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BioDiem
Ltd
Overview
BioDiem Limited (BioDiem) is a Melbourne based company with an
international focus on finding, adding value to and commercialising
world class research for vaccines, infectious diseases and other
therapeutic areas.
BioDiem brings a clear commercial focus to the pharmaceutical development
business and aims to distinguish a select number of viable potential
products and take them to market in a cost-effective manner.
BioDiem has three projects currently underway:
i) Live Attenuated Influenza Vaccine (LAIV)
ii) Coronary Artery Disease (BDM-K)
iii) Antimicrobial Program (BDM-I)
In addition BioDiem has an early stage program, based on a potential
platform technology for developing other vaccines, for which the
first target is a malaria vaccine.
Biodiem is also currently in late stage negotiations for a new
product aimed at treating retinal eye diseases, in particular diabetic
retinopathy and macular degeneration.
Competitive
Advantages
Biodiem’s business model distinguishes them from many other
companies in the “biotech sector”. The typical biotech
is a spin-off by originating scientists from a research institution
that raises funds to set up their own labs and researchers to pursue
a promising, but early stage idea or invention.
BioDiem’s business model is to look for more advanced “products
in the making” arising from many years of research at an institution
where there is already proof-of-concept, preferably in humans. At
that stage BioDiem seeks to acquire the Intellectual Property or
licence-in projects with viable commercial potential and put them
on a development path that adds significant value prior to out-licensing
them to international pharmaceutical companies to get the products
to a world-wide market.
The company has a strong relationship with the St Petersburg Institute
of Experimental Medicine (IEM). This relationship has provided BioDiem
with cost-effective access to valuable research programs with advanced
clinical data. The ability to access projects at a late stage, which
reduces the technical risk, is a significant advantage of Biodiem's
model.
To effectively manage development costs, BioDiem out-sources its
research and development requirements to appropriate institutional
centres of excellence and contract research organisations.
Technology
The company has the following biotech projects currently under
development:
1. Live Attenuated Influenza Vaccine (LAIV)
BioDiem has a licence from the IEM to commercialise the LAIV technology
outside of Russia and the Commonwealth of Independent States (CIS).
The LAIV has been approved for public use in Russia and the CIS
and has been used to vaccinate tens of millions of people over the
past decade. The LAIV is administered by a single-dose nasal spray
and induces a rapid immune response in the mucosal lining of the
nose and pharynx. The LAIV has been tested in Russian clinical trials,
several of which have been conducted in conjunction with the US
Center for Disease Control in Atlanta, conducted to international
standards and published in international journals. The LAIV as used
and tested in Russia has around 93% efficacy in children after a
single dose. Children typically suffer the highest attack rates
during an influenza epidemic, but until now have had low rates of
vaccination. The LAIV compares favourably with currently available
influenza vaccinations, which use a killed virus, administered via
injection.
Market potential - Influenza is a common worldwide health problem.
The disease affects around 120 million people in the United States,
Europe and Japan each year. The Center for Disease Control in Atlanta
has recently upgraded their estimate that a typical flu epidemic
is responsible for 20,000 deaths to 36,000 deaths in the USA. Costs
to the community have been estimated at US$12 billion per year.
Russia is the first country where live attenuated vaccines have
been approved for use against influenza and which are in regular
use. Research on cold-adapted strains of the influenza virus has
also been conducted for many years at the University of Michigan,
who licensed their technology to a US biotech company Aviron that
has now been taken over by MedImmune.
In late December 2002, an FDA Advisory Committee met to review
MedImmune’s (formerly Aviron’s) cold adapted live virus
intranasal influenza product, FluMist®. The Committee recommended
that the FDA approve FluMist® to prevent influenza in healthy
children, adolescents and adults aged 5 - 49.
The Advisory Committee voted in favor of the product’s safety
in the 50 - 64 age group but indicated that they believed the data
set on efficacy in that age group was inadequate at this time. During
the FluMist® Advisory Committee discussion, and as widely reported
in the public domain, the experts on the committee expressed concerns
relating to the potential for triggering an asthma event in children
less than five years of age due to the administration of the FluMist®
cold adapted live virus intranasal influenza vaccine. In children
<5 years old it is very difficult to adequately identify exactly
which children are predisposed to asthma and therefore which children
should be contraindicated. As a result, the Advisory Committee considered
it prudent to advise the FDA that FluMist® should not be indicated
for children under 5 years. The Advisory Committee has requested
additional information from post-marketing studies on a number of
issues including the risk of asthma and wheezing in children and
the comparative safety and efficacy to a licensed inactivated influenza
vaccine, especially to adults over 50 years of age.
