• 9 April 2007
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New Page 1

Serum Institute launches India's first indigenous HIB vaccine

Serum Institute of India Ltd has launched its indigenously developed HIB Vaccine. It has a capacity to produce over 100 million doses of the vaccine. Serum Institute will supply this new age HIB vaccine to GAVI (Global Alliance for Vaccines and Immunisation), PAHO (Pan American Health Organization) and UNICEF

According to Dr Cyrus Poonawalla, chairman, Serum Institute of India Ltd, "With HIB vaccine, Serum Institute achieves one more milestone in its quest for providing high quality vaccines at affordable prices. Serum Institute is the only indigenous manufacturers' of HIB vaccine in India today unlike other vaccine manufacturers who import the bulk. HIB vaccine is fully manufactured in India. Serum Institute has invested significantly in R&D and these efforts are yielding results."

Serum Institute will supply the HIB vaccine at a low price compared to the MNC prices. Serum Institute has established its credentials, by providing quality vaccines to global healthcare agencies, thereby reducing mortality rates due to illnesses like Measles. The vaccine will also be available as SiiHIB Pro.

According to reports, HIB vaccines are used for prevention of infection caused by invasive HIB disease, which is amongst the leading causes of infant mortality in the developing world. HIB vaccine is given to infants along with DPT or alone. Earlier efforts by UNICEF for HIB immunization met with little success as the prices were very high, which led to limited access of the vaccine in many poor countries. Today infant mortality due to the invasive HIB disease is an important issue for WHO.


Maharashtra signs MoUs with three banks for biotech projects

In order to provide timely and adequate credits and other financial needs to the entrepreneurs for setting up biotech projects in Maharashtra, the state government has signed three Memorandums of Understandings (MoUs) with three leading banks, State Bank of India (SBI), Punjab National Bank (PNB) and
Yes Bank.

Dr Kshatrapati Shivaji, development commissioner, (industries) signed these MoUs on behalf of government of Maharashtra and Narayanan Raja, chief general manager, on behalf of the SBI, R K Gupta, general manager, on behalf of the PNB and Sunil Gulati, group president, on behalf of the Yes Bank in presence of Ashok Chavan, minister of industries, government of Maharashtra, Rana Jagjitsinh, minister of state for industries, government of Maharashtra, VK Jairath, secretary (industries), and Rajiv Jalota, CEO, MIDC.

Ashok Chavan, minister of industries, government of Maharashtra, said that biotechnology is one of the most important and rapid growing and potential sectors, for which the state government has given top priority in the state policy. These MoUs are expected to ease out the key concern of getting adequate and timely credit to biotechnology entrepreneurs in the state, especially to the small entrepreneurs for biotechnology projects.

VK Jairath, secretary (industries), said, "Due to fast changing market appetite from inorganic and organic / biotech products, biotech has assumed greater importance and there by opened up huge market opportunities in India and abroad."


GVK Bio in JV with INC Research

GVK Biosciences has entered into a 50:50 joint venture (JV) with Raleigh-based contract research company INC Research to set up INC GVK BIO Private Limited. The JV will establish a dedicated resource capability to offer phase I-IV clinical development programmes in India for INC's global clients, according to a press release. INC Research would conduct its global clinical trials in oncology, CNS, infectious diseases and pediatrics involving phase I-IV studies.

"The joint venture provides an opportunity for GVK BIO to gain access to INC Research's global reach while leveraging on its India-based Clinical Research capabilities," said GV Sanjay Reddy, chief executive officer, GVK BIO.

"Our international base of operations has expanded strategically this last year, with the addition of several new offices in Europe and now India. This joint venture will allow INC Research to further solidify and expand its presence within the world CRO market," said Kelvin Logan, president of INC Research Europe.


Centre enhances S&T plan outlay to Rs 25 crore in 10th Plan

"In order to boost the R&D activities in the country, the central government has enhanced the S&T plan outlay of scientific departments/agencies from Rs 12,022 crore in the 9th Plan to Rs 25,243 crore in 10th Plan and plans to increase it further in 11th Plan," said Kapil Sibal, Union minister for science and technology and earth sciences, in a written reply to a question in the Lok Sabha on March 9, 2007.

