Jubilant, Amgen enter into drug discovery partnership

Bangalore-based Jubilant Biosys, the India based subsidiary of Jubilant Organosys Ltd, and Amgen Inc., California, have entered into a drug discovery partnership, under which the two will collaborate to develop a portfolio of novel drugs in new target areas of interest across multiple therapeutic areas. While Jubilant will develop early preclinical candidates emanating from Amgen's early discovery efforts for an initial term of three years, Amgen will have responsibility for the subsequent pre-clinical and clinical development and commercialization. Amgen will retain or own the drugs developed under the collaboration with worldwide commercialization rights.

The financial terms include a combination of research funding and success-based milestone payments to Jubilant for pre-clinical and clinical development projects undertaken under the ambit of the agreement. The total financial milestone value is subject to successful development and commercialization of the portfolio of novel drugs.

Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director, Jubilant Organosys said, "We are very pleased to expand our relationship with Amgen. This collaboration leverages the innovation capabilities of Jubilant Biosys in pharmaceutical discovery and preclinical development and combining the strengths of Amgen, the world's largest research-driven biotech company, to deliver cost-effective new products. This partnership continues to demonstrate Jubilant's strategy to be India's largest innovation driven integrated pharmaceutical service provider supporting the global pharmaceutical Industry."

Piramal Healthcare acquires Haemaccel plasma products

Piramal Healthcare Ltd (formerly Nicholas Piramal) has announced the completion of a definitive agreement with PlasmaSelect AG, Germany, to acquire PlasmaSelect's polygeline-based blood plasma products marketed under the brand name, Haemaccel. PlasmaSelect also markets the product under the brand name "Emagel" in Italy and "Solucel" in Venezuela. This acquisition is intended to bring global leadership to Piramal Healthcare's polygeline-based blood plasma expansion products. Piramal Healthcare currently markets the products under the brand name Haemaccel in India and under the brand name Haemageline in 17 other countries.

Commenting on the acquisition, Ajay Piramal, chairman, Piramal Group said, "Over the years, we have recognized the compelling potential of the global critical care business. This acquisition is a step forward in that direction and a reflection of our commitment to knowledge and innovation, dynamic action and care."

In 1998, Piramal Healthcare bought Haemaccel-related business in the Indian market along with the manufacturing facility in Mumbai from Sanofi-Aventis, the originator company of Haemaccel. In 2004, Sanofi-Aventis sold its Haemaccel-related rights in 76 countries and its manufacturing facility at Marburg, Germany, to PlasmaSelect AG. The total yearly revenues of Haemaccel and associated brands of Piramal Healthcare and PlasmaSelect together are Rs 60 crore, at current exchange rates.

Bangalore to get stem cell research institution

Recognizing the potential of regenerative medicine, the Government of India has given its approval for the establishment of an Institute for Stem Cell Science and Regenerative Medicine (SCSRM) in Bangalore. The SCSRM institute would be an autonomous institution of the Department of Biotechnology (DBT) under the ministry of science and technology and would be set up at a total cost of Rs 203.10 crore.

The institute will help in developing policies relating to stem cell technologies, identify needs, facilitate conceptualization, and design of new technologies. The Government of India has also decided to integrate the Stem Cell Center (SCC) at Christian Medical College, Vellore, Tamil Nadu, now funded in project mode by DBT, with the SCSRM in Bangalore.

Avesthagen gets nod for pre-clinical evaluation of biopharma products

Avesta Biotherapeutics & Research Private Ltd (ABRPL), a joint venture between Avesthagen Ltd and Meditab Specialities, has got the permission from the Review Committee for Genetic Manipulation (RCGM), under the Department of Biotechnology (DBT), to enter into pre-clinical safety and efficacy evaluation study for three of its biopharmaceutical product development programs. The RCGM has approved ABRPL's applications for conducting a pre-clinical evaluation of the biopharmaceutical products at recognized contract research facilities.

These biopharmaceutical products, being developed by ABRPL, are targeted at important therapeutic indications namely, rheumatoid arthritis, anemia resulting from chronic renal failure or chemotherapy and colorectal cancer. These products are expected to enter into clinical evaluation during early 2009 based on the outcome of the pre-clinical evaluation.

Dr Villoo Morawala-Patell, founder & CMD, Avesthagen Ltd, said, "We are very happy to enter the pre-clinical evaluation marking another landmark in our biopharmaceutical product portfolio. Biopharmaceuticals offer several advantages such as highly effective and potent action, fewer side effects and the potential to actually cure diseases rather than merely treat the symptoms. These advantages, combined with the increasing number of new diseases that can be treated with biopharmaceuticals, are driving enhanced production of these drugs worldwide."

