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A CyberMedia Publication | | October 2010| BioSpectrum | 1

ASIA      2 | BioSpectrum | October 2010 | | A CyberMedia Publication
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                                                           Cover Story

Publisher: Pradeep Gupta
                                                          06       CROs in Asia set to grow 20%
                                                                                                           BioSpectrum Survey 2010

                                                           Country Scan
Editor-in-Chief: Shyam Malhotra
Group Editor:
Chief Editor: Narayanan Suresh
                                        Kingshuk Sircar
Executive Editor: Nandita Singh
Associate Editor: Narayan Kulkarni
Assistant Editor: Ajeesh Anand
                             Sareeta Sajjan
                                                          18       China
                                                                   • TCM at $1.46 billion in global market
Executive-Marketing: Gagan Sagwadiya
                                                                   • Boehringer Ingelheim expands in Shanghai
Senior Correspondent: Amrita Tejasvi
Asst Manager Sales & Marketing: Stanrick Tan
Manager Admin & Sales Support: Saradha Mani
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E-mail:                                        Asia taps the promise of iPS cells
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                                                           Quick Scan
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                                                          16       Research & Development
Vol 1; Issue 5; October 2010
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                                                          27       Events

                                                          05       Edit: Asia CROs to expand globally
                                                           A CyberMedia Publication | | October 2010| BioSpectrum | 3
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ASIA      4 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                           QuickScan                 EDIT

                           Asia CROs to expand globally
                           As more research and clinical services in pharma get outsourced to the
                           Asia region, the new segment of CROs has emerged in recent years. Since
                                 BioSpectrum has been tracking the growth of this segment in the
                           Asian region systematically through an annual CRO survey.
                             So it is time to present the results of the Asia Life Science Services 2010
                             interesting trends. The CRO segment in the region, just a decade old, is
looking beyond and is mapping the whole world. This is an interesting development, indicating the
inherent strength of competence demonstrated in a very short time. Two-thirds of CROs have indi-
cated their priority is client expansion. And to make this happen, Asia’s CROs plan to go to wher-
ever the customers are. This is a major change from the total dependence on customers in North

several recent cases of regional companies too outsourcing their work to local organizations. Also,

world, is now looked upon as a potential client, and CROs will do whatever it takes to reach out to
them, according to the BioSpectrum survey.

the CROs expect to clock annual growth in excess of 20 percent in 2010. The largest orders are still
in the sub-$50 million category.
What the CROs do here is an indication of the trajectory of drug development in the world. Over-
whelming numbers of clinical projects handled by Asia’s CROs are related to lifestyle diseases with
oncology, cardiovascular, central nervous system and diabetes leading the charts. It is a clear indi-
cation that these are the areas where the maximum action is taking place globally.
Of course, some new treatment segments have come up. Gene therapy is a relatively new ac-
tion area and as the special report, “Gene Therapy in Asia Gains Momentum With Strong Pipeline”
shows, lots of research and development work is taking place in Asia. A gene therapy pioneer, Prof

Korea itself now.

due to the high levels of preparedness. The global efforts to equip a dozen companies in the region

stocked with the vaccine and the segments of population most at risk, are getting the supplies.

have blamed the WHO for creating the panic in mid-2009, but the positive impact of the height-
ened global attending, transferring of technology and resources to make vaccines in Asia will help
humanity in the long run.

                                                                          Narayanan Suresh
                                                                          Chief Editor

                                    A CyberMedia Publication | | October 2010| BioSpectrum | 5
         Cover Story
         QuickScan Life Science Services

   CROs in Asia
   set to grow
          BioSpectrum Survey 2010
                                                                                  Survey Findings:
   In an effort to assess the trends in Contract and
   Clinical Research Organizations (CROs) in the Asia
                                           BioSpectrum                                previous year; while the CROs in India have
   conducted Asia Life Science Services BioSpectrum                                   increased the number of customers by over
   Survey 2010. About 250 CROs from all across
                                                                                      percent) and Australia (211 percent).
   local CROs with revenues upto $1 billion received                                  There is a slight increase in the total number
   questionnaires from BioSpectrum in June 2010. In all,                              of staff in 2009 over 2008, in sales and
   39 CROs from India, China, Malaysia, Singapore,                                    marketing, administration and management
   Australia, Taiwan, Thailand, South Korea and Hong                                  divisions except research division.
   Kong participated in the survey.

   The survey revealed that 41 percent of the CROs
   who responded, projected a growth of over 26                                       and IV studies, due to the large patient
   percent in 2010; while 49 percent are set to grow                                  population in the region, cheap labor,
   10-25 percent. Industry reports indicate that the CRO                              sponsors’ eagerness to launch the products
   market is expected to grow at a CAGR of 20 percent.                                in this growing market.
          Projected growth rate in 2010                                               Oncology, cardiovascular, central nervous
                                                                                      system, diabetes and metabolic disease
                             8%                                                       clinical research activities for the companies
                                                                                      respondents are focusing on oncology,
                22%                                                                   which leads the table of focus therapeutic
                                                     13%                              areas of CROs in the region.
                                                                                      Most of the CROs have a plan to expand
                                                                                      their geographical reach to establish direct
                                                     10%                              presence in other countries and in the

                                                                                      focussed on client expansion; followed
                                                                                      by product development (51 percent) and
                  6-10%       11-15%      16-20%      21-25%
                                                                                      revenue growth (41 percent).
                  >26%        No Response

ASIA      6 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                    Cover Story Life Science Services

Some Asian CROs are into both clinical &
contract research        Segment split

Of the 39 respondents of the Asia Life Science Services
BioSpectrum Survey 2010, most respondents say they
are focusing on clinical research while about a third,                                         8.40%
on contract research.

The respondents of the survey noted that as CROs,
they offer end-to-end preclinical to early clinical
development platform for pharmaceutical product de-
velopment, like: integrated target to candidate-ready
solutions across target platforms of kinases, ion chan-
nels, proteases; molecular modeling services, medici-                 Contract Research    Clinical Research
nal chemistry and scale-up services, gene to structure
services, informatics services, genomics and pharma- on the expertise, availability of resources in differ-
cogenomics/pharmacogenetics services, personal/ ent countries, and need of sponsors; the CROs have
whole genome sequencing services. The service also developed specialized skill sets to offer the best of
include process chemistry, drug metabolism and phar- services.
macokinetics and safety assessment, bio
informatics services. A few CROs provide                                                                         -
site management organization (SMO) and                                 vide some of the services like bio-analyti-
some others have developed expertise in                                cal services, pre-clinical services, phase
offering clients with a solutions approach, BioSpectrum Survey 2010 I-IV operational services, central lab
right from conceptualization to essential documents services, clinical trial anagement, clinical data man-
                                                        - agement, bio-statistics, medical writing and medical
sis and publication support.                              translation, regulatory consulting, pharmacovigi-
                                                          lance, CRA in-sourcing, corporate training, feasibility
These CROs offer full range of early- to late-stage clin- studies, protocol and study document development,
ical development services like taking a molecule from project management; quality assurance services,
‘concept-to-clinic’; others offer auxiliary services to study monitoring, study closeout; medical monitor-
support clinical trials through strategic partnerships ing; statistical analysis, clinical trial supplies manage-
with best-of-the-breed service providers. Depending ment and vendor management, safety monitoring.

