• 11 March 2008
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GVK BIO licenses toxicity database to AstraZeneca

GVK Biosciences (GVK BIO) has licensed its Mechanism Based Toxicity Database (MBT) to AstraZeneca. The license represents an extension of the existing license of all the GVK BIO Target and Drug databases. The GVK BIO Databases contain over 3.2 million compounds manually curated from patents and journals and represent over 7 million quantitative SAR data points.

Sreeni Devidas, vice president, business development, GVK BIO said that the MBT provides easily accessible information on known toxic effects of over 13,000 compounds from the literature, which will be made available to researchers in AstraZeneca.

The Informatics division is responsible for analyzing data to transform chemical/biological patterns into knowledge.


British Biologicals with Finland-based Raisio launches Benecol in India

Bangalore-based British Biologicals has entered into a business partnership with Raisio Nutrition of Finland. Under the partnership, it will be launching for the first time in Asia, Raisio's Plant Stanol Ester – Benecol under the brand name Colred Benecol, a nutritional product, which is said to reduce cholesterol naturally.

VS Reddy, MD, British Biologicals, said Raisio had selected British Biologicals, endearingly called "the protein people", for being among India's top company in nutraceuticals. British Biologicals has a good market presence.

Reddy said the company was exporting nutraceutical products to 15 countries and was planning to foray the European and the US markets soon. He disclosed that in the next two months British Biologicals would firm up a business partnership in Russia. It was also developing products to suit the requirements of African countries, thus making its intentions clear of having a pan-global presence.

Presently, the brands under the fold of British Biologicals included B – Protin; D-Protin (for diabetics); Pulmocare (for lungs) Pro-Pl (for pregnant and lactating mothers); Kids Pro (for growing children); Hepa Pro (Hepatoprotector); Meno Pro (for Menopause: Medi Slim (for slimming: AX Kal (alternative to sugar) and now ColRed (which reduces cholesterol naturally).

V Sridhar, executive director, said that British Biologicals enjoyed a market share of around 23 percent in ethical nutrition supplement market and was considered one of the fastest growing nutraceutical companies in India. The company's strength was its research based nutrition supplement. With such R&D, it would soon be launching products in specialities such as orthopedics, oncology, nephrology and cardiology.


GSK launches two innovative vaccines

GlaxoSmithKline Pharmaceuticals has launched two new innovative Diphtheria, Tetanus and acellular Pertussis (DTP) vaccines -Boostrix and Infanrix. Unlike traditional vaccines, acellular vaccines provide far more comfort to parents and the children due to substantially reduced pain, fever and swelling. Worldwide, acellular DTP vaccines are a part of routine immunization.

Infanrix is indicated for childhood immunization against diphtheria, tetanus and pertussis for newborns from 6th week of age. When combined with Hib vaccines, it reduces the number of pricks and visits to the doctor.

Boostrix can be administered to older children above 7 years of age, adolescents and adults and will boost the waning immunity against diphtheria, tetanus and pertussis. Studies have shown that immunity against diphtheria, tetanus and pertussis wanes after childhood immunization as protection lasts up to 4-12 years after vaccination. Due to waning immunity, incidence of pertussis and diphtheria is increasing in adolescents and adults. Of concern is the fact that adults can pass pertussis infection to infants leading to high disease burden. Till date there was no vaccine available in India, which could be given to this age group.

GSK's Boostrix is USFDA approved and well accepted in 58 countries. American Academy of Pediatrics (AAP) recommends Boostrix at 10 years of age.

Dr Hasit Joshipura, managing director, GlaxoSmithKline Pharmaceuticals, said, "GSK India remains committed to providing the latest and most effective preventive care particularly for children. The launch of Infanrix and Boostrix will be a step forward in this mission."


MDR tuberculosis cases continue to rise

Multidrug-resistant tuberculosis (MDR-TB) has been recorded at the highest rates ever, according to a new report published on February 26, 2008. The report presents findings from the largest survey to date on the scale of drug resistance in tuberculosis.

