Download Starpharma to Conduct Animal Trials on Vaginal Microbicide Clover

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Company News
Australia
Starpharma to Conduct
Animal Trials on Vaginal
Microbicide
Clover Secures HiDHA
Oils Supply Contract to
UK
Starpharma Ltd., based in Melbourne, Australia, is
being fully funded by the US National Institutes of Health
(NIH) to conduct trials on a gel’s ability to prevent HIV/
SIV and chlamydia infection in macaque monkeys.
Australian listed functional food ingredient
company, Clover Corporation Ltd., has recently
secured a contract to supply its HiDHA (DHA —
Docosahexaenoic acid) oils for use in Heinz Farley
infant formulas in the UK.
The gel contains a compound known as SPL7013
and is being developed as a topical vaginal microbicide
for application by women before sex to provide broadbased protection against infection by sexually transmitted
diseases (STDs).
Starpharma is currently preparing an Investigational
New Drug application to submit to the US Food and Drug
Administration (FDA) for Phase I testing of the SPL7013
gel in humans.
SPL7013 will be the first dendrimer-based
nanostructure approved for human testing. As dendrimers
are a totally new class of compounds, Starpharma has to
pioneer all aspects of the regulatory development of its
drugs, which are being referred to as “Nanodrugs”.
In previous trials, SPL7013 has been shown to be
effective against a range of STDs, including HIV, herpes,
hepatitis B and chlamydia.
Recent studies conducted by the Division of AIDS
Research in the US National Institute of Allergy and
Infectious Disease (NIAID) have shown that SPL7013
protects cells from infection by a range of HIV-1 and HIV2 strains isolated from HIV patients. Due to the high
potency exhibited by the compound against the clinical
isolates of HIV, it has been selected to advance to NIHsupported trials for the prevention of HIV/SIV infection
in monkeys.
Another study will be conducted to study the
prevention of chlamydia infection. This study will initially
examine the safety of SPL7013 following multiple
intravaginal applications and will then assess its ability
to prevent chlamydia infection.
Starpharma Ltd., a wholly owned subsidiary of
Starpharma Pooled Development Ltd., is a
biopharmaceutical company focused on the development
and application of dendrimer nanotechnologies as drugs
against major diseases.
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The contract is to supply 43 000 kilos of HiDHA
rich oils for a twelve-month period commencing
March 2002. According to Clover’s executive
chairman, Mr Hamish Drummond, the contract would
generate some A$2 million (US$1.08 million) in sales
revenue for Clover.
Clover has developed a prominent position in
long chain polyunsaturates (LCPs), Omega-3
(DHA) and Omega-6 (GLA) oils. LCPs, and
especially DHA, are essential for good health
but are not widely available in the modern diet.
Mr Drummond added, “This UK-based infant
formula product coupled with the recent
announcement that the FDA has approved the use of
DHA in infant formula will lead to the use of these
essential fatty acids in infant formula products
throughout Europe and other parts of the world.”
Research has confirmed that adding DHA to
infant formulas enhances brain and eye development
in babies in the same way breast milk does naturally.
The human brain undergoes rapid growth during the
first 12 months of life, with DHA crucial to maximizing
development and cognitive abilities.
Clover has developed a prominent position in
long chain polyunsaturates (LCPs), Omega-3 (DHA)
and Omega-6 (GLA) oils. Research has shown that
LCPs, and especially DHA, are essential for good
health but are not widely available in the modern
diet.
Clover’s products are based on the richest natural
source of DHA, tuna fish oil. Clover sources this DHA
from South Pacific tuna fish, a sustainable clean source
of tuna stock.
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Company News
China
GlaxoSmithKline
Completes Business
Integration in China
GlaxoSmithKline appears in the China market
with a whole new stance as it rounds up its business
integration in China.
The company’s business and market strategy has
been determined and in this month the new
management ranking would implement its market
strategy in China. The company aims to be the
overlord in China’s medicine industry.
Last year, GlaxoSmithKline invested in both
Tianjin GlaxoSmithKline Co. Ltd. and Suzhou
GlaxoSmithKline Co. Ltd., the total investment
amounting to US$0.218 billion. GlaxoSmithKline
said that the merger of Glaxo and Smithkline not
only complements its business in China, but also
strengthens the company’s competitiveness in China.
After the completion of integration,
GlaxoSmithKline’s first action in the China market
is to cooperate with Switzerland pharmaceutical
giant Novartis to market the latter’s Lamisil
(terbinafine hydrochloride tablet) in China through
the company’s Tianjin branch, which is good at overthe-counter (OTC) market.