In September 2001 BioDiem signed a licensing agreement granting
Merck exclusive rights to develop, manufacture and market BioDiem's
LAIV technology, delivered by nasal spray. In light of the FDA’s
decision on FluMist® and consistent with industry practice Merck
immediately undertook a reappraisal of the commercial potential
and attractiveness of the LAIV as a commercial product of its Vaccine
Division. During this review, Merck has evaluated the potential
product profile of the cold adapted live virus influenza vaccine,
the issues highlighted during the recent FDA Advisory Committee
review of FluMist® and the current strategic research priorities
for Merck.
As a result of this review, Merck has notified Biodiem that they
are ceasing development of the cold adapted live virus influenza
vaccine program. Merck have commented that this was a strategic
R&D prioritization decision that was only reached after extensive
consultation within the company. As a result of this notice from
Merck, Biodiem will reacquire all rights to the flu vaccine and
Merck will return to Biodiem all of the master donor strains including
any and all derivatives, modifications, variations or mutations
thereof. Biodiem is now seeking new opportunities to partner the
LAIV technology with other vaccine manufacturers.
Market Commentary
BioDiem was interested to note the following comments from a Merrill
Lynch report on 6th January 2003:
“Once considered a commodity market, we forecast that the
global vaccine market will achieve compound growth of 13% in the
next five years.
“Our global vaccine market model forecasts sales growth from
$5.4bn in 2001A to nearly $10bn in 2006E.
“The fastest growing vaccine market is for flu vaccines.
We predict that this market will more than double in value to $2bn
in the next five years.”
2. Coronary Heart Disease (BDM-K)
BDM-K is a tissue resolution agent that has also been acquired
from the St Petersburg Institute of Experimental Medicine (IEM).
It will be aimed at assisting the recovery of cardiac function after
a heart attack.
In early human studies, conducted in four Russian cardiac clinics,
BDM-K has shown the potential to be useful in assisting the restoration
of the contractile function of cardiac muscle, with 3 weeks oral
treatment starting a week after a heart attack. For patients treated
with BDM-K, decreases were reported in shortness of breath, tachycardia,
and oedema in the lower extremities associated with the cardiac
insufficiency. BDM-K also had a positive effect on the contractile
function of myocardium, as shown by a significant increase in the
ejection fraction. BDM-K has the potential to assist the quality
and speed of restoring some types of damaged tissue to an improved
state, structure and function, with less scarring.
Coronary heart disease is a major cause of mortality, causing over
half a million deaths in America in 1999. However, initial death
rates from heart attacks have declined as more people get to hospital
and get attention to the point where of the 1.5 million people in
the USA who experience an acute myocardial infarction (AMI), or
heart attack, approximately 1 million will survive requiring post-infarction
treatment and therapy. Returning to a normal life depends upon minimising
the damage the infarction causes to the heart muscle. While it is
likely that more people will survive an AMI the emerging major problem
is the significant proportion of people dying from heart failure
in the 5 years after a heart attack. There are currently limited
significant pharmaceutical treatments available to aid recovery
of damaged cardiac muscle after heart attacks. Market potential
for this indication is estimated to be US$3 billion per year.
BioDiem is in the process of engaging a leading Australian centre
of excellence in cardiac research to collaborate in a developmental
program for pre-clinical work designed to lead to studies in man,
over the next 2 years. Clinical trials could commence within 18
months. BioDiem will soon be lodging international patent applications,
in the name of Biodiem for BDM-K.
3. Animal Feed Additive (BDM-I)
BDM-I is a compound which has been shown to have significant antimicrobial
properties. Biodiem acquired BDM-I from IEM. The product has a number
of potential applications but Biodiem’s primary focus for
BDM-I is as a growth promoting feed additive for intensively farmed
livestock.
There are several reason’s why Biodiem has chosen to develop
BDM-I for use in livestock in the first instance.
First, laboratory in vitro preliminary testing of BDM-I has revealed
that in systems where major existing antibiotics show the development
of resistance by bacteria, no resistance has so far developed with
BDM-I. The apparent lack of developed resistance (in tests to date)
and the low oral absorption properties of BDM-I from the gut have
suggested the potential use for BDM-I as a medicated feed additive,
particularly for use in the poultry and swine intensive growing
industries, to replace the existing use of antibiotics that have
lead to concerns about the spread of antibiotic resistance. In early
stage trials at a Melbourne university, BDM-I produced significant
weight gain in chicks, relative to control groups. Further studies
are continuing to define the potential for BDM-I as an effective
growth promoter in poultry, to replace the increasingly proscribed
use of antibiotic growth promoters. The market for ‘medicated
feed additives’ is estimated to be in excess of US$1.7 billion
per year.
