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Jan 25
Generex receives Ukrainian approval for phase III trial of Generex Oral-lyn
The Ministry of Health of the Ukraine issued an approval letter to Generex Biotechnology Corporation to conduct a phase III clinical trial protocol for Generex Oral-lyn at eight clinical sites in the Ukraine.

The approval represents initiation of the first clinical sites for the pivotal study and permits commencement of screening for suitable patients. This approval is the first of seven countries within which the company will be conducting the phase III trial of Generex Oral-lyn.

The protocol calls for a trial with a six month active treatment period and a 6 month follow up which is expected to include up to 750 patients with Type-1 diabetes mellitus worldwide. The company has already received non-objection letters from both Health Canada and the FDA to conduct this pivotal study. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the company\'s RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by Hba1c in patients with type-1 diabetes mellitus.

\"We are excited to initiate the first of our global phase III centres for our flagship product,\" said Anna Gluskin, the president and chief executive officer, Generex. \"After months of preparation and particular attention to detail and refining the protocol, the Company\'s plans for this pivotal study are starting to become a reality and we look forward to rolling out all the other clinical centres.\"

Generex is engaged in the research, development, and commercialisation of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity.

Jan 25
Siro Clinpharm offers clinical trials for Indian firms in overseas sites
The Mumbai-based Siro Clinpharm Pvt Ltd, one of the leading players in the Indian contract research industry, is planning to offer clinical trials for Indian pharmaceutical companies in overseas sites such as the US and Europe.

According to sources close to the development, the company\'s move comes in the wake of more and more domestic pharmaceutical companies\' entry into new chemical entity (NCE) research. Domestic companies such as Ranbaxy, Glenmark and Wockhardt are already into the NCE research and out-licensing molecules to the foreign players. Most of these companies are out-licensing their molecules at the stage of phase II trials, which required to be conducted in various countries in Europe, North America and Japan.

\"Siro\'s move will enable Indian drug companies to conduct trials in several countries, especially in regulated markets through a single agency. It would also facilitate the companies to conduct trials as per the latest developments in these markets, as Indian (clinical research organisations) CROs are well aware of the developments in these countries. Moreover, it would also enable the Indian companies to save 25 per cent clinical trial costs\", people close to the development said.

Siro Clinpharm has already chalked out plans to expand its overseas presence into the Europe through an acquisition and the deal is expected to finalise shortly. It is part of company\'s global expansion strategy to conduct trials in different geographical locations. The acquisition would enable Siro to conduct trials in various gene pools. Some of the trials required to be conducted in various gene pools, as the companies are present in different countries.

The company offers a comprehensive array of phase I through phase IV clinical research services to clients in India. It also provides a complete selection of clinical research support from clinical trial development through final report and regulatory submission.

Jan 25
Panacea Biotec net up at Rs 28.93 cr in Q3
Panacea Biotec, the second largest vaccine producer in India, has achieved better performance during the third quarter ended December 2007 despite rupee appreciation and lower other income. The company\'s net profit improved by 6.8 per cent to Rs 28.93 crore from Rs 27.10 crore in the similar period of last year. Its net sales increased by 14.8 per cent to Rs 226.35 crore from Rs 197.12 crore. With small rise in equity capital, the earning per share worked out to Rs 4.39 as against Rs 4.50 in the last period.

The company\'s vaccines sales increased by 17.6 per cent during the quarter ended to Rs 177.42 crore from Rs 150.92 crore and that of formulation went up by 3.6 per cent to Rs 49.84 crore from Rs 48.12 crore.

Rajesh Jain, joint managing director, said, \"With a well defined three pronged strategy for currency hedging, volume and price growth, we have been able to successfully manage the challenge posed by the continuously appreciating Indian rupee, faced by all the companies\".

For the first nine months of the year 2007-08, Panacea\'s net sales increased by 5 per cent to Rs 634.92 crore as against Rs 604.78 crore in the previous period. However, its net profit declined by 12.3 per cent to Rs 108.25 crore from Rs 123.39 crore basically due to higher depreciation and other expenses, including R&D expenditure. The vaccines sales for the first nine months increased marginally by 2.4 per cent to Rs 486.23 crore from Rs 475.06 crore and its formulations sales increased by 13.9 per cent to Rs 150.65 crore from Rs 132.28 crore.