Tianjin GlaxoSmithKline recently held a press
conference in Beijing to announce that it would
march into the OTC market. It said that in the Chinese
OTC market, the company has accumulated effective
management and operation experience and
possesses a strong marketing team.
In 2001, GlaxoSmithKline achieved sales of
US$29.5 billion and profit before tax of US$8.8
billion. Among which pharmaceutical sales
accounted for US$24.8 billion with new products
representing 22 percent of total pharmaceutical sales.
GlaxoSmithKline has over 100 000 employees
worldwide. Of which more than 40 000 are in the
sales and marketing area, consisting the largest sales
force in the industry. The company hires more than
42 000 employees working at 107 manufacturing
sites in 40 countries and employs over 16 000 staff
for R&D.
Refrigerators, freezers
and transport containers
for the medical sector
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• Alarm tests
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• Door opening alarm
• Self-diagnosis
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• Forced-air refrigeration
• Digital temperature display
• Audible and visual alarms
• Alarm system with a backup power supply of at least 48 hours in
case of power failure
• Key-operated power switch
• Remote alarms
• Safety thermostat
• Guaranteed operation with an outside temperature between 10°C
and 43°C
• Special insulation
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Email : [email protected] • www.dometic.lu
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Company News
GSK and Gilead Sign
Licensing Agreement for
Hepatitis B Drug in Asia
US-based Gilead Sciences Inc. and
GlaxoSmithKline have recently announced the signing
of a licensing agreement for the rights to commercialize
adefovir dipivoxil, Gilead’s investigational antiviral for
the treatment of chronic hepatitis B, in Asia, Latin
America and other territories.
Under the agreement, Gilead will retain rights to
adefovir dipivoxil in the US, Canada, Eastern and
Western Europe, Australia and New Zealand. GSK will
receive exclusive rights to adefovir dipivoxil solely for
the treatment of hepatitis B in all countries outside of
the Gilead territories, the most significant of which
include China, Korea, Japan and Taiwan.
Adefovir dipivoxil is in Phase III development
by Gilead for the treatment of chronic hepatitis
B. Dosed as one oral 10 mg tablet (once daily),
adefovir dipivoxil belongs to a novel class of
drugs called nucleotide analogues, which are
designed to work by blocking HBV DNA
polymerase.
In these markets, GSK plans to develop adefovir
dipivoxil for patients with chronic hepatitis B who are
naive to therapy as well as for those patients who have
developed lamivudine-resistant HBV.
GSK has agreed to pay Gilead an up-front licensing
fee of US$10 million, and Gilead is entitled to receive
additional cash payments of up to US$30 million upon
achievement of certain milestones. GSK also will pay
Gilead an undisclosed royalty on net sales of adefovir
dipivoxil. GSK will have full responsibility for
development and commercialization of adefovir
dipivoxil in the covered territories.
Adefovir dipivoxil is in Phase III development by
Gilead for the treatment of chronic hepatitis B. Dosed
as one oral 10 mg tablet (once daily), adefovir dipivoxil
belongs to a novel class of drugs called nucleotide
analogues, which are designed to work by blocking
HBV DNA polymerase, an enzyme involved in the
replication of HBV in the body. Adefovir dipivoxil is an
investigational compound and has not yet been
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determined safe or efficacious in humans.
Gilead has recently filed a New Drug Application
for adefovir dipivoxil with the US Food and Drug
Administration and a Marketing Authorization
Application with the European Medicines Evaluation
Agency.
“Adefovir dipivoxil will be a valuable addition to
our portfolio,” said Mr. Howard Pien, president of
pharmaceuticals international at GlaxoSmithKline. “We
hope adefovir dipivoxil will offer a valuable new
treatment option to physicians and will help improve
the quality and duration of life of millions of hepatitis B
patients across Asia, Latin America and other
international areas.”
For the treatment of chronic hepatitis B, GSK also
markets Zeffix in 50 countries worldwide, including
China (as Heptodin), the US (as Epivir-HBV) and Europe.
More than 200 000 patients have been treated with
Zeffix since its first launch in November 1998. With
total 2001 sales of US$148 million, Zeffix is currently
the only licensed oral antiviral treatment for chronic
hepatitis B worldwide.
Tianjin Tasly Steps into
Biopharmaceutical Field
China’s Tianjin Tasly Pharmaceutical Co. Ltd. has
recently entered into an agreement with the Chinese
Academy of Military Medical Sciences on the
technology transfer and development of a Class I
biological new drug named genetically engineered uPA (plasminogen activator).
u-PA, also called recombinant human urine
plasminogen activator, is indicated for thrombolic
cerebro-cardiovascular diseases. Tasly will invest a total
of US$18 million on the development and production
of the drug in collaboration with the Chinese Academy
of Military Medical Sciences.
