• 7 May 2007
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BioNews

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Biocon Group closes FY 2007 at Rs 990 crore

Dr Arun Chandavarkar, COO, Biocon, announced Biocon's financial performance for the financial year ended March 31, 2007. Biocon reported a total income of Rs 990 crore compared to the previous year's business of 793 crore, up by 25 percent. Consolidated revenues from the biopharmaceuticals and enzymes business grew 20 percent to Rs 823 crore from Rs 688 crore, accounting for 83 percent share of the operating revenues in FY 2007. Revenues in the research services and licencing grew by 63 percent to Rs 163 crore from Rs 100 crore, contributing 17 percent to operating revenues in FY 2007. Gaining results from its strong R&D, Biocon increased its R&D revenue expenditure by 86 percent to Rs 38 crore. Q4 FY 07 registered an impressive PAT growth of 15 percent. In FY 2007, Biocon's focus areas have been insulin, branded formulations, investments and technology. Following the success of Insugen in India, it is entering the US market through a marketing company, whose name remained undisclosed. Biocon has been the largest vertical producer of immunosuppressants.

Commenting on the results, Kiran Mazumdar-Shaw, CEO, Biocon, said "Our strategy of building global scale in our products and services businesses has delivered robust profits. This has enabled us to invest incrementally in our innovation led research programs which will deliver attractive shareholder returns in the coming years." In the years ahead, Biocon will continue to make significant investments to progress its innovation pipeline.

 

Reliance to set up life sciences fund

Reliance Life Sciences, an initiative of Reliance Industries Ltd led by Mukesh Ambani, is exploring the potential of launching a new India-based seed fund for the life sciences industry including biotechnology. In this regard, Reliance Life Sciences has entered into strategic partnership with MPM Capital, a US-based global investment management firm that manages $2.5 billion in assets through its BioVenture Family of venture capital funds and MPM BioEquities public market fund. Investing about $45-50 million in this venture capital, Reliance has become a limited partner in MPM Capital's newest fund – MPM BioVentures IV of $650 million.

Dr William Greene, general partner, MPM Capital, said, "MPM and RLS will explore investments in Indian-based companies with a focus on more conventional pharmaceutical products as well those within novel arenas including molecular diagnostics, biosimilars, and stem cells."

Sharing his views about this initiative, Mukesh Ambani said, "The MPM Capital – Reliance Life Science strategic alliance brings about a new framework for fostering innovation by synergizing enterprise and discovery capabilities outside India with people and development competencies in India. With MPM, we will look in the US and locally for co-investment opportunities."

Dr Greene further said, "We expect the collaborative effort to help Reliance deliver on its own vision of coupling US innovation and entrepreneurship with talent and service delivery in India."

KV Subramaniam, president and CEO, RLS, added, "Central to our vision of building a biotechnology industry in India is the creation of a life sciences ecosystem. This work has been ongoing for a few years, but what we have in place now is only the tip of the iceberg. For example, we've invested significantly in a life sciences campus in India. By investing in competencies and infrastructure, by replicating the approach in other biotech-related disciplines, and by working with MPM, we believe the partnership can enable a vibrant life sciences sector in India."

 

Parkison's conquered through stem cell therapy

Bangalore-based Manipal Hospital claims to have made a major breakthrough in the treatment of Parkinson's disease utilizing stem cell therapy.

The patient, Andrew Kisana, a US national, was presented before mediapersons at a press conference organized by the management of the Manipal Hospital.

The doctors said that the patient's bone marrow was harvested at the regenerative medicine department and the mesenchymal stem cells were injected into the part of the brain, which was affected because of Parkinson's disease. Kisana has so far received three injections. This was the first time such a major effort was attempted in India for treatment of Parkinson's disease.

Kisana was suffering from the degenerating disorder for 15 years. After undergoing intensive drug therapy, lesion and deep brain stimulation (DBS), he came to Manipal Hospital.

After stem cell treatment last year, he has shown remarkable recovery in his symptoms and has started walking without support. There has also been significant reduction in body tremors. Since the last six months, his medication for Parkinson's disease too has been withdrawn, doctors said. Andrew Kisana himself typed his responses to queries on his laptop. "The successful recovery of the patient would give hope to scores of Parkinson's cases which affects one per cent of the population. The condition largely manifests in cases above 50 years, but there are younger people being affected. Stem cell therapy now gives such patients a new hope. However, we need to observe the long term clinical effects in larger number of patients to decide whether it is primary or secondary or supplementary treatment option for degenerative disorders," said Dr NK Venkataramana, director, Manipal Institute of Neurological Disorders.

