Shreya launches Recosulin
Mumbai-based Shreya Life Sciences Pvt Ltd has launched its recombinant human
insulin, Recosulin and needle-free insulin delivery device, Recojet, in India.
Announcing the launch of the two products, Sujit Kumar Singh, chairman, Shreya
Group said, "Diabetes is one of the major diseases in India and diabetes
therapy has immense potential. Shreya has entered the area of diabetes care as a
serious long-term player and introduced oral antidiabetics, diabetes-specific
nutrients and recombinant human insulin. We are committed to bringing
world-class diabetes therapy to India and are making major investments in
manufacturing, R&D and marketing to make diabetes therapy affordable to a
larger number of patients."
Recosulin is based on technology from Shreya's
collaborator, Biotechnology General Corporation (BTGC), now known as Savient
Inc., US. According to the company officials, Recosulin was developed using
advanced technology in second-generation rDNA human insulin. While the earlier
technology for human insulin used Methionine as a linker molecule that requires
24 stage unit operations and harsh chemicals like Cynogen Bromide, the advanced
technology from BTGC is claimed to use Lysine and Arginine that requires only 19
stage unit operations and no harsh chemicals.
Shreya will introduce the full range of insulin to suit
individual patient requirements in both 40 IU/ml and 100 IU/ml categories. It
will initially launch Recosulin by importing the finished product from Bioton,
Poland (manufactured using BTGC technology). In the second phase, crystals will
be imported and formulated at the Shreya manufacturing facility at Aurangabad.
Shreya has already ventured into backward integration and the group company,
Shreya Biotech Pvt Ltd is setting up a Rs 60-crore facility in Pune for the
manufacture of insulin crystals. By December 2005, Shreya Biotech will commence
production.
It also launched needle-free insulin delivery device Recojet. Shreya has an
exclusive arrangement with Antares Pharma (a US-based company) through its
partner, Scigen of Singapore.
GSK Vaccines launches Mencevax ACWY
GlaxoSmithKline Vaccines launched its meningitis vaccine, Mencevax ACWY, in
India. Mencevax ACWY checks the spread of Meningococcal meningitis. This will be
useful to Haj pilgrims traveling to Mecca during this time of the year as they
are at a high risk of contracting meningococcal infection due to overcrowding
associated with the Haj pilgrimage. As a precautionary measure, the Government
of Saudi Arabia has made it mandatory for foreign pilgrims to be vaccinated
before entering the country.
Sumer Dheri, general manager, GSK Vaccines, said, "Meningococcal
meningitis has grown to be a serious cause for concern, predominantly affecting
travelers and people living in crowded areas. Vaccination is the most effective,
practical and convenient way of preventing the outbreak of this disease.
Mencevax ACWY is a superior product from our global portfolio and we are happy
to launch it in India for the increased safety of the Haj pilgrims. GSK has been
supplying the vaccine to the Government of India for the past three years and
has now made it available to the private market as well."
The WHO estimates that there are about 5,00,000 cases of Meningoccocal
meningitis worldwide each year.
UK-based CRO forays into India
Chiltern International, a UK-based Clinical Research Organization (CRO),
has set shop in India. Based in Mumbai, it will support global and local
pharmaceutical companies with their drug development objectives in India. Dr
Umakanta Sahoo has been appointed as general manager for the Indian operations.
Dr Sahoo has an MBA and PhD (management) and brings extensive experience from
the pharmaceutical and CRO Industries in India. Dr Sahoo has worked at
Quintiles, Sterling and ClinInvent (all CROs) in India.
"Chiltern's expansion comes at an exciting time, with
the clinical research business in India being facilitated by increased awareness
among investigators and clinical research professionals on ICH GCP, acceptance
on data quality by the global sponsors and the positive orientation of local
regulators (Drugs Controller General of India) to adopt Indian GCP and to amend
the 'Schedule Y of Drugs and Cosmetics Act, 1940," said Dr Sahoo.