Tianjin Tasly, one of the fifteen largest enterprises
in Tianjin, is a famous traditional Chinese medicine
company. Its major product is Compound Danshen
Drop, a leading drug in the treatment of cardiovascular
diseases. Through this cooperation, the company has
diversified its product scope into biological and
chemical drugs.
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Company News
Nova BioGenetics Receives
Chinese Approval for
Antimicrobial Hand Gel
positioned to capture a significant share of the
local market.”
BioShield Technologies Inc. has recently announced that
Nova BioGenetics, an affiliate company of BioShield, has
received approval from China’s State Drug Administration (SDA)
for the country’s first antimicrobial hand gel using Bioshield’s
technology.
Befar incorporates alprostadil, a drug well
recognized for treating ED, with the NexACT®
transdermal delivery technology. Befar is
manufactured in China and marketed in China
and Hong Kong by NexMed’s Asian licensee.
Through Nova BioGenetics and BioShield’s partnership with
MegaStar Universal Ltd., Megastar has been very active in
formulating, testing and creating China’s first antimicrobial hand
gel.
In clinical studies conducted in China,
Befar exhibited two advantages over the
currently marketed oral ED medication —
faster onset time and minimal side effect
profile.
Initial marketing of the product in China and Asia has
produced significant demand and medical acceptance for the
product as it mitigates the vast majority of the bacteria and fungi
that typically create viral illnesses.
BioShield Technologies Inc. is a Georgia, US based
antimicrobial and antiviral company. Its core business is
committed to the discovery, development, marketing and sale of
surface-modifying antimicrobial and anti-viral products.
Its antimicrobial technology is a revolutionary alternative
to conventional sanitizers, disinfectants, or biocides primarily
because it kills bacteria, and viruses, including HIV, on contact
and can remain active for extended time periods.
Dr. Mo further added, “During 2002, we
anticipate additional approvals and filings in
various international markets.”
In the US, NexMed is conducting its Phase
III clinical development programs for AlproxTD. The multi-center trials will enroll up to
2500 patients with mild to severe ED. NexMed
has completed a Phase II multi-center take
home study with its Femprox ® topical
treatment for female sexual arousal disorder.
NexMed Inc. is an emerging pharmaceutical and medical technology company
with a product development pipeline of
innovative topical drug treatments based on
the NexACT transdermal drug delivery
technology.
Hong Kong
India
NexMed’s Alprox-TD
Launched in Hong Kong
US-based NexMed Inc., a developer of innovative topical
treatments based on its proprietary drug delivery technology, has
recently launched a proprietary cream treatment for erectile
dysfunction (ED) called Alprox-TD® in Hong Kong under the
trademark Befar®.
NexMed has been selling the treatment in China since July
2001. In November 2001, NexMed and its Asian licensee filed a
New Drug Application with the Health Sciences Authority for
approval to market Befar in Singapore.
Dr. Y. Joseph Mo, president and chief executive officer of
NexMed, commented,“We are excited about the potential of Befar
in Hong Kong, a small but lucrative market. We believe that as
the first approved topically-applied ED treatment, Befar is well
GlaxoSmithKline’s
Indian Subsidiary to
Source for Raw
Materials
GlaxoSmithKline Pharmaceuticals (GSK),
the global pharmaceuticals company, will soon
commence sourcing of raw materials like viles,
syringes and bottles from its Indian subsidiary.
GSK has sourced from India raw material
such as ranitidine and sulphamethoxazole for
many years. However, it is unlikely that
formulations will be sourced out from India in
the near future on account of regulatory issue.
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Company News
A company spokesperson said, “Though, the
manufacturing facilities of GSK in India are
undoubtedly world class producing formulations of
international quality, we need to significantly
enhance our manufacturing efficiencies to further
up the global manufacturing competitiveness of our
facilities.”
It is now globally accepted that the Indian
pharmaceutical industry manufactures many items
(from the raw materials) required by the industry as
per international specifications and quality. Thus,
many international pharmaceutical companies are
actively contemplating sourcing for raw materials
from India.
Headquartered in the UK and with operations
based in the US, GSK is one of the industry leaders,
with an estimated seven percent of the world’s
pharmaceutical market. It also has leadership in four
major therapeutic areas — anti-infectives, central
nervous system, respiratory and gastro-intestinal/
metabolic.
Socrus Launches NDDS
for Cipro in Intramuscular Dosage Form
Indore-based Socrus Pharmaceutical Ltd. has
recently pipped other Indian pharmaceuticals firms
by coming up with a novel drug delivery system
(NDDS) for ciprofloxacin (cipro) in an intramuscular (IM) dosage form.