The minister said various initiatives have been taken by the government to encourage investment on R&D both in institutions and industry through several measures. These measures include higher allocation to scientific research, setting up of new institutions for science education and research, creation of centers of excellence and facilities in emerging and frontline areas in academic and national institutes, strengthening infrastructure for R&D in universities, encouraging public-private R&D partnerships, grants for industrial R&D projects, income tax relief on R&D expenditure, weighted tax deduction for sponsored research, custom duty exemption on goods imported for use in Government funded R&D projects, tax holidays and national awards for outstanding R&D.

The "Science & Technology Policy-2003" envisages an implementation strategy for revitalization of the S&T institutions in the country. Some of the key elements of the strategy include: S&T governance and investment; Strengthening of infrastructure; New funding mechanisms; Human resource development; and International S&T cooperation. The expenditure incurred on R&D constitutes 0.8 per cent of India's GDP.

BioNews New Page 2

Syngene ties up with Bristol-Myers Squibb

Dr Kiran Mazumdar-Shaw, CMD, Biocon, and Dr Francis Cuss, senior vice president, Bristol Myers Squibb, at the foundation stone laying ceremony of the research facility at Biocon Park in Bangalore.

Syngene, Biocon's subsidiary company, has entered into a research partnership with Bristol-Myers Squibb. Through this symbiotic global partnership, Biocon's Syngene will provide research and development (R&D) services for discovery and early drug development. Bristol-Myers Squibb will significantly increase the scope of its existing relationship with Biocon's Syngene to further develop integrated capabilities in India in medicinal chemistry, biology, drug metabolism, and pharmaceutical development. Under the terms of the agreement, Syngene will partner with Bristol-Myers Squibb through a dedicated research facility at Biocon Park in Bangalore, which was opened on March 21, 2007.

Dr Francis Cuss, senior vice president, Pharmaceutical Research Institute, Bristol Myers Squibb, laid the foundation stone for the facility. Prof H Sharat Chandra, director, Centre for Human Genetics, Bangalore, presided over.

Spread over an area of 1,50,000 sft, the facility will house more than 400 scientists, who will help advance Bristol-Myers Squibb's discovery and early drug development.

"This is the largest collaboration of its kind for Bristol-Myers Squibb. With this association, the company will significantly increase the scope of its existing relationship with Biocon's Syngene to further develop integrated capabilities in India in medicinal chemistry, biology, drug metabolism and pharmaceutical development. The company has mainly collaborated with Syngene to access the abundant talent that is available in India. This collaboration will also help us to sustain and boost our product pipeline," said Dr Francis Cuss.

Kiran Mazumdar-Shaw said, "This is a step change in the way Syngene has been delivering services to its customers. The facility for Bristol-Myers Squibb will be a multimillion stand-alone research center. The establishment of the facility is a culmination of the research endorsement signed in the 1990s with Bristol-Myers Squibb. Syngene will support Bristol in researching new molecules for critical disease areas."

Dr Goutam Das, COO, Syngene, added, "I am optimistic that around the same time next year the new facility for Bristol-Myers Squibb will be inaugurated." On the occasion, Dr Kiran Mazumdar-Shaw and delegates from Bristol Myers Squibb also inaugurated the Phase II of Syngene's new research center. At this expanded facility, Syngene will conduct custom research for other clients.


Biocon unveils renal therapy products

Infosys Foundation chairperson, Sudha Murthy, launching Biocon's nephrology products in Bangalore. Kiran Mazumdar-Shaw, CMD, Biocon, looks on.

Biocon has announced the launch of its new nephrology division and a comprehensive portfolio of renal therapy products. The products were launched by Infosys Foundation chairperson, Sudha Murthy, at a press conference in Bangalore, India, on March 8, 2007, which coincided with the World Kidney Day.

The new immunosuppressants for renal therapy include Renodapt (Mycophenolate Mofetil), Tacrograf (Tacrolimus), Cyclophil ME(Cyclosporine Micro Emulsion USP), Rapacan (Sirolimus) and Erypro (rHuEPO). Immunosuppressants are powerful medicines that inhibit or prevent the activity of the body's immune system.

Speaking at the launch, Kiran Mazumdar-Shaw, CMD, Biocon, said, "With the launch of the nephrology division, Biocon has taken bold strides in the pharma space. Kidney disease is a life threatening disease and is on the increase. About one lakh patients get affected in India every year and only 20 percent of them can afford renal replacement therapy (RRT) for transplant or dialysis. The treatment is challenging and expensive and Biocon is committed to launching affordable drugs. Our products are 35 to 40 percent cheaper than the existing drugs in the market."

