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Australia
EpiTan in Collaboration
to Develop Sustained
Release Form of
Melanotan Drug
EpiTan, based in Melbourne, Australia, will
collaborate with the Southern Research Institute of
the US, in which Southern Research will develop a
sustained-delivery formulation of Melanotan that
requires only one injection for up to a six month
period, for use in the company’s clinical trial program.
EpiTan’s leading drug candidate, Melanotan,
stimulates the production of the skin protective
pigment melanin that gives the skin a tanned
appearance without first requiring exposure to the
harmful effects of ultraviolet light as is found in
sunlight.
Mr. Michael Kleinig, EpiTan’s pharmaceutical
development manager, said, “Southern Research has
the expertise, experience, proprietary technology and
approved facilities to take a sustained-release
formulation of Melanotan from feasibility studies and
product development through process scale up to
manufacture of clinical trial materials (Phase I, II,
and III). As Southern Research have already
developed and licensed very similar sustainedrelease formulations, the associated risks with this
type of product development are greatly reduced.”
The major risk factors for skin cancer are a
tendency to sunburn and an inability to tan after sun
exposure. An estimated 80 percent of all new cancers
occurring each year in Australia are skin cancers.
Annual treatment costs in Australia are in excess of
A$500 million (US$280 million). Two in three
Australians can expect to develop a skin cancer and
one in sixteen will be diagnosed with melanoma in
their lifetime.
In the US, the incidence rate for non-melanoma
skin cancer in white skinned people is 70 times that
of dark skinned people. The global markets for
Melanotan is calculated to be in excess of A$1 billion
(US$560 million) per annum.
Melanotan is at an advanced stage of testing.
Under a US Food and Drug Administration (FDA)
Physician’s Investigational New Drug pilot program in the
US, several clinical studies were successfully performed
on more than 100 human volunteers.
Southern Research, an affiliate of the University of
Alabama at Birmingham, was established in 1941 and has
a long reputation for leadership and excellence in drug
discovery and development of delivery formulations.
EpiTan has the exclusive world rights to continue the
development and commercialization of its drug candidate
Melanotan.
Prima Biomed Invests in
Promising Anti-cancer
Antibody
Prima Biomed, based in Melbourne, Australia, has
recently announced its fourth major investment in a novel
monoclonal antibody that will expand its anti-cancer
program. Test results in mice at Melbourne’s Austin
Research Institute have shown that this antibody prevents
the growth of human cancer cell lines obtained from colon
and prostate cancer.
Mr. Marcus Clark, CEO of Prima Biomed, said,
“Scientists at the Austin Research Institute and Prima’s
Scientific Advisory Panel consider this will be a substantial
treatment for a wide range of cancers as the antibody targets
many types of cancers and based on experiments to date,
it has the added benefit that it does not affect normal healthy
tissue.”
Mr. Clark said, “Our plans with the new antibody
project are to proceed through latter stage pre-clinical
development, commencing the first tests on humans in 18
months.”
Monoclonal antibodies can be genetically reengineered (humanized) to avoid a patient’s own immune
system rejecting them as foreign. The antibodies bind to
the surface of cancer cells leading to direct destruction of
the cell by interference of important cellular pathways.
Monoclonal antibody sales for clinical use have grown
exponentially over the past three years and are now
exceeding A$1 billion (US$560 million) per annum.
Monoclonal antibodies have been successfully used as
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human diagnostic agents for the past two decades.
Therapeutic monoclonal antibodies have gained clinical
prominence and are now used to prevent organ
rejection, treat rheumatoid arthritis, respiratory syncytial
virus (RSV) in children, lymphoma and breast cancer.
Prima Biomed is a biotechnology development and
commercialization organization with first and last rights
over technologies from the Austin Research Institute.
Prima Biomed specializes in immunology and cancer
immunotherapy and adopts technology development
that shows potential for commercial returns within three
years.
The Austin Research Institute is a state of the art
medical research facility located in the grounds of the
Austin and Repatriation Medical Center (A&RMC),
Melbourne, Australia. The use of monoclonal antibodies
in cancer therapy has been a research focus of the Austin
Research Institute for over 20 years.