Socrus has filed for both the local and American
patents for this NDDS and is scouting for a partner
to license it out.
This is the world’s first NDDS for cipro in an
IM dosage form. Socrus plans to obtain the US Food
and Drug Administration approval through the joint
efforts of licensing, manufacturing and a marketing
partner.
Cipro, scheduled to go off-patent by December
2003, is currently available through the oral route
in tablets or intravenous (injectible) route globally.
Usage of cipro was earlier brought into sharper focus
following the anthrax scare in the US.
Cipro administered through the oral/
intravenous route absorbs into the body slowly,
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leading to delayed relief. Intravenous infusion also calls for
hospitalization as its administration of 100ml/200ml is done
drop by drop. As against this, the patient given an IM
injection gets quicker relief and also needs no
hospitalization.
However, according to analysts, injectibles in cipro
account for only 5–10 percent of the US$1.8 billion global
market. Indian giant Ranbaxy had earlier licensed the
exclusive development and worldwide rights for its oncea-day cipro in tablet form to Bayer AG in a US$50 million
deal, plus the royalty.
Cadila to Make Presence
Felt in Dermatological
Market
The Ahmedabad-based pharmaceutical company
Cadila Pharmaceuticals Ltd. is set to increase its presence
in the dermatological sector.
Mr. R. Sahni, senior vice president of marketing for
Cadila, revealed that the company is proposing to enter the
Rs876 crore (US$179 million) topical dermatological market
in a big way in the near future. Cadila has thus far
concentrated on the oral dermatological segment that
mainly constitutes drugs such as antibiotics, anti-allergics
and steroids.
The range of topical dermatological products identified
by Cadila include exclusive and latest molecules for two
chronic skin problems namely acne and psoriasis.
In the acne market, which is broadly divided into
prescription oriented molecules and cosmetic OTC
preparations like Clearasil, CPL is launching the latest
retinoid Adapalene, hailed as a breakthrough molecule in
both the treatment and prophylaxis of acne. The company
proposes to launch the drug next month.
As for the psoriasis market, Crosslands has been the
sole player in a monopoly market. The company imports
the molecule Calcipotriene in its finished form from
Denmark-based Leo Pharmaceuticals and markets it in India.
However, Cadila would be importing the raw material for
the drug and making it in India.
Cadila is also exploring the possibility of entering the
oral acne treatment sector later this year. Mr. Sahni said,
“We have not been able to do this so far as the sole molecule
for this, isotretinol, which though available in the
international market, is fraught with serious side effects
specially if taken by pregnant women.”
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Company News
Japan
Takara Bio Sets up
Organic Produce
Operation to Develop
Health Foods
Takara Bio Inc. has recently announced that it
will set up an agricultural biotechnology branch on
Yakushima Island, southern Japan to produce
organic plants and herbs for the development of
health foods.
To kick off, Takara will be producing health
foods from extracts of ashitaba (Angelica Keiskei),
a unique celery-like vegetable. Research by Takara
has shown that ashitaba contains many substances
that can prevent cancer, as well as large quantities
of elements that stimulate nerve growth factors
(NGF).
NGF stimulate the growth and development
of neurons in the central and peripheral nervous
systems and are promising for the prevention and
treatment for the degeneration of peripheral nerves,
which can lead to senility and diabetes in the elderly.
The new branch will be located at a 210 000
square meter site in Kamiyaku-cho on Yakushima
Island, a World Heritage Site. Takara will purchase
the land five years after the establishment of the
branch.
In addition, Takara will build a “Healing
Village”, where people may refresh their mind and
body by farming in the beautiful natural
environment of Yakushima.
Takara is already creating an agricultural
biotechnology branch in Fukushima prefecture,
northern Japan. With a similar climate to the Tokyo
region, Fukushima is an ideal site for organic health
food production and vegetable-processing.
Takara Bio Inc., based in Shiga, Japan, is
divided into three divisions: DNAtech, which
develops technology and equipment for research
into genomics and proteomics; BIOMedi, which
develops biotechnology applications in geneand cell-based diagnostics and therapies; and
AgriBIO, which concentrates on agricultural
biotechnology.
Aventis and Fujisawa to
Cooperate in Marketing of
Synercid Injection
Aventis Pharma Ltd. and Fujisawa Pharmaceutical Co.
Ltd. have jointly announced that they have formed an
alliance to market the streptogramin antibiotic, Synercid®
Injection.
In recent years, the strong resistance of vancomycinresistant Entercoccus faecium (VREF) to the glycopeptide
antibiotic vancomycin has become increasingly
problematic, especially in Europe and the US. VREF has
also been reported in Japan since 1996, although the
number of cases remains small.