The report, "Anti-tuberculosis drug resistance in the world", is based on data collected between 2002 and 2006 on 90 000 TB patients in 81 countries. It found that extensively drug-resistant tuberculosis (XDR-TB), a virtually untreatable form of the respiratory disease, has been recorded in 45 countries, a WHO release said.

The report also found a link between HIV infection and MDR-TB. Surveys in Latvia and Ukraine found nearly twice the level of MDR-TB among TB patients living with HIV compared with patients without HIV.

Based on the analysis of the survey data, WHO estimates there are nearly half a million new cases of MDR-TB a year, which is about 5 percent of nine million new TB cases of all types. The highest rate was recorded in Baku, the capital of Azerbaijan, where nearly a quarter of all new TB cases (22.3 per cent) were reported as multidrug-resistant.

Proportions of MDR-TB among new TB cases were 19.4 per cent in Moldova, 16 per cent in Donetsk in Ukraine, 15 per cent in Tomsk Oblast in the Russian Federation, and 14.8 per cent in Tashkent in Uzbekistan. These rates surpass the highest levels of drug resistance published in the last WHO report in 2004. Surveys in China also suggest that MDR-TB is widespread there.

"TB drug resistance needs a frontal assault. If countries and the international community fail to address it aggressively now we will lose this battle," said Dr Mario Raviglione, director of the WHO Stop TB Department. "In addition to specifically confronting drug-resistant TB and saving lives, programs worldwide must immediately improve their performance in diagnosing all TB cases rapidly and treating them until cured, which is the best way to prevent the development of drug resistance."


Avesthagen launches 7 plant–based bioactives

Bangalore-based Avesthagen has launched seven new botanical bioactives under the Avesta brand aimed to promote wellness through prevention of specific degenerative conditions like diabetes, bone loss and cardiovascular diseases. The bioactives will be available as dietary supplements as well as in cereal bars and cracker categories.

Avesthagen uses two of its patented technologies to develop the bioactives; Adept, a comprehensive database that brings together traditional medicine with modern systems biology and MetaGrid, a unique algorithm that enables comprehensive constituent profiling. The metabolic fingerprints generated not only help chararacterize the bioactives but also help in quality control and assurance. The MetaGrid also helps maintain batch-to-batch reproducibility of the bioactive, which is an issue in conventional systems. Avesthagen uses cell-based assays and GLP-compliant preclinical studies to ensure safety and efficacy of the bioactives. Organoleptic optimization is done to improve the taste and other properties. The bioactives are manufactured in an ISO 9001:2000, ISO22000:2005 facility.

The bioactives launched include Aspand (controls blood sugar), Teestar (moderates blood sugar levels), Cincata (maintains blood glucose levels), Bonapure (promotes bone growth), Phytossea (assists in inhibiting cartilage degradation), Smartchol (moderates cholesterol levels) and Xanomax (has antioxidant properties).

Dr Villoo Morawala Patell, founder, CMD of chairperson and managing director of Avesthagen, during the launch, said, "We strongly believe that science and technology is the way to bring to the people the immense knowledge base of traditional medicine resulting in quality ingredients that add to taste and health needs. Avesthagen's goal is to incorporate great-tasting, life-enhancing natural ingredients into the world's lifestyle. We have extensively studied the market and our bionutrition development team has created bioactives with variants that hold tremendous uses for the consumer. These seven bioactives will be followed by many more that are in the pipeline.

Chronic diseases contributed approximately 60 percent of the 56.5 million total reported deaths in the world and approximately 46 percent of the global burden of disease in 2001. The proportion of the burden of these diseases is expected to increase to 57 percent by 2020. This increase in the number of chronic diseases and degenerative conditions across the globe has spurred interest in these health-promoting ingredients.


India to open first biofuels and bioenergy science center

The Department of Biotechnology (DBT) in the Ministry of Science & Technology has funded the establishment of the country's first Center of Energy Biosciences (CEB).

The CEB, an investment of $6.1 million, aims to raise an additional $4 million, and has received the specific task of developing cutting-edge biofuels, bioenergy and biohydrogen technologies capable of converting lignocellulosic biomass into transportation fuels.