The hospital's regenerative medicine department is currently carrying out clinical trials in stem cell therapy in 15 spinal cord injury patients besides researching in the use of stem cells in patients of heart attack and leg ischemia, said Satish Totey, chief scientific officer of Stempeutics Research (the regenerative medicine research arm of the hospital).

Ramesh, a patient with spinal cord injury, was treated with stem cell injection. "After the treatment I am able to pass urine and can move my hands. My sensations have also come back," he said.

The Manipal Hospital would launch a stem cell research centre, which would offer courses in regenerative medicine and treatment, R Basil, CEO of Manipal Health Systems, announced.

 

Polyclone, Eppendorf launch eprime

Polyclone Bioservices, a company that develops and delivers scientific software applications and services to biopharma, biotech and academic institutions, has announced the launch of its first product Eprime. Eprime is a software application to design primers for qualitative real time PCR studies. It designs PCR primers and probes for SYBR green, Taqman and Molecular Beacon studies and assays. "In the first year, Polyclone is looking to install about 50-100 licenses in India and is jointly working out the pricing models with Eppendorf-both for domestic and global markets," said Navin Kulkarni, CEO, Polyclone Bioservices. Eprime will be sold by Eppendorf along with the latter's PCR systems.

It maybe noted that Polyclone aims to develop platforms that support genomics and proteomics research, high throughput screening assay development for lead discovery and stem cell research. It plans to provide support system to stem cell research and bring out a stem cell validation and Q&A assay for real time PCR by next year too. Polyclone is also involved in cancer research (cervical cancer) and is developing its own micro array for breast cancer, which it hopes to be launch by next year.

 

AIBA, KOBIOVEN sign MoU

Korea Bio-Venture Association (KOBIOVEN), Seoul and All India Biotech Association (AIBA), New Delhi signed an MoU for mutual exchange and cooperation between the member companies of both Associations. Dr Jong-Sei Park, president of KOBIOVEN and Vivek Singhal, president, AIBA signed the agreement. This is a large range agreement expected ultimately to materialize the growth and development of bioventure enterprises of both nations.

KOBIOVEN and AIBA jointly organized a one-day Bio Road Show in New Delhi to mark the collaboration. Representatives of a large number of Korean bioventure companies like Bioneer, BioMax, BioR&Ds, CellBioTech, Istech, Korean Bio Tech and Indian biotech companies participated in the event. The Korean companies made presentations about their operations and products/technologies, ready for transfer, which created a lot of interest in their Indian counterparts.

 

USV to start clinical trials on hGH

USV Ltd, the largest manufacturer of Metformin, an anti-diabetic drug, has been working on six recombinant products and two peptides. All are in different stages of development of which two are in late stage of clinical trials.

Prashant Tewari, managing director, USV Ltd, said, "We are expected to complete the pre clinical trials on human growth hormone by end of April and will start the clinical trials from June. We are hoping to introduce this in the market post 2008 along with nesiritide.

He further said, "We have been investing about 7 percent of our sales revenue each year on research and development. At present over 180 scientists with 34 having PhDs and 149 having post graduate degrees are working at our state-of-the-art laboratories. We are constantly on the lookout for alliances of mutual interest benefiting from developments in our laboratories."

BioNews New Page 2

Dr Lal PathLabs launches clinical research services

(From L-R) Nitin Jain, head, international business and clinical research, Dr Arvind Lal, CMD and Dr OP Manchanda, COO, at the launch.

Dr Lal PathLabs has launched its clinical research services by opening a dedicated state-of-the-art clinical trial laboratory (central lab) at Gurgaon.

Dr Arvind Lal, chairman and managing director, Dr Lal PathLabs, said, The state-of-the-art 4,000 sft facility set up at Gurgaon is exclusively for clinical trial operations. Besides we are also setting up a mega 65,000 sft laboratory at Rohini in North Delhi, which is expected to be in place by 2008.

He further said, "We are increasing our focus on clinical trial business for three principal reasons -global pharma companies increasingly outsourcing clinical trials to CROs, India's unique genetic diversity being ideal for running clinical trials, and our expertise in conducting laboratory tests, which we have been conducting for many companies for the last 10 years."

