Biocon,
Amylin to jointly develop diabetes drug
Indian biotech major, Biocon, and US-based Amylin Pharmaceuticals have
entered into an exclusive agreement to jointly develop, commercialize
and manufacture a novel peptide therapeutic for the potential treatment
of diabetes.
Amylin and Biocon will collaborate to develop the therapeutic
potential of the compound and share development costs. The research
will center on Amylin’s ‘phybrid’
technology. A phybrid is a peptide hybrid molecule that combines the
pharmacological effects of two peptide hormones into a single molecular
entity.
Under the terms of the development and commercialization agreement,
Amylin will provide expertise in peptide hormone development,
particularly in the area of phybrid technology, as well as metabolic
disease therapeutics. Biocon will utilize its expertise in recombinant
microbial expression to manufacture the compound and also leverage its
experience in pre-clinical and clinical development of diabetes
products.
“This agreement fully leverages the synergistic capabilities
of the two companies. Amylin’s knowledge of peptide
therapeutics and their leadership in the diabetes market, paired with
Biocon’s capabilities in process development, manufacturing
and clinical development, provide this global program with the
potential to effectively bring a novel therapy to patients living with
diabetes,” said Dr Kiran Mazumdar-Shaw, chairman and MD,
Biocon.”
Daniel M Bradbury, president and CEO of Amylin Pharmaceuticals, said,
“This program could unleash the potential of cutting-edge
peptide science to transform the lives of patients with
diabetes.”
Redefine
the frontiers of healthcare: CII conclave
The two-day brain-storming conclave, Life Science Conclave 2009,
organized by the Confederation of Indian Industry (CII) in New Delhi on
August 27-28, 2009, featured six sessions and three panel discussions
that were addressed by 62 eminent speakers. The issues debated in the
conclave provided an opportunity for the Indian pharma and biotech
industry to assess their position in becoming a major partner of the
progress.
Dinesh Trivedi, minister of state for health and family welfare,
Government of India, while speaking at the conclave, stressed on the
need for preventive measures rather than solely focusing on curative
measures. Trivedi also stressed the need to strengthen diagnostic
centers in the country acknowledging the frugal healthcare spending of
the central government in the healthcare segment.
Trivedi emphasized the need for a change in the international and
national attitude, and mindset towards Indian healthcare as it
continues to have the requisite knowledge and skills as well as the
market. He also suggested a novel e-health card system to document the
complete medical history of all citizens down to the village level.
Dr VM Katoch, secretary, department of health research and director
general, Indian Council of Medial Research, while speaking about
India’s wealth of knowledge, underlined the need for removing
the ‘bottlenecks’ to convert this knowledge into
products with further industry and academic co-operation. He also
stressed the need for further inter-ministerial co-operation among the
various government departments.
Citing the strategic importance of India in the pharmaceutical sector,
Bruce Ross, country director, India, US Food and Drug Administration
reiterated the US government’s commitment to continue its
trusting relationship with regulatory counterparts in other countries,
such as India. Ross said that India has the largest number of FDA
approved drug manufacturers outside the US with Rs 6,708 crore ($1.38
billion) of exports to the US market in 2007–08 growing at 39
percent.
Avesthagen
to raise Rs 700 crore from markets
Bangalore-based life sciences company, Avesthagen has revived plans for
an IPO, and will raise about Rs 700 crore from the domestic and
international markets. The funding will be used to commercialize 40
products, which are in various stages of development to market. Having
initially announced the IPO last year, the company had to postpone the
plans after markets fell due to global meltdown.
Dr Villoo Morawala Patell, founder and CMD, Avesthagen, said,
“The IPO is slated to coincide with the time that our
biosimilars are ready to hit the market place. From an investment
perspective, I believe mid-2010 will see a global turnaround and a good
business environment, such that all our stakeholders will benefit from
investing in the company.”
Avesthagen, which currently holds 560 patents will be valued
based on its patent and product portfolios. Avesthagen, which is
expected to touch a turnover of Rs 100 crores this fiscal, is yet to
decide on the bankers, and would like to hold on to the
promoter stake, which is currently at 32 percent while private equity
(PE) players hold up to 28 percent. PE investors include ICICI
Ventures, Fidelity and New York Life Investment Management India Fund.
Each of Avesthagen’s four strategic business units
are expected to run as independent profit centers with dedicated
management teams. Avesthagen has many products in the pipeline that
need to be monetized and brought to the consumer. Recently, the company
cleared one mammalian biosimilar monoclonal antibody product by the
regulatory agency in India for clinical trials, and three other
biopharma products have entered pre-clinicals.
CHiCTR,
CTRI to encourage clinical trials in China, India
Pharma and biotech companies are attempting to combat escalating
R&D costs and lengthy clinical trial timelines by improving
patient recruitment, and the efficiency of clinical trial
analysis/reporting. The biopharmaceutical market has recognized the
opportunities and advantages that exist by conducting clinical trials
in emerging markets. Although these markets offer a number of
significant benefits over traditional clinical trial settings, there
remain a variety of challenges and problems associated with conducting
trials in emerging regions.
Announcing the release of a report on ‘Emerging Clinical
Trial Locations: Market Dynamics and the Changing Healthcare and
Regulatory Environment’ by Business Insights noted that
Russia is one of the world leaders in patient enrolment with an average
patient recruitment rate in 2006 exceeded 4.7 patients per site per
month. For some nosologies, this figure is 10 times higher than in
Western Europe and the US.