                                                                        Revenue generated by CROs
Most CROs are in sub
$50 mn revenue band
CROs with a revenue of $10 million are about 43 per-                                                 35%
cent; 35 percent generate $5 million revenue. About
33 percent of the survey respondents are in the busi-
ness with $10 million-$100 million in revenue and two                         02%
percent of the respondents are doing business worth                            02%                              08%
$100million-$500 million.                                                        05%
                                                                                   05%                   10%
                                                                                         05%     08%
under $50 million. The Asia Life Science Services
BioSpectrum Survey 2010 analysis indicates that most                $0-5 mn        $5-10 mn      $10-15 mn        $15-20 mn
of the clinical research organizations headquartered
                                                                    $20-25 mn      $25-50 mn     $50-100 mn       $100-500 mn
in Asian region, are still in the growing phase, and
can be called small-and-medium-sized CROs.                          >$1 bn      No Response

                                                A CyberMedia Publication | | October 2010| BioSpectrum | 7
         Cover Story
         QuickScan Life Science Services

   Lifestyle diseases rule focus therapeutic areas
   According to World Health Organi-                                                 table of focus therapeutic
   zation (WHO), cardiovascular dis-                                                 areas for CROs in the
   eases are the leading cause of death                                              region with cardiovascular
   globally. Infectious and parasitic                                                (45 percent), CNS (30 percent),
   diseases are the next, followed by                                                diabetes (23 percent) and met-
   cancer.                                                                           abolic disease (19 percent). The
                                                                                     other major therapeutic focus
   In the high-income countries, nine                                                includes infectious disease,
   out of 10 leading causes of death                                                 dermatology,       ophthalmol-
   are noncommunicable conditions,                                                   ogy, neurology and psy-
   including four types of cancer, dia-                                              chiatry, chronic obstructive
   betes, lower respiratory infection,                                               pulmonary disease, medical
   cerebrovascular disease and heart                                                 devices, clinical diagnostics,
   diseases. In the middle-income                                                   endocrinology and gastroen-
   countries, the 10 leading causes of death                              terology. The responses indicate that
   are dominated by noncommunicable con-                                  the APAC region provides good scope
   ditions such as cerebrovascular disease, BioSpectrum Survey 2010 to conduct research in oncology, CNS,
   heart disease, chronic obstructive pulmo-                              respiratory, cardiovascular, endocrinol-
   nary disease (COPD), lower respiratory infections, ogy, dermatology, allergy/immunology, hematology,
   cancers and diabetes. In low-income countries, the nephrology, trauma and orthopedic, rheumatology
   dominant causes are infectious and parasitic diseases and wound healing.
   (including malaria), and perinatal conditions.
                                                            In the area of infectious diseases, studies may be con-
   Oncology, cardiovascular, central nervous system
                                                            viruses and tuberculosis and bacterial infections.
   focus areas of contract and clinical research activities
                                                            The population provides the possibility to run various

   Over half of the respondents of the BioSpectrum APAC                      a unique opportunity to perform research on tropi-
   Contract & Clinical Research Organization Survey                          cal diseases such as dengue, malaria, SARS, diarrhea,
   2010, claim their focus is oncology, which leads the

               APAC: Base field for phase III & IV trials
           Clinical Trials                          The Asia Life Science Services BioSpectrum Survey 2010 report indicates

                     12.08%                         as it has a large patient population, cheap labor, sponsors’ eagerness to

                                                    The governments in the region are adopting pro-industry initiatives
                                                    to attract big multinational CROs, and also regional CROs to conduct
                                                    business and set up operations in different countries. Phase I trials

                                                    that though the region has a large patient population, CROs are not
                                                    keen on conducting phase I trials in this region, due to regulations and
           Phase I                 Phase II         restrictions by local government agencies. In this region 21 percent of
           Phase III               Phase V          CROs conduct phase II trials.

ASIA      8 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                                                                                                           Cover Story Life Science Services

                     Number of Customers                                                                                                                                              Average customer per CRO

1200                                                                                                                                                         120

                                                                                                                           2009                                                                                                                                                2009
1000                                                                                                                                                         100
                                                                                                                           2008                                                                                                                                                2008

 800                                                                                                                                                          80


 600                                                                                                                                                          60


 400                                                                                                                                                          40






                                                                                                                                                                                                                                                                                Hong Kong
                                                                                                                              Hong Kong

                                                                                                         31 Malaysia

 200                                                                                                                                                          20

                     South Korea



                                                                                                                                                                   South Korea















                                                                                                         Talented workforce in great demand
                                                                                                         One of the major challenges in the Asian CRO industry has been the ab-
                                                                                                         sence of adequate competition for talent. This seems to be easing now,

                                                                                                         talented workforce. To address this situation, CROs are now focusing
CRO Destination
68% US-based clients                                                                                                                                                              systems, that encourage excellence and reduce
25% Canadian clients                                                                                                                                                              turnover.

The sponsors of CROs in APAC                                                                                                                                                      Some of the initiatives taken by the CROs
                             -                                                                           BioSpectrum Survey 2010 include: on-the job and off-the-job programs,
cent in 2009 over the previous                                                                                                         providing opportunities for the employee to de-
year; while the CROs in India                                                                            velop the skill sets required to get involved in the company’s main decision-
                                                                                                         making process. Some survey respondents said their HR team has
percent; followed by Singapore                                                                           planned various activities for employee welfare, like quarterly face-to-
with 282 percent and Australia                                                                           face forum of HR team and heterogeneous employee groups through
by 211 percent.                                                                                          a two-way communication platform to provide and get feedback, sug-

The CROs from other countries                                                                            bestowed with the“Role of Honor”.
like China and Hong Kong have
witnessed an increase of 130                                                                             The big CROs provide a workplace environment that fosters individual
percent and 100 percent clientele                                                                        development and organizational growth, besides robust training and
growth respectively, in 2009 over                                                                        development opportunities for employees, making the company, the best
the previous year. According to                                                                          place to grow and build their career, alongside the company’s growth.
the Asia Life Science Services                                                                           The HR team of the CROs conduct in-house education courses for the
BioSpectrum Survey 2010 report,                                                                          staff, and stay informed about current and upcoming developments.
South Korea is leading the table
of average number of clients per
CRO with 114 in 2009; followed                                                                           provide guidelines on what and how to follow-up consistently. A few
by Taiwan with 100 customers                                                                             respondents say they organize annual international conference on har-
per CRO; and China (95 custom-                                                                           monization—good clinical practice (ICHGCP) exams for the staff, to
ers per CRO).                                                                                            ensure the highest working standards.

                                                                                                                                          A CyberMedia Publication | | October 2010| BioSpectrum | 9
         Cover Story
         QuickScan Life Science Services

   Operational delivery, service differentiation
   Major challenges for CROs
   The life sciences market started recovering from the                      technical workforce to interact with potential clients
   global economic slowdown by the end of 2009.

   The services sector in the life sciences industry—con-
   tract and clinical research organizations (CROs)—saw                  Competition for experienced talent: Demand for tal-
   opening up of new opportunities for companies in                      ent in Asia is a challenge in the clinical development
   the APAC region, resulting in competition in the in-                  industry, though this is easing as many reputed univer-
   dustry. Some of the major issues facing the clinical                                                                         -
   research and contract research com-                                                    dates. As the industry in Asia matures,
   panies today are: lack of stable and                                                   more experienced professionals will
                                                          Key challenges                  be available in the market. Companies
   (CRAs), regulatory challenges, patient                                                 are now focusing on talent develop-
                                                              Regulatory issues
   recruitment, patient consent, delivery                                                 ment, training, effective compensation
   of contract.                                               Patient recruitment                                               -
                                                              Human resources             cellence and reduce turnover.
   The respondents of the Asia Life Sci-
                                                   Current situations in
   ence Services BioSpectrum Survey                                             Quality perceptions: The biggest
   2010 noted that the challenges associ-          the industry                 challenge facing the global biop-
   ated with CROs in Asia are similar to                                        harmaceutical industry today is the
   those that exist elsewhere in the world.                                  escalating cost of drug development.
   They differ in degree, rather than type.                                  CROs will be the key in partnering
   For example, regulatory challenges in Chi-                                with biopharmaceutical companies to
                                                 BioSpectrum Survey 2010
   na are well-documented. Thus CROs with                                    offer                         innova-
   on-the-ground experience and the ability to navigate tive            outsourcing      solutions    that    drive
   the Chinese system, have the opportunity to provide
                                                              two distinct challenges—one is immediate, and the
                                                              other is strategic.
   The respondents noted that the present environment
   for drug discovery is complicated by many concurrent Immediate challenge—Operational delivery: Un-
   challenges. These include: rising costs of R&D, patent til the CROs “potential” revenue is converted into
   expiration, increasing regulatory restrictions.

