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GVK Bio forms clinical research alliance with Excel
GVK Biosciences (GVK Bio), an integrated research services provider, and Excel PharmaStudies (Excel), a Chinese clinical research organization, announced a strategic alliance to conduct clinical trials in Asia.
The alliance aims to provide clinical trial sponsors access to the scientific skills, talent pool, flexible resourcing, and cost-effectiveness of both India and China. India has sponsor-friendly regulations and strengths in phase II-III clinical trials; China has strengths in its large market, phase III and post marketing phase IV studies; Through the GVK Bio-Excel alliance, sponsors will be able to increase the speed and efficiency of phase II-IV trials in India and China as required.
Under the terms of the arrangement, GVK Bio and Excel will help sponsors conduct and manage their phase II-IV clinical trials, statistical analysis and medical writing activities. Any India trial for Excel will be carried out by the GVK Bio clinical research team and will be managed by a core project management team of Excel. Similarly, a GVK Bio China trial will be carried out by the Excel team and managed by GVK Bio’s project management team.
“This is a first of a kind alliance between an Indian CRO and a Chinese CRO. The GVK Bio-Excel alliance integrates trial management across India and China and provides sponsors with a single point of contact,” said Manni Kantipudi, president, GVK Bio.
“It is an important step for Excel, and it allows us to provide full services to our clients in both important countries,” said Dr William Xiong, CEO, Excel PharmaStudies.
The decision to form such an alliance comes close on the heels of GVK Biosciences’ increased focus on clinical development. GVK Bio recently strengthened its team by appointing former senior medical director at Pfizer, Dr Shoibal Mukherjee, as its clinical development head. GVK Bio also added new services in pharmacovigilance and medical writing operations from its clinical research facility in Gurgaon, India.

Biocon registers 53% growth in revenues
Indian biotechnology major Biocon has posted a consolidated net profit of Rs 25 crore for the quarter ended March 31, 2009. The consolidated revenues (including AxiCorp) have increased 53 percent from Rs 1,090 crore in FY 07-08 to Rs 1,673 crore in FY08-09. Consolidated revenue (excluding AxiCorp) increased 10 percent from Rs 1,090 crore to Rs 1,194 crore. The EBITDA (including AxiCorp) grew 16 percent from Rs 335 crore to Rs 388 crore.
Commenting on the results, Biocon Chairman and Managing Director (CMD) Kiran Mazumdar Shaw said, “The Fiscal 2009 has been one of our most challenging years wherein foreign currency volatility made it difficult to manage a sharply depreciating rupee resulting in large MTM losses.”
Sales revenue from research services grew 28 percent to Rs 225 crore from Rs 176 crore in FY 2008. Syngene and Clinigene’s EBITDA grew 21 percent to Rs 70 crore, but MTM severely impacted profit earnings resulting in a loss of Rs 18 crore for the year.
Consolidated FY09 earnings have also been burdened with the impact of added depreciation of Rs 16 crore reflecting capital investments incurred to support future growth. Shaw added, “The unpredictable rupee depreciation induced by the global economic crisis has adversely impacted consolidated FY09 earnings, wherein losses of Rs 147 crore on account of MTM were provided.”
The company declared a 60 percent dividend or Rs 3 per share subject to shareholders approval.
Going forward, Shaw said, “The company’s new hedging strategy would be able to address the years ahead with a sense of confidence and resilience. We will be concentrating on R&D and brand building. Our branded formulations business under our healthcare umbrella has made rapid strides in garnering market share for our key brands in cardiology, diabetology, nephrology and oncology. We see this as a high growth segment in our business strategy.”

Policymakers unite to make new generation oral cholera vaccines
The National Institute of Cholera and Enteric Diseases (NICED), Indian Council of Medical Research (ICMR), Department of Biotechnology and the International Vaccine Institute (IVI) met with leading policy makers in the country to discuss how to make available and accessible new generation oral cholera vaccines (OCVs) to prevent and control cholera in India. The meeting had strong representation from the Ministry of Health and Family Welfare, Ministry of Science and Technology and Drugs Controller General of India as well as UNESCO, UNICEF and WHO.
New-generation OCVs have been available for more than two decades. The WHO had recommended their use in the control of endemic and epidemic cholera since 2002, but they have not been extensively adopted. The only WHO-prequalified OCV is the Swedish recombinant B-subunit killed whole-cell vaccine (rBS-WC), Dukoral. Vietnam has produced a cheaper variant of killed whole-cell vaccine devoid of the B subunit. This inexpensive vaccine costs less than a dollar a dose. This vaccine has been used in Vietnam’s public health sector in high risk cholera areas and more than nine million doses have been administered. Since the vaccine does not require any buffer, it is easier to administer.
However, an analysis of the Vietnamese vaccine showed that it complies with WHO guidelines, the vaccine needs to be reformulated and its production technology modified. The IVI worked with the Vietnamese producer, VaBiotech, to develop a killed whole-cell cholera vaccine that meets quality standards. The Seoul, Korea-based international organization transferred the production technology to Shantha Biotechnics Ltd of India.
This improved, low-cost oral whole-cell (WC) cholera vaccine that meets international good manufacturing practice (GMP) and WHO standards for production has been licensed in India after studies in Kolkata and Vietnam showed the vaccine to be extremely safe and effective. The OCV has been licensed on February 24, 2009 by the Drugs Controller General of India.
An economic analysis based on data from the Kolkata study shows that cholera vaccination using the WC vaccine would be cost-effective, and therefore could be an important tool in efforts to control cholera in India and throughout the cholera-endemic world. This modified vaccine has been shown to be safe and immunogenic in Phase II clinical trials in Vietnamese adults and in Indian children and adults as well as safe and effective in Phase III trials in adults and children. The Indian studies were conducted at the NICED in Kolkata, a constituent of ICMR, in collaboration with IVI.
Dr NK Ganguly, advisor to the union health minister, told at the policymakers meeting, “After 38 years of drought in cholera vaccination and cholera outbreaks, it is very heartening to know that there is an affordable orally administered vaccine available now.”
According to Dr John D Clemens, director general, IVI, “The licensor of the vaccine in India, where national regulatory authority is approved by the World Health Organization (WHO), paves the way for a wider use of the vaccine in cholera-endemic populations in Asia and elsewhere.”