Nitin Jain, head, international business and clinical research, said, "For the year ending March 2007, clinical research services, which was earlier a part of the main business has contributed to close to about 8 percent to the total sales revenue of Rs 100 crore. With the launch of the dedicated facility and a separate team to look after this service, we are looking at a target of Rs 10-15 crore for the current financial year. He further said, Besides taking up projects from the domestic companies we are also keen to work for multinational companies. In this regard we are appointed representatives in US and Europe.

Dr Om Manchanda, COO, Dr Lal PathLabs, said, "The prime location of the Gurgaon laboratory, barely 15 minutes away from Delhi's airport will ensure that samples from all over the world reach the lab in the least possible time. The easy access will play a vital role in LPL's success in the clinical trial business."

 

Cabinet gives nod for joint research in vaccines

The Union Cabinet has given its approval for signing the agreement in the field of vaccine research by India and International Institute of Vaccine, Korea.

The signing of the agreement does not have any financial implication for the Central government. On the other hand, it will give opportunities for inputs to the direction and priorities of International Vaccine Institute (IVI), which would be beneficial to India. However, the agreement shall encourage cooperation between India and the International Vaccine Institute, Korea. As per the agreement, India could offer a place on Board of Trustees, and would be able to play a role in formulation of international policy related to vaccines.

Signatories to the IVI Establishment Agreement as of March 2002 are Republic of Korea, China, Brazil, Egypt, Pakistan, Netherlands, Sri Lanka, Sweden, Bangladesh, Bhutan, Ecuador, Indonesia, Israel, Jamaica, Kazakhstan, Kyrgyzstan, Lebanon, Malta, Mongolia, Myanmar, Nepal, Oman, Panama Papua New Guinea, Peru, Philippines, Romania, Senegal, Tajikistan, Thailand, Turkey, Uzbekistan, Vietnam and World Health Organization.

The IVI is an autonomous organization set up at the initiative of the UN Development Programe under the Vienna Convention of 1969.

 

Quintiles India opens central lab in Mumbai

Dennis Gillings, chairman and CEO of Quintiles Transnational Corp, and his wife inaugurating the central lab.

Quintiles India celebrated its 10 years of presence in India in style by opening its new central lab in Mumbai. With the inclusion of central lab to its list of services, Quintiles India now offers all services to its customers in India that are on offerings at the parent organization. Besides its central lab and clinical research businesses, Quintiles India offers electrocardiogram (ECG), interactive voice response (IVR) and data management services.

The new lab expands Quintiles' global central laboratory network and enhances the suite of services offered in the country to support global and regional clinical trials. It will provide access to Quintiles laboratory kits, ensure that all study samples are processed using consistent methods and completed in a timely manner, and will oversee the data transfer for inclusion in the Quintiles Laboratory Information Management System (QLIMS) and the protocol-specific database.

Dedicating the new central lab in Mumbai, Dennis Gillings, chairman and CEO of Quintiles Transnational Corp., said, "The opening of this new lab in India symbolizes the rapid growth and achievement of our team here, as well as the acceptance of India as a center for clinical research. Establishing an office in Ahmedabad in 1997, we have added offices in Mumbai and Bangalore with a full complement of services, expanded our clinical research staff to 750 and have conducted more than 700 global trials across business lines. We also were involved in the training of hundreds of investigators on GCP guidelines and helped put India on the world map for clinical research."

Tom Wollman, senior vice president, global central laboratories, said, "The new lab is harmonized with Quintiles' global network. The India lab has begun proficiency testing for certification by the College of American Pathologists (CAP), and we look forward to adding another lab with this well-recognized global standard of quality to our global footprint.

BioNews New Page 3

MS Swaminathan becomes Parliament member

President APJ Abdul Kalam has nominated renowned agricultural scientist, Dr MS Swaminathan to the Rajya Sabha. Membership to the Rajya Sabha is limited to 250 members, 12 of whom are chosen by the President of India for their expertise in specific fields of art, literature, science, and social services. He was sworn in as Rajya Sabha member in the last week of April.

Dr Swaminathan, has been a recipient of various awards, including the World Food prize in 1987, the Tyler-Honda prize in 1991 and the United Nations Environment Programme (UNEP) Sasakawa award in 1994. He has been Director General of the Indian Council of Agricultural Research and the International Rice Research Institute. He was also the BioSpectrum Life Time Achievement Award winner in 2003.