   These are exerting unprecedented pressure on the                          staff to operationally deliver on their growing back-
   contract research collaborators; and is also a factor                     log, is a major challenge.
   that some CROs have contributed to. There has been
   considerable activity within the pharmaceutical, venture                  Strategic challenge—Service differentiation: In a
   capital, academia and biotechnology communities,                          growing and competitive market, companies have to
                                                                             differentiate themselves or face commoditization.
   through “external innovation”.
                                                                             Respondents to the survey, noted that the challenge
   Some of the respondents pointed out that in this                          for CROs, is to differentiate at a speed faster than
   emerging market, they often faced challenges in                           commoditization. However, this strategic plan—this
   establishing a strong local business, and for support-
   ing all local clinical research stakeholders; in build-                   to know how they are viewed in the market, and at
   ing competencies and capabilities, like: (1) GLP                          the same time, determine what they think their points

   because of logistical issues (3) business development                     match, then the CROs need to focus their organization
   strategies in CRO industry uniqueness.                                    and marketing messages, around those points. If there
                                                                             is no match, then the CROs have to determine what
                                                                             to focus on: either the market’s perception of them, or
                                                                             their operational strengths.
ASIA      10 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                   Cover Story Life Science Services

CROs to
expand globally
Considering the pitfalls of research and develop-
ment (R&D), drying of product pipeline, increasing
cost of doing R&D in the developed world, the big
pharmaceutical players are outsourcing their R&D
activities to Contract and Clinical Research Organiza-
tions (CROs). This has opened up huge opportuni-
ties for many CROs operating in developing world,
                                                                                     Looking Ahead

market potential, the CROs have been working on,
and have adopted many strategies.                                                              33%
Responding to the Asia Life Science Services
BioSpectrum Survey 2010, 84.62 percent of the CROs                             26%
shared that they are working to expand their geo-
graphical reach to establish direct presence in other                                                  16%
countries and regions. For example, regional CROs                                        20%

America, to establish one-on-one contact with the

plan client expansion followed by product devel-
opment (51.28 percent) and revenue growth (41.03                      Geographical Expansion           Revenue Growth
percent).                                                             Product Development              Client Expansion

are also looking at building operations                             biotechnology, Chinese Traditional Med-
in South America and Africa. They plan                              icine, herbal medicine/natural products
to consolidate the existing position of fo-                         and nutraceuticals.
cusing on “Non-regulatory” Studies, by
pitching in for “Regulatory” studies as BioSpectrum Survey 2010 Few CROs are looking at organic as well
well.                                                               as inorganic growth, like acquiring exist-
                                                       ing companies, and working with partners through
Some of the CROs plans to reach out to the compa- strategic alliance. In terms of revenue growth, CROs
nies in the US, particularly the biotechnology hubs in are targeting a minimum growth of 6 percent in the
Boston-New Jersey area and the California cluster.     coming years. The respondents noted that the geo-
                                                       graphical expansion, coupled with product devel-
The CROs plan to focus on the Scandinavian region, opment, will lead to augmented value offering for a
besides the US, by targeting small-to-medium sized larger client base, thus culminating client expansion
biotechnology companies in Finland and Sweden. and revenue growth.
Going forward, the CROs will soon start focusing on
Japan, the second largest pharmaceutical market in The CROs are planning to adopt different strate-
the world, after the US.                               gies and business models that will support them in
                                                       developing a broader customer base from small-and-
In terms of increasing clientele, CROs now focus on medium to big pharmaceutical and biotechnology
autonomous government organizations and uni- companies. These initiatives will act as a unique risk
versities, besides companies in diverse segments share package, which the CROs hope, will work for
of healthcare including pharmaceutical, generics,

                                              A CyberMedia Publication | | October 2010| BioSpectrum | 11
         QuickScan M&As

   Transgene to acquire                             Biomagnetics to acquire Hubei Tianyuan
   US-based biopharma                               US-based, Biomagnetics Diagnostics, a developer of diagnostic systems
                                                    and technology for HIV, hepatitis, tuberculosis and malaria detection,
   Transgene Biotek, India, has
                                                    signed a letter of intent (LoI) with Chinese chemical company, Hubei
   entered into an agreement to
   acquire a US-based oncology bio-
   pharmaceutical company, Maril-                   This expected acquisition is the third of several planned acquisitions, and
   lion Pharma, through an all share                is targeted at a share price in excess of $1.50 for Biomagnetics Diagnostics’
   deal subject to statutory approvals.             common shares. Biomagnetics plans to rapidly transition the trading of its
   Marillion is a clinical-stage com-               shares to the Over-the-Counter Bulletin Board (OTCBB).
   pany focused on the development
   and commercialization of cancer
   treatments.                                      Oridion signs deal with IMI for Japanese market
                                                    Oridion, a Swiss company with global presence in medical devices,
   The combined pipeline of both the                specializing in patient safety monitoring, has signed a new agreement with
   companies is expected to strength-               IMI, a leading distributor of medical equipment in Japan. This agreement
   en the oncology platform. Trans-                 provides Oridion the opportunity to further expand into the Japanese
   gene also has a RNAi platform                    market, with its line of Microstream capnography monitoring products.
   which employs the ‘gene silencing
                                                    Stallergenes, Shionogi sign exclusive partnership
   Stirling to acquire                                                                                                     -
   stake in TeleMedCare                             notherapy treatments for the prevention and treatment of allergy-related
                                                    respiratory diseases, has announced the signing of exclusive partner-
   Australian healthcare group, Stir-
                                                    ship agreements with Shionogi, a Japan-based research-driven pharma
                                                    company, for two sublingual allergen immunotherapy tablet products
   the acquisition of a 65 percent con-
                                                    resulting from the Stalair program—Actair house dust mite tablets and
   trolling interest in TeleMedCare,
                                                    Japanese cedar pollen tablets.
   having completed all the outstand-
   ing documentation.

   TeleMedCare is operational in Aus-
                                                    Fosun Pharma acquires $14 mn of Chindex stock
   tralia and the UK; and delivers tele-            Chindex International, a provider of healthcare products in China, and
   health solutions that allow remote               Shanghai Fosun, a manufacturer of Chinese medicine, have consummat-
   viewing and intelligent reporting                ed a previously-announced stock sale. The closing is part of the strategic
   of a full range of vital signs and               alliance between Fosun Pharma and Chindex to form Chindex Medical, a
                                                    joint venture focused on manufacturing and distributing medical devices
   applications to care for patients at             in China. The joint venture would merge and operate Chindex’s Medical
   any setting.                                     Products division and some Fosun Pharma’s medical device businesses
                                                    in China. The joint venture would be owned 51 percent by Fosun Pharma
                                                    and 49 percent by Chindex.
   Sinopharm signs JV deal
   with Excelsior
                                                    Aurobindo Pharma, AstraZeneca deal
   China-based Sinopharm Group                      Aurobindo Pharma, one of the largest API manufacturers in Asia,
   has entered into an agreement with               with headquarters in Hyderabad, India, has entered into licensing and
                                                    supply agreements with AstraZeneca, a global biopharmaceutical
   establish a joint venture Sinopharm              company, to supply several solid dosage and sterile products for the
                                                    emerging markets.
   venture (JV) has a total investment
                                                    The agreements will support AstraZeneca’s investment in branded gener-
                                                    ics sold in the emerging markets. These products fall under a broad range
   million (RMB 500 million). Sino-                 of important therapeutic segments such as anti-infective, cardiovascular
   sior 49 percent of the joint venture.            not disclosed.