Composed of quinupristin and dalfopristin, Synercid
Injection is the world’s first injectable streptogramin
antibiotic. It exhibits strong antibiotic activity
against VREF and is approved and marketed in over
30 countries worldwide.
Created and developed by Aventis and composed of
quinupristin and dalfopristin, Synercid Injection is the
world’s first injectable streptogramin antibiotic. It exhibits
strong antibiotic activity against VREF and is approved and
marketed in over 30 countries worldwide, including the
UK and the US. Aventis received a Japanese import license
in January 2002.
Aventis and Fujisawa are already cooperating in the
marketing of the anti-allergic Intal® and the glycopeptide
antibiotic Targocid Injection®. The two companies have
agreed to form the alliance for the marketing of Synercid
in Japan, taking into account the nature of Synercid as a
drug for the treatment of such specialized diseases as VREF
infections.
Under this agreement, Fujisawa will be the sole
distributor of Synercid Injection in Japan, and Aventis will
possess the license to import. Fujisawa plans to launch
Synercid in the summer of this year.
Fujisawa Pharmaceutical Co. Ltd. produces and
markets pharmaceuticals, medical equipment and supplies,
home care business, chemicals and animal health products.
The company is one of Japan’s largest drug makers, with
its main strength in antibiotics.
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Company News
Eisai Announces Phase
III Clinical Trial Results
for Vascular Dementia
Drug
Eisai Co. Ltd., based in Tokyo, Japan, has
recently released the results of the second of two
phase three clinical trials conducted in the US and
Europe by Eisai Inc. involving vascular dementia
(VaD) for Aricept®.
The new data reinforces earlier findings that
demonstrated treatment with Aricept significantly
improved cognitive function with vascular dementia
compared with placebo in the double-blind study.
There are no approved treatments for this condition
yet.
VaD is the second most common form of
dementia, accounting for up to one-third of all
diagnosed dementia cases in the US. The
prevalence of VaD increases with age and, as the
number of people in the US age 65 and older is
expected to grow to 69.4 million by the year 2030,
VaD can be expected to be a growing healthcare
issue in society.
The 24-week double-blind randomized study
involved patients who received daily doses of 5mg Aricept, 10-mg Aricept or placebo. The study
included 603 men and women with VaD.
All participants took one or more medications,
with over 80 percent receiving medication to
prevent strokes. Patients who received 5 or 10 mg
of Aricept showed significant improvement in their
cognitive function compared to those taking
placebo.
Evaluation of global function also revealed
significant improvements for patients at the 5 mg
dose of Aricept doses compared to patients who
received placebo. Improvement for patients on the
10-mg dose was not significantly better than
placebo.
Overall adverse events in VaD patients treated
with Aricept did not differ significantly in frequency
compared to Alzheimer’s disease patients. As
expected and consistent with the drug’s known
mechanism of action, side effects related to the
digestive system (including diarrhea and nausea)
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occurred more frequently in Aricept treated patients than
placebo treated patients. Of the 125 patients who
discontinued the study, 89 did so due to an adverse event.
Aricept is an acetylcholinesterase inhibitor. It increases
a neurotransmitter in the brain, acetylcholine serving to
improve the symptoms associated with Alzheimer’s disease.
Aricept has been launched in over 50 counties worldwide
including Japan, the US, the UK, Germany and France.
Eisai Co. Ltd., established in 1941, is a leading
pharmaceutical manufacturer specializing in ethical drugs.
Prescription drugs account for about 90 percent of sales
and are led by Aricept, the firm’s top seller that treats
Alzheimer’s disease.
Marubeni Chicken Plant
Ordered to Shut Down
Marubeni Chikusan Corp. has recently been ordered
by Japan’s Fair Trade Commission (FTC) to cease production
over its intentional mislabeling of some 1700 tons of chicken
during a three-year period from 1999.
According to the FTC, the mislabeling was conducted
at the company’s nine offices, including Sendai and Osaka.
Marubeni Chikusan Corp., a unit of trading house
Marubeni Corp., is the second major meat processing
company to receive an FTC order in relation to false labeling
charges. In March, Tokyo-based Snow Brand Foods Co.
became the first to receive such an order.
The company sold 700 tons of Brazilian chicken
labeled as domestic chicken to 80 mass retailers between
April 1999 and February this year. During the same period,
it sold 1000 tons of ordinary chicken as special brand-name
chicken.
The FTC order also requires the firm to place
advertisements in newspapers and elsewhere to apologize
for its actions and to reveal all facts.