She further stated, "Biocon is already the largest manufacturer of immunosuppressants in India and our new nephrology division offers the most scientifically configured and comprehensive portfolio of renal therapy. We are committed to high quality branded formulations for nephrology with the aim to deliver superior therapeutic benefit. Biocon is poised to be a high quality player in the nephrology market with the most balanced portfolio of brands".

"The size of the nephrology medicine market in India is Rs 300 crore of which the market for immunosuppressants accounts for Rs 125 crore. Biocon is looking at taking 25 percent share of the market in the next five years. The immunosuppressants market is expected to touch Rs 300-400 crore in the next five years," she informed.

Globally, the nephrology market is a $3.3 billion market opportunity. Biocon's target market for nephrology products is primarily the GCC region. It will also market the products in India and extend it to the neighboring countries as well. At a later stage, we plan to enter Latin America and other highly regulated markets," he added.


Avesthagen launches Parsi genome project

Dr Villoo

India's Parsi community is dwindling in numbers very fast and today there are just about 69,000 of them, compared to a few million decades ago. Lower fertility rate has been cited as one of the major reasons for their declining numbers. At the same time, experts have been amazed by the presence of surprisingly large number of very elderly Parsi citizens who have defied age and tend to live much longer than the average Indians.

Now, Bangalore-based Avesthagen has launched an ambitious $27-million (Rs 125 crore) Avestagenome project to identify the genetic basis of the longevity of the Parsi population.

Parsis, or Zoroastrians, arrived from their homeland in Iran to escape persecution by the supporters of Islam, over 1,000 years ago. They landed in Gujarat and subsequently spread to Mumbai, Bangalore and Hyderabad.

Avesthagen's founder and herself a Parsi, Dr Villoo Morawala-Patell said the project aims to build the complete genetic, genealogical and medical database of the Parsi community. The comprehensive database arising out of this project will provide invaluable information on these linkages for all of humanity and not just for the Parsi community alone. The project results will find application in disease prediction and accelerate the development of new therapies and diagnostics.

The conservative community has discouraged inter-community marriages and the close-knit community has been in-breeding over many generations. Genetic experts believe that this in-breeding may have contributed to inheritance of genetic disorders leading to declining numbers. At the same time, they may also have inherited some genes which may be increasing their longevity.

Avesthagen and its partners will collect samples from the community members along with complete genealogical and medical information. The samples will be processed through the highly sophisticated genomics facility at Avesthagen, which is equipped with high-speed polymorphism analysis systems (Sequenom, USA's MassARRAY) and ABI sequencers to identify the causative genes. The data will be statistically analyzed through Avesthagen's bio-informatics channels for processing and creation of the database.

Dr Villoo said, "Avestagenome is a path breaking project which would be instrumental to establish linkage between genes, disease and environmental factors. It would help us predict diseases and would play a catalytic role in development of new therapies and diagnostics."

This project is expected to be completed within five years and is being implemented by a body of eminent stakeholders and opinion leaders within the Parsi community and comprising leading industrialists, clinicians, scientists and others. Avesthagen will bring in seed capital in the form of its high throughput genomics and bioinformatics facilities and other special expertise.


Avesthagen breaks ground for new R&D center

Avestha Gengraine Technologies Pvt Ltd (Avesthagen) has begun construction of its new 2,50,000 sft corporate headquarters and state-of-the-art R&D center. The center is being constructed at ITPL, Bangalore. Avesthagen-One, as the building will be known, promises to be iconic in more than one aspect. Currently, Avesthagen operates out of 50,000 sft at ITPL. Keeping in view its global ambitions, aggressive growth strategy and plans, the management felt that it was imperative to construct an R&D center dedicated to innovation with its systems biology platforms. This center will be designed by Hafeez Contractor.


DuPont opens plant biotech center in India

DuPont will locate its first plant biotechnology research center outside the US at the new DuPont Knowledge Center in Hyderabad.

"The global demand for agricultural crops is very strong. We have the science to help farmers and others across the value chain meet that growing demand, and this research center will help us do that faster," said William Niebur, vice president, DuPont Crop Genetics Research and Development.
Twenty DuPont crop genetics scientists already have begun working at temporarily leased facilities near the site where the new Rs 100 crore (over $20 million) DuPont Knowledge Center will be built. By year-end, DuPont expects the number of crop genetics scientists on site to grow to nearly 100 as part of its $100 million reinvestment plan. The plan will add more than 400 global positions, mainly in research and development, to increase the speed-to-market for new seed products.

