London/Rockville - GlaxoSmithKline and its American partner Human Genome Sciences, Inc. announced today that the European Commission has granted marketing authorisation for belimumab (Benlysta) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. "We and GSK are committed to making Benlysta available in countries worldwide," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are particularly honoured to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development." Belimumab received approval from the U.S. FDA on March 9, 2011. GSK and HGS announced approval from Health Canada on July 12, 2011. Regulatory applications have been submitted and are currently under review in Australia, Switzerland, Russia, Brazil, The Philippines, Israel, Singapore, Taiwan and Colombia. HGS and GSK have been working together on belimumab since 2006. Under the agreement, HGS had responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.
London – The London and the Tokyo Stock Exchanges have announced a new AIM-like market for small and emerging Asian companies. Based in Tokyo, the market – slated for launch by the end of next year – will be a joint venture on an...
London – The London and the Tokyo Stock Exchanges have announced a new AIM-like market for small and emerging Asian companies. Based in Tokyo, the market – slated for launch by the end of next year – will be a joint venture on an equal basis. Tokyo already has an exchange targeting high growth and emerging companies, but stock values have been hit hard over the last months after reaching highs at the beginning of 2006.
London – British scientists could create the country’s first interspecies embryos by the end of the year, after the Government’s fertility watchdog approved the work in principle. Two teams seeking to fuse human DNA with empty...
London – British scientists could create the country’s first interspecies embryos by the end of the year, after the Government’s fertility watchdog approved the work in principle. Two teams seeking to fuse human DNA with empty cow eggs to study diseases such as Alzheimer’s and Parkinson’s are expected to be granted licences in November, now that the Human Fertilisation and Embryology Authority (HFEA) has agreed to look favourably on their applications. The work to make cytoplasmic hybrid or “cybrid” embryos, which are 99.9 per cent human in genetic terms, should then begin immediately at King’s College London and the University of Newcastle upon Tyne, unless it is blocked by a legal challenge. The positive verdict follows a public consultation, which in early September reported 61 per cent approval for the creation of cybrid embryos to improve scientific understanding of diseases. The research, however, is still opposed by some religious and antigenetic engineering groups, who are likely to challenge the HFEA’s legal authority to approve it. Stephen Minger, director of the Stem Cell Biology Laboratory at King’s, who leads one of the teams, said: “It is gratifying to see that the HFEA has listened to the broader scientific and bioethical community.” The ruling comes as scientists await the Government’s latest plans for legislation on interspecies embryos. Ministers have already backed down from a proposal to ban them altogether after pressure from scientists, and the draft Human Tissue and Embryos Bill to be included in the Queen’s Speech exempts cybrids while outlawing true hybrids. This, however, was condemned as excessive in July by a scrutiny committee of MPs and peers, which recommended allowing all such research subject to licensing by the HFEA.
London – The UK has established the National Industrial Biotechnology Facility in Wilton as a testbed for developing cleaner and more sustainable biotech-based processes to replace traditional methods for manufacturing chemicals....
London – The UK has established the National Industrial Biotechnology Facility in Wilton as a testbed for developing cleaner and more sustainable biotech-based processes to replace traditional methods for manufacturing chemicals. The 17 million-euro NIBF facility is sited at the Centre for Process Innovation (CPI), which builds on the area’s tradition of chemical manufacturing with work on functional materials, advanced processing and fuel cells. CPI and other stakeholders planned the NIBF as an integrated facility at which companies use a “gene to kilo” approach to test ideas for commercial feasibility, explains Chris Dowle, CPI’s director of advanced processing. Funding from The Northern Way, of Newcastle upon Tyne, and the regional development agency One Northeast supported building and equipping the facility.
Manchester – John Hutchinson, a key figure at Vernalis, one of Britain’s bestknown biotech companies, resigned at the beginning of September to take up a new job at Renovo. The Manchester University spin-out is currently one of...
Manchester – John Hutchinson, a key figure at Vernalis, one of Britain’s bestknown biotech companies, resigned at the beginning of September to take up a new job at Renovo. The Manchester University spin-out is currently one of the highest valued British biotech companies at the stock exchange. The firm recently signed a deal with Britain’s third largest drug maker, Shire Pharmaceuticals. The contract is worth up to €600 million and includes a codevelopment of a new antiscarring drug with Shire. Hutchinson will now oversee the clinical program for the compound known as Juvista. Shire has made an upfront payment of €90 million, which includes a cash payment and the purchase of Renovo stock. The timing of Hutchinson’s surprising move represents a fresh blow for Vernalis, whose shares dipped sharply in September after a decision from regulators in the United States to delay for the second time a decision on Frova, the company’s flagship drug for menstrual migraine.
London/New York – Individualised medicines are getting ever closer. At the end of August, the US Food and Drug Administration, FDA, added information to the label of BristolMyers-Squibb’s Warfarin about how different genotypes...
