 |
| AB Vajpayee and President Assad of Syria jointly inaugurating the Biotech Center in Damascus |
In its bid to go beyond the national boundaries, India has signed a joint work plan with Syria for bilateral cooperation in biotechnology research. The Executive Work Plan, signed on November 15 on the occasion of the Prime Minister AB Vajpayee's visit to Damascus, has a five-year road map for joint research in varied areas of biotechnology. India has also announced a $1 million grant for the development of Syria's National Biotechnology Center. The Executive Work Plan calls for bilateral cooperation through increased institutional collaboration for joint research activities, and exchange of scientists and technical information.
Announcing the grant after the inauguration of the National Biotechnology Center, the Prime Minister hoped that it would be utilized for establishing a high-quality facility. Vajpayee said such a facility would not only benefit the people of Syria, but also contribute to the improvement of the quality of life of all people in the region. "It would also be a powerful demonstration of the immense peaceful and developmental applications of biotechnology," Vajpayee added.
According to an official statement released by the Prime Minister's Office, Vajpayee stated that the center symbolizes the transition of Indo-Syria relations from its traditional roots to the contemporary age. Through scientific partnerships and alliances, the countries can create value-addition to innovation and commercialize technologies for products, which increase human welfare, Vajpayee believed.
Switzerland, India to set up biotech forum
Pascal Couchepin, President of Switzerland, announced that Switzerland and India have initiated measures to set up a Swiss-Indian Biotech Forum to promote interactions between Swiss and Indian biotechnology companies and institutions. Switzerland has also identified a few Indian sectors as biotechnology, power, and textile machinery as priority areas to strengthen business collaborations. He was speaking to captains of Indian Industry, in a meeting organized by the Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI), in New Delhi.
Pascal Couchepin added that in addition to the bilateral framework, Switzerland and India adhere to WTO multilateral approach and both need a strong and rule-based multilateral trading system. He said that for both countries, the failure at Cancun has been a negative result but expressed happiness that both India and Switzerland are hopeful that the Doha negotiations will start sooner than later.
Referring back to bilateral relations, he said that a new bilateral government agreement to intensify cooperation in the fields of science technology was inked and expressed optimism that the new initiative would lead to increased economic interactions between the two countries in the years to come.
In his address, Vinod Khanna, minister of state for external affairs, Government of India, said that bilateral trade in 2001-02 of $1 billion was well below its true potential.
He said that the signing of two bilateral agreements was significant in view of the potential for synergetic relationship. Khanna added that the agreement would help combine the strengths in research for mutual benefit and enable explore new avenues of cooperation in biotechnology, nano-technology, life sciences, genome research and environmental technologies, where the Swiss have made considerable advances.
In his welcome address, KK Modi, past president, FICCI, said that India and Switzerland have grown to be ideal partners in diverse fields. He said that there were tremendous opportunities for the two countries to join hands in the areas of IT, biotechnology, telecom, e-commerce, health care, chemicals, pharmaceuticals, engineering, agri-business and other areas of applied R&D among others.
Frankfurt woos Indian biotech firms
Frankfurt is ready to welcome Indian and other Asian biotech companies. Frankfurter Innovationszentrum Biotechnologie (FIB) is spearheading this drive and is talking to companies like Shantha Biotech and Biocon. FIB is a unit of the Frankfurt Economic Development Corporation, set up to promote investments in Frankfurt. FIB will be providing contacts with huge German pharmaceutical companies. It also plans to set up a 30m Euro venture capital fund, which will co-invest in research and development projects that Indian biotech firms undertake in collaboration with a German body. Further, Roland Koch, Prime Minister of Hessen State, is expected to visit India early next year to push ahead this project. Koch is scheduled to meet Indian IT and biotech companies in Hyderabad and Bangalore.
Roche Scientific to invest Rs 33 crore in India
 |
| Dr GL Telang, MD, Roche Scientific (India |
Roche Scientific Company (India) Pvt Ltd (RSCIPL), a wholly owned subsidiary of F Hoffman—La Roche plans to invest over 10 million Swiss Francs (about Rs 33 crore) in India over the next fiscal year. The investment areas will entail initiating global clinical trials in India, new therapies and extended access programs, said Dr GL Telang, managing director, RSCIPL.