 

Meet on healthcare biotechnology focuses on personalized medicine

The Innovative Center for Biosciences organized a national conference on healthcare biotechnology on April 20-21, 2007 at IISc, Bangalore. The conference was meant for exchange of knowledge among the professional fraternity for mutual interaction and sharing of knowledge among the fellow members for overall betterment of healthcare industry.

Distinguished guests from the industry and professional fraternity from the country including Dr Padmanabhan, former director, IISc, Bangalore and Vidyashankar, secretary, IT and BT, participated in the two-day conference. The conference highlighted the important characteristics of Indian healthcare biotech firms including biomedical systems, biopharmaceuticals, bioinformatics, nanotechnology, IPR and attention was paid towards the need for development and application of personalized medicine.

The advent of personalized medicine will benefit all the healthcare players, pharma companies, diagnostic companies, patients and physicians, the speakers noted. This would result in making better medication choices.

Dr SK Mitra, Himalaya Healthcare, drew attention towards the draining of students specialized in biotechnology into the BPO sector, resulting in a shortage of skilled manpower.

The conference also discussed new developments, new materials and their contribution to the healthcare biotech industry. "Healthcare industry needs new investments. It needs new productivity enhancing measures and a new wave of entrepreneurship" said Dr Padmanabhan.

Vidyashankar said, "India has been successful to catch up with the rest of the world and the Bangalore biotech park, with an investment of Rs 450 crore, makes it ahead of the rest of the country."

 

Wockhardt signs in licensing pact with Advanced Biotech

Wockhardt has signed an in-licensing agreement with US-based Advanced Biotechnologies to market a patent-protected product, Kelocote, a unique silicone gel to treat scars. And it plans to launch Kelocote in the domestic market in the third quarter of 2007.

Habil Khorakiwala, chairman, Wockhardt, said, "Wockhardt is committed to cater to the unmet medical needs of Indian patients. We will soon introduce a patented gel Kelocote to treat scars and keloids arising from accidents, burns, surgery and acne.

Kelocote is currently marketed in North America, Europe, Australia and South-East Asia. In India clinical trials are in progress. The clinical data from various countries has already proven its efficacy and cost-effectiveness.

Kelocote is a unique silicone gel for scars arising from accidents, burns, surgery and acne as well as skin disorders such as dermatitis and varicella. It is also useful in treating keloids, which are fibrous growths formed over healed wounds. Kelocote is available as an easy-to-apply gel form with self-drying action.

 

Indo-Australian Biotech Fund set up to support joint research activities

India and Australia have signed a MoU to foster cooperation between the two countries in the field of biotechnology. Under the MoU signed between the DBT and the Department of Education Science &Training, Government of Australia, an Indo-Australian Biotechnology Fund has been set up. The fund consists of A $6 million from the Australian government with a matching Indian grant over five years.

The objective of the fund is to develop and support collaborative research activities, which draw upon complementary science and technology strengths in India and Australia. It will support Indian and Australian scientists, from both the public and private sector, for collaborative and leading edge science and technology in order to contribute to the economic, social and environmental well being of both countries.

In the first round, the following priority areas have been identified: biomedical devices and implants, stem cells, vaccines/medical diagnostics, transgenic crops, nutraceuticals and functional foods; and bioremediation.
Meanwhile Kapil Sibal, the Union minister of science and technology and earth sciences, has announced seven new projects and two workshops that will facilitate and support biotechnology research collaboration between India and Australia. The successful proposals are from the research areas of transgenic crops, vaccines, biomedical devices and implants, bioremediation and nutraceuticals.

 

EGOM lifts current freeze on SEZs

The Empowered Group of Ministers (EGOM) on Special Economic Zones (SEZs) decided, inter-alia, to lift the current freeze on SEZs, with tighter rules and prescribed a ceiling on the size of SEZs, which has now been fixed at an upper limit of 5000 hectares. EGOM met on April 5 in New Delhi and discussed various issues relating to SEZs.

A few decisions taken at the EGOM meeting are as follows:

Upper limit of the area required for multi product SEZs to be fixed at 5000 hectares. However, the state governments may prescribe a lower limit. The minimum processing area limit be fixed uniformly at 50 percent for multi product SEZs as well as sector specific SEZs.

In respect of pending applications for SEZs, these may be processed for in principle, formal approval, notifications subject to the condition that the state governments would not undertake any compulsory acquisition of land for such SEZs.