Chiltern International, established in London in 1982, provides support for
clinical operations, project management, data management, biostatistics, medical
writing, quality assurance and regulatory and medical affairs services to the
pharmaceutical, biotechnology and medical device industries.
|
Focus on tropical cutting
edge technology, Sibal advises Indo-US S&T forum
Development of tropical and frontier technologies by
Indian and US scientists through innovation that enable India to bypass
the lack of physical infrastructure should become the over-arching
priority for the Indo-US science and technology forum, the minister of
state for science and technology and ocean development, Kapil Sibal, said
at the Round Table on "Indo-US Public-Private Partnership in R&D
and Technology Endeavors" organized by FICCI. Sibal emphasized on
"dual use" innovative technologies for giving an impetus to
projects in tropical areas such as food and agriculture, healthcare and
water while at the same time concentrating on frontier technologies in
space, defense, biotechnology, IT and nanotechnology.
Nandan Nilekani, CEO and president, Infosys and David
Evans, under secretary, Smithsonian Institute, USA, saw three models for
the forum to move forward: one, embedding the players from both sides in
the loop where US companies can leverage the human capital from India;
two, participation of US capital; and three, Indian companies could
network with academic institutions in the US for understanding the latest
advances in research first hand.
The R&D applications in life sciences session was
chaired by Dr MK Bhan, secretary, DBT, who stressed on the need of public
private partnerships due to the high costs involved in biotech research.
He further added that technologies fostering welfare of the masses like
salt, drought and cold tolerant genes and plant species should be jointly
developed.
Addressing the concluding session of the meeting, Dr RA
Mashelkar, DG, CSIR recommended a three-pronged approach to give a fillip
to partnership between public and private S&T institutions in the two
countries - rely on superior S&T like bioinformatics, genomics, etc;
move to destinations which offer R&D at affordable cost; and adopt
innovative alternative approaches such as reverse pharmacology in medical
research.
Rodney Nichols, governing body member, Indo-US S&T
forum and former CEO, NY Academy of Sciences outlined the operational
objective of public-private partnership: reduction in cost, cost and risk,
acceleration of research, complementing the core competencies of
scientists from both countries and advise and collaboration on a sustained
basis.
Outlining proposals to strengthen the Indo-US Public
Private Partnership, Dr Amit Mitra, secretary general, FICCI suggested
organizing seminars in key Indian centers, road-shows in the US,
conducting major technology summits in the US and India and creation of
opportunities for one-to-one interaction for collaboration in specific
projects.
"We aim to develop India as a
biotech hub, next only to the US"
-Dr Amit Mitra, secretary general, FICCI.
 What
is the focus of FICCI biotech committee?
We aim to catalyze the national biotech policies in the country,
empower bioentrepreneurship, nurture global playing, facilitate
comprehensive understanding about biotechnology industry in the country
and promote meaningful international regulatory mechanisms. We want to
channelize the potential of Indian biotechnology from the lab to the
application stage especially in the pharma and agri segments. We have
taken up the IPR and clinical trial related concerns of the industry to
the government. The mission of our biotech committee is to develop India
as a "biotech hub", next only to the US.
What is the agenda of the
US-India High Technology Cooperation Group (HTCG) and FICCI's role in
it?
HTCG was established in November 2002. It is made up of trade
representatives from the two governments to promote bilateral trade in hi
tech areas including biotechnology. This group provides a standing
framework for discussing high-technology issues of mutual concern. FICCI
has been actively associated with the Indian and US Government during the
consultations. During the HTCG meeting at Washington in November this
year, our biotech committee made several recommendations, which have been
taken at the highest policy level. These are: Free flow of biological
materials between India and the US when used for pure research purposes;
US FDA to recognize the clinical trials conducted in India; and American
Type Culture Collection (ATCC) should set up their subsidiary office in
India. We have proposed doing seminars in various cities in India jointly
with the US embassy and have also made available the use of our website to
extensively disseminate developments.
