ThromboGenics transfers thrombolytic agent technology to Bharat Biotech
ThromboGenics NV, Belgium, has announced the successful completion of technology transfer to Bharat Biotech International Limited, India, for the manufacture of THR-100, a novel variant of recombinant staphylokinase. THR-100 is a thrombolytic agent developed for the treatment of acute myocardial infarction (AMI) and other vascular diseases, based on its ability to dissolve blood clots.


ThromboGenics had earlier announced the completion of a licence agreement with Bharat Biotech to manufacture, develop and commercialize THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing countries.


Bharat Biotech will use its manufacturing capabilities, and the technological expertise acquired from ThromboGenics, to produce clinical-grade material for upcoming clinical trials. THR-100 has completed Phase II clinical trials in Europe for treatment of AMI, and is expected to enter Phase III in India later this year.


Source: www.bionity.com
Immunotherapeutics to invest in R&D and production
Immunotherapeutics Ltd., India, a 100 per cent subsidiary of American Bio Sources (ABS) Inc., the United States, has earmarked an investment of Rs 1 billion (about US$25 million) to establish R&D and manufacturing facilities. The locations are being identified at Hyderabad and Bangalore. The investments will be sourced through public funding.


The company will manufacture novel vaccines for prevention of infections, monoclonal antibodies (MABs), cancer therapeutics and cardio-vascular bio-pharmaceuticals, said Dr. Niranjan Kumar, Chairman and Managing Director. The company will receive technology from its parent company and also offer its facility for contract manufacturing services, stated Dr. Kumar. “We will also look at alternate locations like Pune for an R&D laboratory and New Delhi for manufacturing plant as part of our nation wide activities,” he added. Immunotherapeutics is ready for clinical trials in India for the novel bacterial and viral vaccines, which are already launched globally. The company will go in for production in 2008-end and products will be available in India by mid-2009.


Source: www.pharmabiz.com
Acambis wins FDA approval for new smallpox vaccine
Acambis plc, the United Kingdom, has received approval from the United States Food and Drug Authority for its smallpox vaccine ACAM 2000, the first new bio-defence vaccine to be licensed since the United States government launched Project Bioshield in 2001. The company previously supplied 192.5 million doses of the vaccine under the investigational new drug application, and the licence paves the way for it to agree to a deal with the Centres for Disease Control and Prevention (CDCs) for a warm base manufacturing contract to maintain the stockpile. The warm base contract will require Acambis to keep its United States facility in readiness to manufacture ACAM 2000.


Military personnel are required to be vaccinated if they are posted to threat areas, and it is planned to switch from the current Dryvax vaccine manufactured by Wyeth, the United States, to ACAM 2000 now that it is licensed. Those doses will be supplied from the CDC’s stockpile. ACAM 2000 has an equivalent safety and efficacy profile to Dryvax, but is manufactured in cell culture using animal-free serum.


More than 3,800 subjects were vaccinated in two Phase III studies of ACAM 2000. One demonstrated non-inferiority to Dryvax in producing a scab at the injection site in people not previously vaccinated against smallpox – a generally accepted surrogate endpoint. There was a 96 per cent response in the ACAM 2000 group compared with 99 per cent in the Dryvax group. The second study demonstrated non-inferiority to Dryvax in generating an immune response in subjects previously exposed to the older vaccine. According to Acambis, apart from the United States, ACAM 2000 has been sold to 14 other governments.


Source: www.bioworldtoday.com
Affymetrix and Empire Genomics enter into licensing agreement
In the United States, Empire Genomics LLC has obtained a non-exclusive, worldwide licence to a number of Affymetrix patents covering the manufacture, use and sale of nucleic acid microarrays and related products and services for comparative genomic hybridization. The arrays and services may be used for research or diagnostics. “This agreement with Affymetrix enables Empire Genomics to bring its innovative genomics platform to market while continuing the advancement of personalized medicine. We fully expect that focusing in the field of copy number variation will lead to the discovery of the genomic causes of multiple diseases, as well as advanced therapeutic treatment strategies,” said Empire Genomics CEO Mr. Anthony Johnson.


Source: www.bionity.com
Dow AgroSciences and Hexima collaborate on cotton seed
Dow AgroSciences, based in the United States, has announced an agreement with Australia’s Hexima Ltd. to test cotton plants using Dow’s proprietary genetic constructs. The agreement involves the completion of a series of research activities, and testing over the next 18-24 months, resulting in the production of viable transgenic cotton seeds to provide better solutions and more options for cotton growers. “This collaboration represents Dow AgroSciences’ commitment to provide differentiated solutions to customers globally through unique technology and capabilities,” said Mr. Daniel R. Kittle, Dow AgroSciences Vice President for R&D.


Source: www.seedquest.org
Dako enters new collaboration on targeted NSCLC therapies
Dako of Denmark has entered into collaboration with Genentech, OSI and Roche for the clinical development and application for a pre-market approval supplement and CE marking of EGFR pharmDxTM for its use as a potential test in the assessment of patients of non-small cell lung cancer (NSCLC) considered for treatment with Tarceva® (erlotinib).