ASIA      12 | BioSpectrum | October 2010 | | A CyberMedia Publication

A CyberMedia Publication | | October 2010| BioSpectrum | 13
         Segment Focus iPS Cells

   Asia taps the promise of iPS cells
                                                  -                          human islet cells from iPS cells, and the creation of
   whelmed with research and discoveries, and every                          next generation diabetes cell therapies.
                                                                             Singapore’s ES Cell International acquired
   bring revolution in the drug discovery process, even-
                                                                             by US company
   tually leading to a better health care environment.
   One of the recent discoveries that has grabbed the at-                    Working on the strategy to strengthen its market
   tention and focus of researchers is induced pluripo-                      position, California, US-based BioTime, a biotech-
   tent stem cells or iPS cells. It                                                                 nology company that devel-
   can be made to become many                                                                       ops and markets products
   cell types found in the human
   body, and therefore, it acts as a                                                                  cells and regenerative medi-
   medium for scientists to create                                                                    cine, announced earlier this
   a model of disease that could                                                                      year about it’s acquisition of
   be used to develop drug, and
   this would presumably slow                                                                         International,   a    human
   down disease generation.                                                                           embryonic stem cells technol-
                                                                                                      ogy company. The company
   IPS cells can be used for treat-
                                                                                                      had revealed that it would
   ing diseases and disorders
                                                                                                      use iPS technology to reverse
   like diabetes, heart disease,
                                                                                                      the developmental aging of
   repairing cartilage and bone
                                                                                                      normal human cells.
   damage and Alzheimer’s dis-
   ease.                                                                                              Mesoblast to develop
   Hype or Hope                                                                                       novel treatments
                                                                                                     Sensing the positive impact of
   The question that often spurs
                                                                                                     having expertise in iPS cells,
   among the drug discovery
                                                                                                     Mesoblast Limited, an Aus-
   companies is about the real prospects of iPS cells and
                                                                             tralian biotech company, committed to the develop-
   whether it is just hype, or an actual hope for the health
                                                                             ment of novel treatments for orthopedic conditions,
   care industry. There are various concerns for scien-
                                                                             entered into preclinical research of iPS cells, about a
   tists, researchers as well as for the pharmaceutical
                                                                             year ago, and is focusing on iPS cells for its applica-
   companies regarding the robustness of iPS cells and
                                                                             tion in cardiac muscles, cartilages, heart cell repair
   its application for an effective use.
                                                                             and musculoskeletal repair.
   iPS cells may act as a model disease to study
   because they are derived directly from the patient. iPS                   RNL Bio finds cancer-suppressive stem cells
   cells are being considered as a great hope and more                       South Korea-based RNL Bio, a biopharmaceutical
   advantageous in stem cells therapy because they do not                    company specialized in adult stem cells therapeutics
   destroy the human embryos, like in embryonic stem                         that recently announced that adult stem cells are iden-
   reducing the complexity of transplants. The discov-                       cal study, is doing research on iPS cells with adipose-
   ery of iPS cells has been able to nurture interest in the                 derived mesenchymal stem cells.
   regenerative medicine industry.                                           Taiwanese researchers find breakthrough
   The application of iPS cells is wide, and is a promis-                    Showing its strength in research and development
   ing revenue generation tool in the long run. Keeping
   in mind the potential of iPS cells in the years to come,                  Research Institutes in Taiwan, have announced a
   few pharmaceutical companies have already forayed                         breakthrough in stem cells research through experi-
   into this space.                                                          ments that successfully turn cells in the umbilical vein
   Kyoto University collaborates with Novocell                               into iPS cells. Researchers said that the iPS cells can
   to study human islet cells                                                be turned into cells of the nerves, skin, liver, pancreas
                                                                             and other organs and by doing so, the cells may, in
   In December 2008, Novocell, a stem cells engineering
                                                                             the future, become key to treating diseases.
   company based in San Diego, US, collaborated with
   Kyoto University, Japan, to explore the creation of                                                 Amrita Tejasvi in Singapore

ASIA      14 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                        QuickScan APAC

A CyberMedia Publication | | October 2010| BioSpectrum | 15
         QuickScan R&D Hits

   FDA clears Chinese                                  Lotus ready with R-Bambuterol for trials
   Traditional Medicine                                Lotus Pharmaceuticals, a developer, manufacturer and seller of
                                                       medicine and drugs in China, has completed production of Active
                                                       Pharmaceutical Ingredient (API) and tablets of R-Bambuterol for use in
                                                       clinical trials, according to China’s State Food & Drug Administration’s
                                                       stringent regulations.

                                                    Glenmark discovers NCE for pain, respiratory
   Tianjin-based Tasly Pharmaceu-                   Glenmark Pharmaceuticals, an Indian pharmaceutical player in the
   tical’s Compound Danshen Drip-                   discovery of new molecules has announced the discovery of a Novel
   ping Pill, passed the US FDA
   phase II clinical trials in July 2010,           TRPA1 receptor antagonists for pain and respiratory disorders.
   taking it one step closer to getting             TRPA1 belongs to Transient Receptor Potential (TRP) family of ion chan-
                                                    nels, that have generated a lot of interest as pain targets due to their distin-
   markets, the company’s President                 guishing role in peripheral and/or central pain signal transmission.
   Mr Yan Xijun stated at a press
   conference in Beijing recently.
                                                       Neurotech to initiate phase I testing of AAD-2004
   With domestic sales of over $148
   million last year, the drug, mainly                 Neurotech Pharmaceuticals, South Korea, has begun dosing in the phase
   used to treat angina and coro-                      I clinical testing of AAD-2004. The compound was developed as a dual

   Chinese patent Traditional Medi-                    nerve injury in Alzheimer’s disease, Parkinson’s disease, and amyo-
   cine to pass phase II trials of the                 trophic lateral sclerosis.
   FDA, known for its strictness in ap-                The phase I clinical trial was initiated to evaluate the safety, tolerabil-
   proving drugs.                                      ity, and pharmacokinetics of AAD-2004 in healthy volunteers in April
   The FDA has also approved the
   drug to enter the phase III trials.                 completed.

                                                    Thai study reveals safety concerns of nanoproducts
   Starpharma starts                                A recent study by researchers at National Nanotechnology Center
   VivaGel phase II study
   Australian pharmaceutical compa-
   ny, Starpharma, has commenced                    model to represent the human skin environment.
   its phase II study of VivaGel for
   the treatment of bacterial vagino-               Application of silver nanoparticles in textile materials is one of the most
   sis (BV), following receipt of ethics            interesting applications to improve the quality of the products, includ-
   approval.                                        ing wound dressings and anti-bacterial clothes. Meanwhile, there is also
                                                    increasing concern on the safety of these nanoproducts.
   Starpharma said that the US Food
   and Drug Administration (FDA)
   has accepted and cleared its inves-                 OvPlex: S Korea study begins for KFDA approval
   tigational new drug (IND) applica-                                                                                       -
   tion for the study.                                 laborators in South Korea, to begin the 220-patient study required for
                                                       South Korea Food and Drug Administration (KFDA) approval for the
   This phase of the clinical program                  distribution of OvPlex.
   will investigate the treatment of
   BV with a once-daily-for-seven-                     The trial will be conducted by Principal Investigator Prof Byoung-Gie
   days treatment of VivaGel, and its                  Kim of Samsung Medical Center and Sungkyunkwan (SKK) University
                                     -                 School of Medicine. Prof Kim assisted HealthLinx in securing further
   gation of its use in both treatment                 key institutions to participate in the trial including Asan Medical Centre
   and suppression of recurrence.                      and Seoul National University Hospital.

ASIA      16 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                                            QuickScan APAC

              BioSpectrum has launched Asia Digest

 A first-of-its-kind product focused on providing you business
 information on the Asian life sciences industry.
 The information is tailored to suit the requirements of life science
 professionals in the European and American markets. This monthly digital
 magazine will feature major development in the Asian life sciences market.