The company has entered into a MoU with Punjab University, Chandigarh for a Drug Discovery Project. Panacea and Punjab University will collaborate to identify a lead molecule with an aim o bring a drug superior to existing marketed products in the therapeutic area of psychiatric disorders. As per the agreement the university would transfer chemical and biological information on molecules to Panacea to develop as drugs.

Jan 25
Cipla posts net profit growth of 14% in Q3
Cipla Ltd, a Mumbai based third largest pharma company in India, has posted better performance during the quarter ended December 2007 despite strong rupee in terms of US dollar. The company\'s net profit increased by 14 2 per cent to Rs 210.65 crore from Rs 184.38 crore in the corresponding period of last year. Its net sales increased by 25.4 per cent to Rs 1104 crore from Rs 881 crore. The earning per share went up to Rs 2.71 from Rs 2.37 in the last period.

Its domestic sales increased by 19.3 per cent during the quarter under review to Rs 519.51 crore from Rs 435.30 crore and its Exports surged by 22.3 per cent to Rs 510.92 crore from Rs 417.87 crore. Exports as per cent of net sales improved to 49.6 per cent from 49 per cent in the similar quarter of last year.

For the nine months period, Cipla has achieved net sales of Rs 3105 crore as against Rs 2634 crore in the first nine months of last year, a growth of 17.9 per cent. However, its net profit declined by 2.6 per cent to Rs 521 crore from Rs 535 crore. The profit before interest, depreciation and taxation also declined by 1.5 per cent to Rs 732 crore from Rs 743 crore. The company\'s exports during the nine months ended December 2007 improved by 16.7 per cent to Rs 1,460 crore from Rs 1,251 crore in the last period.

Jan 25
1000 Genomes Project launched
A much awaited 1000 Genomes Project to sequence the genomes of at least 1,000 people from around the world to create the most detailed and medically useful picture to date of human genetic variation was launched by British, American and Chinese scientists.

Drawing on the expertise of multidisciplinary research teams, the 1000 Genomes Project will develop a new map of the human genome that will provide a view of biomedically relevant DNA variations at a resolution unmatched by current resources. As with other major human genome reference projects, data from the 1000 Genomes Project will be made swiftly available to the worldwide scientific community through freely accessible public databases.

The project will receive major support from the Wellcome Trust Sanger Institute in Hinxton, England, the Beijing Genomics Institute, Shenzhen (BGI Shenzhen) in China and the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH).

\"The 1000 Genomes Project will examine the human genome at a level of detail that no one has done before,\" said Richard Durbin, Ph.D., Wellcome Trust Sanger Institute, who is co-chair of the consortium. \"Such a project would have been unthinkable only two years ago. Today, thanks to amazing strides in sequencing technology, bioinformatics and population genomics, it is now within our grasp. So we are moving forward to build a tool that will greatly expand and further accelerate efforts to find more of the genetic factors involved in human health and disease.\"

Any two humans are more than 99 per cent the same at the genetic level. However, it is important to understand the small fraction of genetic material that varies among people because it can help explain individual differences in susceptibility to disease, response to drugs or reaction to environmental factors. Variation in the human genome is organized into local neighborhoods, called haplotypes, which are stretches of DNA that are usually inherited as intact blocks of information.

Recently developed catalogs of human genetic variation, such as the HapMap, have proved valuable in human genetic research. Using the HapMap and related resources, researchers already have discovered more than 100 regions of the genome containing genetic variants that appear to contribute to common human diseases such as diabetes, coronary artery disease, prostate and breast cancer, rheumatoid arthritis, inflammatory bowel disease and age-related macular degeneration.

However, because existing maps are not extremely detailed, researchers often must follow those studies with costly and time-consuming DNA sequencing to help pinpoint the precise causative variants. The new map would enable researchers to more quickly zero in on disease-related genetic variants, speeding efforts to use genetic information to develop new strategies for diagnosing, treating and preventing common diseases.

