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Industry Watch
Australia
Aspect Medical Systems and
Brain Resource Company
Partners in MCI Study
A
spect Medical Systems Inc has agreed to fund The Brain Resource Company (BRC) to conduct a
clinical study aimed at developing markers for Mild Cognitive Impairment (MCI).
More than 80% of patients with MCI develop Alzheimer's disease within ten years, at a rate of 10%
to 15% of patients per year. Estimates are that in addition to the four million Americans with Alzheimer's,
another eight million suffer from MCI. This is becoming of increasing concern to the medical fraternity given
the aging population.
Aspect is recognized as a global market leader in brain monitoring, having developed the first clinically
proven and commercially available direct measure of the effects of anesthetics and sedatives on the
brain.
This technology has been used to assess more than 12.2 million patients and is utilized in more than
68% of the best hospitals with operating rooms in the U.S and is available in more than 160 countries. Of
particular importance, earlier this year Aspect and Boston Scientific Corporation announced a strategic
alliance to develop brain monitoring technology for diagnosing and treating depression and alzheimer's
disease.
BRC is particularly pleased to have been selected by Aspect to contribute to this component of the
alliance. BRC is to receive A$500,000 to conduct this study.
About Aspect Medical Systems Inc
Aspect Medical System’s was founded in 1987 to develop
technology that could measure a then unknown element
of patient status — the direct effect of drugs and disease
on the brain. Today, Aspect is recognized as a pioneer
and global market leader in brain monitoring, having led
the way to develop proprietary technologies that directly
measure these effects and ultimately improve the quality and
cost effectiveness of patient care. Aspect’s premier product
(Bispectral Index (BIS) technology) became the first clinically
proven and commercially available direct measure of the
effects of anesthetics and sedatives on the brain.
About BRC
The Brain Resource Company provides a comprehensive
methodology to assess brain and body function. BRC has
set up the world's first standardized international database
which brings together an unprecedented breadth of data.
This includes: personal history; neuropsychological tests
(memory, attention etc); electrical brain-body function
(speed of information processing); brain structure; and
genetics coupled with new ways of analyzing the brain. BRC's
standardized methodology is currently employed in over 50
sites in six countries (USA, Europe, South Africa, Australia)
by a wide range of users.
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Contact Details:
Aspect Medical Systems Inc
Address: 141 Needham Street,
Newton, MA 02464
+617 559 7000
Tel:
+617 559 7400
Fax:
[email protected]
email:
Contact Details:
Brain Resource Company
Address: PO Box 737,
Broadway NSW 2007,
Australia
+61 2 9211 7120
Tel:
+61 2 9211 2710
Fax:
[email protected]
Email:
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Industry Watch
Australia
Mesoblast and
Cordis Collaborate on
Adult Stem Cell Heart Trial
A
ustralian adult stem cell company, Mesoblast Limited announced
that Cordis Corporation, a Johnson & Johnson company, will join
forces in its upcoming adult stem cell Pilot Cardiac Clinical Trial
through an agreement with Mesoblast’s American affiliated company,
Angioblast Systems Inc.
Mesoblast’s chief scientific adviser, Professor Silviu Itescu, said that the
collaboration would be the world first clinical use of the latest Biosense
Webster Inc cardiac injection catheter technology for cell delivery.
“This is a significant endorsement of the clinical potential of our
proprietary adult stem cell technology,” Professor Itescu said. The principal
investigator of the Pilot Clinical Trial at Newcastle’s John Hunter Hospital,
Dr Suku Thambar, will use the Biosense Webster NOGA XP catheter
technology to deliver the proprietary adult stem cells directly into the
damaged heart muscle of up to ten patients suffering from severe multivessel coronary artery disease.
““The advantage of this latest technology is the speed with which will
allows us to assess viable heart muscle where cells can be accurately
delivered,” Dr Thambar said. “This should maximize the potential benefit
of adult stem cells for patients with ischemic heart disease, while providing
clinicians with a user-friendly method to deliver the cells”.
Mesoblast executive chairman, Mr Michael Spooner, said there was
substantial international interest in Mesoblast’s imminent clinical trials
and platform technology.