The Austin Research Institute has a worldrecognized team of 100 researchers dedicated to
combating cancer and finding ways to treat many
common diseases by using the most recent advances in
genetic engineering and immunology.
China
LifeScan Eyes China as
Market and
Manufacturing Base
LifeScan Inc., the world’s leading producer of selfmonitoring blood glucose meters, is not only eyeing
China as a good market, but also a good manufacturing
base.
Mr. Eric Milledge, group chairman of LifeScan, said
that more of the company’s manufacturing of diabetes
meters will be moved into China, and the projects are
expected to become bases from which the company
will launch its products worldwide.
LifeScan has entrusted AML, a world electronics
manufacturer based in Dongguan in Guangdong
province, to produce one kind of monitoring meter
called SmartScan.
China has the largest population of people with
diabetes in the world. Facing the large market, Mr.
Milledge said that the first priority should be investing
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in education and health awareness. He said, “We vow
to improve the awareness of diabetes in China and
expect to make the world’s most populous country the
production center for our new products.”
Ninety percent of people with the disease have type
two diabetes, and symptoms such as blurred vision, dry
skin, increased hunger and thirst may not be obvious,
making diagnosis difficult.
Mr. Milledge said, “Very often, 60 percent of people
with type two diabetes do not know they have it, and in
China the rate is as high as 70 percent.”
LifeScan, Inc., a part of healthcare giant Johnson &
Johnson, is a leading maker of ONE TOUCH® Brand
Blood Glucose Monitoring Systems. The monitoring
meters of LifeScan now holds a 30 percent share in the
worldwide market.
US-based Amarillo
Biosciences to Supply
Nutraceuticals to China,
Taiwan and Pakistan
US-based Amarillo Biosciences Inc. has recently
announced supply agreements with STC International
for the territories of China and Taiwan and with Majsons
Corp. (Karachi) for the territory of Pakistan.
MaxisalTM, a patented dietary supplement, is the
trade name for pharmaceutical grade anhydrous
crystalline maltose, which has been found to relieve
complaints of dry mouth, enhance salivary function, and
promote oral comfort. Amarillo Biosciences, Inc. is the
exclusive worldwide (outside Japan) supplier of Maxisal
for the dry mouth market.
Dr. Joseph M. Cummins, president and CEO of
Amarillo Biosciences, Inc. said, “Researchers estimate
that at least 20 percent of the population over 50 years
of age suffer from persistent complaints of dry mouth.
The number of people with dry mouth is even greater if
you include people who suffer from autoimmune
diseases or take one of the many prescription
medications that cause dry mouth.”
Dr. Cummins concluded, “Our innovative, new
product will enable us to continue to take advantage of
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the many growth opportunities in the biotechnology
market. We believe this dry mouth market is poised for
significant growth.”
Amarillo Biosciences Inc. is a pioneer in the
research of low-dose orally administered interferon
alpha as a treatment for a variety of conditions including
Sjogren’s syndrome, fibromyalgia syndrome, Behcet’s
disease, hepatitis B and C, and opportunistic infections
in patients who are HIV positive.
India’s first world class Hepatitis-B vaccine. The
company has an installed capacity to produce 40 million
doses per annum of the vaccine, which is of high purity,
efficacy and tolerability with no major side effects.
The Department of Scientific and Industrial
Research of India had given the company the best R&D
Award in Biotechnology for the year 1998. Shantha
Biotechnics is also involved in collaborative research
with leading research institutions in India.
India
WHO Certification for
Shantha Biotechnics’
Hepatitis-B Vaccine
Hyderabad based Shantha Biotechnics has recently
become the first Indian company to obtain World Health
Organization (WHO) certification of a Hepatitis-B
vaccine.
The Andhra Pradesh government had to obtain the
Hepatitis vaccine last year from a South Korean
company for lack of indigenous producers. Mr.
Varaprasad Reddy, managing director of Shanta
Biotechnics, said, “They can now buy from us as we
qualify eligibility norms fixed for the program.”
