Shantha to develop rotavirus vaccine for childhood diarrhoea

Shantha Biotechnics, in collaboration with the global non-profit health organization PATH, is developing a multivalent vaccine against rotavirus with the technology licensed from the US National Institutes of Health (NIH). Shantha and PATH are working in partnership to accelerate development of the new vaccine.

"We are excited about working on the multivalent rotavirus vaccine, which has the potential to save many lives," said Varaprasad Reddy, managing director of Shantha Biotech.

There are two licensed vaccines for rotavirus, RotaTeq (Merck & Co.) and Rotatrix (GSK) but these are not currently available in India. PATH is working with Shantha Biotech and other emerging manufacturers to develop promising candidates into safe, effective and affordable vaccines.

"Because bringing new vaccines to market is a key component in improving affordability, PATH is pleased to be partnering with Shantha to develop the rotavirus vaccine to meet India and other countries' needs," commented Rajat Goyal, director of PATH's Advancing Rotavirus Vaccine Development project. Shantha was selected following a rigorous assessment of its technical and business merits, for its willingness and capacity to meet WHO vaccine standards.

Shantha plans to carry out the clinical trials following completion of preclinical toxicology studies and expects to start clinical trials in the year 2008.

Suracell selects BioServe as its exclusive DNA testing partner

BioServe, a leading provider of genetic testing services, has announced that it has been selected by Suracell as its exclusive DNA testing partner.

Suracell, a leader in the emerging field of personal genetic health, has developed a proprietary and fully integrated information technology platform to identify genetic markers related to a number of biological processes that have been shown to be associated with healthy aging.

Through this agreement, BioServe will receive samples collected from patients seeking to take advantage of Suracell's unique programs. BioServe extracts DNA from a buccal swab collected from the de-identified patient. Next, the DNA quality is verified before undergoing analysis using a panel of proprietary single nucleotide polymorphisms (SNPs) selected by Suracell. BioServe then transmits the analyzed data back to Suracell using Suracell's proprietary information technology platform. Suracell subsequently delivers the results to the requesting physicians and health care practitioners. BioServe is one of the few DNA testing laboratories that have been awarded the CLIA certification, the highest standard in lab certification.

In addition, BioServe is the first company providing DNA testing services to utilize Suracell's proprietary "genetic testing web portal." This portal provides a single point of access for physicians and health care centers, allowing them to use the internet to order genetic testing services for patients from participating laboratory service providers.

Aptuit to invest more than $100 million in Laurus Labs

Global contract drug development firm Aptuit, and Hyderabad-based Laurus Labs have announced the formation of a contract drug development company, Aptuit Laurus in India. The company will combine Aptuit's global offerings in drug development with Laurus' R&D and manufacturing expertise and newly built state-of-the-art facilities to provide established and emerging pharmaceutical companies with integrated services, technologies and manufacturing capabilities that span the entire drug development lifecycle. Aptuit plans to invest over $100 million over the next four years to build upon Aptuit Laurus' development, manufacturing and informatics capabilities.

"Laurus Labs shares our strategic vision to build an end-to-end drug development services partner with high service levels and an emphasis on technology, and their offerings align neatly with ours," said Michael A Griffith, founder and CEO of Aptuit.

"Aptuit is the ideal strategic partner for Laurus," said Dr Satyanarayana Chava, founder and CEO of Laurus Labs. "Our strengths are complementary, and we are very focused on the value and efficiencies to be gained for our customers in having access to a full range of research, development and manufacturing capabilities and services on a truly global scale. We see this as a very powerful combination, one that benefits our customers quite uniquely."

The new entity will use the trade name Aptuit Laurus, and will be based in Hyderabad with additional facilities in Vishakhapatnam and Bangalore. Aptuit Laurus will comprise Laurus' newly-established 160,000 sft R&D facility in Hyderabad, which already employs over 200 scientific personnel; Laurus' large-scale manufacturing plant, which is currently under construction on over 34 acres of land in Pharma City, Vishakhapatnam; and Aptuit's existing Informatics Development and Support group of 100 employees in Bangalore.

Aptuit Laurus will be led by Dr Satyanarayana and his existing management team, which will expand as new services are added, and will be governed by a newly established Board of Directors.

Micro Labs launches ophthalmology division

Bangalore-based Micro Labs has announced the launch of its new ophthalmology division, Micro Lumira. With this, the company increased the number of divisions in its portfolio from 12 to 13. This is a strategic move by the organization keeping in mind the potential size of eye care market. The division will be headed by S Rajagopalan, president.

