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.