Biocon, Asia’s leading
biopharmaceutical enterprise, released preliminary data from a recently
concluded clinical study conducted in India, on IN-105, its novel oral
insulin candidate for the treatment of diabetes.
Initial data analyses show that IN-105 did not meet its primary
endpoint of lowering HbA1c levels by 0.7 percent as compared to placebo
although an unexpectedly high placebo response was also observed. Post
hoc analysis of self monitored blood glucose levels in the IN-105 arm
and the placebo arm indicated large reductions in pre-meal glucose
levels in the placebo arm strongly suggestive of behavioral
modification, and which might have confounded the primary endpoint
Additionally, in further post hoc analyses, significant reductions in
HbA1c levels as compared to placebo, and HbA1c reductions of up to 0.8
percent were observed in the IN-105 arm of several subsets of the
studied patient population. Further assessment of the data is on-going.
Dr Kiran Mazumdar-Shaw, CMD of Biocon, said, “Based on these
encouraging results, Biocon is committed to continue its global
development of IN-105 in partnership with a global pharmaceutical
partner for which we plan to initiate partnering discussions.”
On secondary safety endpoints, IN-105 demonstrated an excellent overall
safety profile with no incidence of serious adverse events, and no
occurrences of clinical hypoglycaemia. Data also shows that the drug is
weight neutral and non-immunogenic.
Monsanto announces nine new projects
Monsanto, a global bioagri company that provides solutions and
agricultural products, announced several projects across platforms, and
crops designed to improve farmers’ on-farm productivity and
profitability as part of its annual pipeline update.
The company announced key projects and insisted on pipeline
collaboration with Germany-based BASF Plant Science, which was expanded
to include wheat. Yield and stress projects advancing phases this year
include nitrogen-utilization corn, second-generation higher-yielding
soybeans and higher-yielding/stress tolerant wheat.
Following last year’s record-breaking 11 project advancements, this
year’s nine advances are testament to the depth of the company’s
R&D pipeline. Additionally, four of the advancements are new
projects that were added to the pipeline, demonstrating that discovery
work brings new opportunities.
ICMR plays down fears on congo fever
After a first ever case of human
infection with Crimean Congo Hemorrhagic Fever (CCHF) virus being
reported from Ahmedabad, Indian Council for Medical Research (ICMR), an
apex body for the formulation, coordination and promotion of biomedical
research in India has assured that CCHF outbreaks can easily be
controlled by proper hygiene and infection control measures in the
hospitals where patients are admitted.
Earlier the tests conducted at National Institute of Virology (NIV),
Pune, confirmed the presence of CCHF virus in blood as well as urine
samples of a patient. The CCHF virus is known to be transmitted among
animals through ticks. There is serological evidence of CCHF infection
being present in India in animals which however do not get the disease.
It does not produce disease in animals but kills 20-40 percent of human
beings who get the disease. So far, a team of doctors and technicians
surveying six villages within a radius of five kilometers of Kolat
which is about 40 kms from Ahmedabad in Gujarat detected 78 persons
with symptoms of the viral fever.
CCHF is a viral haemorrhagic fever of the Nairovirus group. The disease
was first described in the Crimean in 1944 and given the name Crimean
haemorrhagic fever. The disease is endemic in many countries in Africa,
Europe and Asia, and in 2001, cases or outbreaks have been recorded in
Kosovo, Albania, Iran, Pakistan, and South Africa.
Qteros, Praj sign marketing deal
the US-based developer
of a unique and highly-efficient consolidated bioprocessing (CBP)
platform for the low-cost production of cellulosic ethanol, and Praj
Industries, a leader in the development of innovative technology and
engineering solutions for the production of biofuels and biochemicals
based in India, have announced a strategic partnership to accelerate
commercialization efforts for industrial-scale cellulosic ethanol
The agreement leverages both Qteros’ broadly patent protected and
highly-flexible CBP platform with Praj’s research capabilities and its
technology, process design, engineering and construction expertise to
deliver fully-integrated engineering design packages for the low-cost
production of ethanol from a broad variety of non-food based feedstocks.
Qteros and Praj will collaborate on a highly-focused, multi-year
development program with the objective of rapidly developing and
commercializing process design packages (PDPs) that enable cellulosic
ethanol production using Qteros’ Q Microbe-enabled CBP platform and
Praj’s technology and expertise in the conversion of biomass to ethanol.
This unique licensing model serves to provide both a highly-efficient
and low-cost solution to the market, while also allowing Qteros and
Praj to deploy their capital in an efficient and leveraged manner.
Importantly, the companies plan to retrofit Praj’s existing pilot plant
in Pune with Qteros’ technology platform, which will then become the
foundation for accelerated production scaling as part of its commercial
Zero swine flu causality in 2011
With the number of reported deaths being nil out of the 10 laboratory
confirmed cases during the first week of 2011, the year has started on
good note on the swine flu casualities. According to the Indian Health
Ministry’s statewise data of influenza H1N1, for the week ending
January 9, 2011, the total 10 death cases were reported from different
parts of the country. The four cases were reported from Tamil Nadu and
one each from New Delhi, Maharashtra, Kerala, Karnataka, Punjab and
Gujarat. Out of that, not a single death has been reported so far.