Briefing the media about the future plans of the company Dr Telang said, " Roche India will increase its present strength from 40 to 55 by mid next year." Roche which has sold therapies worth more than 35 million Swiss francs in India in areas of oncology, virology, transplantation and in general pharma segments including areas like osteoporosis and epilepsy announced a reduction of prices of its existing therapies like Xeloda, Mabthera, and Cellcept by nearly 25 percent. With this Xeloda will now be available at Rs 18,000 down from Rs 30,000 per therapy, while the treatment cost of Mabthera has been brought down to Rs 80,000 from Rs 95,000. Cellcept will now cost Rs 16,500 instead of Rs 23,000 and the price of Herceptin has been reduced to Rs 100,000 from Rs 120,000, said Sangita Topiwala, head (planning and development), RSCIPL.
"Our decision to further invest in the country and reduce the prices of the therapies, reflects Roche's continued commitment to the Indian healthcare community and to innovation in scientific research," Dr Telang said. Roche is also looking at introducing therapies in the areas of dermatology and osteoporosis in India. Therapies like anti-CMV and treatment of bone metastasis are in the pipeline for India in the coming year, he added.
"Roche's focus is not just the diagnosis and treatment of manifest diseases. The integrated healthcare approach is increasingly offering ways of identifying and targeting diseases early, when their damaging effects can still be prevented and we intend to follow the same international practices of Roche in India, " said Juerg Haefelfinger, deputy director, Roche Pharmaceuticals, Basel. Continuing he said the Roche has 67 compounds in its portfolio, which are under phase 1-3 clinical trials.
Roche is in the business of "complete healthcare solutions", which includes diagnosis, treatment and monitoring. It has plans to introduce Avastin and Valcyte as part of its extended access program wherein a molecule, which is in an advanced stage of trials internationally, will be made available for treating Indian patients. However, Dr Telang clarified that the product introduced through this program may not necessarily be marketed in India. This extended access program would enable hands on experience for the Indian physicians and the ready availability of the treatment for needy patients.
Cadila Healthcare develops complex typhoid vaccines
Ahmedabad-based Cadila Healthcare Ltd (Zydus Cadila) is understood to have developed complex typhoid vaccine. Besides, it has developed recombinant protein products, which are presently undergoing toxicological studies. So far Cadila Healthcare has 41 Indian patents and 42 patents in foreign countries to its credit.
As an opportunity-focused organization, Cadila Healthcare believes that the biggest investment that an organization can make for tomorrow is by investing in research today. It has started working on developing and adding new products to its basket. It has a strong technical team of 300 people in its research program. The company's research focus comprises coverage of synthetic organic chemistry, process research and drug delivery (NCE, NDDS, biotechnology) with a growing focus on rapidly growing lifestyle-induced diseases.
The company's divisions, Zydus Biogen and Zydus Pathline, focus on immunologicals, vaccines, and diagnostics. In the year 2002-03, its biological and diagnostics product revenues accounted for nearly 2 percent and 3 percent share of its consolidated revenues of Rs 1,130 crore, respectively. The growth initiatives are likely to remain a sustainable feature of the company. It has also entered into a win -win alliance with Berna Biotech of Germany and Biosidus of Argentina, which enjoy a deep therapeutic presence in vaccines and in biotechnology.
Global outsourcing market is increasing at 12%
 |
| Dr G Hughes, scientific director, Technomark Consulting Services |
The $10 billion global outsourcing market for drug development is growing at 12 percent per annum said Dr Graham Hughes, scientific director, Technomark Consulting Services Ltd. Although there are about 1,600 CROs of various types in the world, Dr Hughes said only top 20 CROs have a market share of over 60 percent and this share is increasing. Of which over 50 percent are in public sector.