The scientific goals of the 1000 Genomes Project are to produce a catalog of variants that are present at 1 per cent or greater frequency in the human population across most of the genome, and down to 0.5 per cent or lower within genes. This will likely entail sequencing the genomes of at least 1,000 people. These people will be anonymous and will not have any medical information collected on them, because the project is developing a basic resource to provide information on genetic variation. The catalog that is developed will be used by researchers in many future studies of people with particular diseases.

\"This new project will increase the sensitivity of disease discovery efforts across the genome five-fold and within gene regions at least 10-fold,\" said Francis S. Collins, M.D., Ph.D, director, NHGRI. \"Our existing databases do a reasonably good job of cataloging variations found in at least 10 percent of a population. By harnessing the power of new sequencing technologies and novel computational methods, we hope to give biomedical researchers a genome-wide map of variation down to the 1 percent level. This will change the way we carry out studies of genetic disease.\"

With current approaches, researchers can search for two types of genetic variants related to disease. The first type is very rare genetic variants that have a severe effect, such as the variants responsible for causing cystic fibrosis and Huntington\'s disease. To find these rare variants, which typically affect fewer than one in 1,000 people, researchers often must spend years on studies involving affected families. However, most common diseases, such as diabetes and heart disease, are influenced by more common genetic variants. Most of these common variants have weak effects, perhaps increasing risk of a common condition by 25 per cent or less. Recently, using a new approach known as a genome-wide association study, researchers have been able to search for these common variants.

One use of the new catalog will be to follow up genome-wide association studies. Investigators who find that a part of the genome is associated with a disease will be able to look it up in the catalog, and find almost all variants in that region. They will then be able to conduct functional studies to see whether any of the catalogued variants directly contribute to the disease. The 1000 Genomes Project builds on the human haplotype map developed by the International HapMap Project. The new map will provide genomic context surrounding the HapMap\'s genetic variants, giving researchers important clues to which variants might be causal, including more precise information on where to search for causal variants.

Going a major step beyond the HapMap, the 1000 Genomes Project will map not only the single-letter differences in people\'s DNA, called single nucleotide polymorphisms (SNPs), but also will produce a high-resolution map of larger differences in genome structure called structural variants. Structural variants are rearrangements, deletions or duplications of segments of the human genome. The importance of these variants has become increasingly clear with surveys completed in the past 18 months that show these differences in genome structure may play a role in susceptibility to certain conditions, such as mental retardation and autism.

In addition to acclerating the search for genetic variants involved in susceptibility to common diseases, the map produced by the 1000 Genomes Project will provide a deeper understanding of human genetic variation and open the door to many other new findings of biomedical significance.

The sequencing work will be carried out at the Sanger Institute, BGI Shenzhen and NHGRI\'s Large-Scale Sequencing Network, which includes the Broad Institute of MIT and Harvard; the Washington University Genome Sequencing Center at the Washington University School of Medicine in St. Louis; and the Human Genome Sequencing Center at the Baylor College of Medicine in Houston. The consortium may add other participants over time.

The project depends on large-scale implementation of several new sequencing platforms. Using standard DNA sequencing technologies, the effort would likely cost more than $500 million. However, leaders of the 1000 Genomes Project expect the costs to be far lower -- in the range of $30 million to $50 million -- because of the project\'s pioneering efforts to use new sequencing technologies in the most efficient and cost-effective manner.

In the first phase of the 1000 Genomes Project, lasting about a year, researchers will conduct three pilots. The results of the pilots will be used to decide how to most efficiently and cost effectively produce the project\'s detailed map of human genetic variation.

The first pilot will involve sequencing the genomes of two nuclear families (both parents and an adult child) at deep coverage that averages 20 passes of each genome. This will provide a comprehensive dataset from six people that will help the project figure out how to identify variants using the new sequencing platforms, and serve as a basis for comparison for other parts of the effort.

The second pilot will involve sequencing the genomes of 180 people at low coverage that averages two passes of each genome. This will test the ability to use low-coverage data from new sequencing platforms to identify sequence variants and to put them in their genomic context.

The third pilot will involve sequencing the coding regions, called exons, of about 1,000 genes in about 1,000 people. This is aimed at exploring how best to obtain an even more detailed catalog in the approximately 2 percent of the genome that is comprised of protein-coding genes.