Shanta Biotechnics’ Shanvac B recombinant DNA
Hepatitis-B vaccine received the WHO, Geneva
certificate that signifies that the Indian Hepatitis-B
vaccine will be eligible for supply to all UN agencies
for their global Hepatitis-B immunization programs.
Mr. Reddy said, “We have already received Unicef’s
letter of intent to purchase 8.5 million doses in the year
2002–03.”
Hepatitis-B is a liver disease caused by the
Hepatitis-B virus (HBV). Jaundice is its most visible
symptom. HBV damages liver tissue and can lead to
cirrhosis of liver or liver cancer.
It is estimated that one in every 20 Indians is a
carrier of the HBV. One percent of all adult deaths in
India are due to Hepatitis-B. 68 percent of chronic liver
diseases and 80 percent of all liver cancers are due to
Hepatitis-B.
Shantha Biotechnics has indigenously developed
HIV Detection Kit
Developed by Bhat
Biotech
Bhat Biotech India (P) Ltd., based in Bangalore, has
recently developed the Pareekshak HIV 1/2 Triline test,
the first indigenously developed card test to detect HIV
infection.
Bhat Biotech chairman and managing director, Dr.
Shama Bhat, said,’’We are waiting for the final approval
from the drug controller to introduce the product to the
market. The product has a huge potential and we would
be able to introduce it in a much more affordable price
compared to foreign companies.’’
Dr. Bhat said that compared to the most popular
and cheaper Elisa test or spot tests, the card test is much
easier and does not require a highly skilled person to
conduct the test. Also, the kit for rapid card test could
be stored under room temperature, when for both other
tests it should be stored at four degree Celsius.
Bhat Bio-tech India (P) Ltd. is specialized in the
design, development, manufacture and marketing of
diagnostic test devices for various types of tests like
hepatitis, pregnancy and HIV. It has developed HCV
(hepatitis C) kits, malaria, cancer, and TB diagnostic tools
that are yet to be launched in the market. It makes
recombinant protein reagents for industrial biotech
products.
Dr. Bhat said that the company plans to enter into
the manufacturing of biotech-based pharma products
and hopes to tie up with a multinational company for
this. “We are looking at biotech-based generic products
like insulin, hepatitis-B, of which the patents are already
expired,” he added.
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US FDA Approves
Ranbaxy’s Cefpodoxime
Proxetil
India’s Ranbaxy Laboratories Ltd., through its
wholly owned subsidiary Ranbaxy Pharmaceuticals
Inc. (RPI) in the US, has received final approval from
the US Food and Drug Administration (FDA) to
manufacture and market Cefpodoxime Proxetil for
Oral Suspension which is the bio-equivalent to
Vantin® for Oral Suspension from Pharmacia and
Upjohn Co.
The drug is indicated for the treatment of patients
with mild to moderate infections caused by
susceptible strains of a variety of micro-organisms
such as those that cause pharyngitis and/or tonsillitis,
community acquired pneumonia, acute bacterial
exacerbation of chronic bronchiti and uncomplicated
skin and skin structure infections.
It is anticipated that at the time of launch,
product will be distributed broadly to all distribution
points in the US, including wholesalers, pharmacies,
hospitals, etc.
This product represents yet another addition to
the expanding RPI product portfolio of anti-infectives
that consist not only of solid dosage forms but also
includes a growing number of products in liquid
versions and other “value added” dosage forms.
Cefpodoxime Proxetil for Oral Suspension is
indicated for the treatment of patients with
mild to moderate infections caused by
susceptible strains of a variety of microorganisms.
Ranbaxy Laboratories Ltd. is India’s largest
pharmaceutical company. It manufactures and
markets branded generic pharmaceuticals and Active
Pharmaceutical Ingredients (APIs). Ranbaxy’s
continued focus on R&D has resulted in several
approvals in developed markets. The company sells
its products in over 100 countries and has an
expanding international portfolio of affiliates, joint
ventures and alliances, ground operations in 25
countries and manufacturing operations in seven
countries.