Against the rise in the R&D expenditure on developing New Chemical Entities (NCE), there has been a fall in the number of NCEs. This is making the cost per NCE to rise relentlessly. Citing the trends in the R&D, Dr Hughes noted that development times are not speeding up. The number of subjects shows little variation in recent years. Fewer trails are included in the dossiers. To over come these, he suggested to speed up the R&D activities and to reduce the time to market the product. Increasing the efficiency, reducing wastage, and concentrating on major indications will help cut the cost on R&D per NCE.
The industry is under unprecedented pressure and the companies are reluctant to change to different types of outsourcing. To over come these, he said, CROs have to look at other industry strategies. Companies have to judiciously balance between strategic and tactical outsourcing as strategic outsourcing takes time to implement and must be continually worked, as it isn't easier than the tactical outsourcing. Strategic outsourcing needs top-down corporate-wide approach and also needs attitude changes across the company. "In CROs, outsourcing is regarded as a core competency, while in other industries attitudes are characterized by trust, openness, long-term thinking, partnership, risk sharing and quality," added Dr Graham Hughes
Intas to launch biotech product by Q1 of 2004
 |
|
Dr Urmish Chudgar, director, Intas Pharma |
Experienced in the marketing of bio-generics and hepatitis B vaccine in the domestic market, Ahmedabad-based Intas Pharmaceuticals Ltd, has decided to install dedicated manufacturing infrastructure for development, manufacture and marketing of pharmaceutical products obtained through "recombinant DNA biotechnology".
Speaking to BioSpectrum, Dr Urmish Chudgar, director, Intas Pharma said the company has already invested Rs 26.50 crore in the project. The total project cost when fully completed is estimated to be Rs 35 crore. The maiden product would shortly undergo phase III clinical trials and is slated to hit the domestic market by the last quarter of this fiscal year. The company has also received permission to carry out animal toxicity studies on other products too.
Intas, with support from Technology Development Board, government of India, developed two protein-derived products—fabrin glue and lyophilized cryoprecpitates. Dr Chudgar added, "The opportunities in biotechnology and oncology products in the international markets give us the momentum to grow in near future."
It has embarked on an intensive program for development and analytical testing of new formulations including biotech formulations, with the objective of partnering with top multinationals for formulation research and providing regulatory support. An independent facility equipped with modern technology and manned by professionals is the focal point of this initiative.
Intas Pharma, besides stressing on newer areas like
biotechnology and oncology, continues to focus on cardiovascular,
neuropsychiatry and gastroenterological and pain management therapeutic
segments. Intas has a good international presence. About 20 percent of its
current turnover of Rs 293.23 crore is on account of exports to Latin American,
East Asian and European markets. Intas further intends to enhance its global
presence on its technology strengths and the quality of its products. It has
initiated marketing operations in developed markets with objective of achieving
a
critical mass and intends to form strategic business units to expand its
operations in the US, UK and the rest of Europe.
Ahmedabad-based Synchron Research Services Pvt Ltd, one of the top five contract research services organizations in the county, is targeting to double its revenue by end of this fiscal. For the year ending 2002-03, Synchron's revenue stood at around Rs 2.5 crore.
Speaking to BioSpectrum, Shruti Shukla, senior manager, business development, Synchron said, "We offer services designed to meet the specific needs of clinical development and registration of new pharmaceutical products and medical devices. We ensure confidentiality, reliability and quality to the sponsor. We adhere to the international standards of good clinical and good laboratory practices."
The experienced and qualified team at Synchron includes physicians, clinical pharmacologists, pharmacists, pharmaco kineticians, biostatisticians and other graduate staff. Starting with 12 beds, its clinical research unit—focusing on bioavailability studies— has a facility of 28 beds with adequate recreation and dining facilities to participating volunteers. "Now we are planning to increase the capacity to 36 beds," Shukla added.
Synchron has an onsite analytical laboratory, which houses sophisticated analytical instruments. It develops and validates bioanalytical methods according to ICH guidelines in a variety of matrices in support of clinical studies. To monitor the activities of the clinical studies, it has an independent ethics committee. "The ethics committee is headed by Prof. NS Parmar, director, institute of pharmaceutical sciences, Nirma University of Science and Technology, Ahmedabad and includes a practicing dental surgeon, social worker, advocate and some lecturers from the pharmacy colleges," she added.