“Mesoblast’s strategy is to have the strongest possible approach to
commercializing our technology by working closely with global dominant
players in our areas of interest. The relationship with the Johnson and
Johnson companies, Cordis and Biosense Webster, is indicative of this
strategy. Importantly, under this agreement we will retain all of our
Intellectual Property rights associated with our platform adult stem cell
technology and will remain free to pursue all commercial options,” Mr
Spooner said.
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Industry Watch
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson
company, is a worldwide leader in developing
and manufacturing interventional vascular
technology, including the drug eluting
Cypher stent. Through the company's
innovation, research and development,
physicians worldwide are better able to
treat the millions of people who suffer from
vascular disease.
About Biosense Webster
Biosense Webster Inc, a Johnson & Johnson
Company, pioneered electrophysiology (EP)
diagnostic catheters more than 30 years ago
and continues to lead the industry as an
innovative provider of advanced diagnostic,
therapeutic, and mapping tools. As the leader
in navigation systems, Biosense Webster's
technology includes the largest installed base
of navigation systems worldwide in leading
hospitals and teaching institutions.
About Mesoblast Ltd
Mesoblast Limited is a publicly listed
Australian
biotechnology
company
committed to the development of novel
treatments for orthopedic conditions,
including the commercialization of a unique
adult stem cell technology aimed at the
regeneration and repair of bone and cartilage.
Mesoblast has the worldwide exclusive rights
for a series of patents and technologies that
have been developed over more than ten
years and which relate to the identification,
extraction and culture of adult mesenchymal
precursor cells (MPCs). The technology has
achieved outstanding results in pre-clinical in
vivo studies in the regeneration and repair of
large bone fractures. Mesoblast has acquired
a 33.3% interest in Angioblast Systems
Inc, an American company developing the
platform MPC technology for the treatment
of cardiovascular diseases, including repair
and regeneration of blood vessels and heart
muscle.
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Contact Details:
Cordis Corporation
Tel:
+800 781 0282
Fax:
+215 325 4183
URL:
www.cordis.com
Contact Details:
Biosense Webster Inc
Address: 3333 Diamond Canyon Road,
Diamond Bar, CA 91765, U.S.A.
Tel:
+909 839 8500
Fax:
+909 468 2905
Contact Details:
Mesoblast Limited
Address: Level 39, 55 Collins Street,
Melbourne 3000, Australia
Tel:
+61 3 9639 6036
Email:
[email protected]
URL:
www.mesoblast.com
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Industry Watch
Australia
Apollo Life Sciences Begins
Sale of Human Cell-expressed
Proteins Globally
A
pollo Life Sciences announced that it will begin the sales of human cell-expressed proteins
into the global research reagents market. Apollo is the only company in the market offering a
range of proteins expressed exclusively from human cells rather than from traditional bacteria,
insect or rodent cells.
The market for protein reagents, used in experimental research, includes researchers in universities,
pharmaceutical companies, research institutes and hospitals. Worldwide annual sales of protein reagents
are estimated to be worth US$400 million per annum, with an annual growth rate of 15%.
Apollo’s proteins, which are distinctive because they have human attachments (post translational
modifications). They perform like proteins found in the human body. Proteins expressed in bacteria, insect
or rodent cells have different attachments. As a result of this, they behave differently, both in experiments
and in the human body. This can influence their effectiveness as therapeutics. Apollo’s proteins will enable
scientists to extend research in new directions and advance understanding of many diseases and human
biological functions.
“Apollo’s proteins will allow researchers in Australia and around the world to perform many experiments
that they have previously been unable to do by allowing them to better simulate human effects and
therefore better predict clinical trial outcomes,” said John Priest, Apollo’s chairman and chief executive
officer.
“Commercializing these proteins has in the past been technically very difficult,” said Dr Alan Watts,
Apollo’s scientific director. “Apollo has developed some proprietary processes which enable it to produce
these proteins commercially. We are going to market with a starting range of 50 proteins and ten protein
detection kits and we are on track to continue extending the product range. Twenty more proteins are
in advanced development. Entering this market is strategically important for Apollo because it offers the
advantages of R&D reagents’ low regulatory barriers to entry and high margins, enhanced by low cost
distribution industry practices,” said Mr Priest.