Notification in respect of the 83 cases of formal approvals, documents for which have been submitted by the developers may be issued by the department of commerce after due verification, including issues concerning any dispute relating to land. Major amongst pending notifications are Ramky Pharma City SEZ at Visakhapatnam, and Wockhardt Pharma SEZ at Aurangabad.

 

India, EPO sign MoU on bilateral cooperation in IPRs

India has signed an Memorandum of Understanding (MoU) with the European Patent Office (EPO). As part of the MoU a one-year work plan that includes programs for human resource development, automation and data exchange between the two offices has been finalized.

The MoU was signed between the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) and EPO by Dr Ajay Dua, secretary, department of industrial policy and promotion (DIPP), ministry of commerce and industry and Prof. Alain Pompidou, president of the EPO, in the presence of Kamal Nath, minister of commerce and industry.

An important component of the cooperation program which will run from mid-2007 to mid-2008 is the provision for training at the European Patent Office for 10 senior patent examiners from India; and training by three EPO experts of 20 to 30 patent examiners in India.

 

Apollo Hospital Group, IBM partner to introduce 'Health Hiway'

IBM and Apollo Hospital Group have announced a joint go-to-market initiative to build Health Hiway, a national health data network to provide a diverse set of software applications for the healthcare segment.

Conceptualized and developed by Apollo, based on IBM's IT infrastructure, the Health Hiway initiative will facilitate the rollout of hosted applications that are global best in class point of solutions, with the objective of creating a basket of offerings that will create maximum impact on the hospitals' clinical and financial performance. IBM will offer its hardware, middleware and services infrastructure, while Apollo Hospitals Group will offer its healthcare domain expertise.

Making the announcement at a press conference on April 12, Ashvani Srivastava, president strategic initiatives, Apollo Hospitals Group, said, "This initiative is our effort to offer industry and global best practices to the other players so that the industry as a whole benefits from this strategy. Standard based, common platform initiative will bring cost containment, yet more importantly use this data for patient care and later for research and analytics."

Commenting on the initiative, Mohammed
H Naseem, vice president, healthcare, IBM India said, "Other than a few large hospitals in India that have successfully implemented IT, most seem to be grappling with too much choice and very little understanding to evaluate the options. Vendor approach also does not make things simpler, and most implementations do not last beyond a few years. Our technology experience coupled with Apollo's domain expertise will enable us to serve the industry with efficient and effective solutions."


Roche Scientific launches Neulastim in India

Roche Scientific Company (India) has introduced Neulastim (pegfilgrastim) in India. Neulastim, to be administered as a single fixed dose per chemotherapy, is priced at Rs 22,000 per unit of 10 vials. It is indicated for incidence of febrile neutropenia (fever associated with severe drop in infection- fighting white blood cells) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Dr GL Telang, managing director, Roche Scientific Company (India), said, "Neulastim will play an important role in supportive care of cancer patients by providing tailored and more convenient protection against febrile neutropenia, a serious side effect of chemotherapy treatment, to the patients undergoing myelosuppresive chemotherapy."

He further said, "Studies conducted on 100 patients for a period of 45 days in India were satisfactory. This pre 1995 molecule has been imported from Switzerland and distributed to the patients in India by Taksal Pharma Pvt Ltd.

In India, Roche's therapeutic focus is mainly in the segments of oncology, virology and transplantation. It has launched in all 19 products including 12 products in the oncology space, two in virology and four in transplantation and one in hematology. Besides carrying out the scientific activities, Roche participates in the local phase IV and global clinical trials. At present it has five projects on hand with few are in phase III studies.

 

"No proposal before government to ban sale of GM seeds"

The government has no plan to impose a ban on the sale of genetically modified (GM) seeds in the country. Informing this in the Lok Sabha on March 12, Kanti Lal Bhuria, the minister of state for agriculture, said, There is no proposal with the government to ban production and sale of GM seeds duly approved by the GEAC on the basis of their suitability in the various agro-climatic zone with regards to their performance.

At present Bt cotton is the only GM crop approved for commercial cultivation by the Genetic Engineering Approval Committee (GEAC) in the ministry of environment and forests, on the basis of environmental and bio-safety evaluations. Harmful effects of Bt cotton seeds on human and animal health, plant life and environment have not been reported. Bt cotton seeds are being produced and marketed in the country by private seed companies. The government has organized public awareness programs to educate the farmers about the risks and benefits associated with the GM crops.

 

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