During its two-year production phase, the 1000 Genomes Project will deliver sequence data at an average rate of about 8.2 billion bases per day, the equivalent of more than two human genomes every 24 hours. The volume of data -- and the interpretation of those data -- will pose a major challenge for leading experts in the fields of bioinformatics and statistical genetics.

Among the populations whose DNA will be sequenced in the 1000 Genomes Project are: Yoruba in Ibadan, Nigeria; Japanese in Tokyo; Chinese in Beijing; Utah residents with ancestry from northern and western Europe; Luhya in Webuye, Kenya; Maasai in Kinyawa, Kenya; Toscani in Italy; Gujarati Indians in Houston; Chinese in metropolitan Denver; people of Mexican ancestry in Los Angeles; and people of African ancestry in the southwestern United States.

The data generated by the 1000 Genomes Project will be held by and distributed from the European Bioinformatics Institute and the National Center for Biotechnology Information, which is part of NIH. There will also be a mirror site for data access at BGI Shenzhen. In addition to a catalog of variants, the data will include information about surrounding variation that can speed identification of the most important variants.

Jan 25
Wockhardt Hospitals to expand in metros and tier-II cities
Wockhardt Hospitals Limited, which is going public for its expansion plans, intends to establish additional healthcare facilities across India through a series of Greenfield and Brownfield projects. The expansions will take place in Bangalore, Mumbai, Kolkatta, Hyderabad and New Delhi. This will take the total number of hospitals from 15 to 31 by 2010.

The Group is currently expanding its bed capacity at Wockhardt at Mulund in Mumbai and building new hospitals in southern and northern Mumbai, Delhi, Bangalore and Kolkatta. It is pursuing Brownfield projects in selected Tier II cities such as Madgaon (Goa), Bhopal, Nashik, Bhavnagar, Ludhiana, Jabalpur, Bhuj, Patna Hubli and Varanasi. \"In many of the Tier II cities, we expect to be among the first major private healthcare service providers to commence tertiary care operations\", stated Anil V Kamath, managing director, Wockhardt Hospitals Limited.

The hospital major will develop a network of regional specialty Intensive Care Unit (ICU) hospitals which will act as referral centres to the super specialty centres for advanced and tertiary care procedures. It has two regional ICU hospitals in Vashi at Mumbai and Chord Road in Bangalore. These are 40-50 ICU bed centres manned with 30 doctors and trained intensive care specialists. \"In the long term, our ICU network strategy will contribute to the reduction of the average length of stay at the super specialty hospitals,\" stated the Wockhardt Hospitals chief.

Jan 25
UNICEF releases \'State of the World\'s Children 2008\' report
The United Nations Children Fund (UNICEF) has launched its annual global flagship report, \'State of the World\'s Children 2008\' in New Delhi. The new report highlights the number of children who die below the age of five years. The new report goes beyond the numbers to suggest actions and initiatives that should lead to further progress.

The new information in \'State of the World\'s Children 2008\' is drawn from household survey data as well as material from key partners, including the World Health Organization and the World Bank.

The approach to child survival that the report advocates sees the best disease-specific initiatives combined with investment in strong national health systems to create a continuum of care for mothers, newborns and young children that extends from the household, to the local health centre, to the district hospital and beyond.

The report is of great significance as approximately four million babies die globally, each year in their first month of life. The highest rate of neonatal death is found in sub-Saharan Africa where, on average, one child in every six dies before their fifth birthday. However, the largest absolute number of newborn deaths occurs in South Asia, of which India bears the greatest burden - one million.

\"Community-level integration of essential services for mothers, newborns and young children, and sustainable improvements in national health systems can save the lives of many of the more than 26,000 children under five who die each day,\" said Ann M. Veneman, UNICEF executive director at the global launch. \"The report describes the impact of simple, affordable life-saving measures, such as exclusive breastfeeding, immunization, insecticide-treated bed nets and vitamin A supplementation, all of which have helped to reduce child deaths in recent years\".