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Japan
Takeda in Five Year
Partnership with Oxford
Diabetes Center
Japan’s Takeda Chemical Industries Ltd. has recently
entered into a five-year partnership with the Oxford Center
for Diabetes, Endocrinology and Metabolism (OCDEM) in
the UK. With its donation of 3.2 million yen (US$240
million), Takeda will join the center’s partnership board
which currently consists of Oxford University, the National
Health Service (NHS) and Novo Nordisk.
Once the building is complete, it will become the
world’s leading integrated center in all areas relating to
diabetes, especially type 2, and other disorders of the
endocrine (hormone) and metabolic systems.
The Oxford Center for Diabetes, Endocrinology
and Metabolism will become the world’s leading
integrated center in all areas relating to diabetes,
and other disorders of the endocrine and
metabolic systems.
Construction of Phase 1 of the new center is due for
completion in December 2002.
The investment by Takeda will be used to provide an
additional space for university research facilities in Phase
2 of the center, which is scheduled to open in 2003.
OCDEM is a world-leading integrated center focusing
on research, clinical care and education in endocrine and
metabolic diseases with the goal of understanding disease,
and facilitating and accelerating the search for cures and
new treatments.
Takeda is a research-based global company with its
main focus on pharmaceuticals.
It is the largest pharmaceutical company in Japan and
one of the leaders in the world. In the UK, Takeda’s products
are distributed through two wholly owned companies.
Takeda UK Ltd., located in Buckinghamshire, is
marketing ACTOS, an antidiabetic drug, and AMIAS, an
antihypertensive drug in UK, and Takeda Europe Research
and Development Center Ltd., located in London,is
working for Takeda’s pipeline drugs throughout Europe.
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Mochida and Lundbeck
Agree on Escitalopram in
Japan
Japan’s Mochida Pharmaceutical Co. Ltd. has recently
been granted by H. Lundbeck A/S to develop, manufacture,
and sell Escitalopram in Japan. Lundbeck Japan K.K., a
Lundbeck subsidiary, retains the same rights in Japan.
Escitalopram is an Selective Serotonin Reuptake
Inhibitor (SSRI) developed by Lundbeck, and it has been
approved in 12 countries in Europe, and is awaiting final
FDA approval for marketing in the US for depression.
Escitalopram is a successor of citalopram, a worldwide
used drug with proven efficacy and excellent tolerability.
Escitalopram belongs to the class of antidepressants, the
SSRI’s, indicated for the treatment of depression and panic
disorders.
H. Lundbeck A/S is an international pharmaceutical
company engaged in the research and development,
production, marketing and sale of drugs for the treatment
of psychiatric and neurological disorders.
Mochida Pharmaceutical Co. Ltd., with headquarters
in Tokyo, has diverse product lines ranging from
neurological agents, cardiovascular agents, anti-infectives,
metabolic agents, hormone preparations, biological
preparations; diagnostic reagents for fertility/infertility and
cancer; medical electronics and equipment such as carbon
dioxide surgical laser unit and diode laser units for relief
from pain; and healthcare products such as collage
moisture lotion.
Agreement on mGluR
Agonists for Taisho and
Merck
Taisho Pharmaceutical Co. Ltd. of Japan has recently
signed a license, development and marketing agreement
with Merck & Co. Inc. to develop mGluR (metabotropic
glutamate receptor) agonists for the treatment of diseases
of the central nervous system, including schizophrenia.
The license agreement gives Merck exclusive
worldwide rights (ex China) and co-exclusive rights in
Japan. In Japan and China, Taisho retains certain
development and marketing rights.
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mGluR is a metabotropic glutamate receptor of
which eight subtypes are currently known. Although
the mechanism of action is not completely
understood, scientists believe mGluR receptors may
play a variety of key roles in brain pathology. The
subtypes known as mGluR2 and mGluR3, for
example, are related to the neurotransmission of
glutamate in the brain.
As abnormal neurotransmission of glutamate
is believed to be a factor in the pathology of
schizophrenia, mGluR agonists may be
potential new treatments for this disease.
As abnormal neurotransmission of glutamate is
believed to be a factor in the pathology of
schizophrenia, mGluR agonists may be potential new
treatments for this disease. Taisho has synthesized
and characterized several compounds that show high
affinity to mGluR.
