Intas Biopharma acquires US–based BPD

Intas Biopharmaceuticals Ltd (IBPL) has acquired US-based biotechnology corporation, Biologics Process Development, based in Poway, California. With acquisition process underway, both companies are actively pursuing plans to work closely towards fulfillment of common business objectives in the area of Contract Research and Manufacturing Services (CRAMS). With agreement in the final stages of completion, the financials has been undisclosed and will be accordingly announced at a later stage.

The development will facilitate and assist IBPL's foray in the US market especially to expand its CRAMS business. With mutual understanding and agreement, Dr Scott M Brown shall continue as president and CEO of BPD and Dr Rajeev Datar shall be the new CEO of BPD.

Sharing the details of the development, Dr Datar, said, "With Intas Biopharmaceuticals and BPD coming together, the two companies complement technical strengths of each other. Both the companies shall gain expertise from the synergies in technical areas like gene expression optimization, medium optimization cell culture/fermentation services, protein purification scale-up and analytical services thereby expanding the scope of CRAMS activities."

Dr Brown, said, "We are pleased to become associates with Intas Biopharmaceuticals who are leaders in area of biologics in India. Jointly we compliment each other on technology front and we, at BPD, are looking forward to jointly work with Intas Biopharmaceuticals in the area of R&D and explore new technology frontiers."

Biocon launches pre-filled safety syringes

Biocon has launched a safety device in the form of pre-filled syringes for two of its life saving products, Erypro Safe and Nufil Safe, in collaboration with US-based Safety Syringes, a manufacturer of drug delivery systems. Erypro Safe is used for the treatment of chronic kidney disease and Nufil Safe is used for cancer treatment.

Pre-filled syringes are advantageous for self-injecting patients. This allows patients a high degree of flexibility, independence and easy handling in a home setting. The pre-filled syringe device incorporates features that provide for simple and safe handling, a discrete appearance of the injector and a retractable needle that reduces the chances of injuries during injection. The device is tamper proof and ensures that the syringe is non-reusable thus ensuring safety.

Elaborating on the launch, Kiran Mazumdar-Shaw, CMD of Biocon, said, "In line with our philosophy of differentiation, we are pleased to introduce Erypro Safe and Nufil Safe as pre-filled syringes with advanced safety features. Safety Syringes of US have developed a novel pre-filled device that enhances safety and convenience of use. We are delighted to be able to collaborate with them and introduce this proprietary device to the Indian market for the first time which will greatly benefit the patients."

Rakesh Bamzai, Biocon's president, marketing said, "Biocon is committed to cater to the needs of patients across the country and this technology would be advantageous to patients. The launch is significant as it allows for product differentiation in the market."

Dabur OncQuest is now OncQuest Laboratories

OncQuest Laboratories (formerly Dabur OncQuest) announced its existence as an independent entity moving away from being a part of Dabur Pharma, effective December 31, 2007. OncQuest Laboratories was incorporated in January 2008.

Aditya C Burman, managing director, OncQuest Laboratories, said, "We have been thinking about increasing our footprint on the molecular diagnostics space for global CROs for a while now. One of the initial roadblocks has been the concerns of these CROs and pharmaceutical companies in inking a Non Disclosure Agreement (NDA) with a business unit of a pharmaceutical company. Hence, OncQuest Laboratories came into being in order to facilitate faster growth in the CRO business space. This has also given us an opportunity to look at higher investments towards people and technology, along with optimization of existing facilities and infrastructure."

OncQuest is unique in Southeast Asia with its singular focus on clinical oncology diagnostics. The new integrated research facility provides a strong foundation for OncQuest to grow within the field of genetic oncology.

DBT calls off consultation on proposed NBRA

The Department of Biotechnology had organized a regional consultation in Bangalore on June 11, 2008. The purpose of this consultation was to deliberate on various issues involved in the constitution of a National Biotechnology Regulatory Authority, and measures to be adopted to move the Bill in the monsoon session of Parliament. The DBT had invited people from the industry, academia, state pollution control board, Greenpeace and other organizations.

However, during the NBRA consultation, a big group of anti-GM activists interrupted the session, making a huge drama and demanding justification from the DBT officials for the absence of the Karnataka state government officials in the consultation process. The activists also threatened the DBT that they would involve MLAs into the matter and make it a central issue.

As a result of the huge agitation and argument between the activists and the DBT officials, the consultation process was finally called off as they claimed that not one Karnataka government official or regulatory authority had been invited to participate in the meeting. The activist group demanded that the consultation process should be organized again but in a state agricultural university and in the presence of farmers, government officials, media and farmer organizations.

The DBT officials stated that a letter had been sent to the state chief secretary informing him about the consultation.

