Current development of regenerative medicine products!!

Leading the way Business Posted on 18/07/2012 by Lorraine O'Hanlon @galwayindoThe global market potential for regenerative medicine products could be as high as $118 billion by 2013 and innovative Galway company Orbsen Therapeutics is working to target part of this rapidly expanding market, CEO Brian Molloy tells Lorraine O'Hanlon Earlier this year, US company Osiris Therapeutics received authorisation from the Canadian department of health to market its stem cell therapy Prochymal for the treatment of acute graft-versus-host disease in children who have received bone marrow transplants, marking the world's first regulatory approval of a manufactured stem cell product. Referring to the move as an important domino in the acceptance and development of stem cell therapies, Orbsen Therapeutics CEO Brian Molloy explains that adult stem cells appear to display an ability to combat inflammation and to promote healing and the repair and regeneration of tissue. "What that means is that if you have an inflammatory disease, for example rheumatoid arthritis, or when there's an inflammation of a particular organ or area of the body, stem cells seem to help calm down that inflammation" he says, adding that there are hundreds of ongoing trials across the world where stem cells are being used to treat a wide range of different conditions currently not being adequately treated by traditional drugs. There are currently up to 400 regenerative medicine products on the international market, with more in development. At NUI Galway, Orbsen Therapeutics is working on the development of an extensive range of therapies for conditions including osteoarthritis, acute respiratory distress syndrome and diabetes. Formed in 2006 to develop and commercialise new intellectual property built up by researchers at the Regenerative Medicine Institute (REMEDI), Orbsen has developed a novel proprietary technology enabling them to isolate pure and defined stromal cells, which it is hoped will allow the development of a range of human therapies. Led by Head of R&D Dr Stephen Elliman, the company is currently expanding rapidly and the number of employees is expected to increase to around ten by the end of the year. It is also hoped the company will begin clinical trials in 2014. The development of spin out companies from universities can be difficult, according to NUI Galway MBA graduate Mr Molloy, as a marrying of both business and scientific skills is required. He believes, however, that Orbsen is proving to be a "very good model for how you can bring university generated research into a commercial field by partnering up with commercial experts in the private field". Mr Molloy is a Director of financial advisory firm HC Financial Advisers, based in Oranmore. HC provide a range of business consultancy services to start-up and established firms and Mr Molloy serves as Orbsen Therapeutic's interim CEO under a business consultancy arrangement. NUI Galway remains a shareholder in the company and Mr Molloy explains that the business model for the privately owned company is very lean compared to the old style model of commercialisation of university developed spin outs, which would have involved "a very significant amount of capital being spent on getting the company up to a certain level of critical mass". He adds that it's much more difficult at the moment to source money than it had been in previous years, and that the focus now for start-up biotech companies such as Orbsen Therapeutics is really on keeping the operational costs as low as possible and "focus on the science". Despite the difficult economic climate, Orbsen's bids to secure funding over the years have proven very successful. The company will shortly commence a new round of fundraising and is currently seeking High Potential Start-Up status from Enterprise Ireland. The company has also secured significant EU funding and is lead SME on a EU Seventh Framework Programme (FP7) research initiative on diabetic complications. €6 million has been allocated to bring Orbsen's novel therapy to clinical trial in collaboration with leading researchers within NUI Galway and across Europe and the US. "There are a huge number of illnesses and conditions where having an anti-inflammatory and immunomodulating product is of massive importance, that's why billions are being spent by 'Big Pharma' and international biotech companies to develop into this space. "Orbsen is ideally positioned because we are in the process of securing our IP [intellectual property] around our subpopulation of cells, we are in compliance with the emerging future regulatory requirements with regard to purity and definition of our cell product and we're doing it at a relatively low cost whilst leveraging the really high quality research coming out of NUI Galway," he says, adding that two of REMEDI's directors, Prof. Timothy O'Brien and Prof. Frank Barry, are also directors at Orbsen."As well as a multi-billion euro market potential there is also the added value of knowing that if our product delivers as we hope it will, it has the potential to improve and save people's lives," says Mr Molloy.