Rolly Dureha |
India can influence future development of biotech crops: Ford Runge
India has been identified as a country of influence to lead future
developments of biotech crops, according to a study on "Global diffusion of
plant biotechnology: International adoption and research in 2004". The
study was conducted by C Ford Runge, director, University of Minnesota's
Center for International Food and Agriculture Policy and distinguished McKnight
University professor of Applied Economics and Law. Plant biotechnology has gone
global with research and production underway. Out of 63 countries, 18 are
actively growing biotech crops and R&D is being conducted in another 45
countries, the report said. The global commercial value of biotech crops grown
in 2003-04 crop year was $44 billion, 98 percent of which came from five
countries -Argentina, Brazil, Canada, China and the US. These grow one or more
of four biotech enhanced crops - soybeans, cotton, corn and canola. The study
estimated that in the next decade as more developing countries grant approvals
to biotech crops under active research, their global value will increase nearly
five-fold to $210 billion. The study pointed out that India has the potential to
develop rapidly in this area on the strength of more than 20 academic and
research institutes involved in plant biotech research covering 16 crops. Many
Indian scientists hope to usher in a second "Green Revolution" while
adding another facet to its already booming knowledge-based economy, it added.
Besides India, Latin America, Africa, Australia and China were identified as the
centers of influence that will help lead agribiotech crop development in the
future. Meanwhile, China has emerged as a major center for biotech research. Its
government has invested several hundred million dollars, ranking it second in
the world in biotech research funding behind the US, the report found.
Spacelabs, SIRO tie up
SIRO Clinpharm Pvt Ltd has entered into a strategic partnership with US-based
Spacelabs Medical Data, an OSI Systems company, a leading global provider of
patient monitoring systems. Through this alliance, SIRO will offer centralized
cardiac safety monitoring services including centralized ECG, Holter and
ambulatory blood pressure monitoring services to any of the clinical studies
that it manages in India.
"Spacelabs Medical Data has nearly two decades of successful experience
in providing centralized services in more than 80 countries worldwide. The
alliance with SIRO will benefit us by extending our operational reach in the
emerging clinical research market of India," said Marc Hagan, general
manager, Spacelabs Medical Data. "The addition of core ECG services through
medical data will allow us to offer our clients a unified end-to-end solution
for their clinical research needs in India," said Dr Gautam Daftary,
executive director of SIRO Clinpharm.
Sysmex Corp. to source blood chemistry analyzer from Transasia
 |
| Suresh Vazirani, chairman and
managing director of Transasia Bio-Medicals Ltd and Hisashi Ietsugu,
president & CEO, Sysmex Corporation, Japan exchanging a bouquet of
flowers after signing the agreement between the two companies. |
In a significant development, Japanese diagnostics major,
Sysmex Corporation, has finalized an agreement with Mumbai-based Transasia
Bio-medicals Ltd, to source a high throughput clinical chemistry system, Chemix
800 (blood chemistry analyzer). The agreement was formally announced by Hisashi
Ietsugu, president and CEO, Sysmex Corp. and Suresh Vazirani, chairman and
managing director, Transasia Bio-Medicals Ltd.
As part of this agreement, Transasia has developed and
customized a clinical chemistry system, in a record time of less than eight
months using the latest design tools like PRO-E solid modeling, RUP for
software, advanced embedded software programming and debugging tools, to be
marketed worldwide by Sysmex Corp. Japan, under the joint brand name "Sysmex
Transasia". The agreement would be valid for six years and during this
period the total sales of the analyzer are expected to be worth Rs 100 crore in
valuable foreign exchange.
