you personally, for your employees and
your research?
You have to appreciate that for my employees and I this
acquisition was the next logical step on a path that we have
been following for the past eight years or so. In 1998,
Dr. Mariana Spetea and I began working on a special
therapeutic concept with the aim of developing a potent
analgesic with a favourable side effect profile. This
substance should only work on the peripheral nervous
system, i.e. not cross the so-called blood-brain barrier to
have any effect on the brain. Working in cooperation with
an international research team we came across AS006
during the course of our experiments. Sanochemia means
that we now have a partner with sufficient resources to
finance the next decisive developmental steps.
Annual Report 2005/2006 · Interview with Professor Schmidhammer
Sanochemia is also the perfect partner in that the company
has considerable expertise in the areas of the production
and clinical development of analgesics.
What is so special about AS006?
Investigations of this substance in various animal models
have confirmed the extremely high level of potency of
AS006 and its excellent tolerance properties. Previously,
there existed a dilemma that highly effective opiates were
associated with a range of strong side effects such as
sedation, respiratory depression and risk of addiction.
This problem was first solved by AS006 – a so-called
morphinane. This was an outstanding success and
one that we are very proud of. Yet, our goal is not only
to publish exceptional experimental data; we aim to
develop and launch a product based on this substance
that represents a real benefit to patients – to attack pain
at its source and bring sufferers a life free of pain.
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Please explain again exactly what morphinanes
are?
Morphinanes are substances which possess a chemical
structure similar to that of morphine, itself a natural mixture
of substances found in opium. We have specialised in this
class of substances and have been able to demonstrate
that they are not only suited to the development of potent
analgesics, but also possess the potential to yield new
active pharmaceutical ingredients for the treatment of
numerous different diseases. Our role in the cooperation
with Sanochemia will also be to develop further such
substances and to establish their efficacy and tolerance in
animal models – just as we did with AS006.
How will the development tasks associated with
AS006 be shared between AlcaSynn and
Sanochemia?
Each of us should do that which they do best. We have,
for years, been one of the world’s leading research groups
in the field of opioid substance development and will
conduct research and development prior to trials in man, i.e.
the so-called pre-clinical development of opiates and other
developmental substances. AlcaSynn will be supported
by Sanochemia in the area of clinical development, i.e. the
use in human subjects. Sanochemia will ultimately also
manufacture the new drug on an industrial scale.
Which developmental steps are due next?
We are currently working together with Sanochemia on
the synthesis of AS006 so that the substance can be
manufactured at their facility in Neufeld in accordance
with GMP guidelines and in sufficient quantities for the
clinical trials necessary to secure regulatory approval.
This entails compliance with internationally recognised
standards of good manufacturing practice relating to
active pharmaceutical ingredients. The manufacture of the
substance according to these high qualitative standards is
a precondition for conducting toxicological and clinical
trials in man.
When do you expect to start clinical trials and how
does the rest of the developmental schedule look?
Drug development, ranging from the identification of the
active pharmaceutical ingredient through to marketing authorisation
for use in patients, takes an average of around
ten years. We have already taken a number of key steps
along this path. We will soon be carrying out the first toxi-
cological and pharmacological safety tests allowing us to
plan on starting the first clinical trials in the second half
of 2008. The clinical phase prior to obtaining marketing
authorisation is made up of three stages. In the first clinical
phase, AS006 will be tested in healthy probands. This takes
around one year. Once the analyses have been completed
and the results evaluated, AS006 will enter the second
clinical phase of development when it is tested in patients
experiencing acute or chronic pain. This phase can take
one to two years. In the third and final clinical phase prior
to filing for marketing authorisation, AS006 will be tested
in a larger study group made up of several thousand
patients over a period of two to three years. This is the big
test for AS006 in which it has to demonstrate its efficacy
and tolerance, also when compared to competitor products.
So it will be a long time before you can expect to
see the first revenues generated by AS006?
No. We expect to see the first revenues generated by AS006,
in the form of advance and milestone payments, a lot
earlier than that. Together with Sanochemia, we are
Annual Report 2005/2006 · Interview with Professor Schmidhammer
already on the look-out for a partner who can finance the
cost-intensive clinical phases and take on the subsequent
marketing of the product. With such a partner on board,
we will see the first revenues from AS006 long before it is
launched.
The experts in a company that develops new
substances need a never-ending supply of ideas.
What are you currently working on at AlcaSynn and
what prospects do these projects have?
Firstly, we are concentrating on the known effects of
morphinanes on the opioid system. These substances can
act either as stimulants or inhibitors. Their wide variety of
chemical structures gives rise to a large number of different
opiate pharmacological profiles. It is already known that
opiates are suited to the development of substances to
treat clinical conditions as diverse as itching, intestinal
obstruction and Parkinson’s.
We are also working on a totally independent project
that aims to explore the fact that certain morphinane
substances specifically address other receptors and
enzymes. This provides the potential to develop an
entirely new class of patented substances for use in
treating conditions such as forms of dementia and
dermatological problems.
It is clear that we cannot pursue all of these projects at
the same time, but I would just like to make clear the
potential offered by our patented technology. Still, for some
of the indications I mentioned, we already have extremely
promising data from tests in animals. On the basis of
these results, I am convinced that this development
pipeline will contribute to the sustained commercial
success of AlcaSynn Pharmaceuticals.
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