Dako possesses substantial technical knowledge regarding the utility of immunochemistry for use in characterization of EGFR protein expression in tumour cells and markets EGFR pharmDx to assess clinical colon cancer tissue specimens for the presence of the EGFR protein, thereby assisting the physician in choosing appropriate therapy. Genentech, OSI and Roche have access to substantial proprietary and confidential technical and scientific information regarding their product Tarceva and were seeking a capable diagnostic collaborator.


Source: www.bionity.com
Baxter signs flu vaccine deal
Baxter International, based in the United States, has entered into an agreement to supply the United Kingdom with flu vaccine in the event of a bird flu pandemic. The company is in the final stages of testing for a vaccine against H5N1 strains of avian influenza. Baxter will manufacture its pandemic vaccine in a serum-free, vero cell-based system that accelerates vaccine availability. The vaccines produced using this process can be released within approximately 12 weeks, significantly earlier than with traditional egg-based systems, the company said. The vero cell culture gives Baxter the flexibility to quickly respond to emerging variant pandemic virus strains.


Source: www.sciencedaily.com
Dyax Corp. collaborate with Bayer Schering Pharma for therapeutic antibodies
Dyax Corp., the United States, has entered into an agreement with Bayer Schering Pharma AG, based in Germany, for the discovery of therapeutic antibodies. Under the terms of this agreement, Dyax will identify therapeutic antibodies for two targets provided by Bayer Schering Pharma. Furthermore, these research activities may be expanded to allow Dyax to work on additional targets and/or allow Bayer Schering Pharma to exercise an option for an antibody library licence.


Dyax will receive clinical milestone payments and royalties on net sales that may result from Bayer Schering Pharma’s development and commercialization of any antibodies discovered through the collaboration. The agreement also provides Bayer Schering Pharma with sub-licences to relevant third-party antibody phage display patents that may be used with Dyax’s technology.


Source: www.bionity.com
Ablynx and Boehringer Ingelheim in global strategic alliance for nano-therapeutics
Ablynx, Belgium, and Boehringer Ingelheim, Germany, have announced a major global strategic alliance to discover, develop and commercialize up to ten different Nanobody® therapeutics. Ablynx expects to receive €75 million during the research term of the collaboration, which includes €15 million proposed equity investment by Boehringer Ingelheim in Ablynx. Besides, Ablynx will receive development milestone of up to €125 million as well as undisclosed royalties payments for each Nanobody developed.


Ablynx and Boehringer Ingelheim will collaborate in the discovery of Nanobodies against agreed targets across multiple therapeutic areas including immunology, oncology and respiratory. Both parties will propose target opportunities for the collaboration with the goal of bringing Nanobody-based products rapidly to patients in need. The German company will be exclusively responsible for the development, manufacture and commercialization of any products that result from the collaboration. Ablynx will have some co-promotion rights in Europe.


Source: www.bionity.com
ITC takes over Australian agri-biotech company
Diversified major ITC Ltd., India, has taken over the Australian agri-biotech company Technico Pty. Ltd. for an undisclosed sum, as part of a strategy to strengthen its foods business. The deal was executed through its subsidiary Russell Credit. An ITC spokesperson said the acquisition of Technico will help improve the profile of the company’s foods business.


Technico is an agri-biotech company with operations in Canada, China, India and Middle East through its subsidiaries. It provides bulk potato supply chain management, and has the award winning ‘Technituber’ seed technology, which it claims would revolutionize the global seed potato industry. The potato company provides supply chain solutions to global customers by using proprietary technology and a technology platform to implement affordable early field generation seed potato programmes, reduce seed exposure to soil-borne pathogens and rapidly introduce new varieties.


Source: www.economictimes.indiatimes.com
Generex Biotech to collaborate with Rochester University on avian influenza vaccine
Antigen Express Inc., the wholly-owned immunotherapy subsidiary of Generex Biotechnology Corp., the United States, has entered into an agreement with the University of Rochester as part of its efforts to develop a novel vaccine against the potentially pandemic avian influenza. The collaboration brings together Prof. John Treanor, at the Department of Medicine at the University of Rochester Medical Centre, and the novel peptide vaccine technology pioneered by Antigen Express.


Antigen Express is involved in the clinical development of peptides designed to potently stimulate CD4+ T helper cells through enhanced interaction with MHC class II molecules. Earlier this year, the Company began Phase I clinical studies of proprietary peptides derived from the hemagglutinin protein of the H5N1 avian influenza virus in healthy volunteers. Modified peptide vaccines for avian influenza can be manufactured by a fully synthetic process at lower cost but higher speed and quantity of production relative to traditional vaccines. Furthermore, the peptides are derived from regions of the virus that are similar enough in all H5N1 virus strains such that they would not have to be newly designed for the specific strain to emerge in a pandemic.


Source: www.bionity.com