Following the agreement Suresh Vazirani said, "This agreement for
worldwide distribution is a major achievement for Transasia and India. Transasia
has placed India among the select few developed countries to offer such high
technology bio-medical products to the world." Hisashi Ietsugu noted that
as part of expansion plans in the field of clinical chemistry, Sysmex had been
evaluating proposals from various companies worldwide for the past two years, to
meet their needs for an automated clinical chemistry system with a speed of up
to 600-tests per hour.
| Ocimum,
Genome Explorations tie up
Ocimum Biosolutions, a provider of bioinformatics
solutions and Laboratory Information Management System (LIMS) based in
Hyderabad, has entered into a tie-up with Genome Explorations Inc. of USA.
"Initially, we will market our products and services through Ocimum
Biosolutions. Based on the feedback and enquiries, we are eager to set up
an R&D center in India," noted Dr Divyen H Patel, founder and
CEO, Genome Explorations. Genome Explorations offers software solutions
- Affymetrix Microarray Suite (MAS), advanced clustering solutions (GeneSifter.Net
and GeneMaths), services and products such as Biotin label cRNA, RNA
Quality Check and Quantitation, GeneChip microarray hybridization and data
analysis.
Ocimum Biosolutions and Genome Explorations jointly
organized a series of conferences in Mumbai, New Delhi, Bangalore and
Hyderabad to familiarize the scientists and researchers involved in gene
expression studies with the latest developments in gene expression
analysis and tools that can revolutionize conventional research methods
and also to understand their needs. Anuradha Acharya, CEO, Ocimum
Biosolutions said, "DNA microarrays are the most widely used tools
for large-scale analysis of gene expression. We see that the largest
future market of DNA microarrays is expected to be for clinical
diagnostics."
... Ocimum licenses Pharmatracker to Cerilliant
In another development, Ocimum licensed its LIMS solution,
Pharmatracker, to Cerilliant Corp., Texas. Cerilliant provides chemical
reference materials and custom chemical services to diverse industries and
Pharmatracker was selected to track and manage these multiple labs
efficiently and accurately. Joe Rettinger, technical operations manager,
Cerilliant informed, "Pharmatracker was selected because its design,
flexibility and architecture were well suited to meet our needs."
"I found the power of Microarray
technology compelling"
Dr Divyen H Patel, CEO, Genome Explorations.
What are current trends in the bioinformatics
tools?
 Currently
in the US, this industry is worth about $50 million a year. In Asia and
Europe, the potential of this market is double of that of the US. But at
present, the technology has not realized its full potential in these
continents, as it is not being utilized in a big way there. I see
outsourcing samples/data for mining and analysis as an increasing trend.
For instance, initially when we started, there were just two companies but
now, three years down the line, there are 10 such companies running
worldwide.
How has Genome Explorations
grown?
The potential of microarray data analysis is huge and the value it adds to
the data is amazing. I was fortunate to make use of this technology, when
it was initially introduced for interpretation of information. And I found
the power of this technology compelling. We were the first to provide
"complete solution" for gene expression profiling. We started
our company in November 2001. In the first year of setting up, our
turnover was about a million USD. Now our business is steadily increasing
and doubling every year. Presently we are getting business from about 100
companies and have 200 clients. Currently we have a good infrastructure
base and the strength of some very good publications based on our studies.
How can the alliance between Ocimum and Genome
Explorations help the Indian biosciences community?
In India, the application of microarray technology has a huge potential.
First of all we offer a very cost effective solution as expenses involved
in having an Affymetrix setup is huge. Secondly the range of diseases and
research programs that are going on in the country are very unique and the
microarray technology can transform the data completely.
What are your future plans?
We are currently into contract research and subsequently want to move to
product development. We would later expand into the manufacturing of
clinical diagnostic tools and kits and drug discovery programs. |
Industry keen on collaborating to develop anti HIV vaccines
The leaders of Indian pharmaceutical and biotechnology industry have
expressed their solidarity for the country's vision of developing a preventive
HIV/AIDS vaccine, at a workshop in Delhi. They discussed the importance of
private sector participation in fighting the menace as HIV/AIDS is draining
economies of vital resources and is affecting the private sector at micro and
macro levels.