                           Log on to
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Editorial:                                            A                                          Publication

                                                         A CyberMedia Publication | | October 2010| BioSpectrum | 17
 CyberMedia Singapore Pte Ltd, 1 North Bridge Road, #14-03 High Street Centre, Singapore 179094 Tel: +65-63369142 Fax: +65-63369145
         CountryScan China
         QuickScan APAC

   TCM at $1.46 billion in                          Golden Meditech raises $40 mn
   global market                                    Golden Meditech, a major healthcare enterprise, has said that its medical
                                      -             devices business has successfully raised $40 million from a number of re-
   icine (TCM) in the global market                 nowned private equity investors. The proceeds will fund the construction
   was valued at $1.46 billion in 2009,             of new production lines for both medical devices and medical accessories
   according to Wang Guoqiang, di-                  to aid in the formation of joint-venture with Fenwal, Zurich.
   rector of the State Administration
   of TCM. Mr Wang, who is also Vice                  HighRes set to place first automation platform
   Minister of Health, said the number
                                                      HighRes Biosolutions, the specialist in laboratory automation for life sci-
   of countries and regions that rec-
                                                      ences, is building a system for an undisclosed laboratory in Shanghai,
   ognize the advantages and special
                                                      China. The new system will be installed in the fall of 2010 by HighRes
   features of TCM in treating modern
                                                      and Tekon Biotech, the Asian distributor representing HighRes in this
   diseases are on the rise, and many
   countries are seeking cooperation
   with China on TCM.                                 HighRes’ patented instrument docking technology is said to have revo-
                                                      lutionized laboratory automation, making integrated systems, such as
   Traditional Chinese medicines are
   mostly mixtures of a number of in-
                                                      includes HighRes’ new self-sterilizing automated incubator, SteriStore.
   gredients or medical plants such as
   herbs, that makes them much more
                                                    New hope for diabetics from Chinese herbs
   a quantitative sense, than western
   drugs.                                           herbs including Rheum palmatum and Polygonum cuspidatum, shows
                                                    promise as an agent that could reduce the impact of type 2 diabetes.
   China-Biotics ranks
   62 among 100 fastest-                            plays a role in the body’s response to sugar contained in a person’s diet.
   growing companies                                blood stream.
   China-Biotics, a developer, manu-
   facturer and distributor of probi-               In response, the body releases insulin, and this hormone triggers various
   otics products in China, has been                actions that help to clear excess glucose from the blood. The body, how-
   ranked 62nd on Fortune’s 2010                    ever, also has another set of hormones known as glucocorticoids, that have
   “Fastest-Growing Companies” list.
                                                    this enzyme increases glucocorticoids’ ability to act.
   Fortune’s 100 fastest-growing com-
   panies list includes foreign and do-
   mestic companies traded on a major                 Yongye opens new production facility
   US stock exchange, with an annual                  Yongye International, a manufacturer of “Shengmingsu” brand plant and
   revenue and net income of at least                 animal nutrient products in China, has inaugurated new production fa-
   $50 million and $10 million, respec-               cility in Wuchuan County, Inner Mongolia.
   tively, a market capitalization over
                                       -              The company’s new facility is capable of producing 20,000 tons per an-
   enue and earnings growth over re-                  num of Shengmingsu plant nutrient product and 10,000 tons per annum
   cent quarters, among other criteria.               of Shengmingsu animal nutrient product, for a total production capacity
                                                      of 30,000 tons per annum. The company expects the new facility to be-
                                                      come fully operational in the fourth quarter of 2010.
   China-Biotics, commented, “We are
   honored to have been distinguished
   by Fortune as one of this year’s 100
                                                    Renhuang gets patent for product package design
   Fastest-Growing Companies. The                   Renhuang Pharma, a manufacturer and distributor of botanical products,
   long-term growth prospect for our                bio-pharmaceuticals and traditional Chinese medicines in China, an-
   business model is gaining traction
   within the global professional in-               granted the company, patent protection for the product packaging design
   vestment community.”                             for its Compound Honeysuckle Granules, one of Renhuang’s leading Tra-
                                                    ditional Chinese Medicine Products. The patent term is 10 years.

ASIA      18 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                                    CountryScan China

Sinopharm, Becker form                  Mindray launches M7 portable ultrasound system
strategic alliance                      Mindray, a developer and manufacturer of medical devices based in China,
China National Pharmaceutical
Group (also known as Sinopharm)                                                                              -
and Becker & Associates Consult-        ogy, bringing a new level of imaging performance to a compact portable
ing of US, have formed a strategic      system.
alliance to bring high-level clinical
and regulatory consulting services      include octal-beam imaging technology, that provides excellent temporal
to China.                               resolution, along with an innovative implementation of multiple tissue
The two companies will also iden-       harmonic imaging technologies, to improve image quality for technically
tify medical devices, drugs and bio-
logics to be exported to China and
subsequently distributed by China        S-Evans Biosciences opens lab, R&D facility
National Pharmaceutical Foreign
Trade Corporation (Sinopharm
Foreign Trade).
                                         ogy license partner in China, has opened a new laboratory operation and
The alliance brings together two         research and development (R&D) facility located in a hi-tech park desig-
leading healthcare powerhouses,          nated to become an epicenter for stem cell and genomics R&D; cellular
and sets the stage for improved          therapies and stem cell cryopreservation services.
collaboration between Chinese
and American medical device,
pharmaceutical and biologics            Boehringer Ingelheim expands in Shanghai
manufacturers.                          Boehringer Ingelheim, an independent German drug company, has inau-
                                        gurated its new “Center of Competence” (CoC) in Shanghai. As part of the
Thermo Fisher opens
Tech Center in Shanghai                 optimizing active pharmaceutical ingredients (APIs) and chemical inter-

                                        and analytical chemists have been recruited for the CoC.

                                         Yangtze River to promote TCM in the Netherlands
                                         Yangtze River Pharmaceutical Group has signed a collaborative agree-
                                         ment with Zuid-Holland (northern Holland) government, and Leiden
                                         Bio Science Park, to promote traditional Chinese medicine (TCM) in the

technology provider to the life sci-     The cooperation includes carrying out TCM research and development,
ences industry, has opened a tech-       establishing medical research center and overseas subsidiaries and pro-
nology center in Shanghai, building                                                                            -
on its engineering and develop-          pean market. In addition, Yangtze River plans to build its talent pool
ment capabilities, to meet the spe-      with Leiden University.

The center houses engineers and         China’s liver cancer drug market to triple by 2014
support staff, focused on devel-                                                                                     -
oping a robust product pipeline         ceutical and healthcare issues, has found out that sales of therapies to treat
to serve China-based customers          hepatocellular carcinoma (HCC) in China, will nearly triple from $53
across a range of industries, in par-   million in 2009 to $144 million in 2014. Fueling this growth will be great-
ticular, life sciences, environmental   er access to medical care, a growing drug-treated patient population and
monitoring and consumer product         a rising number of higher-income HCC patients requesting the more-

                                                A CyberMedia Publication | | October 2010| BioSpectrum | 19
         QuickScan Japan