About Apollo Life Sciences
Apollo Life Sciences is an Australia-based biopharmaceutical
company which is creating, manufacturing and marketing
next-generation therapeutics based on natural human
proteins to protect and improve human health. These
advanced proteins are used to treat a wide range of disorders
associated with disease and aging.
Apollo’s proteins are expressed from human cells and are
expected to offer therapeutic advantages in terms of safety
and effectiveness because they more naturally mimic proteins
in the human body. Apollo also has a human-expressed
protein-based topical therapeutic treatment for psoriasis in
a Phase 1b clinical trial. The trial has progressed successfully
through the first two stages and completion of the final stage
is scheduled for 20 December 2005. Analysis and results of
the trial are expected to be finalized in the first quarter of
2006.
Contact Details:
Apollo Life Sciences Limited
Addrees: Apollo Life Sciences Limited,
Level 1, 147 Queen Street
Beaconsfield NSW 2015
Tel:
+61 2 9310 1800
Fax:
+61 2 9699 8615
Email:
[email protected]
URL:
www.apollolifesciences.com
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Industry Watch
India
Wockhardt Introduces
Hepatitis A Vaccine into
Indian Market
W
ockhardt Ltd has introduced its new generation hepatitis A vaccine in the
markets in south India. The vaccine is made available in collaboration
with China-based Zhejiang Pukang Biotechnology Company Ltd
China. The drug is being launched in Kerala, Karnataka and Tamil Nadu recently.
According to Wockhardt, a consignment of 50,000 vials of the live attenuated
vaccine produced from H-2 strains, to be sold under the brand name ‘Biovac’ are
being airlifted from China and will be available in all cities throughout China.
The vaccine provides a protection for 15 years and also offers the
convenience of a single dose for both children and adults. It can be
administered subcutaneously in the dermatoid region of the arm.
The response from the medical professionals regarding this vaccine has
been overwhelming and the first batch of the 50,000 vials would last four
to five months. The immunogenicity and tolerability of the vaccine were
confirmed after clinical trials on 200 children at KEM hospital in Pune.
Wockhardt had also been permitted by the Union Government to advertise
the product and has chalked out a strategy to create awareness among the
medical professionals.
The international vaccine was first developed by Dr. Mao, who is the main
investor for the vaccine. Over 120 million people had been administered the vaccine
so far.
About Wockhardt Ltd
Based in India, Wockhardt is a global, pharmaceutical
and biotechnology company that has grown by
leveraging two powerful trends impacting the world
of medicine: globalisation and biotechnology. It
is distinguished by a strong and growing presence
in the world’s leading markets, with half of its
revenue coming from Europe and the United States.
Wockhardt’s market presence covers formulations,
biopharmaceuticals, nutrition products, vaccines and
active pharmaceutical ingredients.
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Contact Details:
Wockhardt Ltd
Address: Wockhardt Towers,
Bandra-Kurla Complex,
Bandra (East), Mumbai - 400 051,
Maharashtra, India.
Tel.:
+ 91 22 2653 4444
Fax:
+ 91 22 2653 4242
Email:
[email protected]
URL:
www.wockhardt.com
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Industry Watch
India
Transgene Biotek Develops
Oral Delivery of Insulin and
Hepatitis B Vaccine
T
he Hyderabad-based Transgene Biotek Ltd has collaborated with the
pharmacology division head, Dr Prakash V Diwan at the Indian Institute
of Chemical Technology to develop oral delivery platforms for insulin and
hepatitis B vaccine. The pre-clinical trials on oral delivery of insulin and hepatitis B have
demonstrated positive results. The drug is to be administered in liquid form as oral drops.
This new invention will help the diabetic population, showing not only the reduction of
blood glucose levels compatible to that of the injectable insulin but also the clinically
significant plasma insulin levels lasting up to 24 hours. This is a significant achievement
since the sustainable plasma insulin levels up to 24 hours implies the possibility of reducing
the frequency of insulin doses resulting in high patient compliance and better management
of diabetes. With the pre-clinical trials providing the necessary data, the management has
initiated steps to take it to the next stage of clinical trials in India and Europe simultaneously.
Similarly, the pre-clinical trials on oral delivery of hepatitis B vaccine have demonstrated the
generation of anti-body titres to a single dose of oral delivery comparable to that of injectable
hepatitis B vaccine. The company claims to be the first to have developed this technology
to deliver hepatitis B vaccine through oral route. Oral administration of this vaccine which
provides the easy administering of the vaccine to the infants and children, combining with cost
reduction, shall be a major factor in the disease control of this viral infection across the world.