"We have tied up with Covance to conduct phase I clinical trails. Our clients' list includes Wockhardt, Cipla, Shantha Biotech, Bharath Biotech, Alembic and Torrent. Since clinical trials /bioequivalence is a small part of the drug delivery system we find no competition in the CRO space in India, as we have been getting repeated satisfied clients," said Shruti Shukla. "I feel India needs 20 more CROs. India has more population with diverse patients' lists. We have less over heads compared to CROs in western world," she added.
Synchron offers feasibility studies, protocol development, investigator identification, independent ethics committee submission, regulatory affairs, clinical trail co-ordination, clinical trial project management data management, statistical data analysis, GCP training courses and bioavailability and bioequivalence studies. In the last four-and-half years, Synchron has done 110 bioequivalence studies and 10 clinical trails of which two studies have been completed. Synchron is also planning to tie up with the Nizam Institute of Medical Sciences to conduct bioequivalence studies.
Molecular Connections expands
Molecular Connections announced that it has expanded its infrastructure and moved the development center to a new location in Bangalore. The move will enable the company to enhance its service capabilities to meet the growing curation and annotation needs of its customers.
Commenting on the move, SR Vaikuntanath, vice-president (finance and administration) mentioned, "By using our ODC facility, partners can fulfill their needs for of high quality informatics service at lower costs and faster turnaround time along with high-regard for intellectual property."
Molecular Connections is a joint venture between Idea2solutions, an incubator promoted by the founders of the Dr Reddy's group and Institute of Infocomm Research, Singapore. It utilizes proprietary Natural Language Processing (NLP) based tools and expert in-house scientists to extract key biomedical information from literature and public databases. It has built Netpro, the single largest database of more than 30,000 protein-protein interactions extracted from literature and expert validated manually.
APIDC gets fresh commitments, CSIR to seek funds for its biotech projects
 |
| Sarath
Naru, MD, APIDC fund |
India's first national fund focused on biotechnology companies, APIDC-VCL, has received fresh commitments for Rs 10 crore from Bank of Baroda and Rs 5 crore from Punjab National Bank, taking the total to Rs 56 crore. It targets a total of Rs 150 crore corpus. It had earlier got commitments from various financial institutions, including Andhra Bank, LIC, GIC, UTI Bank besides the Andhra Pradesh government. It has invested to a tune of Rs 8 crore in Bioserve, Biotechnology, Genomik Design Pharmaceutical and Silico Insights.
In another development, The Council of Scientific and Industrial Research (CSIR) is in talks with APIDC Venture Capital for partnership for biotechnology projects. CSIR has a number of labs that are working on significant projects and APIDC Venture Capital will work with these labs to identify technologies and products that are currently under development and catalyze the process of bringing them to the market. "The idea is to work actively with these labs, identify their intellectual property and commercialize it," said Sarath Naru, managing director of the fund. Naru added, "CSIR has the distinction of filing about 184 patents in 2002. About 5-10 percent of the research can be commercialized. APIDC has already chosen 11 technologies, but it will shortlist and is expected to end up with four products." The project is modeled on similar lines like the Beacon Venture, a fund that is working with Boston University.
Two new facilities come up for Millipore India
 |
|
Francis J Lunger, chairman, CEO and president, Millipore, dedicating the Millipore India Process Development lab in Bangalore |
Francis J Lunger, chairman, CEO and president, Millipore, dedicated the Millipore India Process Development and Access Services laboratories in Bangalore in November. The Process Development Lab will assist Indian biopharmaceutical companies in developing and scaling up manufacturing processes for new biopharmaceuticals. Millipore provides key products and technologies for the scale-up of biotherapeutics, including chromatography and membrane technology. The firm also provides expertise in process engineering and protein chemistry.
Millipore India's Access Services Lab, the fourth of its type in the world, will assist Indian biotech and pharmaceutical customers in meeting their quality standards, and in meeting stringent local and international regulatory requirements. The lab will conduct validation, microbiological analysis and retention studies. It will also provide the much needed support and services to biotech and pharmaceutical companies for microbiology training and offsite services including quality systems, audit support, and process optimization.