Veeda Oncology acquires ION Clinical Research

Veeda Oncology announced the acquisition of US-based International Oncology Network (ION) Clinical Research. Veeda Oncology and ION have also agreed to a five-year exclusive agreement under which Veeda Oncology will provide clinical research support to the ION network of sites. The acquisition of ION Clinical Research would provide Veeda with immediate access to the 50 ION sites that conduct oncology clinical research in the US.

Commenting on the acquisition, Binoy Gardi, co-group managing director and co-founder, Veeda Group, said "The agreement with ION substantially increases our ability to provide our sponsors with rapid global accrual of oncology patients beyond our relationships with institutions in India, Eastern Europe, Western Europe as well as our current site relationships in the US."

Matt Bowman, president and CEO, Veeda Oncology stated, "The access to the 50 ION Clinical Research sites significantly compliments our strategy of rapid access to oncology patients for global clinical trials. In addition, all of the personnel of ION Clinical Research will be joining Veeda Oncology and we are very pleased to be adding such terrific oncology professionals".

Hikal commissions new multipurpose agro chemical plant at Taloja

Hikal Ltd announced the inauguration of their new multi-purpose agrochemical plant. The plant is located at the company's existing manufacturing facility at Taloja originally set up in 1995. Hikal had announced in March 2008, that it had signed a long term contract manufacturing agreement with Bayer CropScience AG, for supply of active ingredients for crop protection products.

"We are happy that the multi purpose plant has been commissioned and supplies will commence in the second half as planned. This is an important project for Hikal and it will have a significant impact on our agrochemical business. We see many such opportunities in this sector given the current global scenario with crop protection products. We look forward to building on the existing relationship we enjoy with Bayer CropScience," said Jai Hiremath, vice chairman and managing director, Hikal Ltd.

LabVantage unveils new release of Sapphire

LabVantage Solutions Inc. announced the commercial availability of Sapphire Release 5 Laboratory Information Management Suite (LIMS). Sapphire is an industry leading LIMS that consolidates functionality typically found in multiple laboratory systems. "By collaborating with our diverse global customer base, we combine our LIMS expertise and their critical insights to continually define the functional and technical features of Sapphire," said Ron Kasner, vice president, corporate development, LabVantage. "The result is that Sapphire R5, more than any other LIMS solution, has the technical depth and breadth required to deliver the most complete and versatile, multi-site, and multi-language enterprise backbone for laboratory informatics."

Chennai-based DeRisk IT Solutions Pvt Ltd (DeRisk IT) is launching a new operation in India to introduce Governance Risk and Compliance (GRC) technology to the Indian market. DeRisk IT will also provide a broad range of IT services including security, audit and assurance solutions to life sciences companies.

The move follows the appointment of DeRisk IT as the new authorized partner by Achiever Business Solutions (ABS), a recognised European leader in GRC management software. Under the terms of the partnership agreement, DeRisk IT will provide the widely acclaimed AchieverPlus GRC solution to the India, Middle East and Asia- Pacific markets. To do this, DeRisk IT will exploit its position as a key player across different verticals markets including MNCs. DeRisk IT will also provide full sales and support services for Achiever Business Solutions and therein expand Achiever Business Solutions' growing presence as an international market leader.

AchieverPlus software provides a single point of access for GRC management for all areas of risk management, compliance management and regulatory affairs, including quality, health and safety, financial, I T security and environmental management, across the industry including life science.

Specific solutions for the highly-regulated business areas include: Sarbanes Oxley, Life Sciences (FDA 21 CFR Part 11), ISO 9001, ISO 14001/18001 and more.

Commenting on the tie-up, S Senthil Kumaran, chief executive officer, DeRisk IT noted, "Indian businesses are generally, considered as not-so-serious about compliance. However, this is in no way a true reflection as most have woken up to the reality that effective GRC management is critical to success. With this fundamental change of approach, the market has widened considerably and businesses are actively looking for solutions. The knowledge and competencies of DeRisk IT combined with the AchieverPlus range makes for a perfect fit".

"Many companies in India are now global players and are subject to the same pressures, in terms of governance, risk and compliance, as companies in any other part of the world. We are delighted therefore to partner with DeRisk IT as they bring with them an enormous knowledge and experience of the Indian market across numerous industry sectors. We are confident that DeRisk IT will capitalize upon the huge demand in India for cutting-edge, enterprise-wide GRC systems," added Cherry Rance, marketing and strategic alliances manager, Achiever Business Solutions.