Setting the vision for the future, Kapil Sibal, union
minister of state for science and technology and ocean development, said,
"A smooth regulatory regime is essential for our private sector to develop
and manufacture effective and accessible vaccines. Also the importance of this
kind of advocacy cannot be overstated. Business leaders have a unique
opportunity to be strong and the vision advocates for greater action and
partnership with other sectors. We hope this beacon of leadership will inspire
all businesses, large and small, around the world to push for a vaccine. Care
for those suffering is an important human obligation. Other forms of prevention
can limit the damage but only a vaccine can, one day, rid the world of
AIDS".
 |
Dr Seth
Berkley, president and CEO,
International AIDS Vaccine Initiative |
Dr Seth Berkley, president and CEO, International AIDS
Vaccine Initiative noted, "The success and phenomenal growth of Indian
companies in pharmaceutical R&D over the last few years proves their
potential capabilities in the field. Research on preventive AIDS technologies,
especially a vaccine, presents several opportunities for the Indian industry.
The Indian vaccine industry currently positioned as the third largest supplier
of vaccine in the world along with its large pool of experts and highly skilled
medical scientist supported by world-class research facility, has the unique
opportunity to become the vaccine hub of the world. The R&D opportunities
that Indian pharmaceutical and biotechnology companies can consider are
immense."
The Indian industry is in a better position to explore the
scope for its own involvement in the years to come, felt Dr S V Kapre, executive
director, Serum Institute of India. However, he added, that to formulate
measures to increase the scale the sector's engagement area, it is imperative
to understand and address the challenges it faces. He said, "Over the years
the Indian industry has been able to reach a stage where it has become a global
force. This allows it to get involved in newer challenges."
Ranjit Shahani, vice chairman and managing director, Novartis
India, stressed on the need for industry and government to step up investment in
healthcare in India including R&D and delivery mechanisms. He said,
"Public Private Partnership is one of the potential strategies to address
the challenges. Clearly, the successful amalgamation of the skills of the
private industry and government bodies is also required in the research and
development of AIDS preventive technologies."
Deliberations at the workshop on Preventive Health Technologies with special
focus on Preventive AIDS Vaccine, organized by the Indian Council of Medical
Research (ICMR), the National AIDS Control Organization (NACO) and the
International AIDS Vaccine Initiative (IAVI), focused on identifying
factors/mechanisms aimed at creating a more conducive policy regime, explore
areas of potential interest for Indian industry to undertake R&D efforts in
this area and also explore innovative models of partnership. Senior policymakers
and group of industry representatives attended the meeting including
representatives from Novartis, Panacea Biotech, BD Biosciences, Serum Institute
of India, Chembiotek Research International, and Rallis India.
NBRI transfers Bacillus-based technology to Biotech International
The National Botanical Research Institute (NBRI), Luckno w, has transferred
plant growth promoting Bacillus-based microbial inoculants technology to Biotech
International, a biofertiliser and biopesticide manufacturing company in Delhi.
The technology has been developed by Dr Shekhar Nautiyal in collaboration with
Dr HB Singh, head, plant pathology group at NBRI. Since 1995, NBRI has filed and
obtained several patents for the technology developed using novel plant growth
promoting bacteria namely Pseudomonas, Bacillus and Rhizobium. The products thus
developed have the potential to control phytopathogenic fungi, promote plant
growth, improve tolerance for abiotic stresses, and solubilize phosphate even
under abiotic stress conditions.
The products are useful as plant growth enhancers and biopesticides for seed
soil and foliar applications. The niche microbes involved have been isolated,
identified and characterized under quality-controlled conditions. A process has
been developed for commercial manufacture of these products keeping in view
local needs and national/international market potential. Powerful blend of novel
microbes (Pseudomonas, Bacillus, Rhizobium, and Trichoderma) constitute a
synergistic and stable blend of inoculants that may be applied to agronomic
crops, flowers and vegetables to digest organic wastes such as press mud, farm
manure and vermicompost, etc and to recover degraded ecosystems.
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