   Takeda to develop                                PMDA approves ClearStream’s balloon catheters
   pandemic flu vax                                 UK’s medical technology company, ClearStream Technologies, has
   Japan-based Takeda Pharmaceutical                received approval from the Pharmaceuticals and Medical Devices Agen-
   has received a government subsidy                cy, Japan (PMDA), to sell its advanced percutaneous transluminal angio-
   of $42 million (¥3.6 billion) to sup-            plasty (PTA) balloon catheters in the country. It will be sold under the
   port the investment associated with
   the development and production of                The catheters are to be marketed by Cordis, a worldwide leader in inter-
                                                    ventional vascular technology.
   Takeda is granted subsidy, par-                  The approval is for the full range of the products’ balloon sizes and is said
   ticularly for the cell culture-based             to make the world’s longest usable PTA balloons (220mm) available in

   comprises, establishment of pro-
   cess development and testing facili-
   ties for production of vaccine; and                 HALO Radiofrequency Ablation System in Japan
   performance of development work                     BARRX Medical, US, a provider of endoscopic treatment solutions for
   needed to advance cell culture-                     treating precancerous lesions of the esophagus as well as other chron-
                                                       ic gastrointestinal diseases, has signed an exclusive agreement with
   clinical testing and license.                       Japan’s Medico’s Hirata for distribution of the HALO Radiofrequency
                                                       Ablation System in Japan. Japan has one of the highest concentrations of
                                                       esophageal squamous cell cancers in the world.
   Branded pharma drives
   Japanese market                                  Z-Medica ties-up with Nihon-Kohden
   The pharmaceutical market in                     Z-Medica, a medical device company based in the US, developing innova-
   Japan was valued at $69.4 billion in             tive hemostatic agents, has signed an exclusive distribution agreement with
   2009, says a new report by Compa-                Nihon-Kohden, Japan’s manufacturer, developer and distributor of medi-
   nies and Markets.                                cal electronic equipment. The agreement allows Nihon-Kohden, exclusive
                                                    rights to distribute Z-Medica’s QuikClot line of hemostatic agents to hospi-
   Key growth drivers for branded
                                                    tal, military and law enforcement markets throughout Japan.
   pharmaceuticals include use of
   chronic high-value innovative
   treatments driven by an increas-                    Quintiles’ Japanese lab gets CAP accreditation
   ingly elderly population, the high                  US-based Quintiles has announced that its new lab in Tokyo, Japan has
   proportion of the healthcare bud-                   received accreditation from the College of American Pathologists (CAP),
   get spent on pharmaceuticals, com-                  joining the largest network of fully harmonized, CAP-accredited central
   pared to other developed pharma-                    labs in the world.
   ceutical markets, and the low level
   of generic penetration.                             Quintiles began providing laboratory services in Japan in 2008 through
                                                       an alliance with Medca Japan. In March 2010, Quintiles opened its own

   ReproCELL to launch
   human iPS cells products
                                                    Chugai seeks MHLW nod for anti-cancer drug, Xeloda
   new line of products in the autumn
   of 2010, offering neuronal cells                 with the Japanese Ministry of Health, Labour and Welfare (MHLW), seek-
   derived from human iPS (induced                  ing approval for Xeloda. The compound indicates “advanced or refractory
   pluripotent stem) cells. The com-                gastric cancer in patients who are not candidates for curative surgery”, for
                                                    the anti-cancer agent capecitabine.
   offer iPS cell-derived neuronal cells,
                                                    As a result of the review committee held in April 2010, the MHLW
   dopaminergic neurons, motor neu-                 requested that Chugai develop Xeloda for the indication of “unresect-
   rons and cerebral nerves.                        able advanced or recurrent gastric cancer.” Then on August 3, 2010, the
                                                    review committee concluded that an “NDA based on evidence in the

ASIA      20 | BioSpectrum | October 2010 | | A CyberMedia Publication

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                                                 A CyberMedia Publication | | October 2010| BioSpectrum | 21
         QuickScan Australia

   Australia, S Korea                               First Gamma Knife surgery for brain cancer
   pharma markets: APAC
                                                    Gamma Knife surgery on a 33-year-old man with multiple small brain
   favorites                                        tumors, with its new Leksell Gamma Knife Perfexion system, making it the
   Australia along with South
   Korea is the most attractive                     radiosurgery.
   pharmaceutical market in Asia
                                                    MUH and the Australian School of Advanced Medicine (ASAM) partnered
   Monitor International (BMI)’s Busi-              with Genesis Care, a provider of cancer management services, to procure
                                                    the system, which is located in Genesis Care’s radiation therapy depart-
   third quarter of 2010.                           ment at MUH.

   However, Australia’s pharma-
   ceutical rating has dropped from                   GTG settles dispute with two US biotech cos
   68.1 in second quarter of 2010 to                  Australian biotechnology company, Genetic Technologies (GTG) has
   66.9 in third quarter of 2010, due                 settled disputes with two US biotechnology companies. Beckman
   to a re-assessment of its market                   Coulter of California, and Clinical Data of Massachusetts, have each,
   risks. Although, on a global scale,                now entered into appropriate settlement agreements with Genetic Tech-
   Australia is placed seventh, owing                 nologies. These two settlements are a consequence of the patent-infringe-

   risks, compared to other markets.                  Western District of Wisconsin, earlier this year.
   Australia’s pharmaceutical market                  However, GTG has not disclosed, the precise commercial terms of these
   mostly comprises patented drugs
   ($5.50 billion), followed by over-                 provisions contained within the settlement agreement.

   billion) and generic drugs ($0.98
   billion). Pharmaceutical expendi-                Clinuvel’s UV-protective drug to be tested for vitiligo
   ture as a percentage of GDP is 0.83              Scenesse, a new drug developed in Australia to protect skin from light
   percent, below both the regional                 and UV will soon be tested as a repigmentation therapy in vitiligo, a
   (1.05 percent) and global (1.36 per-             common disorder which causes skin to gradually lose its pigment or tone.
   cent) averages.
                                                    Clinuvel Pharmaceuticals will commence trials in October 2010.

   Subsidized Abraxane
                     Specialised Ther-                Broadvector floats $8.5 mn, to list on ASX
                     apeutics, Austra-
                                                      Biotechnology company, Broadvector, Australia has lodged a prospectus
                     lia, has enabled
                                                      with Australian Securities & Investments Commission (ASIC), an inde-
                     more than 240
                                                      pendent Australian government body, to raise up to $8.5 million. It will
                     patients to have
                                                      be used to advance the clinical development of a new prostate cancer
                     free and sub-
                                                      therapy and a second therapy that repairs the common problem of asep-
                     sidized     access
                                                      tic loosening of hip replacements.
                     to the world’s
   leading cancer drug Abraxane
   (nanoparticle       albumin-bound
   paclitaxel), a novel type of che-
   motherapy, via its compassion-
   ate program. These patients have                 Phylogica, MedImmune to pursue novel antibiotics
   various types of cancers, including              Phylogica, a public Australian drug discovery company has entered into
   pancreatic and lung cancer. These                an agreement with US-based MedImmune, to evaluate Phylogica’s propri-
   patients have been chosen by their               etary Phylomer peptide library for novel antimicrobial peptides.
   oncologists after failure of other
                                                    The agreement between MedImmune, the worldwide biologics unit of
   treatments, where it is believed,
                                                    AstraZeneca, and Phylogica establishes a plan for collaborative discovery
                                                    between the companies, with potential development and commercializa-
   Abraxane chemotherapy.
                                                    tion of resulting novel antibiotics by MedImmune.

ASIA      22 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                                      CountryScan India

India to start overseas                   Indian biotech industry to be worth $8 bn by 2015
inspection of trial sites                 The Indian biotechnology industry is set to grow at a CAGR of 20 percent
The Drugs Controller General of           to achieve a market size of $8 billion by 2015. This has been estimated by
India (DCGI) has announced that           the recently released Confederation of Indian Industries (CII)-Yes Bank
India would soon commence over-           Knowledge Report on the life sciences industry.
seas inspection of clinical trial sites    The report titled, ‘India Life Sciences: Vision 2015’, has attributed this to
                                      -   the various new developments in the industry, like the many initiatives
sure that safe medicines are being        to support the industry by the Union and State governments.
imported to the country.