The center has the charter to develop bio-based renewables in order to reduce India's rising dependence on petroleum fuels and to cut down emissions of greenhouse gases. For the purpose, the CEB will establish advanced pilot biofuel plants and create research partnerships with leading biotechnology, industry and academic organizations from India, the US and other countries. The center is to be established at the University of Mumbai, Institute of Chemical Technology.

BioNews New Page 1

Dubai BT firm to provide IEMs screening for newborns

Dubai-based biotechnology company Eastern Biotech & Life Sciences is offering supplemental screening for more than 50 rare and treatable metabolic disorders in the newborns. Inborn errors of metabolisms (IEMs) prevent babies from processing food properly, leading to an accumulation of toxic chemicals (i.e. phenylketonuria, galactosemia) in the blood that are harmful for their normal development

The screening is performed on a small sample of blood obtained by pricking the baby's heel. The tests detect abnormal levels of these chemicals shortly after the baby is born.

Using the results from IEMs screening, physicians have an advantage of recognizing specific illnesses before the onset of symptoms, thereby paving the way for early intervention.

According to Dr Sanjida Ahmed, director, research, at Eastern Biotech, the supplemental screening program identifies these conditions soon after the birth and starting the treatment before the babies suffer brain damage or other permanent disorders. The effect of genetic and congenital disorders in Arab countries is high.


Satyam opens life sciences center

India's fourth largest IT services exporter Satyam Computer Services, has opened a life sciences center of excellence in Hyderabad to provide software solutions to drug and pharmaceutical firms.

"The center of excellence is a critical investment we have made. It will provide flexibility and ease of customization, enabling faster implementations and therefore a better return on investment," said Ram Mynampati, president, commercial and healthcare business of Satyam.

"Life sciences (software solutions) is one of the fastest growing markets and contributes up to six percent of our revenues. We have moved from almost nothing to six percent in four years," he said.


Veeda CR establishes clinical pharmacology unit for renal impaired patients

Ahmedabad-based Veeda CR has opened its new clinical pharmacology unit (CPU) at Muljibhai Patel Urological Hospital (MPUH), Nadiad, Gujarat. The unit was inaugurated by Dinsha J Patel, minister of state for petroleum and natural gas and Dr Nilima Kshirsagar (director professor, infectious diseases and interdisciplinary research, Maharashtra University of Health Sciences). Veeda will conduct phase I /II clinical studies in renal impaired patients, at the unit.

Dr Kiran Marthak, director, Veeda CR, said, "Conducting Phase I studies on renal impaired patients is highly important as many drugs are excreted by the body via the kidneys and a knowledge of the influence of kidney function on drug metabolism is essential to drug development. Veeda Clinical Research is very proud to become the first ever CRO to establish a specialized renal CPU in India"

Studies involving renal impaired patients are particularly important for newly discovered drugs for which the way in which the body handles the drug is not known.

Veeda would also utilize this unit for carrying out clinical trials related to urology like Ca Prostate and Ca Bladder, which may necessitate admission in the ward which is in the hospital and immediately adjacent to the intensive care unit. The unit has six fully monitored beds and all the supporting facilities necessary for the safe conduct of clinical trials.

Veeda CR will have access to the experienced manpower of the hospital as well as the facilities available like kidney dialysis machines, pathology laboratory, X-rays and CT scan.


AMRI acquires pilot plant facilities in India

Albany Molecular Research Inc. (AMRI) has bought FineKem Laboratories, a manufacturing facility located in Aurangabad. This acquisition will significantly accelerate AMRI's ability to make custom pilot scale intermediates in India, which is expected to commence in the second quarter of 2008.

Expanding on the company's acquisition of manufacturing facilities in Aurangabad and Navi Mumbai in July 2007, the addition of custom pilot scale manufacturing also complements AMRI's current chemical development process capabilities in Hyderabad. Additionally, the purchase ensures the addition of another compound, ISMN (Isosorbide Mononitrate), to AMRI's generics portfolio.

AMRI intends to implement upgrades over the next few months to bring the existing facilities into compliance with the USFDA regulations for manufacturing clinical trial materials and commercial drug substances. Anticipated costs related to purchase and upgrades are not expected to be material to AMRI's results of operations or financial position.

