• 12 May 2006
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Biocon's new biologics facility inaugurated


Biocon's new biologics facility inaugurated

Finance minister, P Chidambaram recently inaugurated Biocon Biopharmaceuticals, claimed to be India's largest multi-product biologics facility at Biocon Park, Bommasandra Industrial Area - Phase IV.

Biocon established Biocon Biopharmaceuticals Private Limited (BBPL) in collaboration with CIMAB, representing the Centre of Molecular Immunology, Cuba. The state-of-the-art cGMP compliant facility is designed to manufacture a broad range of novel and bio-similar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon, said, "The facility is also designed to cater to contract manufacturing needs of international biopharmaceutical companies. Biocon's multi-disciplinary technological capabilities and growing expertise in clinical development has enabled rapid advances in the field of protein therapeutics. Biocon believes that such novel products of biotechnology will provide quantum growth drivers for the future."

The l,20,000 sft building spread over three floors comprises process, laboratory and technical support areas. The new facility represents a significant advancement in terms of technical sophistication over Biocon's existing facilities and comprises three distinct modules - cell culture module for monoclonal antibodies and other cell culture products; aseptic formulation and filling module for sterile products in vials, cartridges, lyophils and syringes; and quality control module.

Dr Arun Chandavarkar, president, operations, said, "The new facility is benchmarked to the highest regulatory standards and will position Biocon and Biocon BioPharmaceuticals as a key global player in the field of cell culture fermentation technology. The plant is designed with an in-built 4-fold expansion capacity keeping in mind Biocon Biopharmaceuticals' research pipeline and global market trends. This new facility will provide immediate job opportunities to over a hundred scientific and technical personnel."

IMRB survey reconfirms benefits of Bt cotton

As against the general notion about the failure of the cotton crop, IMRB International (a part of the WPP's Kantar Group of Companies) with over three decades of market research experience in India has found that farmers who planted Bollgard cotton earned an additional Rs 2,100 crore in income based on 3.125 million acreage penetration for the 2005 crop.

According to Nikhil Rawal, senior vice president and executive director, IMRB International, "This second IMRB survey of Bollgard has reconfirmed for us the earlier findings that farmers stand to benefit from the usage of this technology. A total of 31 districts were covered as part of the research out of the 80 cotton districts across cotton growing states in India. Better yields and less pesticide usage have been the key triggers for farmers choosing Bollgard over conventional cotton."

The IMRB International survey estimated that there has been a 64 percent or 4.16 quintals per acre increase in Bollgard yields when compared with conventional cotton. The net profit increase for farmers using Bollgard is Rs 6,727 per acre or over 118 percent. It also observed that there is a reduction of an average 2.4 pesticide sprays against bollworm that translates to a 25 percent reduction in total pesticides spend.

IMRB International interviewed 4799 farmers across 31 cotton-growing districts in Punjab, Haryana, Rajasthan, Andhra Pradesh, Karnataka, Tamil Nadu, Madhya Pradesh, Maharashtra and Gujarat. This survey reconfirms that for the fourth successive year, the benefits of Bollgard cotton to Indian farmers included better yields, reduced pesticide use and higher profits.

ICRI partners with Cranfield University

To drive an international perspective to clinical research education in India and to deliver on India's growing demand for skilled clinical research professionals, Mumbai-based Institute of Clinical Research (India) has entered into an academic alliance with Europe's research led institution, Cranfield University, the UK. This alliance would further the cause of ICRI in India in grooming professionals in clinical research to face exciting challenges posed by the pharmaceutical sector and also pave the way for new career opportunities in this field.

An agreement to this effect was signed between the two collaborating organizations in the presence of Vicky Treadell, the deputy high commissioner, British High Commission.

Commenting on the alliance, Dr SK Gupta, dean, Institute of Clinical Research (India) said, "The association with Cranfield University would help the ICRI to impart innovative education through an international exchange of knowledge dissemination in clinical research, which would further help deliver on the growing demand for highly skilled clinical research professionals in India."

Speaking on the occasion, Prof. Clifford Friend, deputy vice chancellor, Cranfield University said, "This alliance gives us an opportunity to address the growing demand for clinical research professionals in India. The perfect combination of ICRI's networking with the Indian pharmaceutical sector and their current course orientation and Cranfield University's distinctive competences in biomedical sciences and clinical research data studies bring immense potential to furthering the cause of clinical research in India."

Cranfield University would undertake responsibility for the quality academic orientation in clinical research and training methodologies, evaluative studies, project assessment, knowledge exchange and final certification of Cranfield-ICRI's two-year full time Masters program in clinical research.