Satyam to provide comprehensive drug safety management

Satyam Computer Services, a leading global consulting and information technology services provider, has formed an alliance with Sciformix Corporation, a US-based, life science Knowledge Process Outsourcing (KPO) company, to deliver end-to-end data management services in pharmacovigilance.

The partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor the safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting. The alliance also enables the organizations to offer these services in a way that is both cost-efficient and scalable, via a proven global delivery model.

Additionally, the alliance leverages Sciformix's in-depth understanding of the pharmaceutical and life sciences domain with Satyam's proven drug safety Business Process Outsourcing (BPO) capabilities. It will provide services to a wide range of clients in the pharmaceutical, biotechnology and life sciences industries.

Kishore Rachapudi, Satyam's global head of life sciences said, "We will leverage our extensive experience managing large-scale IT and BPO solutions and work with Sciformix to offer a scalable platform for delivery of drug safety services. At the same time, we reaffirm our commitment to providing the widest range of services through the most advanced global delivery models available."

Biotech drugs sales grew 12.5% in 2007: IMS Health

Biotech drugs market globally are on a roll. According to newly released study by IMS Health, global prescription sales of biotech drugs increased 12.5 percent in 2007 to more than $75 billion. The report also mentions that the global biotech market grew at nearly double the rate of the global pharmaceutical market, which increased 6.4 percent in 2007. This is twice as fast the global prescription drugs market.

"The biotech market has expanded dramatically during the past five years, consistently exceeding overall pharmaceutical market growth two-to-three fold," said Murray Aitken, senior vice president, Healthcare Insight, IMS. "Recent innovations, the continued expansion of approved indications for existing products, and the gradual uptake of biotech products outside the US have fueled that growth, and improved the quality of life for millions of patients across a growing number of disease areas." IMS Health is a New York Stock Exchange listed provider of market intelligence to the pharmaceutical and healthcare industries.

The report said, during the past five years, the range of biotech products and their use in multiple therapy areas have steadily increased, creating a major source of market growth. Twenty-two biotech products generated sales exceeding $1 billion in 2007, compared with just six products in 2002.

According to IMS, in the next five years, the global biotech market will more closely parallel the traditional pharmaceutical marketplace, reflecting changing industry dynamics.

GBL collaborates with PATH Malaria Vaccine Initiative

Gennova Biopharmaceuticals Ltd (GBL) is collaborating with the PATH Malaria Vaccine Initiative (MVI) to create a dedicated malaria vaccine manufacturing facility. PATH MVI is a focused vaccine development program created through a grant from the Bill & Melinda Gates Foundation.

Under the GBL-MVI agreement, MVI will provide partial financial support to GBL to establish a cGMP compliant manufacturing facility able to produce recombinant protein-based malaria vaccine candidates. Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals, said, "The funding was based on the scientific and business synergies that exist between the two organizations."

MVI is providing financial support for the first time to equip a dedicated recombinant protein manufacturing facility to produce cGMP grade malaria vaccine candidates for use in Phase I and Phase II clinical trials.

Dr Christian Loucq, director, PATH Malaria Vaccine Initiative, said, "At the PATH Malaria Vaccine Initiative, we believe in making investments that move the field forward. With this investment, we are helping to fill the community's need for a facility where high-quality manufacturing of recombinant proteins can take place."

The National Institute of Malaria Research (NIMR), India will conduct epidemiological studies using human sera from malarial endemic regions in India. NIMR will also conduct Phase I and II human clinical trials for the selected vaccine candidates at its well-established clinical trial centers.

Emcure Pharmaceuticals opens oncology facility

Emcure Pharmaceuticals has announced the launch of their new oncology plant at Hinjwadi, Pune. The facility is spread over an area of 70,000 sft. Emcure's total investment for the oncology formulations facility and API facility exceeds $25 million.

Committed to offer the latest in cancer therapy in India and world wide, the oncology division will manufacture and market the products at an affordable cost. The facility is designed to comply with the requirements of global regulatory authorities. The facility is based on the latest isolation technology that will ensure protection of the products, operating personnel and environment.

The company also inaugurated its subsidiary Gennova Biopharmaceuticals' Malaria Vaccine Facility that will develop and manufacture malaria vaccine candidates for worldwide clinical trials. Gennova is also located at Hinjwadi, Pune. The new facilities were inaugurated by Sharad Pawar, minister for agriculture, Government of India.

"The oncology market in India is estimated at Rs 400 crore and is growing at the rate of 30 percent. We aim to achieve 15-20 percent market share in this segment within next five years," said Satish Mehta, CEO, Emcure Pharmaceuticals. Arun Khanna, COO, Emcure Pharmaceuticals, said, "In India, patients have limited access to the latest cancer therapy. We will offer a vertically integrated solution for cytotoxic drug substance and drug product manufactured at our facilities at an affordable price."