In conjunction with the purchase, FineKem's managing director, Rakesh Doshi, will join AMRI India as executive director and COO, reporting to Dr Prasad Raje, managing director of AMRI's current Aurangabad and Navi Mumbai facilities.

"We are pleased to announce the addition of this new product offering," said AMRI chairman, president and CEO, Thomas E D'Ambra. "As we continue to explore and expand the ability of AMRI to provide value and flexibility around the globe, the purchase of this site increases the cost-competitive solutions available to our customers for their outsourcing needs," he added.


Biogérant '08 techno-management fusion event held

Biogérant '08, the two-day annual corporate event organized by PGDM (Biotech) at SIES College of Management Studies, Nerul, Navi Mumbai, was held on January 13-14, 2008.

The theme for Biogérant '08 was "Double Helix - Synergy towards Excellence".

The event primarily focused on the favorable alliance between research and management functions and proved to be a powerful learning experience for young managers.

The modules for the corporate seminar on the first day covered interesting and challenging issues like turning concepts into companies (dynamics of starting a new biotech company), synergy between scientific research and management, ethical issues and contract manufacturing and ended with a panel discussion on Biotech Futura.

The inaugural address was delivered by Dr Borkar, executive director, Serum Institute of India. Eminent guests from the top echelons of top biotech and pharma companies like Biocon, Avesthagen, Reliance Life Sciences, Rossari Biotech, Varda Biotech, VHB Life Sciences and Royal Energy shared from their wealth of experience and knowledge to a 150 strong student audience who listened with rapt attention.

Day 2 was for the inter-collegiate student events, with competitions testing intelligence and creativity of the participants. The students were also further enriched by a special workshop on biosafety awareness by Esco Biotech. Making the event truly focused for the biotech industry were the sponsors Shimadzu Analytical (India), BioSpectrum and Genecity Laboratories.

While Biotechnology is a research and knowledge driven sector, many managerial issues of this niche segment need to be specially addressed. Biogérant '08 successfully highlighted these issues and the need for synergy towards excellence. The event was part of an annual eight-day corporate festival Virtualities.


Ansari calls for increasing agri productivity

The fifth edition of BioAsia 2008 was inaugurated by India's Vice President Hamid Ansari in Hyderabad on February 7, 2008. Inaugurating the event, Ansari pointed out that India was one of the first countries in the world to have focused on biotech as early as in the Eighties. The biotech focus got mentioned in the 6th Five-Year Plan.

The biotech industry attracted entrepreneurship, innovation, state support, private and venture capital funding. "And biotech is even more important now for the following reasons. One, biotechnology lies at the intersection of agri sector and the knowledge sector. India is the second largest food producer and biotech can be a tool for improving the productivity. The second reason is that biotech is straddled to areas of health and food. The third reason is that biotech is the best means to leverage India's biodiversity. The Indian subcontinent occupies 2.4 percent of the total global surface area, but 7.6 percent of total mammal species, 12.6 percent of bird species, 11.7 percent of fish and six percent of flowering plants that were present in the world, apart from varied climatic zones and rich human capital. The fourth is that biotechnology is a new wave of technology that will have a much more transformative impact than IT. And the last but not the least, biotech will bring together partnerships and innovation."

The industry grew by 40 percent during the last five years and the turnover during 2006-07 was over $2 billion. "It is estimated that the annual turnover by 2010 will be $10 billion," added Ansari

He also unveiled a plaque marking the inauguration of Biotechnology Incubation Centre (BTIC), located at Shapoorji Pallonji Biotech Park, and another plaque marking the laying of foundation for the Centre for Stem Cell Sciences.

Chief Minister YS Rajasekhara Reddy said that his government was committed to the growth of the biotechnology as this technology is complementary to other measures that will wipe out poverty and hunger. He promised to extend all support to the industry and will also promote science at the school level.