Shasun to launch its first rDNA product in 2007

Recognising the role of biopharmaceuticals in the future of global pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle quality and strengthening corporate profitability, Chennai-based Shasun Chemicals and Drugs Ltd, a premier service provider to the pharmaceutical industry has been engaged in developing technologies for recombinant biogenerics using the microbial expression platform. And it will launch its first biotech product r-Streptokinase in 2007.

Speaking to mediapersons in Mumbai, Govindarajan, CEO, Shasun Chemicals and Drugs Ltd said, "One of our product under development has successfully cleared animal toxicity studies and is under clinical testing. Meanwhile, we have developed capabilities in the area of biotechnology services like upstream and downstream processing, analytical and quality assurance. And the cGMP production facility for biopharmaceutical proteins is nearing completion. We are looking for tie-ups with suitable co-marketing partners to launch these products in the Indian market.h

Shasun offers services in research, development and manufacturing (including Contract Research and Manufacturing Services- CRAMS) and set up its biotech R&D facility in 2002. Currently it has a team of 22 scientists. It is also looking for tech transfer and discussions are on with a couple of companies for the same, Govindarajan said.

Shasun reported a significant growth in the business of CRAMS as its revenue grew to Rs 38 crore in 2005-06 from Rs 24.5 crore (2004-05). The company recently acquired the pharmaceutical custom synthesis business of the Rhodia Group, the UK and is targeting to close FY07 with a Rs 750–800 crore and FY08 with Rs 1000 crore.

Indian groups oppose patenting of AIDS drug

The Indian Network of People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers' Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds.

"We are objecting to the patenting of Combivir because it is not a new invention but simply the combination of two existing drugs. More importantly, the granting of such a patent risks increasing the cost of anti-retroviral treatment for many people living with HIV/AIDS, thereby further increasing the burden on developing countries already struggling to treat patients," said KK Abraham, president of INP+. Combivir is a widely used fixed dose combination and is used extensively in projects run by international aid organization Medecins Sans Frontieres (MSF). Almost all the Combivir used by MSF is generic. India, Burkina Faso, Mongolia, Central African Republic, Malawi, Peru, the Republic of Kyrgizstan, Cambodia, Ukraine and Swaziland are other countries also identified by the Global Fund as using generic Combivir, the release said.

Mascon files its first patent in bioinformatics

Mascon Life Sciences has filed its first patent, which is also probably India's first patent as well, in the bioinformatics arena. This invention is in the field of theoretical biology. Here the DNA is converted into a unique signal, which is further processed in order to extract the needed biological features. The authors for the invention are Vivek Kumar Singh, Vivek Gangadhar Mahale and Dr Avinash Purusottam Agnihotry.

"This patent is in the basic sciences area and is going to revolutionize the entire bioinformatics research", commented Vivek Mahale.

"We have developed different mathematical models and functions for different biological features. The theory of decoding the DNA sequence into a unique signal is of very basic in nature and has produced remarkable results when applied to extract the features from a genome", said the Vivek duo.

According to Vivek Singh, "This work is in true essence the genius of mathematics applied to biology". He further added, "We have efficiently tackled problems like gene finding, promoter prediction, splice site detection, alternate splicing codon degeneracy and phylogenetic cluster analysis. The proposed algorithm was found far more efficient and accurate than even presently available ab-initio methods for coding region identification." "This is a fantastic job. This is the very first patent we have ever acquired as a group and a great accomplishment", said Gowri R Shanker, director, operations, Mascon Global Ltd.

The patent has been filed as Indian Patent vide Patent Application No. 953/DEL/2005, and the US patent has been applied for. The patent is titled "Method for conversion of DNA sequence to a number string and application therefore in accelerated drug design".

Panacea Biotec opens pharmaceutical formulation plant at Baddi

Panacea Biotec has commenced production in its new pharmaceutical formulation plant at Baddi, Himachal Pradesh with an investment of around Rs 45 crore. This plant is in compliance with global standards including US FDA and UK MHRA, SA MCC and WHO cGMP.

Situated amidst picturesque surroundings in the state of Himachal Pradesh, Panacea Biotec's facility in Baddi is spread over 70,000 sm and will cater to the manufacturing of oral and topical pharmaceutical finished dosage forms. The facility is equipped with modern equipment and machinery to meet the regulatory standards of the US, European and South African markets.

The Baddi facility with high capacities and scope for future expansion is designed to produce various formulations viz. tablets, capsules, ointments and liquids. The facility has an installed capacity of 900 million tablets, 120 million capsules, 12 million ointment/gel tubes and 1.2 million litres liquid orals per annum.

Inaugurating the plant, Rajesh Jain, joint managing director, said, "Our Baddi facility is a showcase of the latest in modern technology and is equipped with ultra modern and sophisticated machines and integrated packaging lines. The plant will produce high quality healthcare products accessible and affordable for all. This facility will give a competitive edge to the company as we continue to innovate and step up our growth strategy. This new manufacturing facility will support our future growth and facilitate rapid rollout of new products".