DuPont today has major plant biotech research centers in Delaware, Iowa and California, along with 90 plant genetics research centers around the globe. Plant biotech scientists at the DuPont Knowledge Center will develop biotech traits and technologies that will be incorporated into multiple crops for markets around the world. The trait discovery work conducted on site will help create advanced seed products to meet the growing global demand for increased food production, improved animal feed products and expanding energy needs.
"This research facility reinforces the importance of India as a global center of scientific excellence," said Balvinder S. Kalsi, president and CEO, DuPont India. "The center will allow us to access tremendous scientific talent in this region in support of DuPont's efforts to create products that address the food, feed, fuel and materials challenges of the 21st Century."
The plant biotech scientists will move into the DuPont Knowledge Center when it is completed in 2008. The DuPont Knowledge Center will accommodate more than 300 scientists and other employees when fully operational, providing research and development capabilities to help drive the company's business growth in India and around the world. It will be the seventh major DuPont R&D facility outside the US; the others are located in Shanghai, China; Utsunomiya, Japan; Hsinchu, Taiwan; Kinston, Canada; Wuppertal, Germany; and Meyrin, Switzerland.

The DuPont Knowledge Center is expected to house research programs for several businesses, including subsidiary Pioneer Hi-Bred International; DuPont Crop Protection; Chemical Solutions Enterprise; Electronic Technologies; Surfaces; Building Innovations; Titanium Technologies, and; Performance Coatings.

BioNews New Page 3

AstraZeneca opens $15-m PR&D lab in Bangalore

Pharma major AstraZeneca inaugurated its $15-million state-of-the-art Global Process Research & Development Laboratory (PR&D Lab) in Bangalore on March 21, 2007. This is the company's fourth PR&D facility and the only one outside of Europe.

Declared operational by AstraZeneca CEO, David Brennan, the facility will strengthen the existing global PR&D programs and provide support to the company's existing drug discovery program at Bangalore, engaged in finding a cure for tuberculosis (TB). The co-location of drug discovery and PR&D scientists will help AstraZeneca maximize scientific interactions and enable shared use of infrastructure.

"The facility will leverage India's strength in process chemistry," said Brennan. The PR&D lab can accommodate up to 75 process scientists and according to Brennan, it is more than likely to be fitted-out to its capacity by 2009. Currently, it houses 35 scientists.

While one of the key objectives of the PR&D lab is to focus on New Chemical Entities (NCEs), the facility is dedicated to tuberculosis, a disease that is present in latent form in at least one-third of the population. "The growing resistance to the existing TB drugs, coupled with lack of patient compliance results in relapse. The objective is to shorten the therapy duration and improve patient compliance," said Brennan. The facility is expected to handle potential TB drug candidates by 2010.

"By 2010 AstraZeneca is likely to identify drug candidates for TB, we are pretty close," said Dr Jan Lundberg, executive vice president for the global discovery research at AstraZeneca.


AstraZeneca declared Best Safe Industry

AstraZeneca has secured the first place in "Best Safe Industry" in medium scale category at the 36th National Safety Day on March 4, 2007 at Bellary, Karnataka.

Bhasker Iyer, managing director, AstraZeneca Pharma India Ltd, said, "We are delighted to be recognized for our safety, health and environment (SHE) standards. To demonstrate our commitment towards SHE, we have had no fatal accidents since the inception of the plant in 1981. AstraZeneca has invested significantly on safety systems in the plant and all employees are well trained on the safety aspects of the machines."

The award is towards the recognition of safety, health and environment systems available in the plant and the good work done towards the society under corporate social responsibility. The award was presented by the labour minister, Iqbal Ansari, at the 36th National Safety Day organized by the Directorate of Industries and Boilers, Government of Karnataka in collaboration with the Karnataka chapter of the National Safety Council.

UN Misra, vice president-operations, AstraZeneca Pharma India Ltd, said, "At AstraZeneca we are very concerned about protecting the environment. Our manufacturing facility is equipped with state-of-the-art technology to treat all effluents and the discharge is used to maintain our greenery spread over 40 acres. The credit goes to all the employees at the facility."


"Government is keen to promote rapid biotech industrial growth"

The government is keen to promote rapid biotech industrial growth, which is already of $ 1.5 billion in terms of revenue and is growing at 40 percent, Dr MK Bhan, secretary, department of biotechnology, has said.