With the pre-clinical trial data providing exciting results, the management is in discussions with
one of the biggest pharma companies in the world to out-license the oral delivery of insulin as
a first step.
Contact Details:
About Trangen Biotek
Transgene Biotek is a public limited company and one of
the first biotech companies in India. Products in the pipeline
include a quadrivalent meningococcal meningitis vaccine
that is in the final stages of human clinical trials in Africa,
and various therapeutic proteins in collaborations with other
companies
Transgene Biotek Ltd
Address: 68, 69 & 70, IDA Bollaram,
Anrich Industrial Estate,
Medak District – 502 325,
Andhra Pradesh, India
+91 8458 279103
Tel:
+91 8458 279755
Fax:
[email protected]
Email:
APBN • Vol. 9 • No. 23 • 2005
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Industry Watch
Japan
Peruseus Proteomics’s Background
P
eruseus Proteomics (PPMX) was founded in February 2001 as a biotech venture company
that develops, manufactures and distributes antibody-based therapeutics, diagnostics and
life science research products using proprietary antibody production technology with high
affinity and specificity in the area of mainly lifestyle-related diseases and cancers. PPMX is the
first biotech venture company to emerge from the Japanese government’s Millennium and Focus
21 Projects.
Since April 2003, PPMX has been involved in a national research project called “BioNanochip
for the Analysis of Protein Interactions” sponsored by the New Energy and Industrial Technology
Development Organization (NEDO). As a member of this project, PPMX functions as the
developmental partner for the generation of high-quality antibody-based therapeutic and diagnostic
products to improve and extend life expectancy.
Japan’s Bioventures Today
—Peruseus Proteomics Inc
Peruseus Proteomics’s Business
PPMX develops, manufactures and distributes
antibody-based pharmaceutical, diagnostic and
life science research products using proprietary
protein expression technology and processes.
The company’s three core businesses are the
development of antibody-based therapeutics,
antibody-based diagnostics and antibody research
reagents.
Fig.1 Monoclonal antibody production process.
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Antibody-based Therapeutics
Antibody-based Diagnostics
Antibody Research Reagents
Industry Watch
PPMX utilizes a careful screening and selection process to identify
highly functional monoclonal antibodies as potential seed compounds for
use in disease therapeutics. By selecting the antibody that has the function
of cytotoxic activation of cancer cells, PPMX develops therapeutics
targeting various cancers, namely liver, pancreas, urinary bladder, kidney,
uterus cancers and brain tumor. PPMX also develops small molecular
compounds drugs through the analysis of biological information typified
by protein localization, complex formation and modification which could
be obtained by utilizing nuclear receptor antibody with high affinity and
specificity.
PPMX develops high sensitivity monoclonal antibodies for use in
diagnostic kits capable of detecting novel disease biomarkers at a level
and precision that far surpasses current diagnostic methods. Currently
four types of diagnostic kits are in the final stages of development. PPMX
aims to realize a customized medicine by developing diagnostic markers
which can accompany treatment drug for cancer.
PPMX offers a number of high quality research monoclonal antibodies,
directed against the nuclear hormone receptors and epigenetic markers,
for use in a variety of research applications, including western blot,
immunohistochemistry and immunoprecipitation. PPMX has successfully
created and commercialized all of the 48 nuclear receptor antibodies.
Peruseus Proteomics’s Technology
PPMX produces various highly functional antibodies and applies them in the development of therapeutic
and diagnostic products. There are two core techniques that are used in producing antibodies with high
affinity and specificity.
Budded Baculovirus (BV) Expression
Technology
Budded Baculovirus (BV) Expression Technology is the technique
to display large amount of target protein in their native structure on the
surface of Budded Baculovirus, a type of virus only found in insects.