London/New York – Individualised medicines are getting ever closer. At the end of August, the US Food and Drug Administration, FDA, added information to the label of BristolMyers-Squibb’s Warfarin about how different genotypes may affect drug response to the blood thinner. FDA officials claimed this as huge step for personalised medicine becoming reality. The additional label information will help physicans to prescribe an individual effective dose and to separate responders from non-responders to the drug. For safe use of Warfarin, this might be essential as it can be metabolised in different ways. Genetic variations in the vkorc1 and cyp2C9 genes particularly increase the risk of bleeding and are said to cause 35% of Warfarin dose variation. Tests for the gene variations are offered by a range of commercial labs and could cost up to US$450. A decision from the FDA on whether Warfarin standard therapy requires genetic testing is expected by the end of the year.
Silence Therapeutics plc (London, UK) has strengthened its core management team with Jeffery Scott Vick (45) as Group CEO. Vick began his career as business analyst and biotech venture capitalist and then worked in senior...
Silence Therapeutics plc (London, UK) has strengthened its core management team with Jeffery Scott Vick (45) as Group CEO. Vick began his career as business analyst and biotech venture capitalist and then worked in senior management roles with DepoTech Corp., Cytovia Inc, and at Genset S.A. In 2003, Vick became Vice President Corporate Development and Intellectual Property of Centelion SAS.
London – Researchers at the University of Manchester have identified evidence of several new genes behind the chronic inflammatory disease rheumatoid arthritis (RA). Prof. Jane Worthington and her team at the University’s...
London – Researchers at the University of Manchester have identified evidence of several new genes behind the chronic inflammatory disease rheumatoid arthritis (RA). Prof. Jane Worthington and her team at the University’s arthritis research campaign Epidemiology Unit made their findings as part of the largest ever study carried out by the WTCCC of the genetics behind common diseases. The Wellcome Trust Case Control Consortium is funded by a12 million and involves 50 research groups in Britain and more than 200 scientists in the field of human genetics. The researchers identified a number of new genes implicated in coronary heart disease, type 1 and type 2 diabetes, Crohn’s disease, bipolar disorder and hypertension. 17,000 DNA samples have been analysed – two thousand for each disease and three thousand as control samples. In particular, RA research could be boosted by the obtained results as the team around Worthington found a number of new genes involved in the development of the illness. Before the study, only two genes had been known to be behind 50% of the genetically determined susceptibility. “We believe the genes we have found may determine who develops RA or how severe the disease becomes”, said Dr. Anne Barton, a clinician at the University of Manchester.
London – Europe should weigh the benefits as well as the risks when evaluating new farm technologies that may be the key to future food security, an advisory report for the UK government has recommended. The ACRE (Advisory...
London – Europe should weigh the benefits as well as the risks when evaluating new farm technologies that may be the key to future food security, an advisory report for the UK government has recommended. The ACRE (Advisory Committee on Releases to the Environment) study said it was time for “a more balanced and holistic” approach to regulation. “We can’t wall off avenues that we need in the future”, said ACRE Chairman Chris Pollock. His report stated that the current approvals system for genetically modified crops, which focuses purely on potential risks, was unbalanced. Under the current rules, evidence of potential environmental benefits such as the reduced herbicide use leading to lower CO2 emissions were not considered. The commission recommends a wider approval process that should be expanded to include changes in farming practices such as biofuels that also have an environmental impact. Among others, the change from spring to winter sowing for arable crops and a shift from hay cutting to silage production is suggested by the authors.
AstraZeneca has been one of the most active pharma companies in terms of buying biotech firms. Just this year, the Anglo-Swedish pharma giant spent US$150 million on anti-infective specialist Arrow Therapeutics and took over the...
Hamish Cameron joined CAT as Chief Executive in 2006 following CAT’s acquisition by AstraZeneca. Dr Cameron, a physician by training, joins CAT following a number of senior research and development appointments in AstraZeneca, including Head of the Cardiovascular Therapy Area and Head of Medical Research in over 20 years with the company. He is a Fellow and past Board Member of the Faculty of Pharmaceutical Medicine. Cambridge Antibody Technology is a biopharmaceutical company specialised in the discovery and development of new antibody medicines. CAT has a proprietary platform technology for isolating human monoclonal antibodies using phage display and ribosome display systems. The company has large phage antibody libraries, currently incorporating more than 100 billion antibodies.
Euro|BioTech|News Approximately one year ago, AstraZeneca (AZN) bought Cambridge Antibody (CAT) for a1 billion. How has CAT changed during this time?
Cameron: It‘s important to remember that AstraZeneca bought CAT for what it was, and not to change it – CAT is not being turned into a typical AstraZeneca R&D site. However, CAT is likely to change over time as the company expands and takes on new staff, but AstraZeneca is working hard to retain what is so successful about CAT, namely its collaborative working style and its culture. Thus, CAT has retained its brand identity and local management structure. Since the acquisition, both companies have been very busy, building on the success of the alliance established in 2004. Initially, we spent time defining CAT’s responsibility within the AstraZeneca group and aligning the two organisations. Since then we have begun working towards joint goals and towards AstraZeneca’s stated ambition that, by 2010, 25% of its product development candidates will be biopharmaceutical products. With the acquisition of MedImmune, this aim has already been achieved. By the way, AstraZeneca is delighted with the progress being made: expansion plans have been announced and the first CAT-derived product candidate (from the collaboration) has been selected and has entered ‘scale-up’.