In March, Marubeni Chikusan admitted that its branch
office in Sendai passed off chicken imported from Brazil as
higher-priced domestic chicken. It was revealed that the
company falsified descriptions of 5–8 tons of imported
chicken each year during 1999 and 2001.
Its president Mr. Hitoshi Nishizono recently admitted
to the Japanese agricultural ministry that the illegal labeling
practices might also have occurred at other offices.
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Company News
Korea
business partners worldwide.
Medi-Hut International’s
Tussle with KFDA
Medi-Hut International, a joint venture between
Medi-Hut Co. Inc. of the US and a Korean
international distributor of medical supplies, has
recently suffered a setback.
Export sales of the company’s medical syringes
and other products to overseas markets have been
affected by obscure regulations of the Korean Food
and Drug Administration (KFDA).
Until now, KFDA still refuses to issue the
“Certificate of Free Sales” which certifies that a “firm
is authorized to manufacture medical devices under
the Pharmaceutical Affairs Law, and the item(s) is
permitted to be freely sold in domestic and overseas
markets” to Medi-Hut.
Overseas import firms are only familiar with
the name “Medi-Hut International”. There is
thus a discrepancy between the company
name that appears on the cer tificate
(“Hangook Medi-Hut”) and the name known
by its business partners.
As this certificate is required as proof by some
importing countries, Medi-Hut’s export sales
performance is potentially threatened.
When Medi-Hut first registered with KFDA as a
foreign-invested company in Korea, the company
gave its legal name as “Hangook Medi-Hut” in
Korean characters on the “Certificate of FDI Company
Registration”, although the name Medi-Hut
International also appeared in English on the same
document.
As Medi-Hut’s main business is outside of Korea,
the company has used only the name Medi-Hut
International for all its promotional materials,
packaging, letterheads, etc.
As a result, overseas import firms are only
familiar with the name “Medi-Hut International” from
day-to-day business dealings. There is thus a
discrepancy between the company name that appears
on the certificate (“Hangook Medi-Hut”) and the
name (“Medi-Hut International”) known by its
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In the past, the application form as well as the actual
certificate were issued only in the Korean language; and
herein lies the root of the problem. The KFDA insists that
the English certificate should carry the phonetic translation
of the company’s legal Korean business name, or in this
case, “Hangook Medi-Hut”.
KFDA’s argument is that by adhering to the phonetic
translation of a company’s name, further confusion can
be avoided in the event that another company establishes
a business named “Medi-Hut International” (in Korean
characters), though such a scenario is highly unlikely due
to copyright infringement laws.
KFDA’s reluctance to grant the certification can
destroy Medi-Hut’s credibility with its clients, and may
also cause lucrative business ties to be severed.
Malaysia
Top Glove to Set up Eighth
Plant near Shanghai
Malaysia’s world-leading glove manufacturer Top
Glove Corp. Bhd. plans to set up its eighth plant near
Shanghai to produce PVC gloves.
Dr. Lim Wee Chai, chairman and managing director
of Top Glove, said that construction of the plant is targeted
to begin by the end of this year. The company would invest
about RM11.4 million (US$3 million) to add another 12
dipping lines upon completion of its first phase.
Top Glove currently has six plants with 58 dipping
lines, which now produce about 3.6 billion pieces of
gloves a year. Five of the plants are in Klang and Ipoh,
Malaysia while one is in Phuket, Thailand.
The company is also starting construction of its
seventh plant in Hatyai, Thailand next month. The plant
would be completed by end of this year and provide
another 20 dipping lines within a year.
According to Dr. Lim, Top Glove would have an
additional 40–50 dipping lines from its Hatyai and
Shanghai plants in the next three years. The two plants
would produce about three billion pieces of gloves a year.
He said that with this scale, Top Glove would be one
of the world’s top three latex glove manufacturers by next
year. It is currently in the world’s top five and targets to be
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number one by 2005.
Top Glove Corp. Bhd., established since 1991,
is one of the world’s leading manufacturers and
exporters of high quality latex examination, nitrile,
surgical, household and industrial gloves based in
Malaysia. Over the years, it has expanded to a
production capacity in excess of 300 million pieces
of gloves permonth or 3.60 billion pieces of gloves
per year.
Chemical Company of
Malaysia to Focus on
Pharmaceuticals
Chemical and fertilizer firm Chemical
Company of Malaysia Bhd. (CCM) is planning to
turn its pharmaceutical businesses into the main
source of income in the near future.
Mr. Lim Say Chong, managing director of CCM,
said that the company sees much better long-term
potential from its newly developed pharmaceutical
businesses. Its wholly owned subsidiary Upha Corp.