The lab confirmed cases since May 2009 stood at 46,152. Out of
that, the total confirmed death cases were numbered 2,728. Again, since
May 2010, the total number of the lab confirmed cases that were
reported stood at 3,282. Out of that, the reported number of deaths
Besides the efforts made by Indian Health Ministry, the international
agencies also played a good role in tackling swine flu. The World
Health Organization (WHO) provided the financial assistance
amounting to about $533,000 (
2.43 crore) besides the technical
guidance from time to time to conduct district level training for rapid
response teams. UNICEF, another UN agency, supported the Indian
government in developing information, education, communication (IEC)
materials for print and audio-visual media and for field publicity.
FBAE completes a decade of activity
The Foundation for Biotechnology Awareness and Education (FBAE), a
non-profit, grass root society formed to support sustainable
development through biotechnology awareness and education in India
successfully completed a decade in science-based activity. With
academicians, scientists and researchers as members, it was formed to
bring together the global scientific community in 2001.Inaugurated by
Prof. G Padmanabhan, former director, Indian Institute of Science,
Bangalore, and presided over by Dr S Shantharam, the FBAE has since
then actively conducted and participated in various workshops and
seminars all over the country.
The foundation creates scientific awareness about modern biotechnology
and educate the public and stakeholders about the perceived and
potential risks and benefits of this emerging technology.
Qiagen opens subsidiary in India
Netherlands-based biotech company, Qiagen has formed an India
subsidiary, Qiagen India, and has started direct sales in the country.
Until now, Qiagen products have been sold in India through distributor
partnerships. Qiagen has been active in India since 1995 and has
developed numerous initiatives, partnerships and a strong network. The
company expects that this enhanced presence will further contribute to
its position in the market. The new office in New Delhi is an
initiative to expand Qiagen’s footprint in emerging regions.
Nixon Biotech develops anti-HIV
Nixon Biotech, an Indian biotech company, has developed a herbal
mineral immunity enhancer for HIV/AIDS to inactivate the virus without
any toxic effect on the body. If it proves its safety and effectiveness
without any side-effects and gets green signal from the regulators in
India, then this will be the first anti-HIV Ayurvedic formulation in
the world to tackle AIDS. Currently, the anti-HIV formulation is being
availed by the patients who are being treated at its campus. However,
the company is yet to have the manufacturer’s license and has applied
for the same.
Nixon Biotech is an ayurvedic pharma company that has been working on
the natural AIDS immunity enhancer. The company started working on the
project since 2005.
According to the company, the blend of minerals, antioxidants and herbs
are combined and optimized to give the body the essential nutrients
required for improving general condition and overcoming weakness. This
natural formulated medicine helps in promoting the protein and
carbohydrates in the metabolism of body.
Mr Ravi Goel, chairman of Nixon Biotech said, “The dosages for the
patients are recommended in form of IC-50 and IC-80. While the IC-50
reduces the virus by 73-95 percent, the IC-80 completely wipes out the
Lab project to assess vaccine formulation
The MSD Wellcome Trust Hilleman Laboratories has announced its frist
project, it will be a feasibility study into how new technologies might
be used to develop a rotavirus vaccine designed specifically with
developing country needs in mind. Formulations based on dissolving thin
strips or granules will be examined for their potential to improve
product stability, transportation and affordability. The therapeutic
focus of the project has been selected because of the tremendous global
impact of rotavirus diarrhea on childhood mortality. If the initial
study is successful, options to further develop the technology for
rotavirus and other oral vaccines of importance to developing country
health will be explored.
“Many first-generation vaccines have not been developed with the
specific needs of countries with poor infrastructure for vaccine
delivery in mind. This is a much needed exploration of how to tackle
one of the greatest public health and logistics challenges in the
developing world — distributing life-saving vaccines without the
requirement for large bulk shipments, expensive warehousing and costly,
difficult-to-maintain refrigerated shipping paths from the
manufacturing plant to the patient,” said Dr Altaf A Lal, CEO, Hilleman
The project is a three-way collaboration between the Hilleman
Laboratories, MSD and Medicine in Need.
Pharma announces strategic divestment
India-based Aurobindo Pharma Limited (APL) has entered into a
definitive agreement with China National Pharmaceutical Group
Corporation (Sinopharm) to divest in its subsidiary company Aurobindo
(Datong) Bio Pharma, China (ADBPL), subject to regulatory approvals.
Sinopharm will acquire the shares through its subsidiary company
Sinopharm Weiqida Pharmaceutical.
ADBPL is engaged in manufacturing of 6APA, a derivative of Penicillin-G
and most of its production is consumed by APL India. In past the
performance of ADBPCL has been affected due to economies of scale and
is incurring losses. After acquisition of 51 percent equity in ADBPL,
the investors will further infuse capital to enhance its shareholding
to 80.50 percent, reducing APL share in the JV to 19.5 percent. APL’s
loan of $23 million to ADBPL will entirely be paid back.
Sinopharm group will infuse sufficient funds to relocate plant as
required by local government in China and significantly enhance
capacity and downstream products leading to better economies of scale
and reduced cost of production. APL’s investment of 19.50 percent will
be strategic in nature to ensure uninterrupted supply of raw materials
at competitive price. Over the past six years, APL has undertaken a
paradigm shift from API to formulations business. Hence, the board
feels that the said divestment is in the best interest of the company.