Schizophrenia is a serious mental disorder
characterized by loss of contact with reality,
hallucinations, delusions, abnormal thinking, and
disrupted work and social functioning. It is a major
public health problem throughout the world,
affecting an estimated one percent of the global
population.
A significant medical need exists for better
treatments for schizophrenia that are more efficacious
and tolerable. Many of the currently used
medications are associated with side effects, and the
disease is often not controlled with currently available
therapies.
Merck & Co., Inc. is a leading world wide
research-driven pharmaceutical products and
services company with total sales in 2001 of
US$47.71 billion and net income of US$7.281
billion. Merck discovers, develops, manufactures and
markets a broad range of innovative products to
improve human and animal health, directly and
through its joint ventures.
Taisho is the leading non-prescription
pharmaceutical company in Japan and the second
ranking in the world. Through steady internal growth,
Taisho has also been strengthening its research and
development efforts in the area of prescription drugs.
Taisho collaborates with domestic and foreign
pharmaceutical companies.
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New Company Stem Cell
Sciences KK Formed
A new Japanese biotechnology company, Stem Cell
Sciences KK (SCS KK) located at the Kobe Frontier
Medicine Precinct was recently formed as a joint venture
between Australia’s Stem Cell Sciences Ltd. (SCS) and
Japan’s Sosei Co. Ltd. (Sosei).
Mr. Shinichi Tamura, CEO of Sosei, said, “We intend
to nurture this kind of joint venture in Japan with Western
biotech companies when we see strong synergy between
their business strategy and evolving Japanese situation.”
Licenses granted to SCS KK by SCS are for the SCS
patented stem cell technologies relating to the growth,
differentiation and purification of embryonic stem cells.
These technologies provide a range of highly purified cell
types, such as neurons and cardiac cells, for gene and
drug discovery.
SCS technologies have already been licensed to
world leading pharmaceutical companies such as Aventis
and Glaxo Smith Kline, as well as other
biopharmaceutical companies.
SCS KK will exclusively market the discovery
platform technologies of SCS and those developed by
SCS KK throughout Asia. SCS in turn will market the
combined two technologies in all other territories, and
partner with SCS KK to create safe and effective stem
cell-based therapies for the global market.
Licenses granted to SCS KK are stem cell
technologies relating to the growth,
differentiation and purification of embryonic stem
cells. These technologies provide a range of
highly purified cell types for gene and drug
discovery.
SCS KK will also undertake collaborative research
and development programs with world leading stem cell
researchers at the newly created RIKEN Center for
Developmental Biology (RIKEN CDB). SCS KK and SCS
will combine in-house technologies with those arising
from their academic research collaborations such as ones
with RIKEN CDB and the University of Edinburgh’s Center
for Genome Research (CGR), accelerating discovery and
progress towards new cell therapies.
SCS KK commercial operations will start immediately
through presentation of SCS discovery technologies to
the Japanese pharmaceutical industry.
SCS KK, the first Japanese stem cell therapy
company, is headquartered in Kobe, on the Bay of
Osaka.
SCS is an Australian company conducting research
on stem cells for immediate application in drug and
gene discovery and longer-term applications to
regenerative medical therapies.
Sosei Co. Ltd. is a private Japanese
biopharmaceutical company focused on drug
development. It enriches the core product pipeline via
in-licensing compounds at late stages of development
from Western and Japanese companies, by its
distinctive drug re-profiling platform (DRP) and
through its internal R&D, capitalizing on its extensive
global network established over the past ten years.
Korea
In Brief
CrystalGenomics Inc.
CrystalGenomics Inc. is a biopharmaceutical
company that boasts of several state-of-the-art
technologies for the generation of novel drug leads. It
has been devoted to innovation of the target-oriented
structural genomics using X-ray crystallography and
nuclear magnetic resonance (NMR) spectroscopy.
Disease targets are selected through
CrystalGenomics’ unique evaluation process — named
as CrystalTechTM (CET). Technological methods for cloning,
expression and purification of proteins are simultaneously
improved at CrystalGenomics. The initial screenings of
crystallization are then performed using robot systems,
followed by the X-ray measurement at synchrotron. With
advanced facilities such as focused undulator beamline,
MAD phasing and other cutting-edge technologies,
protein structures are elucidated.