(M) Sdn. Bhd. and CCM Pharma, which
manufactures and retails pharmaceutical products,
manage the group’s healthcare business.
The pharmaceutical businesses brought CCM
a pre-tax profit of RM5.6 million (US$1.5 million)
last year, down from RM5.9 million (US$1.6 million)
the previous year. Mr. Lim said that the decline is a
temporary hiccup, as steps have been taken to
rationalize and consolidate the manufacturing sector
as well as strengthen its distribution and brand
building effort.
The company is looking at building more
brands of pharmaceutical products and increasing
the number of its Prima Health retail centres. For
greater access to the latest medical research, the
company has since 1997 invested in US-based
Impax Laboratories Inc. and Cardiome Pharma
Corp., which develop and commercialize specialty,
generic branded pharmaceuticals.
Mr Lim said, “CCM has a 14 percent stake in
Impax and six percent in Cardiome. We have the
exclusive rights to distribute the products from both
companies in this part of the world except for Japan
and Taiwan.”
Philippines
Monsanto Philippines
Harvests Bt Corn
Monsanto Philippines has recently harvested Bt corn
in its field trial site in Pangasinan, Philippines. This is one
of the eleven trials conducted in various parts of the
Philippines during the dry season cropping.
The harvesting is strictly supervised by the Bureau of
Plant Industry and is also witnessed by representatives from
other national and local government agencies.
The members of the Scientific and Technical Review
Panel of the National Committee on Biosafety of the
Philippines also monitored the harvesting. According to
Mr. Ronald G. Cabangbang, product development
executive of Monsanto, two Bt corn varieties are field tested
in the area. These are Yieldgard 818 and YieldGard 838.
These Bt corn varieties are specifically evaluated for
resistance to Asian corn borer and compared with
commercial corn hybrids. Results confirmed the
effectiveness of the Bt corn varieties in controlling Asian
corn borer infestation.
Unlike traditional varieties of corn, Bt corn exhibits
healthier plants, undamaged stalks, and cleaner cobs. The
benefit of the Bt technology in protecting yield is
clearly demonstrated. Data from the Pangasinan field trial,
including those in the other ten trial sites for dry
season evaluation of Bt corn, will be released soon by
Monsanto.
Singapore
Air Products Installs First
Cryogenic Abatement
System in Singapore
Air Products and Chemicals Inc. has recently completed
the installation of a cryogenic solvent recovery system at
Schering-Plough’s new manufacturing plant in Singapore.
The Cryo-Condap® system, to abate volatile organic
compounds from the pharmaceutical manufacturing
process, is the first of its kind in Singapore. Air Products has
over 70 of this system installed worldwide to cater for a
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www.asiabiotech.com
Company News
range of industries including fine chemicals,
pharmaceutical and refrigeration recycling.
development in relation to drugs and genome based
diagnostics.
The system works on a basis of cryogenic
condensation. Its uses liquid nitrogen in a heat
exchanger to cool down a waste gas stream. The solvent
can then be separated from the waste gas stream and
either is re-processed for use in the manufacturing
process or disposed of, depending on the characteristics
of the solvents and regulatory requirements.
The BioEnterprise Asia (BEA) Group is a consortium
of life science enterprises dedicated to identifying,
nurturing and managing the development of innovative
new technologies and high growth enterprises in
healthcare, the life sciences and related technology
areas.␣
The carrier gas is then “virtually solvent free” and
can be safely dispersed into the environment. In this
process, up to nine different solvents are treated.
A spokesman of the company said, “We have
worked closely with Schering-Plough to develop, build
and deliver the hi-tech recovery system on budget and
within a very short space of time — ready for the
anticipated mid-year opening of their new plant. Our
cryogenic team is dedicated to delivering bespoke
systems which provide the most efficient environmental
solution to meet legislative demands now and in the
future.”
Air Products and Chemicals Inc. is the world’s only
combined gases and chemicals company. It is a market
leader in the global electronics and chemical processing
industries, and a longstanding innovator in many
industrial markets, including coatings, adhesives and
ployurethanes.
BioEnterprise Asia and
Ocimum Biosolutions to
Jointly Set up R&D
Facilities
BioEnterprise Asia, based in Singapore and
Ocimum Biosolutions have recently signed a
Memorandum of Understanding (MoU) in Hyderabad,
India to form a joint venture called Ocimum
BioEnterprise Labs.
The MoU is exchanged between Dr. Gurinder
Shahi, CEO of Bioenterprise Asia and Ms. Anuradha
Acharya, CEO of Ocimum Biosolutions Ltd.