Dr Bhan informed that the department would be implementing several new programs next year such as new institutions for translation health science and research, stem cell biology, animal biotechnology, marine sciences and applications, food and nutrition. Time bound, multi-institutional grand challenge programs are planned in food and nutrition, vaccines and diagnostics, medical devices, molecular breeding of crops for improved yield and quality and microbial bioprospecting. There are also plans for establishment of agri-food parks in the agri-food cluster in Punjab, which would host start-up companies. The department will establish the proposed the Agri Food Biotechnology Institute and a Central Food Bioprocessing Unit in this Punjab agri cluster.

"To promote small and medium industrial R&D activities and effective functioning of biotechnology parks, a biotechnology industry, research assistance center (BIRAC), and program for collaboration with large industries, technology management system for biotechnology with technology transfer units will also be set up," he said.

He also noted that the department has launched Small Business Innovative Research Initiative (SBIRI) aiming at public-private partnership and forging effective links between academia and industry in up scaling and validation of laboratory research to commercialization. The overwhelming response from small and medium industries resulted in 200 applications and 34 proposals have been supported in areas of product development in agriculture, health care, aquaculture and animal sconces.


Zenotech signs pact with Ranbaxy for global entry into biosimilars

Zenotech Laboratories Limited (ZLL), a specialty generic injectables company with strong expertise in the area of biotechnology, has signed a global clinical development and marketing agreement with Ranbaxy Laboratories Ltd for its first biosimilar product, G-CSF (filgrastim).

The agreement involves upfront licensing fees and profit sharing after launch. The financial part of the agreement was not disclosed. Under the agreement, Ranbaxy has committed resources to introduce the G-CSF product for global marketing beginning with markets in the EU where regulations for biosimilars are in place.

Dr Jayaram Chigurupati, CEO, Zenotech Labs said, "No Indian biosimilar product so far has been launched in the EU due to the substantial investments involved in clinical trials and the regulatory expertise required. Both these aspects pose significant barriers to entry. We are proud to associate with Ranbaxy for development of G-CSF for the European Union and eventually for the US market. G-CSF will lead the way for the development of other biosimilar molecules within the Zenotech portfolio. These products will be manufactured in Zenotech's US FDA/EU approvable biologics facility in Hyderabad".

Malvinder Mohan Singh, CEO and managing director of Ranbaxy Laboratories Ltd, said, "This agreement signals Ranbaxy's foray into biosimilars by pooling in Ranbaxy's significant regulatory and front-end infrastructure with Zenotech's expertise in the development and manufacture of biosimilar products. This also strengthens our existing alliance with Zenotech for oncology products given our strategic stake in the company."

Ranbaxy launches Atorvastatin in Denmark

Ranbaxy Laboratories has launched the generic Atorvastatin, a cholesterol-lowering drug that is marketed by Pfizer as Lipitor in Denmark.


PPD licenses statin from Ranbaxy Laboratories

Ranbaxy Laboratories and PPD made an announcement that PPD has acquired an exclusive worldwide license to develop, manufacture and market Ranbaxy's novel statin for the treatment of dyslipidemia.

Under the terms of the agreement, Ranbaxy will be entitled to receive milestone payments upon the occurrence of specified clinical events. In the event of approval to market a drug product, Ranbaxy will be entitled to receive royalties on sales of the drug and sales-based milestones. PPD will be responsible for all costs and expenses associated with the development and commercialization of the compound, including preclinical and clinical studies. Ranbaxy has retained co-marketing rights to the compound in India.


India, Croatia sign joint declaration to strengthen cooperation in S&T

India and Croatia have signed a joint declaration for strengthening scientific and technological cooperation between the two countries. The union minister for science and technology and earth sciences, Kapil Sibal and the Croatian minister of science, education and sports, Dragan Primorac, signed the declaration in Zagreb.

The joint declaration pursues the Programme of Cooperation in science and technology for the period 2005-08 being implemented by the department of science and technology on the Indian side and ministry of science, education and sports on the Croatian side. It aims at further expanding and intensifying two-way exchanges between the scientific R&D communities of India and Croatia.

With a view to effectively pursuing the above objective, the parties agreed to establish a joint fund of €1 million, for which each party will make an equal contribution. The next meeting of the joint committee shall be organized within three months to develop modalities and identify projects under this fund. Both parties agreed to work out joint projects for FP7 Programme of EU.

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