UNICEF country representative in India Dr Gianni Murzi said, \"We can reduce child mortality in India through these interventions and the sustained strengthening of health systems with increased community participation. Integrated health, nutrition and sanitation interventions are essential to make a significant dent in the problem of child survival in the country\".

\"The world will not achieve the millennium development goals (MDGs) without India. In order to do this, proven and cost effective interventions must be scaled up without delay. The government, UN, civil society, private sector as well as academic institutions must unite for Indian children in a concerted and urgent effort,\" he said.

The report emphasizes the need to empower local communities to provide immediate assistance to sick or severely malnourished children while seeking transfers to medical facilities. These communities generate necessary demand for quality health care and their engagement is vital if marginalized and remote populations are to be reached.

\"Stepping up investment in health systems will be crucial if we are to meet the child health targets set by the United Nations, but progress can be made even when health systems are weak,\" said Dr. Margaret Chan, director-general of the World Health Organization from Geneva. \"Innovative programmes in many countries show that an integrated approach where each child is reached with a package of interventions at one time can bring immediate benefits\", he added.

The report provides examples of successful government initiatives in India. The Integrated Management of Neonatal and Childhood Illnesses (IMNCI) initiative promotes neonatal health and survival while low cost interventions in the Integrated Child Development Services (ICDS) significantly improve health care for infants and young children leading to nutritional improvements in a short period of time.

Jan 25
Price control on medical devices likely, chemicals ministry panel to meet on Jan 24
A move to bring in a system of price control on medical devices is on cards. India is currently using a large number of medical devices for various health problems and many of them are imported while some are being manufactured in the country. And prices of many of these products are not considered to be justified considering their quality parameters.

A committee was thus, set up by the Union ministry of chemicals and fertilisers some time back to explore the possibility of price negotiations of medical devices and patented drugs. This committee is likely to hold a meeting on January 24, to arrive at a pricing mechanism for imported medical devices.

The seven member committee chaired by the deputy secretary for pharmaceutical industry, ministry of chemicals and fertilisers, has earlier decided to initiate talks with the representatives of medical devices industry and further actions will be carried out with the meeting on 24th, official sources said.

\"Right now, the committee is expecting to hold a meeting on January 24. As per the agenda, the committee will be going to discuss the pricing of imported and patented medical devices,\" said Paresh Johri, deputy secretary, ministry of chemicals and fertilisers.

The medical devices market in the country, which is currently reported as around US$ 2 bn of size, is expected to grow at a rate of 15 to 20 per cent to reach a market size of about US$ 5 bn by the end of 2012, according to a FICCI-Ernst & Young study in 2007. Imports of ophthalmic equipments, orthopaedic and plastic surgery equipments are growing fast and the major suppliers of the high end products are overseas companies.

Almost 30 foreign players, has received import clearance for their products in India in 2007. The increasing market need and the in-flow of medical devices from overseas countries has raised the concern of government over the quality, usage and price of the devices, said a member of the committee.

The committee has also invited views from general public and other stakeholders for consideration before finalisation of its recommendations and has requested the views to be submitted before February 10, 2008.

However, sources close to the development points out that the committee, which has been revised in December 2007, is yet to achieve momentum. The committee meeting on December 12th was not attended by some of the seven members and the discussions were not upto expectations, revealed sources.

Jan 25
Cadila, Prolong ink pact to develop anaemia drug
Cadila Healthcare Ltd has entered into pact for collaboration for development of a next generation therapeutic protein, \'PEG-EPO\', for the treatment of severe anaemia with Prolong Pharmaceuticals Inc., a US-based, venture-backed drug delivery research and development company.

Severe Anaemia is a condition where the haemoglobin (Hb) level or number of circulating red blood cells (RBCs) is significantly reduced. This is common in chronic renal failure (CRF), cancer patients undergoing chemotherapy, some chronic inflammatory diseases, heart failure, surgical settings and critically ill patients. The first generation drug, EPO, did wonders to the treatment of this condition. However, new advances in therapy can improve EPO\'s therapeutic profile, offer greater convenience, and lower treatment costs. PEG-EPO promises to be a third generation drug.