Second, BioDiem intends to have trials undertaken for the purpose
of achieving registration of BDM-I as an animal feed additive in
Australia, potentially within 2 years. Testing will be outsourced
to several research institutions and contract research organisations.
An international patent application has recently been lodged in
the name of Biodiem. Clearly, this is a much faster route to market
than that for market approval of a human pharmaceutical.
Third, the studies undertaken to obtain registration of BDM-I as
a growth promoter for use in livestock will also be valuable in
showing its effectiveness as an antibiotic for use in livestock
thus opening up access for the product to a market worth in excess
of $5 billion.
As BDM-I has broad-spectrum antimicrobial properties Biodiem will
also seek to license the product to pharmaceutical companies for
potential use for the following conditions:
(i) Critical care antifungal market - total market of around US$1.5
billion. The level of toxicity compromises most current treatments
for serious fungal infections;
(ii) Critical care antibacterial market - market potential of around
US$0.5 billion. Preliminary in-vitro testing reveals that BDM-I
has a significantly lower risk of drug resistance developing;
(iii) Community care antifungal market - total market of around
US$3 billion. Opportunities exist in the treatment of fungal nail
infections, tinea and vulvovaginal Candida.
4. Platform vaccine technology
Biodiem has initiated an early stage program to develop a platform
technology for new vaccines, based on use of an attenuated viral
vector to deliver antigens into targeted tissues. The creation of
a malaria vaccine will be the first target, as a joint collaborative
venture between the St Petersburg IEM, BioDiem and an Australian
University.
5. Age-related retinal eye diseases
Biodiem’s success with the IEM developed flu vaccine and
its licence to Merck has led to introductions to other significant
research institutions in Russia.
Biodiem is currently in late stage commercial negotiations for
another promising project with evidence of success. This particular
project involves a novel synthetic compound relating to the treatment
of age-related retinal eye diseases. The lead indications in this
case are age-related macular degeneration and diabetic retinopathy,
some of the leading causes of loss of vision in people over 55,
and for both of which there is currently a significant unmet medical
need. The market for such a compound is estimated to be in excess
of US$2 billion per year. In early stage human studies in Russia
in 63 patients with macular degeneration, 88% of patients showed
an improved ophthalmoscopic picture of the eye fundus, and 85% of
patients had some improvement in visual acuity.
Corporate
Alliances/Partnerships
Relationship with the St Petersburg Institute of Experimental Medicine
(IEM)
As already mentioned, BioDiem has strong links with the IEM, which
developed the LAIV vaccine. The IEM achieved international prominence
early in the 20th century, when Nobel Prize winner Pavlov worked
with dogs to establish the basis of conditioned reflexes. Over the
course of the century the IEM has developed a broad-based research
capacity in many areas of biology and medicine.
The IEM is recognised as one of the pre-eminent research institutions
in Russia. Its Director, Academician Boris Tkachenko, is a leading
medical scientist with responsibility for several hundred scientists,
technicians and other staff. He now holds the prestigious position
of Vice-President of the Russian Academy of Medical Sciences (RAMS).
RAMS has oversight of about 380 Medical Research Institutions throughout
Russia. IEM and contacts with other RAMS research institutions in
Russia provide BioDiem with an outstanding source of under-utilised,
cost effective, high-grade research that it can draw on for commercial
opportunities.
Partnering Opportunities
Biodiem has the following projects available for partnering:
i) Live Attenuated Influenza Vaccine (LAIV)
ii) Coronary Artery Disease (BDM-K)
iiii) Antimicrobial Program (BDM-I)
Biodiem is also currently in late stage negotiations for a new
product aimed at treating retinal eye diseases, in particular diabetic
retinopathy and macular degeneration.
In addition BioDiem has an early stage program, based on a potential
platform technology for developing other vaccines, for which the
first target is a malaria vaccine.
| Contact Person |
Tom Williams
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| Job Title |
Chief Executive Officer |
| Address |
Level 10, South Tower
459 Collins St |
| City/Suburb |
Melbourne
Victoria 3000 Australia |
| Email |
Twilliams@biodiem.com |
| Phone |
+61 3 9613 4100 |
| Fax |
+61 3 9613 4111 |
| Website |
www.biodiem.com |
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