Ocimum BioEnterprise Labs will set up R&D
facilities at the ICICI Knowledge Park in India. Areas of
interest will include technology and product
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Dr. Shahi said, “BioEnterprise Asia recognizes the
tremendous untapped potential of scientific insight and
nascent technologies in India.”
The␣ BEA Group currently include Lynk
Biotechnologies in the proteomics and drug
development arena and Asia Pacific Genomics in the
genomics arena and others in the areas of medical
device and biomedical IT, surfactants and specialty
biomaterials and bioinformatics and molecular
modeling arenas.
Ocimum Biosolutions is a life sciences research
and development company with focus on bioinformatics
and contract research services with operations both in
the US and India.
Ocimum Biosolutions has its US Headquarters in
Indianapolis, Indiana. The Indian arm of Ocimum
Biosolutions is located in Hyderabad. The company’s
primary focus is to be a one-stop destination for
bioinformatics consulting needs and also on
development of key ready-to-use bioinformatics
software modules, contract research and training.
Taiwan
US Criticare Expands
Partnership with Taiwan
BioCare
US-based Criticare Systems Inc. has recently
expanded its partnership with Taiwan’s BioCare Corp.
to include the distribution and service of Criticare’s
products in China and Taiwan.
BioCare is a subsidiary of the Koo’s Group, the
second largest company in Taiwan. The agreement calls
for Criticare Systems Inc. labeled product to be
manufactured in Taiwan and China by BioCare, who
will now be responsible for complete sales and service
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in those countries.
BioCare currently manufactures a major percentage
of Criticare’s products in Taiwan. This is being expanded
to a new 300 000 square feet facility, shared with other
Koo’s Group subsidiaries near Shanghai, China.
Criticare’s President Mr. Emil Soika stated, “We expect
this arrangement to open opportunities for significant
growth that could not be unlocked through a traditional
international sales network.”
“BioCare has proven to be a valued high quality
partner with astute insights into the emerging Asian
markets. We believe that this strategy will dramatically
improve Criticare’s business potential in these markets.”
Criticare is an international medical device company
headquartered in Waukesha, Wisconsin, US. It designs,
manufactures, and markets cost-effective patient
monitoring systems and noninvasive sensors for a wide
range of hospitals and alternate health care environments
throughout the world.
Invested by Grand Pacific Petrochemical Corp. of the
Koo’s Group, which is one of the most influential
enterprises in Taiwan, BioCare Corp. is one of the largest
biomedical device manufacturers in Taiwan. The company
dedicates its professionals to developing products and
services worldwide.
Rules & Regulations
AstraZeneca, with a research facility at Brisbane’s
Griffith University, has a collection of more than 40
000 mainly rainforest plants, insects, fungal samples
and marine organisms gathered under deals with the
governments of Queensland, Papua New Guinea,
China and India.
As part of the arrangement, a royalty stream is
guaranteed to Griffith University should any products
develop from AstraZeneca’s on-campus research. The
Queensland Museum and Brisbane Herbarium as
collectors will receive 15 percent of the royalty.
Under licensing agreements with the
governments of Western Australia and Queensland,
BioProspect is systematically collecting thousands of
native plants for screening. After testing the chemistry
of 400 trees in the Atherton Tableland area of Northern
Queensland, BioProspect discovered a naturally
occurring insecticide, which it is now developing.
Under the deal, BioProspect has to use
Queensland facilities and services to develop the
discovery and ensure as much spin-off as possible
goes back to the state of origin. The Australian
government is yet to introduce new regulations
covering bio prospecting.
The deal agreed to in The Hague requires
companies or collectors seeking information from
indigenous peoples to secure “prior informed
consent’’ beforehand. The international meeting wants
nations to pass this and other agreed guidelines for
bio prospecting into law.
Australia
Companies to Need License
for Bio-prospecting
A recent meeting in The Hague has agreed on
guidelines for national licenses to access genetic resources.
This will allow poor countries to make money from drugs
and other new products synthesized from their indigenous
plants.
At least three Australian organizations are reported
to be racing to gather massive collections of Australian
plants, insects, marine life and other organisms before the
voluntary agreement is adopted.
These are the Perth-based company BioProspect,
multinational drug and agrochemical company
AstraZeneca, and the Australian Institute of Marine
Sciences.
India
Small Firms Seek More
Time to Implement GMP
Recognizing funding constraints of India’s small
pharmaceutical units, a panel working on India’s drug
and pharmaceutical policy has recently suggested
that the deadline to implement World Health
Organization’s (WHO) good manufacturing practices
(GMP) be extended by one year to 31 December
2004.
It has also suggested that the small scale industry
(SSI) units be given financial assistance to bring them
up to par with international GMP requirements.
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