The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials
Registry in India (CTRI) have helped to encourage all clinical trials
in these regions to be registered before the enrolment of the first
participant, and to disclose the mandatory 20 items of the WHO
International Clinical Trials Registry Platform (ICTRP) dataset.
By the end of May 2009, 895 clinical trials were registered in India,
as against 150 clinical trial approvals in the year 2006 by the Drug
Controller of India (DCI). India is able to offer significant
cost savings compared with clinical trials conducted in western
countries. Phase I trials are approximately 50 percent cheaper than
western equivalents, while phase II and phase III are 60 percent less
expensive.
The Chinese CRO market was valued at Rs 1,209 crore ($250 million) in
2008. The market is expected to grow at a CAGR of 33 percent over the
next four years to reach Rs 3,825 crore ($791 million) in 2012. By that
time, Chinese CROs will account for an estimated 2.3 percent of the
global CRO market.
India
to monitor CROs closely
In an effort to give a conducive business environment to CROs in the
country the Indian regulatory agency has released draft rules for
mandatory registration of all Clinical Research Organizations (CRO)
across the country. Approved by the Drug Technical Advisory Board
(DTAB), India, the draft guidelines are to standardize practices among
such organizations and mandate strict adherence of standard operating
procedures.
The guidelines are not standalone and the objective is to improve
overall quality of clinical trials by working hand-in-hand with other
applicable rules, like Schedule Y, Indian GCP guidelines and Ethical
Guidelines for Research on human subjects by ICMR.
According to the draft made available to the public, the guidelines
cover all organizations, individuals, institutions and companies that
take the responsibility of initiation, management or coordination of a
clinical trial. Thus, the draft rule makes it clear that the CRO can
carry out its activities according to the contract with the sponsor,
only if it is duly registered under the rules by the licensing
authority. Before the organization registers, it needs to declare that
the licensing authority has the right to inspect its premises at any
given time and examine the process, procedure and documents of any
trial taken care by the organization.
ISO
certification for Cryo-Save India
Cryo–Save India, a part of Cryo-Save Group,
Europe’s largest adult stem cell storage bank, achieved a
significant milestone with TUV Rheinland, Germany, conferring the India
operations an ISO 9001:2008 certification. TUV Rheinland, a leading
quality management systems registrar from Germany, certified Cryo-Save
India after examining the lab on various parameters.
Cryo-Save India is dedicated to the highest quality standards and is
the only company in its category to have received ISO 9001:2008
certification from TUV Rheinland, within such a short duration since
commencement of its operations. The certification from TUV Rheinland
helps to strengthen the processes and systems employed by Cryo-Save
India, which include fully-automated systems that ensure no human
intervention in storage and retrieval process along with a unique dual
storage process.
As part of the ISO 9001 process, TUV performed on-site assessments,
examining the Cryo-Save India documention procedures and audited its
overall operations. To determine continued compliance with ISO
9001:2008, TUV would conduct periodically scheduled audits at
Cryo–Save India and examine and monitor its business
operations. Quality Council of India, the authority in India for
ISO-related standards, too can conduct random audits to verify
organization’s compliance to declared practices.
SIRO
Clinpharm expands operations in Europe
SIRO Clinpharm, a global Contract Research Organization (CRO) with its
base in India, US, Europe and Israel, has opened its new office in
Prague, Czech Republic.
“Czech Republic has an excellent resource base of Good
Clinical Practice (GCP) trained, well-qualified clinical research
personnel. Our new office in Czech Republic will further strengthen our
operational capabilities in Europe,” said Scott Spector,
president, Strategic Operations, Europe.
Dr Ladislav Pecen will be in charge of operations in Czech Republic for
SIRO. To begin with, SIRO will roll out clinical monitoring,
biostatistics and statistical programming services from the new office.
From its offices in Offenbach, Germany, and Mumbai, SIRO has been
offering these and other services like clinical data management,
quality assurance, medical writing, medical affairs and
pharmacovigilance for more than a decade.
“We established our presence in Europe with the acquisition
of Omega Mediation, a Germany-based CRO in April 2008. During the last
18 months, as a part of our global strategy, we have expanded our
capabilities by opening offices in north east and south east Europe. We
have already started eyeing other countries in Western Europe for
further expansion,” said Dr Chetan Tamhankar, CEO of SIRO
Clinpharm.
MakroCare
signs partnership with OmniComm
Indian CRO MakroCare has partnered with OmniComm Systems, one of the
fastest growing companies and a leader in integrated electronic data
capture (EDC) solutions for clinical trials.
“MakroCare offers a best-of-breed suite of clinical
technologies for managing global clinical trials, including customized
interactive voice response (IVR) and web applications, comprehensive
clinical trial management systems (CTMS) and drug safety and
pharmacovigilance systems. The integration of the TrialMaster System
into our clinical platform offers our customers an extremely powerful
solution,” said Dr Rajeev Naithani, director, CDM.
“Partnering with OmniComm allows CROs to offer their
customers a first class EDC product and gives them a competitive edge
in the bidding process,” said Stephen Johnson, COO of
OmniComm. “It’s a win for everyone involved, the
CRO, OmniComm and most importantly the clients that we serve.”
With this partnership, MakroCare is entitled to use with the flexible,
intuitive and robust EDC solution, TrialMaster. For clinical trials, a
dedicated hosted environment and comprehensive training and support for
TrialMaster.