After the target three-dimensional structures are
determined, CrystalGenomics uses the advanced
technique, CrystalTechTM (CVT), to screen chemical
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compounds in silico. The final design and synthesis of the drug
is based on the structure of the compound that binds to the
active site of the target protein. This compound is identified
using CrystalGenomics’ proprietary NMR technology —
CrystalTechTM (CHT)
Medical and agricultural companies will stand to benefit
from a collaboration with CrystalGenomics as it can help to
reduce costly overall R&D time and expenses by developing
drug candidates more efficiently and specifically. Furthermore,
it is predicted that in the coming post-genomic era, the value of
protein structural information will continue to increase in the
area of target identification and drug discovery. As a company
dedicated to high-throughput structure determination and rapid
drug-lead generation, CrystalGenomics is poised to define an
emerging field and to capture a large international market.
BioLeaders Corporation
BioLeaders Corp. was first established in January 2000 at
the BioVenture Center in the Korea Research Institute of
Bioscience and Biotechnology (KRIBB) in Daejon. The company
is involved in three main areas of research.
In preparation of the post-genomic era, BioLeaders Corp.
is currently developing expression systems for the production
of industrial proteins and enzymes. Bacterial systems, such as
Bacillus and Lactobacillus are used as host cells to develop
antibiotics, in line with the company’s continuing pursuit of
harmonized human biotechnology.
BioLeaders Corp. is also tapping into the application of
uncultivated microorganisms (UMO) for development of
industrial protein and enzyme resources. The method of
screening and isolation of UMO has great potential as a good
business project, as it does not require many natural resources.
Furthermore, UMO are easily available; about 10 percent of
global microbial resources (approximately 4800 species) are
reported as microorganisms, of which 90 percent are UMOs.
BioLeaders Corp. has developed a patented polyglutamic
acid (PGA)-producing strain of Bacillus subtilis var.
chungkookjang. PGA is highly water-soluble and biodegradable,
and can be used as a skin moisturizer, hydro-gel, moisture
absorber, neutraceutical and medical material. PGA from this
particular strain (which is isolated from Korean soybean paste
chungkookjang) has higher molecular weight (more than
3 000 000 Da) than conventional PGAs from other Bacillus
strains. Lastly, BioLeaders Corp. has plans to produce amino
acid polymers for bio-cosmetics and biodegradable polymers.
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Rules & Regulations
Australia
Scientists Hope to Avoid
Stem Cell Barriers
The Adelaide-based laboratories of
biotechnology firm BresaGen Ltd. are working on
a procedure they hope will avoid Australian federal
laws banning therapeutic cloning.
The Council of Australian Governments agreed
to allow the use of stem cells from excess IVF (invitro fertilization) embryos, but imposed a national
ban on all forms of human cloning.
The envisaged procedure known as embryonic
stem (ES) cell-based nuclear reprogramming
involves several steps. In step one according to
BresaGen researcher Dr. Daniele Pralong, a number
of ES cells are fused together to form one large ES
cell.
The embr yonic stem (ES) cell-based
nuclear reprogramming should leave
behind an ES cell with a new DNA imprint
and ES cell characteristics such as
developmental plasticity and a capacity for
rapid division.
In step two, an adult cell nucleus is added to
the large ES cell. In step three, the large ES cell
nucleus is removed. Theoretically this should leave
behind an ES cell with a new DNA imprint and ES
cell characteristics such as developmental plasticity
and a capacity for rapid division.
BresGen’s manager of clinical development,
Mr. Chris Juttner said that the procedure should be
permitted because the cells could not grow into
fetuses and so could not be used for human
reproductive cloning.
To date, Dr. Pralong’s team has succeeded only
in reprogramming neural progenitor cells using a
hybrid cell in which both nuclei remain in place.
BresaGen has offices and laboratories in
Adelaide, Australia and Athens, Georgia, US and
has three divisions, protein pharmaceuticals, cell
therapy and reproductive biotechnology.
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