GlaxoSmithKline’s Q1 sales up by 9.3%
GlaxoSmithKline Pharmaceuticals Ltd has announced its financial results for the first quarter ended March 31, 2009. The company has posted a net sales growth of 9.3 percent compared to the previous quarter, while Profit Before Tax (PBT) has grown by 7.9 percent, on a comparable basis.
Commenting on the performance during the quarter, Dr Hasit B Joshipura, managing director, said “The company’s major products in the priority range, including vaccines, registered good growth. During the quarter under review, we launched Cervarix, our vaccine for protecting women against cervical cancer and the initial response for the same has been encouraging.”

Jubilant FY09 revenues up 41%
Jubilant Organosys Limited, an integrated pharmaceutical industry player and one of the largest Custom Research and Manufacturing Services (CRAMS) company in India, announced its financial results for Q4/ FY2009.
Commenting on the company’s performance, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director, Jubilant Organosys Ltd, said, “We are happy to conclude FY 2009 with a record top line growth, which is fueled by the robust performance of our pharma and life sciences business (PLSPS). Despite the global economic slowdown, the company has reported very robust organic growth due to its strategic thrust on moving up the value chain in its PLSPS business. The earnings from this segment will be strengthened further with positive outcomes from the drug discovery and development services. Our focus on driving synergies, capacity utilization and business collaboration with global pharma companies will enable us to build future growth momentum.”
FY2009 revenues grew by 41.3 percent to Rs 3,517.9 crore from Rs 2,488.9 crore the previous fiscal. The growth momentum continued to come from the PLSPS business, where revenues stood at Rs 2,323.7 crore from Rs 1,530.2 crore last year. During the year, the company strengthened its position in CRAMS. Revenues from this business grew to Rs 1,963.2 crore from Rs 1,306.9 crore. This comprised Rs 489.5 crore in revenues from the CMO business in FY2009 as compared to Rs 204.9 crore in FY2008. Revenues from international operations were at Rs 2,176.9 crore from Rs 1,394.0 crore. Revenues from the IPP business were at Rs 1,194.2 crore from Rs 958.7 crore last year.
The company is well placed to report a steady top-line growth of over 15 percent driven by the PLSPS business in FY2010. The growth will be led by expected new product launches in the radiopharma segment, new customer approvals in the CMO business for sterile and non sterile products and robust revenue streams from the Drug Discovery Development Services (DDDS).

Persistent Systems develops Virus LIMS
Persistent Systems, an Outsourced Product Development (OPD) services company, announced the development of Virus Laboratory Information Management Software (Virus LIMS) for the National Institute of Virology (NIV), located in Pune. VirusLIMS is a secure web based information management system which is designed to manage field and laboratory information for clinical and laboratory testing.
“We are happy to be able to develop the Virus LIMS software for NIV which will facilitate accurate information flow and ensure that NIV is able to effectively respond to public health threats. Life sciences is an exciting and important domain for Persistent Systems and this development is one of our achievements towards excellence,” said Dr Anand Deshpande, chairman and managing director, Persistent Systems.
According to Dr AC Mishra, director, NIV, “National labs like NIV are required to deal with large number of specimen inflow which increases in an outbreak situation and during surveillance studies. This makes it critical for us to have a robust information management system in place. The VirusLIMS software developed by Persistent Systems provides us with the required infrastructure and enables NIV to capitalize on advances in information technology for managing clinical and laboratory testing across various centers.”