The state's minister for Major Industries J Geetha Reddy said that investments worth Rs 320 crore had flowed into the state since the first BioAsia. The proposed investments include Rs 1,000 crore from Biocon, Rs 500 crore (Avesthagen) and Rs 300 crore (Dupont). The investments were expected to create employment for about 60,000 people. The BTIC will also house the Rs 500-crore National Animal Resource Facility for Biomedical Research and a biotechnology incubation centre set up jointly by the Indian Institute of Chemical Technology and the Department of Biotechnology.


Kareus, Connexios to discover novel treatments for Alzheimer's disease

Kareus Therapeutics and Connexios Life Sciences will collaborate in the discovery of novel therapies for Alzheimer's disease. Kareus will bring to the collaboration its expertise in the understanding of novel mechanisms in the pathology of Alzheimer's while Connexios will bring in its proprietary network biology platform as well as its systems pharmacology driven small molecule discovery capabilities.

Dr Uday Saxena, co-founder and managing partner of Kareus, said, "We can now look at molecular pathways that normally get overlooked with a single target approach. It is like buying a new home and finding a map of all the roadways that it is connected with. We believe this alliance will accelerate our discovery of new therapeutics and targets."

Dr Suri Venkatachalam, CEO, Connexios Life Sciences, said, "This partnership allows us to get into a completely new therapeutic area and we can leverage the deep understanding of the biology of Alzheimer's."


Biocon acquires 70% stake in AxiCorp for $43.5m

Bangalore-based Biocon is acquiring a 70 percent stake in German pharmaceutical company, AxiCorp for a consideration of approximately $43.5 million. This will enable the marketing and distribution of a range of pharmaceuticals including generics, biosimilars, biologics and innovative pharmaceutical products in Germany and Europe.

AxiCorp is a specialized marketing and distribution company established in 2002 by a group of industry experts to address the lucrative generics and parallel distribution market in Germany and Europe.

With the strategic investment in AxiCorp, Biocon establishes its first presence in Europe in order to market its injectible insulin on its own, and also to build up marketing and distribution capabilities for many other products of its portfolio.

Elaborating on the acquisition, Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said, "AxiCorp is a key strategic investment for Biocon as it heralds our European foray for biosimilars like recombinant human insulin. Biocon is investing in AxiCorp's entrepreneurial team and its highly differentiated business model, which will help us build strong marketing and distribution capabilities in Europe. Both companies share a common vision of affordable healthcare, which we can deliver through a combination of Biocon's low cost manufacturing and AxiCorp's low cost distribution."

"The clinical development costs involved in commercializing bio-similars and biologics limit small and mid-sized pharmaceutical companies in Europe to participate in this emerging segment," said Dirk Ullrich, who has managed the diabetology business of Sanofi-Aventis before he became general manager of AxiCorp in 2007. "Biocon will now make it possible for AxiCorp to assert its position in this important therapeutic segment," he added.


Transasia Bio-Medicals awarded ISO 13485

Transasia Bio-Medicals, a provider of solutions for clinical diagnosis, has been awarded ISO 13485 (Quality Management Systems for Medical Devices) by UL India, a certifying body to foster quality assurance and improvement.

UL India is an affiliate of US-based Underwriters Laboratories, which is one of the world's largest conformity assessment service provider.

According to a company press release, Transasia Bio-Medicals is one of the few Indian companies which has been awarded the ISO 13485. The certification has reinforced the vision of the company to provide quality medical diagnostic products and services at affordable prices, through cost and quality conscious systems of materials and process control.

From its modest beginning in 1979 as a marketing firm for a few imported diagnostic equipments, Transasia today has the largest sales and installation base with over 15,000 installations all over the country supported by a network of 85 service centers and zonal offices at metros and major cities backed by a strong force of trained engineers and customer training personnel. The company, which is ISO 9001:2000 certified, has also been rated as India's largest in vitro diagnostics company (2006) by McEvoy & Farmer, USA (International experts on IVD markets). It has strategic alliances with some leading names in the diagnostic world like Sysmex Corporation-Japan, Medica-USA, Wako-Japan, Biohit-Finland, Grifols-Spain, CAN Ag-Sweden and Diesse-Italy among others.


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