The modalities are being worked            Ranbaxy sets up production facility in South Africa
out for training inspectors, bring-
                                           Ranbaxy (SA), a wholly owned subsidiary of Ranbaxy Laboratories,
ing exporters on the board.
                                           India, opened its new state-of-the-art manufacturing facility, Be-Tabs
The Indian Ministry of Health &            Pharmaceuticals Manufacturing Plant, at Johannesburg, South Africa.
Family Welfare is working at ensur-
ing quality and safety standards.
                                          GEAC permits three more GM crop trials
Dr Reddy’s launches
world’s first generic Eprex               committee considered requests from three companies – Syngenta Bio-
Hyderabad based Dr Reddy’s Lab-           sciences, JK Agri Genetics and Dow Agrosciences India, and permitted
oratories has launched Cresp—the

world, and the only one in India.
Cresp has been approved in India           Criticare Systems gets FDA nod for eVision 9100
for the treatment of anemia due to         Criticare Systems, the wholly-owned subsidiary of Opto Circuits (India)
chronic kidney disease and anemia          (OCI), India’s leading developer and manufacturer of patient monitor-
due to chemotherapy.                       ing systems and interventional products, has received Section 510(K)
                                           US FDA (United States Food & Drug Administration) clearance on new
                                           modular patient monitoring system - eVision 9100.

which is engineered to have a lon-
ger half life, increasing (up to 3         distribute eVision 9100 in most parts of the world, particularly in the
times) the time it remains in the          US, which is one of the largest markets for patient monitors.
                                          World’s third cloned buffalo born
Jubilant signs $51 mn                     After producing two cloned buffalo calves, Haryana-based National
CRAMS deal                                Dairy Research Institute (NDRI), through the new and advanced ‘Hand-
                                          guided Cloning Technique’, has cloned another buffalo calf, named
Jubilant Organosys, a custom re-          Garima-II on August 22, 2010. This cloned buffalo calf is different from
search and manufacturing ser-             the earlier cloned calf because, in this case, the used donor cell was
vices (CRAMS) company in India,           embryonic stem cell.
has signed a long-term contract in
CRAMS business with an undis-
closed, leading US-based life sci-         Varian establishes radiotherapy training center
ences company.                             Varian Medical, a manufacturer of medical devices for treating cancer
The total contract is valued at $51
                                           to train medical physicists and technologists working on the company’s
million. This is a take-or-pay con-
                                           cancer treatment systems. The center in Mumbai is equipped with 16
tract, with agreed quantities. Fur-
ther, the company is in discussions
                                           therapy treatment simulations, is expected to enable the country’s grow-
to increase the contract to more
                                           ing number of radiotherapists and medical physicists to train without
than two-and-a-half times.
                                           having to travel overseas.

                                                  A CyberMedia Publication | | October 2010| BioSpectrum | 23
         CountryScan South
         QuickScan APAC Korea/Thailand

   S Korea aims to be in                            Daewoong to distribute Medivir’s Xerclear
   top 5 by 2016                                    Medivir of Sweden has announced the appointment of South Korea’s Dae-
                                                    woong Pharmaceutical as its exclusive distributor for Xerclear in South Korea.
   BioKorea 2010, was held in South
   Korea’s capital Seoul, from Sep-                 Under the terms of the agreement, Daewoong will be responsible for
   tember 1-3, 2010 with participants               obtaining the regulatory approvals, and for marketing, sales and distribu-
   from biotechnology, pharmaceu-                   tion of Medivir’s cold sore product in the territory. In consideration of the
   ticals, medical technology com-                  rights granted to Daewoong, Medivir will receive upfront and milestone
   panies, research institutes and
   government agencies from coun-
   tries like the US, Japan, India,
                                                      NecLife enters S Korea with Cefuroxime Axetil
   Mr Sakong II, Chairman and                         Nectar Lifesciences (NecLife), an integrated pharmaceutical organiza-
                                                      tion in India, has received approval from Korean FDA (KFDA) for key
   Association, said that the South                   product, Cefuroxime Axetil (Amorphous).
   Korean government has recognized
   biotechnology as the knowledge-
                                                      further progress made by the company in the regulated markets.
   based industry that steers growth.
   He also added that by signing FDA                  NecLife expects business potential for the approved molecule “Cefurox-
   agreements, and by realizing the                   ime Axetil Amorphous” to be approximately $10 million.
   importance of intellectual prop-
   erty and technology transfer, South
   Korea is all set to become one of the
   top 5 bio powers by 2016.
                                                    Hanmi top investor in pharma R&D
                                                    tical companies invested around
   Elekta opens facility for                        $112.2 million (KRW132 billion) in
   cancer management                                research and development (R&D).
                            South Korea,            R&D investment as a percentage
                            the      world’s
                            15th      largest
                            economy, is the         2009—an increase of 0.3 percent.
                            site of Swedish-
                                                    According to the statistics released
                                                    on August 16, 2010 by Medipana
                            newest interna-
                                                    News, Hanmi spent $38.8 million
                                                    (KRW45.1 billion) on R&D in the

   and clinical solutions for treating
   cancer and brain disorders.
                                                    (KRW82.4 million), was the larg-
                                                    est in 2009 among KOSDAQ listed
   in South Korea’s radiosurgery                    pharmaceutical companies.
   market, with an installed base of
   16 Leksell Gamma Knife units.
   With increased local presence,                     Thai institutes, govt ink R&D collaboration
                                    -                 The National Science and Technology Development Agency (NSTDA) of
   ing position in radiosurgery and                   Thailand in association with King Mongkut’s University of Technology
   strengthen its share of the radio-                 Thonburi (KMUTT) has entered into a Memorandum of Understanding
   therapy market, thereby making                     (MoU) with the Thailand government’s Department of Medical Sciences
   cancer care available to more peo-                 (DMSc). It is aimed at promoting cooperation in research and develop-
   ple in the country.                                ment (R&D) in medical science, vaccine production, bio-medical product
                                                      and drug compounds.

ASIA      24 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                    CountryScan Taiwan/Malaysia

Taiwan pharma market                    ScinoPharm to invest in Tanvex Biologics
clocks $3.9 bn in 2009                  ScinoPharm, a leading active pharmaceutical ingredient (API) developer
                                        and manufacturer headquartered in Taiwan, will make an investment in
growth rates in the years 2005-         Tanvex Biologics, a US company registered in the State of Delaware, USA.
2009, the Taiwan pharmaceutical         ScinoPharm’s investment is in the form of tangible assets, intellectual
market is expected to stabilize, and    properties, as well as cash.
starting from 2010, will show slight
deceleration in growth over the          Pen-size plasma sterilization device
years up to 2014, says a new report                                                                           -
from Research & Markets (R&M).           ing at National Cheng Kung University (NCKU), Tainan, Taiwan, has
                                         led Dr Chih-Chiang Weng and a research team to develop a pen-size
The      Taiwan       pharmaceutical
                                         plasma sterilization device that can sterilize instruments and wounds,
market generated total revenues
                                         by relying on the process of plasma sterilization.
of $3.9 billion in 2009, representing
a compound annual growth rate            The device can eliminate common bacteria such as Escherichia coli,
(CAGR) of 6.5 percent for the period     Staphylococcus aureus and thermophilic bacilli within 90 to 120 seconds
spanning 2005-2009. In comparison,
the Chinese and Japanese markets         treatment, wound healing and medical equipment sterilization.
grew with CAGRs of 20.1 percent
and 2.3 percent respectively, over      Pharmaniaga sees improvement, Q2 profit up 63.7%
the same period, to reach respective
                                        Malaysia’s top pharmaceutical company,
values of $23.8 billion and $66.89
                                        Pharmaniaga Group has announced its re-
billion in 2009.
                                        enues were 3.2 percent ahead of the same
Varsity-industry meet
to discuss biomedical
                                        down by 26.3 percent at $10.4 million
cooperation                             (RM32.8 million).
President Michael Ming-Chiao Lai
of National Cheng Kung University       Performance for the second quarter (Q2) of
(NCKU), Tainan, Taiwan, and             2010 however, showed a marked improve-
Chairman Tai-Chiang Gou of
Foxlink, Taiwan-based company           ahead by 10.3 percent at $100.3 million
that designs, manufactures and
sells connectors, cable assemblies,
power     management       devices,     million).
battery packs on an Original
                                        Commenting on the results, Managing Director of the company, Mr Mo-
                                        hammad Abdullah said, “I am very encouraged by these numbers we
Original Design Manufacturing

in a general discussion of the
                                        we are to mitigate the impact of rises in selling, distribution and personnel
cooperation of biomedical industry
                                        costs. The gains we have made in all these areas are now showing through
development in Taiwan and
                                        and will help us sustain this momentum for the rest of the year.”
reached a consensus to arrange
future meeting to further explore       For the second quarter of 2010, the Group’s revenue of $110.6 million
the topic.                              (RM350.3 million) was 5.1 percent higher than the $105.3 million (RM333.2
                                        million) registered in the same quarter last year. However, despite the in-
Foxlink Chairman Tai-Chiang Gou
has met NCKU President Michael
                                        lion) in the same quarter last year.
visited NCKU College of Medicine
                                        According to sources, the company is planning to invest more than $95
NCKU College of Medicine.
                                        years to grow its business.