Speaking on the occasion, Pankaj Patel, chairman and Managing Director Zydus Cadila, mentioned \"This deal marks Zydus\'s foray into the area of novel improved biologicals. There is a strong unmet medical need in this space, and we are committed to discover, develop and provide better as well as safer alternatives to patients at affordable prices\".

The Zydus-Prolong pact seeks to increase productivity in the drug development of this next generation therapeutic protein by leveraging the combined strengths of both companies. As per the agreement, both companies will utilize Prolong\'s differentiated PEGylation technology to make PEG-EPO. This joint development will help in developing an optimized drug candidate with improved therapeutic properties. Both partners will also be equitably sharing risk and reward for this collaborative programme.

PEGylation is the only FDA-approved protein delivery technology that transforms proteins into superior drug products, by attaching a polyethylene glycol (\"PEG\") polymer to a therapeutic protein. This process results in an improved product with significantly enhance potency, fewer side effects, and a reduced dosing frequency.

Zydus Cadila will leverage its expertise in carrying out a focussed drug development programme, starting from pre-clinical candidate selection, filing of the Investigational New Drug, undertaking pre-clinical studies and human clinical trials and marketing it in mutually agreed upon territories globally. The collaborative programme will bring an edge to Zydus\' global biologics strategy with the introduction of an improved biologic product.

\"Prolong is excited about this unique development partnership with Zydus, given their focus and strong in-house capabilities on drug development,\" commented Dr Abe Abuchowski, president and COO. \"This collaboration will also enable Prolong to capitalize on the cost effective drug development capabilities that India offers\". YES Bank was the strategic advisor to Prolong for the transaction.

Jan 25
Rs 155 cr investment in Karnataka biotech sector during 2007
The Karnataka state, which is known for receiving hefty investments in the field of IT, has received around Rs 155 crore of investments in the biotechnology sector during the year 2007. A total of 54 new units have been set up in the state during the year, taking the total number in this sector to 224. The units are primarily in the bio-pharma space followed by the bioinformatics initiatives.

The industry is aware about the availability of the qualified technical resources and the success of the companies here. The investments are expected to take a three-fold increase once the Biotech Park \'Bangalore Helix\' is set up, M N Vidyashankar, principal secretary to the Karnataka government\'s Department of information technology, biotechnology and science & technology, told Pharmabiz.

The reasons for attracting such a large number bio-pharma research labs and manufacturing units in the state are attributed to the industrial friendly policies, salubrious climate, availability of large technical pool from the pharmacy, engineering and medical colleges together with the presence of leading research institutes like Indian Institute of Science, National Centre for Biological Sciences and Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR). Several bioinformatics companies have sprung up here because of the state\'s information technology expertise. The extension from IT to BT was only a matter of application, Vidyashankar added.

Among the leading bio-pharma companies in the state in the areas of research and manufacture include Biocon, Avesthagen, Animal Biotech, Aurigene, Bangalore Genei and Biovel Life Sciences. In the drug discovery space, there are Advinus Therapeutics and Jubilant Drug Discovery Centre and in the bio-informatics space there are companies like ArisGlobal Software, Bigtec, Genotypic Technologies, IBM and Infosys to name a few.

Among the new entrants in the state in 2007 are Advinus Therapeutics, Biovel and Anthem Biosciences.

In view of the strong IT base and the global reputation Bangalore enjoys as the world\'s fourth largest technology hub, the city is fast turning into a \'bio cluster\'. The Biocon Park in the Bommasandra Industrial Area and the upcoming Bangalore Helix Biotech Park along with the Advinus and Jubilant infrastructure provide a global perspective to the biotech sector.

While the Indian biotech sector is valued at Rs 8,400 crore, ending March 2007 with a growth rate of 35 per cent, Karnataka\'s share is Rs. 3360 crore registering over 25 per cent growth.

The state government with the contributions of the Vision Group on Biotechnology headed by Kiran Mazumdar-Shaw is all set to announce the revised version of the Biotech Policy which will not only continue to be industry-friendly but provide all support for the sector to grow over the next decade. \"Karnataka was the first state to announce the Biotech Policy and now the revamped version will make it the most progressive document for the sector. It is expected to increase the investments\", Vidyashankar said.