Euro|BioTech|News Earlier this year, AstraZeneca acquired MedImmune. How does this affect your plans? How will CAT and MedImmune work together in the future?
Cameron: AstraZeneca‘s acquisition of MedImmune represents a transformational step in delivering AstraZeneca’s biologics strategy: the combination of MedImmune with CAT creates, in one transaction, a fully integrated biologics and vaccines business within the AstraZeneca group. However, as the AstraZeneca acquisition of MedImmune was only completed on 18 June, the level of detail that can be disclosed at this time is very limited and AstraZeneca, together with MedImmune and CAT, are currently considering the ways in which the organisations will work together going forward. The structure, organisation and ‘operating model’ of this new organisation will become clearer over the next few weeks and months.
Euro|BioTech|News There are numerous pitfalls in integrating a small biotech company into a large pharma conglomerate. What are the main difficulties and what are your solutions?
Cameron: The companies were well known to each other, having worked well together since the alliance was established in 2004 – even so, there was an inevitable steep learning curve immediately following the acquisition, although we took great care not to overload people at the very beginning. The two organisations are (still) very different – a result of their relative sizes and varying ways of working. For example, CAT‘s structure is flatter and people have broader jobs than their colleagues at AstraZeneca. The main concerns have been retaining CAT‘s culture while expanding the organisation rapidly and extending CAT‘s expertise to a wider range of therapy areas. The increased level of interaction between the two organisations is being managed carefully, so as not to overload anyone with too much process or bureaucracy.
Euro|BioTech|News How many key employees have left since the acquisition?
Cameron: Following the acquisition, the three executive directors left the company, very amicably. This was unsurprising and is normal practice following such a significant transaction. In addition, another couple of ‘corporate’ staff left the organisation a few months after the acquisition. Aside from this, the great majority of our staff have remained and our staff turnover is steady.
Euro|BioTech|News Will you be taking on new staff?
Cameron: Yes, we have already begun recruiting additional staff and plan to double in size over the next few years. This means taking on around 300 new people in addition to the 300 or so we already have.
Euro|BioTech|News There was criticism from analysts that the acquisition price of $1.3 billion that AstraZeneca paid for CAT was too high. What is your opinion on this after having accompanied the integration process for more than seven months?
Cameron: AstraZeneca always believed it had paid a fair price for CAT. However, it is worth noting that any valuation of CAT at the time of the acquisition should include the Humira royalty stream. The disposal of this asset to Royalty Pharma alone stood for $700 million.
Euro|BioTech|News Shortly before the acquisition, CAT announced that the company had to postpone the break-even. Additionally, competitors in the antibody market have outperformed CAT in recent years. What can AstraZeneca do to make CAT’s processes more efficient?
Cameron: The acquisition will build on the success of the CAT-AstraZeneca alliance established in 2004 and which concentrated on inflammatory and respiratory disorders. Following the acquisition, CAT’s discovery expertise, early development capabilities and skills in collaborative working are being fully supported and exploited as well as extended across all AstraZeneca therapy areas. AstraZeneca’s global reach and capabilities are being combined with CAT’s know-how and biotechnology culture to create a world-leading combination. At the time of the acquisition, CAT had reported operating profits for both the first and the second quarter of 2006, had established a royalty stream from sales of Humira by Abbott and had a strong pipeline of antibody product candidates being developed by both CAT and its licensees. Euro|BioTech|News How much space is there left for CAT to conduct its own research programs?
Cameron: As well as working collaboratively with AstraZeneca across all of AstraZeneca’s therapy areas, CAT is operating a ‘parallel stream’, which will account for approximately 10% of CAT’s R&D activities. This will help to retain the ‘biotech culture’ of innovation and creativity that makes CAT what it is and which made CAT attractive to AstraZeneca.
Euro|BioTech|News Will AZN be conducting biotech activities outside of CAT?
Cameron: The acquisition of CAT represents a major, long-term strategic investment by AstraZeneca in novel biological therapeutics. AstraZeneca intends to grow a leading biopharmaceuticals capability and CAT is the foundation of this long-term strategy.
London – Urgent action is needed to tackle antibiotic resistance, or more people will die from what were previously treatable infections. This is the message of the new report ‘Tackling antibacterial resistance in Europe’ by the...
London – Urgent action is needed to tackle antibiotic resistance, or more people will die from what were previously treatable infections. This is the message of the new report ‘Tackling antibacterial resistance in Europe’ by the European Academies Science Advisory Council (EASAC). The report identifies the major challenges and opportunities for policy development in tackling antibacterial drug resistance. In particular, the experts recommend supporting the development of diagnostic tools which are sensitive, simple and cheap to use at the point of care and are able to differentiate between a range of pathogens.B
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more