Emcure Biotech to conduct clinical trials of TNK

Emcure Biotech to conduct clinical trials of TNK-t- PA

Emcure Biotech, a Pune-based company has received approval from the Genetic Engineering Approval Committee (GEAC) to conduct clinical trials of r-Mutant Tissue plasminogen Activator (TNK-t- PA) subject to DCGI clearance. Emcure proposes to conduct open label multi-centric non-comparative clinical trials to assess the efficacy and tolerability of TNK-TPA in the treatment of acute myocardial infraction at six centers with at least five patients from each centre.

Emcure that currently markets a basket of products such as Erythropoietin (Vintor and Epofer), Granulocyte Colony Stimulating Factor (Emgrast) and hormones such as FSH, HCG and HMG (Materna range), has been carrying out research to create a range of life saving recombinant human biogenerics.

Emcure has a world-class R&D facility with segregated areas for mammalian and yeast/bacterial cell based research as well as upstream and downstream processing facilities. It has a team of experienced research scientists and technologists with expertise in rH gene technology, process optimization and downstream processing for biotechnology. The current pipeline comprises products focusing on nephrology, oncology, cardiovascular and gynaecology. Emcure plans to offer a portfolio of biopharmaceuticals including growth hormones, gynaecological and infertility hormones, oncology products, nephrology products and thrombolytics.

Biocon's net profit falls 12 percent

Biocon Ltd posted a net profit of Rs 1.74 billion in fiscal 2005-06 as against Rs 1.98 billion in 2004-05, registering a negative growth of 12 percent year-on-year (YOY).

Its total income, however, increased by nine percent for the fiscal year under review to Rs 7.93 billion as against Rs 7.28 billion a year ago.

For the fourth quarter (January-March 2006), the company posted a net profit of Rs 480 million as against Rs 420 million in the same period the previous year, registering a 13 percent increase YOY.

Also for the fourth quarter, total revenue is Rs 2.15 billion as against Rs 1.78 billion for the same period a year ago, a rise of 20 percent.

Biocon chairperson Kiran Mazumdar-Shaw said, "We have sustained a healthy 30 percent operating margin for fiscal 2005-06 despite a fiercely competitive environment. This enables us to continue to invest in our discovery-led research programs."

GSK to import Papilloma virus vaccine for clinical trials

GlaxoSmithkline (GSK) Asia Pvt Ltd, Mumbai has received green signal from the Genetic Engineering Approval Committee (GEAC) to import Cervarix human Papilloma virus vaccine from its parent company GlaxoSmithkline (GSK) Biologicals, Belgium for conduct of phase III B clinical trials in India.

According to reports, GSK proposes to conduct a double blind-randomized, controlled study to evaluate the immunogenicity and safety of the Cervarix human Papilloma virus vaccine in Indian females aged between 18-35 years.

After detailed deliberations, the committee that met on February 8, 2006 under the chairmanship of BS Parsheera, additional secretary, Ministry of Environment and Forests and chairman, GEAC accorded approval for conduct of phase III B clinical trials with Cervarix human Papilloma virus vaccine in India subject to DCGI clearance.

Roche launches Tarceva in India

Roche Scientific Company (India) Pvt Ltd, a part of the Roche Group has introduced Tarceva (erlotinib), a novel therapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen in India.

Speaking to mediapersons in Mumbai, Dr GL Telang, managing director, Roche Scientific Company (India) Pvt Ltd said, "Tarceva is an innovative breakthrough in the treatment of lung cancer. It is the only epidermal growth factor receptor-inhibitor to have demonstrated a survival benefit in lung cancer. It has been approved in the US since November 2004 and in EU since September 2005."

Giving details about the product, he said, "It is an oral tablet taken once a day and has the potential to treat many types of solid tumors. Tarceva will bring in a ray of hope to sufferings by alleviating the severe and debilitating symptoms that characterize advanced diseases such as cough, pain and breathlessness. The three-month treatment will cost Rs 3.30 lakh. It has been working with government and regional cancer centers across the country so that the therapy would reach the needy."

Roche has already recruited 15 patients in the last three months for the therapy under the Expanded Accessibility Program that aims at promoting the therapy among the Indian patient community. More than 1,69,000 people are diagnosed each year in India with cancer of the lungs and bronchi.

Serum to conduct clinical trials of its rDNA products

Serum Institute of India, a leading vaccine manufacturer of the world, has received green signal from the Genetic Engineering Approval Committee (GEAC) to conduct clinical trials of r-erythropoietin, Human Granulocyte Colony Stimulating Factor (r-G-CSF) and PEG-GCSF.