Micro Lumira has been launched with an objective to offer wide range of ophthalmic medications across all therapeutic segments at an affordable cost. These drugs will be manufactured at Micro Labs' state-of-the-art eye drop facility at Bommasandra, which is Asia's largest set up with an investment of Rs 70 crore. This facility has been designed in line with the world's quality accreditation requirements of different regulatory bodies like US FDA and UK MHRA. The capacity of the facility is to produce two lakh bottles of ophthalmic preparations per day.

Speaking on the occasion, Dilip Surana, managing director, Micro Labs, said, "Eye care market has vast, untapped potential. We bring a unique proposition to our stakeholders by providing world class medicines manufactured at our facility at Bommasandra at affordable prices. Micro Lumira will bring us closer to achieving our mission of becoming the No. 1 player in eye care market."

S Rajagaopalan, president, added, "We have a highly trained and motivated sales force that will introduce newer eye care formulations to various ophthalmologists across the country. Through this vast network of 'Feet on Street', we intend to achieve threefold increase in our sales in the next three years."

The facility has latest technology with best equipment from countries like Germany, Italy, Switzerland and Japan.

TCG Lifesciences inks pact with Forest

TCG Lifesciences has announced a strategic collaboration with Forest Laboratories Holdings, a wholly owned subsidiary of Forest Laboratories, to discover small molecule drug candidates for inflammatory diseases. Working closely with Forest scientists, Chembiotek, the chemistry and biology arm of TCG Lifesciences, will carry out discovery research to identify and optimize lead molecules.

The program will focus on an integrated approach involving chemistry, biology, ADME and animal pharmacology capabilities of Chembiotek. Forest will have full ownership of the compounds developed under the collaboration with unencumbered worldwide rights, and will fund all subsequent drug development and commercialization activities. Forest will pay Chembiotek undisclosed discovery milestones.

Commenting on the collaboration with Chembiotek, Dr Ivan Gergel, senior vice president of scientific affairs, Forest Laboratories and president of the Forest Research Institute said, "We are pleased to commence this discovery research collaboration with Chembiotek. This collaboration is part of our continued commitment to fill our early stage pipeline through discovery partnerships. We believe that Chembiotek has the commitment throughout its organization and the quality of personnel necessary for the success of this program."

Swapan Bhattacharya, managing director, TCG Lifesciences, said, "This partnership with Forest is a culmination of the skills, capabilities and scale of operations we have developed over the past few years at TCG Lifesciences and more specifically at Chembiotek. In addition to our strong chemistry capabilities, we have developed the best biology and computational skills among CROs in India. Our talented and dedicated team of scientists has made this possible. This transaction represents the fourth integrated discovery project we have signed this year."

Johnson & Johnson selects ArisGlobal as its pharmacovigilance partner

ArisGlobal, a provider of pharmacovigilance and safety systems to the life sciences industry, has announced its strategic partnership with Johnson & Johnson. Johnson & Johnson will deploy the ArisGlobal Total Safety suite of products on a global basis to replace its in-house systems.

Johnson & Johnson's goal was to select a partner who could supply a single, harmonized platform to provide global, state-of-the-art safety case management, signal detection and surveillance capabilities. In addition, Johnson & Johnson needed a partner with a shared vision and strategy to evolve and develop systems to meet the current and future demands of a global organization such as Johnson & Johnson.

"We chose ArisGlobal because they understand our business environment and demonstrated excellent commitment during our business and technology requirements sessions. The services and functionality provided with ARISg combined with our development partnership with ArisGlobal to enhance ARISg will support our requirements," said William Truhe, vice president of informatics, benefit risk management at Johnson & Johnson Pharmaceutical Research & Development. "With ArisGlobal's ARISg robust feature set, flexible data model ,intuitive user interface and ability to integrate with our key systems, Johnson & Johnson will incorporate this solution into our existing enterprise-wide processes, knowing that they have the ability to perform enhancements at an efficient pace.".

"The fact that Johnson & Johnson has entrusted ArisGlobal to support their most critical business needs is extremely satisfying. It is widely known that Johnson & Johnson has been at the forefront of drug safety initiatives and our partnership with them will allow us to develop a solid pharmacovigilance and risk management platform to satisfy the demands of government, the regulators and the consumer," said Simon Sparkes, vice president, global sales and marketing at ArisGlobal.

Bilcare-ACRP to uplift clinical research infrastructure in India

Bilcare Research has launched the India Chapter of Association of Clinical Research Professionals (ACRP) along with inauguration of its first academic center at Pune, India. This is ACRP's first chapter in India and will be a gateway for quality clinical research training in the Asian region.

In association with ACRP, Bilcare Research Academy plans to impart training to hospitals, clinical research organizations and other intermediaries in the clinical research business to enhance the understanding and thereby upgrade the standard in the region.

To accomplish this goal, Bilcare has already tied-up with Bangalore Diabetic Hospital and nine other hospitals across the country where customized programs will commence shortly.

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