                                                A CyberMedia Publication | | October 2010| BioSpectrum | 25
         QuickScan PEOPLE

   New CEO, CFO for                                   J Mash is new regional director of PACRA
   BioPharm Asia                                      Asia Global Research, a leading clinical research organization
   BioPharm Asia, a producer,
                                                      and Regional Director of Pan-Asian Clinical Research Asso-
   distributor and retailer of medici-
   nal and herbal products in China,
   has announced the appointments
                                     -              Dr Mudge joins HalcyGen Pharma
                                                    HalcyGen Pharma, Australia has announced the appointment of Dr
   (CFO). Mr Li and Mr Liu replace
                                                    Stuart Mudge to the position of Global Regulatory and Clinical Affairs
   Mr Qin who resigned his positions
                                                    Manager. Dr Mudge brings more than 10 years of industry experience in
   CFO on July 26, 2010.

                                                      Prima appoints Sr VP for CVac programs
   Sudhir Kant joins                                  Australian health care company, Prima BioMed, has announced the
   Avesthagen                                         appointment of Dr Sharron Gargosky as Senior Vice President for the
   Mr Sudhir Kant is                                  company’s CVac clinical programs. Dr Gargosky brings 18 years experi-
   the new COO of Av-                                 ence in the biotechnology and pharmaceutical industries, and has worked
   esthagen, a Bangalore,                             in senior positions for three different companies that have successfully
   India-based integrated                             received FDA approval for orphan drugs.
   systems biology plat-
   form company that
   focuses on achieving convergence                 Renhuang gets interim CFO
   of food, pharmaceutical and popu-
                                                    Renhuang Pharmaceuticals, a Chinese developer, manufacturer and
   lation genetics leading to predic-
                                                    distributor of botanical products, biopharmaceuticals has appointed Ms
   tive preventive and personalized
                                                    nent replacement.
                                                    Reporting directly to Mr Shaoming Li, the company’s Chairman and
   Stirling has new group                                                                                          -
   CEO                                                                                                             -
   Australia-based Healthcare group,
                                                    will transition to the role of an Assistant to the CFO to ensure a seamless
   Stirling Products has appointed Mr
   Business Development Manager,
   responsible for the global sales                   Dr Zhang is new Chief of NeoStem
   initiative and continued develop-
                                                      NeoStem, an international biopharmaceutical company with operations
   ment of the TeleMedCare ehealth
                                                      in the US and China, has appointed Dr Ian Zhang, as the new President
                                                      and Managing Director of NeoStem (China). Dr Zhang is the former

                                                      on the steering committee managing the acquisition and integration of
   Dr Roger Aston resigns                             Applied BioSystems. He is also the former Head of Corporate Develop-
   Australian pharma, Clinuvel has
   announced the resignation of its

   Aston. Dr Aston was appointed to                 Mindray appoints Chief Strategic Officer
   Clinuvel’s Board in March 2005,                  Mindray Medical, a developer, manufacturer and marketer of medical
                                                    devices in China, has appointed Mr Minghe Cheng as Chief Strategic Of-
   Board from September 2005 until
                                                    model development, short and long-term strategic program planning
                                                    and corporate structure and operation-process optimization.

ASIA      26 | BioSpectrum | October 2010 | | A CyberMedia Publication
                                                                                                       QuickScan EVENTS

International biotech meet in Kuala Lumpur
The BioMalaysia Conference, Malaysia’s largest             conference will feature keynote, plenary and parallel ses-
annual international biotechnology conference is sched-    sions from world renowned biotechnology scientists, key
uled for November 2-4, 2010 at Kuala                                        policy makers, and captains of the bio-
Lumpur, Malaysia.                            Curtain Raiser                 technology industries covering the latest
                                                                            biotechnology trends, policy issues, tech-
The event aims to bring together on a      BIO MALAYSIA                     nological innovations, and commerciali-
platform more than 40 world renowned              Nov   2-4, 2010           zation opportunities.
international and local biotechnology
experts who will share their knowledge, experience, in-       A wide range of topics are to be covered including: Suc-
sights and inspirations on the latest trends, updates and     cessful Commercialization, Funding and Investment,
developments affecting the biotechnology industry.            Technology Transfers, BioInformatics, Clean Technol-
                                                              ogy, Benchmarking Biotech Hub, Regulatory Frame-
The three-day event will showcase informed business           work, Healthcare Biotechnology, Industrial Biotechnol-
decisions as hot issues to be discussed for business ex-      ogy,    Agriculture Biotechnology, Biomanufacturing,
pansion, with new partnerships and customers. The

     MEDIA PARTNER                         EVENTS
     EVENTS                                                                                  BioPartnering China
                                                                                           October 31–November 2, 2010
                                          Clinical Biochemistry                            Shanghai, China
       Generics R&D Asia 2010
     October 13-15, 2010
                                          Seoul, Korea                                     network/biopartnering_china
     Shanghai, China
                                          URL:                            /3rd_Announcement_Download.                        Nano Thailand 2010
                                          pdf                                              November 18-20, 2010
                                                                                           Pathumthani, Thailand
       Vaccine manufacturing                BioPartnering Europe                           URL:
     world 2010 &                         October 10-12, 2010
     Biomanufacturing world 2010          London, UK
     October 18-21, 2010                  URL:
     Shanghai, China                                                                       December 1-2, 2010
     URL:                                                            Location: Hilton Hotel, Singapore
                                            Pharma Innovate Asia Taiwan                    URL: http://www.wbresearch.
     php?page=home-2                      October 15, 2010                                 com/logipharmaasia/home.
                                          Taipei, Taiwan
       AusBiotech 2010                    URL: http://www.pharmain
     October 19–22, 2010                                                                     BioPharma India Convention
     Melbourne, Australia
     URL: www.ausbiotech2010.                                                              December 6-8, 2010
                                            BIT’s 1st Annual World                         Grand Hyatt, Mumbai, India
                                                                                           URL: http://www.terrapinn.
                                          October 21-23, 2010                              com/2010/biopharmaindia/
        Stem cells Asia                   Bayshore Hotel, Dalian, China
     October 26–29, 2010                  BIT Conferences
     Singapore                            url: http://www.bitlifesciences.
     URL: www.terrapinn.                                                                   December 9–13, 2010
                                          com/wcf2010                                      Bangalore, India
     media.stm                                                                             URL:
                                            2nd Annual World Stem Cells
        BioMalaysia                       & Regenerative Medicine                            ICSTIE 2010 - 3rd International
     November 2–4, 2010                   Congress Asia                                    Conference on Science &
     Kuala Lumpur, Malaysia               October 26-29, 2010                              Technology
     URL:          The Ritz Carlton, Seoul, Korea
     biomalaysia                          URL: http://www.terrapinn.                       Penang, Malaysia
                                          com/2010/stemcellsasia/                          URL:

                                                A CyberMedia Publication | | October 2010| BioSpectrum | 27
         QuickScan APAC

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