Jahanara Parveen, Chennai

Biocon's Q1 FY09 impacted by Rupee volatility

India's leading integrated biotech company, Biocon Ltd has reported a difficult financial performance for the three months ended June 30, 2008. Revenues for the quarter was Rs 277 crore, earnings before income-tax and depreciation Rs 70 crore and profit after tax Rs 15 crore. However, income from biopharmaceuticals income (excluding licensing) showed a 40 percent increase in PAT to reach Rs 39 crore. Branded formulations related to cardio-diabetes, nephrology and cancer drugs showed growth.

During the quarter, Biocon filed 23 new patents and progressed well in clinical development of oral insulin and anti-bodies. Commenting on the results, Kiran Mazumdar-Shaw, chairman and managing director, Biocon, said, "Biocon's Q1 FY '09 performance has been unfortunately impacted by Rupee volatility which has seen us make a Mark-to-Market provision of Rs 26 crore. We have consciously been conservative in making this provision. Our business fundamentals are robust, which is well demonstrated by the strong profit growth in our core biopharmaceutical business. The absence of licensing income this quarter has had a disproportionate impact on profitability. However, we are confident that licensing income will be significant this fiscal. We are particularly encouraged by the good growth demonstrated by our branded formulations, where several brands have attained high-rankings in their respective product segments in India. Syngene has had a particularly difficult quarter. Management is confident of compensating for this in the quarters ahead especially with the BMS facility becoming fully operational in Q3 FY '09. Clinigene is now fully operational at its new facility and is on track to deliver good growth this fiscal."

Biocon, Abraxis launch Abraxane in India

In another development, Biocon Ltd and Abraxis BioScience Inc., a fully integrated biotechnology company launched ABRAXANE (paclitaxel protein-bound particles for injectable suspension, albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Abraxane is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration).

In October 2007, Abraxane was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the US. According to the companies, the Phase III clinical trials in the US demonstrated that Abraxane nearly doubled the response rate, significantly prolonged time to progression, and improved overall survival in the second-line setting versus solvent-based Taxol in the approved indication.

Stempeutics begins pilot studies for dilated cardiomyopathy in India

Dilated Cardiomyopathy, a heart muscle disease that is characterized by thinning and weakness of the heart muscle, has no known cause and can affect as many as 5-8 people in every lakh of population, per year. Researchers at Stempeutics Research Pvt Ltd (SRPL), a Bangalore-based stem cell company, which is focused on research, therapeutics and therapy in the field of regenerative medicine, has initiated an experimental safety and feasibility study in dilated cardiomyopathy patients with no option of treatment, using mesenchymal stem cells at its centers at Manipal Hospital in Bangalore and Kasturba Medical College, Manipal.

According to reports dilated cardiomyopathy leads to dilation of the ventricles and the pumping chambers and consequent symptoms of congestive heart failure. Some of causes leading to dilated cardiomyopathy could include genetic and familial factors, infections especially viruses and inflammation, autoimmunity, cytotoxicity and cell loss. In most instances a specific cause is not identifiable.

"Dilated cardiomyopathy can be present for some time without causing significant symptoms. With time, however, the enlarged heart gradually weakens, leading to symptoms and signs of heart failure. Typical symptoms of heart failure include: fatigue, weakness, shortness of breath, sometimes severe and accompanied by a cough, particularly with exertion or when lying down, and swelling of the legs and feet, resulting from fluid accumulation that may also affect the lungs (congestion) and other parts of the body," said Dr Anil Bhat, director and head cardiology, Manipal Hospital, Bangalore

Dr Satish Totey, chief scientific officer, SRPL, said, "The search for newer therapeutic approaches has begun. Cell transplantation is emerging as a potential novel therapeutic approach for the treatment of dilated cardiomyopathy that has the potential to restore cardiac function by inducing revascularization, and regenerating and protecting cardiomyocytes. Bone marrow derived mesenchymal stem cells are a potential candidate for the cellular therapy in heart diseases."

Panacea Biotec enters hospital biz

Vaccine maker Panacea Biotec is foraying into the hospital business by setting up a 220-bed multi-specialty hospital with Gurgaon-based Umkal Medicals. Panacea Biotec has picked up 75 percent stake in Umkal's project at Gurgaon and expects the hospital to be operational by January 2010. The Delhi-based pharma and vaccines major has signed an agreement with Umkal, which has three hospitals in Delhi and the national capital region (NCR). However Panacea's interest in Umkal will be limited to the Gurgaon project.

According to initial estimates the project will cost around Rs 80 crore. The company will target overseas patients and affluent Indians, which would be close to 25-30 percent of the market. Rajesh Jain, joint MD, Panacea Biotec said, "It is the company's long-term strategy to enter the private healthcare segment to make the company a leading health management company. Based on the experience from this project, we may look at starting a hospital chain."