Serum proposes to conduct a multi–centric, randomized, single-blinded comparative two arm clinical trials to assess the efficacy and tolerability of r-erythropoietin at three centers. About 30 patients per center will be enrolled in the study.

Similarly the company has proposed to conduct multi-centric, comparative, non-inferiority, three-arm superiority clinical studies to assess the efficacy and tolerability of Human Granulocyte Colony Stimulating Factor (r-G-CSF) and PEG-GCSF in three different centers with a total of 135 patients having 45 patients per group.

The GEAC that met under the chairmanship of Dr Amit Ghosh, co-chairman of GEAC on January 13, 2006, gave its approval to Serum Institute to conduct clinical trials.

AICBA for Environment Protection Act

Illegal seeds have been a major concern for the seed industry as well as for government regulators. The government has initiated various penalty clauses for the people involved in buying, selling or trading illegal seeds. The All India Crop Biotech Association (AICBA) along with seed partner companies has initiated various educational programs to create awareness among the farming community on the benefits of biotechnology.

The market surveys conducted by independent agencies also suggested that farmers have incurred huge losses and that they feel cheated using illegal seeds as these seeds are of very inconsistent quality. In order to secure the future benefits of cotton biotechnology for farmers, AICBA has recommended to the government the enforcement of the Environment Protection Act and Clear and Effective Intellectual Property (IP) Laws. RK Sinha, executive director, AICBA said, "The proper implementation and enforcement of laws governing the production and sale of biotechnology products will ensure the integrity and quality of the seeds, return tax revenues to the government for further progress in agriculture and rural development, provide appropriate environmental regulatory oversight and meaningful enforcement of IP protection and also encourage biotechnology innovators to continue to bring their products to Indian farmers."

Human Biological to manufacture and market r Hepatitis B vaccine

Hyderabad-based Human Biological Immunological, an arm of Indian Immunologicals Limited, manufacturer of a wide range of veterinary biologicals, animal health products required by the veterinary profession will manufacture and market r Hepatitis B subject to DCGI clearance.

Human Biological Immunological has completed the conduct of phase III clinical trials in accordance with the approvals granted by the Genetic Engineering Approval Committee (GEAC) and DCGI. The committee concluded that the containment facilities at the R&D and production premises of Human Biological Immunological are adequate to meet the environmental safety regulation for production of r-Hepatitis B vaccine.

Ranbaxy invalidates Atorvastatin patent in Austria

Ranbaxy Laboratories has said that a five-judge panel of the Supreme Patent and Trademark Board of Austria (OPM) has unanimously affirmed an earlier ruling of the Austrian Patent Office, invalidating claims 1-3 (all claims sought by Ranbaxy to be invalidated) of Pfizer's Austrian Patent AT 207896, covering Atorvastatin calcium (Lipitor).

On March 29, 2005, the Patent Office had ruled AT 207896 invalid for lack of novelty over Pfizer's International Patent Application PCT/US89/00719, published as WO 89/07598 and lack of inventive step over United States Patent No. 4,681,893.

"We are pleased with the decision rendered by the Supreme Patent and Trademark Board of Austria. Our success further validates our strategy to successfully commercialize Atorvastatin in Austria, and potentially other healthcare markets in the future. It is anticipated that this will have a positive impact on healthcare costs, by providing a high quality, generic alternative at affordable prices," said Malvinder M Singh, CEO and MD of Ranbaxy.

Best Biotek gets university certified research centre tag

Best Biotek Research Labs, a Bangalore-based biotech training and research centre has been recently recognized as a university certified research centre from Kuvempu University, Karnataka.

Best Biotek is India's first and only ISO 9001-2000 certified biotech training and research center and one of the fastest growing biotech training and R&D centers in the country. It has also got the unique distinction of being the first ISO 9001-2000 certified company.

FICCI -EU-GTZ biotech resource center at Ahmedabad

The Federation of Indian Chambers of Commerce & Industry (FICCI), in collaboration with the European Union (EU) and GTZ (German Technical Cooperation) has established a biotech resource center at Ahmedabad. The prime objective of the center is to act as a platform to knit bilateral relationship between small and medium scale entrepreneurs (SMEs), R&D institutes and academia.

The center has prepared a report "Expanding Horizon- Biotechnology Gujarat" which relates the present status and perceivable opportunities in Gujarat. The chief minister of Gujarat, Narendra Modi released the report at the FICCI's national executive committee meeting.

An advisory committee comprising eminent contributors to the biotech segment in the state of Gujarat has been constituted. The committee members include Pankaj Patel, chairman and managing director, Zydus Cadila Healthcare Ltd, Piyush Palkhiwala, managing director, Maps India Ltd, Dr Arjun Mehta, managing director, Gujarat Life Sciences Pvt Ltd, Vadodara and Dr Harish Padh, director, BV Patel PERD Centre, Ahmedabad.

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