The technology was developed by Professor Takao Hamakubo at the
Laboratory for System Biology and Medicine (LSBM), a division of the
Research Center for Advanced Science and Technology (RCAST) at the
University of Tokyo. PPMX holds its exclusive license. It is often crucial
to express target molecules in their native structural conformation in the
process of producing antibodies with high affinity and specificity for use
in therapeutic and diagnostic applications. Peptide or protein expressed
by E. Coli are normally used for target protein expression. However, this
method does not always reflect the native structure and function. By
using BV Expression Technology, the native structure and function are well
maintained even for complicated membrane proteins like GPCR and it is
superior as immunogen.
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Industry Watch
Monoclonal Antibody Production
Technology
The antibody production process involves injection of the expressed
target protein as an antigen into the mouse to produce antibody that attaches
to the antigen by its immune function. It is, however, often difficult to
produce functional antibodies against the desired target proteins due to
immunotolerance of the animals used. PPMX has developed, in collaboration
with LSBM, a variety of techniques to overcome immunotolerance to the
target antigen, while simultaneously manipulating the immune response to
produce monoclonal antibodies exhibiting high functionality. The research
and development team at PPMX has more than 20 years of experience in
producing monoclonal antibodies with reputations of their high quality.
Market Overview in Japan
Antibody-based Therapeutics
Antibody-based Diagnostics
Nuclear Receptor Antibodies
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Biopharmaceuticals include vaccines, antibody-based pharmaceuticals
and interferon targeting various cancers, infections and autoimmune
disorders. The global biopharmaceutical market in 2004 was approximately
4 trillion yen with an annual increment of 17%, with the antibody-based
pharmaceuticals accounting for 25% of the market with an annual increment
of 50%. The market size of Japanese biopharmaceutical in 2004 was
approximately 348 billion yen, of which 8.1 billion yen was antibody-based
pharmaceuticals. The discovery of various cancers and other disease-related
antigens and the innovation of antibody producing technique contribute
greatly to the increase in development of vaccines and antibody-based
pharmaceuticals. The market for anticancer on which PPMX focuses was
approximately 377 billion yen in 2004 in Japan, and it is expected to increase
to 415 billion yen by 2006.
The market size of in vitro diagnostics in Japan in 2004 was approximately
320 billion yen, of which 138 billion yen was antibody-based diagnostics
with an increase of 3.8% from previous year. The market for the antibodybased diagnostics in Japan for 2005 is expected to be around 142 billion
yen, an increase of 2.5% from 2004. The current market size of the cancer
diagnostics is estimated at approximately 40 billion yen.
The world market for drugs targeting nuclear receptors accounts for
10–15% of the entire drug market. The research on drugs targeting nuclear
receptors for treatment of life-style related diseases is gaining more attention
as these nuclear receptors are transcription factors playing a role of on-off
switch for genes, and are thus extremely important as targets. As its life style
is getting more westernized, Japan is said to have approximately 7 million
hypertension patients, 2.3 million diabetes patients, and hyperlipemia patients
that are approximately 40% of the total populations. These symptoms have
close relationship with the occurrence and the progression of Japan’s top three
killer, cancer, stroke and cardiac diseases if left untreated. As the number
of patients of such life style-related diseases increase, the demand for such
drugs is expected to rise sharply.
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Industry Watch
Peruseus Proteomics’s Partnership
Through a partnership with CMIC Co Ltd PPMX announced on September 27, the
establishment of a highly sensitive method for determining the blood protein PTX3, a promising
new marker for predicting the risk of arteriosclerosis. This method makes it possible to identify
vascular inflammation at an early stage. PPMX plans to launch a research reagent kit in Japan and
overseas. In addition, together with CMIC, it will develop a full-scale test service for universities
and other research institutions, general practitioners and pharmaceutical companies. The two
companies will develop an in vitro diagnostic and target to obtain approval by 2008.
There is an increasing trend globally in licensing out the technologies by bio ventures
to pharmaceutical giants at the early development stage of a product. Such tie-ups are still
extremely rare in Japan, however, PPMX is more open for tie-ups with pharmaceutical giants
at the early stage of development.
* This article is contributed by JAIC Asia Holdings Pte Ltd as a part of collaboration with World Scientific Publishing Co Pte Ltd.
Contact Details:
Peruseus Proteomics Inc.
Address : 4-7-6 Komaba, Meguro-ku, Tokyo,
153-0041, Japan
Tel :
+81 3 5738 1705
Fax :
+81 3 3481 5760
Email : [email protected]
URL :
www.ppmx.com
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