Sudhir Kant, president, Millipore India, stated that the two new labs will help meet long-term needs of the pharmaceutical and biotechnology industries.
Kant also noted that Millipore India was partnering with the Biotech Institute to offer a structured and practical course for training of MTech (biotechnology) students. There is a shortage of such trained professional people in India, and worldwide.
Nandan Agro to unveil new formulations
Nandan Agro Farms is working on preparing seven formulations from an indigenous medicinal plant, safed musli. Botanically called chlorophytum borivilianum, the medicinal plant is rich in herbal steroids and versatile in therapeutic value. Nandan's first product, Bio Rhythm, has been positioned as the answer for Viagra. During the last seven years, the company has set up a commercial farming base for safed musli in various states through contract farming.
Accelrys to increase its Bangalore workforce
 |
| Mark J Emkjer, president, Accelrys |
Accelrys, the software subsidiary of Pharmacopeia Inc., a company involved in developing technology for better drug discovery, will be increasing its workforce in its Bangalore R&D center. The company whose Center of Excellence in Bangalore has been functioning since February this year said that it will continue to invest in its Indian operations. "We have presently close to 50 people in the R&D center here and we will be looking to increase that to more than 100 in the next eight months time," said Accelrys president Mark J Emkjer. The company has similar R&D setups in San Diego, USA and Cambridge, UK.
According to the company, the Bangalore center will be working on all its informatics products including chemical and material informatics product lines along with porting of two of its products to the Linux platform. The Accelrys product line spans the segments of bioinformatics, cheminformatics, matinformatics and modeling and simulation software. The center will also work on creating a common architecture and a unified, integrated platform for all the products.
"Traditionally most of our products have been confined to the Unix platform. The Bangalore team is currently involved in porting two of our expert modeler programs, Insight II and Catalyst, to the Linux platform. Both products should be introduced to the market by the end of the year," said Emkjer. Accelrys has partnered with IBM for this specific project.
He added that as far as the server side was concerned, "the battle is already won" by Linux but Windows will continue to rule on the desktop side for sometime in the future at least. The company is conducting a survey among its customers and will be ready to port products as and when customers evince interest on the same.
Accelrys India Operations VP Harsha Patel added, "As far as high end, modeling and simulation products are concerned, I think there is huge potential and opportunities for growth for Linux. It is the lower end of software, like the spreadsheet and word processing, that will continue to be dominated by Windows for sometime."
Emkjer also said that the company would be interested in future acquisitions of companies close to the space in which it operates. According to him, Accelrys should have a list of prospective companies to go after by the end of this year. When asked about whether the list will contain any Indian companies, Emkjer refused to comment though he did not deny the possibility.
The company, which was formed in 2001 as an amalgamation of five companies, notches close to $100 million in revenue, with US contributing 50 percent the rest being divided among Europe and APAC.
Emkjer believes that the biotech industry can see a better future if it adopts the process of 'co-opitition', where companies will work together, accelerate the drug discovery process and bring down drug costs. He also believes that such integration is not far in the future. This head of the software arm of Pharmacoepia Inc., whose products aid in the drug discovery process, believes that the Bangalore R&D center forms a strategic link in the company's development plans and promises huge investments into the same.
Sathya Mithra Ashok
|
Gujarat to release BT policy in late December The government of Gujarat is expected to release the draft biotech policy by December-end or January next year. The sources in the government said that the draft report was ready and it will be placed before the cabinet for approval. Rajesh Kishore, secretary, Department of Science and Technology, government of Gujarat, said, "We have carefully studied the biotech policies of other states. We have taken all steps to give prominence to promote biotech industry in a big way in the state. We have tried to provide the best biotech policy."
GIDC developing Biotech park at Vadodara The Gujarat Industrial
Development Corporation (GIDC) has already commenced the development of
biotech park at Vadodara. GIDC earmarked 90 hectares of land at Savli near
Vadodara. The park will be equipped with incubator with standard design,
state-of-the-art common R&D lab, technology and information center and
research
|