Siro Clinpharm, ACT Solutions enter strategic alliance
Mumbai-based Siro Clinpharm, a leading Indian CRO, and Advanced Clinical Trial Solutions LLC (ACT Solutions), Flemington, NJ, USA, a service provider in oncology drug development, have tied up to offer global oncology clinical development solutions in North America, Europe and India.
“We are delighted to add ACT Solution’s North American expertise in our service offering to our customers. This alliance is the first step for Siro in creating delivery capabilities in North America,” said Dr Chetan Tamhankar, COO, Siro Clinpharm.
Patricia Devitt Risse, president, ACT Solutions commented, “We are excited about aligning our strengths in oncology with Siro’s international delivery capabilities. This alliance expands our ability to deliver capabilities in Europe and India.”

IGIB completes whole genome sequencing of zebrafish
Institute of Genomics and Integrative Biology (IGIB), which is a constituent laboratory of the Council of Scientific and Industrial Research (CSIR), has completed the whole genome sequencing of a wildtype strain of zebrafish (Danio rerio). This work marks India’s entry into the arena of whole genome sequencing of animals. The zebrafish genome is about half the size of the human genome, containing about 1,700 million DNA base pairs. The research team at IGIB generated
over 89 gigabases of DNA sequences in two months time resulting in over 20X coverage of the zebrafish genome. The zebrafish represents a test case whose pipeline will be used downstream for genetic variation analysis with the goal of improving human health.
The whole genome sequencing of a single wildtype strain of zebrafish was completed in about two months. The whole genome sequencing of approximately 100 of the offspring is expected to complete by 2012.

Novo Nordisk among world’s most ethical companies
Novo Nordisk, a world leader in diabetes care, has been ranked for the second consecutive year as one of the top ethical companies for 2009 by international think-tank Ethisphere. Novo Nordisk has been ranked as one of the world’s most ethical companies as a result of its real, sustainable and ethical leadership.
More than 10,000 of the world’s leading companies were analyzed for a period of six months in six continents, across 35 industries before arriving at the final list.

Novo Nordisk spreads haemophilia awareness
World Haemophilia Day is commemorated on April 17 each year to raise awareness about haemophilia, a congenital blood disorder which is rapidly spreading across the globe. Almost 50 percent of haemophilia patients require treatment for bleeding several times per month. India is home to over one lakh such patients, although only about 13,000 patients are registered with Hemophilia Federation of India (HFI). Though the disease is incurable, it can be managed through anti-haemophilia factor injections. One of the most feared complications of the treatment of haemophilia is the development of inhibitors.
Novo Nordisk, which is focused on improving treatment options and providing better access to care, organized a slew of activities across cities in India in association with various partners. Some of these included free screening of haemophilia patients for inhibitors at St John’s Hospital in Bangalore, and at HFI in New Delhi and at the Haemophilia Society, Mumbai. Novo Nordisk has also organized a Haemophilia Management Training session at Kolkota.

The Bill & Melinda Gates Foundation opens Grand Challenges Explorations applications
The Bill & Melinda Gates Foundation today announced the opening of Round 3 of Grand Challenges Explorations (GEC). A five-year, Rs 495 crore initiative to encourage bold and unconventional research on new global health solutions, GEC offers researchers the chance to win grants worth Rs 49.5 lakh to further their research.
The topic areas for which proposals will be accepted in this round include: low-cost diagnostics for priority global health conditions; new tools to accelerate the eradication of malaria; new vaccines for diarrhea, HIV, malaria, pneumonia and tuberculosis; and new ways to induce mucosal immunity. Proposals are being accepted online at www.grandchallenges.org/explorations through May 28, 2009.
“We hope to hear from researchers of every age, on every continent, and from disciplines that don’t typically focus on global health or even biomedical research,” said Dr Tachi Yamada, president, global health program, the Gates Foundation.

Suven records 18% growth in revenues
Suven Life Sciences, a Hyderabad-based biopharmaceutical company specializing in Central Nervous System (CNS) diseases, announced its unaudited financial results for the year ended March 2009. Its revenues grew by 18.64 percent to Rs 14.61 crore. Suven’s thrust on innovative R&D in drug discovery continued to grow and its total spending for the year stood at Rs 3.1 crore.
The phase I study of SUVN-502 in 67 healthy volunteers has been successfully completed in March
2009. SUVN-502 is a potent, safe, highly selective, brain penetrant and orally active antagonist at a no peripheral CNS receptor site 5-HT6, intended for the symptomatic treatment of Alzheimer’s disease, Schizophrenia and other disorders of memory and cognition like attention deficient hyperactivity disorder (ADHD) and Parkinson’s disease.

Novozymes Biopharma, Millipore launch first animal-free product
Novozymes Biopharma and Millipore have launched the first product from their alliance to supply animal-free cell culture supplements for bioprocessing. CellPrime rTransferrin AF is the first animal-free alternative to serum-derived human or bovine transferrin for industrial cell culture and upstream biopharmaceutical
applications.
“We are pleased with the launch of our first commercial product and with the tremendous progress we have made in the first year of the alliance. Both Novozymes and Millipore share a vision for providing biopharmaceutical manufacturers with a broad range of animal-free supplements for industrial cell culture applications. The launch of animal-free transferrin for industrial scale production represents the first step toward that shared vision,” said Caspar Foghsgaard, senior manager, Novozymes Biopharma.