Pharmaceutical Technologist - May 2008 - (Page 6)

Industry highlights Pharma’s big headache Generics and low approval rates are only some of the industry’s problems Pharma’s current and future revenues are under threat and have prompted the industry to adopt a range of strategies to survive, according to a report from Datamonitor. Companies are being bombarded with competition from generics, increasingly tough pricing and reimbursement, a clamp down on healthcare spending and the need to treat patients for longer because of the ageing population. In response, drug management strategies are gaining more prominence and, according to Alistair Sinclair, Datamonitor Senior Pharmaceutical Analyst, many companies are embarking on merger and acquisitions (M&As) and licensing. “These are used to gain access to new drug candidates, increased presence in the emerging markets and capitalizing on the growing role of patients as consumers,” he says. Fewer drugs are gaining approval, partly because of the greater scrutiny regarding drug safety. Following the controversy with Vioxx in 2004, US legislators significantly expanded FDA’s authority by passing the FDA Amendments Act of 2007. It is not yet clear to what extent FDA will use its new powers, but according to Dr Tijana Ignjatovic, Datamonitor Senior Pharmaceutical Analyst: “FDA has the potential to increase development costs, reduce market penetration and impact approval rates. However, the new FDA power to demand postmarketing studies may actually be beneficial for certain drugs that would not have been approved otherwise.” To fill gaps in pipelines and offer a solution to problems, many companies have turned to M&As, and the number of deals made in 2007 has increased with respect to the previous year. However, with deal values rocketing, M&As will become a strategy that fewer players will be able to afford or adopt. Instead, they will have to turn to more radical solutions, such as readdressing internal R&D processes. “While M&As may only offer short-term solutions, the economies of scale attained through such moves are limited,” says Sinclair. “Therefore, those companies forced to take alternative measures may, ultimately, reap greater rewards in the long run.” www.datamonitor.com Adam Gault/Getty Images Europe’s first hybrid embryos created Preliminary data on the first human hybrid embryos created in Europe have been presented at a recent lecture in Israel. The research has yet to be verified and the lead scientist of the project, Lyle Armstrong, who is part of the North East England Stem Cell Institute (UK) and is based at the UK’s International Centre for Life in Newcastle, will be following the peer-review system, as is normal procedure. “These are preliminary findings from ongoing research,” says John Burn, Head of the Institute of Human Genetics at Newcastle University. “Once fully validated, Armstrong will be submitting the work for peer review and publication. If the team can produce cells that will survive in culture, it will open the door to a better understanding of disease processes without having to use precious human eggs. Cells grown using animal eggs cannot be used to treat patients on safety grounds, but they will help bring us closer to the day when new stem cell therapies are available.” Armstrong and his team were granted a licence by the UK’s Human Fertilisation and Embryology Authority (HFEA) in January to conduct the groundbreaking research, and have now created human embryos from ‘banked’ cells derived from a human embryonic stem cell line and a cow egg. The studies are being heavily regulated under the conditions of the licence. A second group of scientists based at London Imperial College (UK) was also granted a licence in January. Although controversial, it is believed that the work could ultimately lead to the development of new therapies for debilitating human conditions, such as Parkinson’s disease and strokes. However, the researchers stress that the embryos produced will only be used as a scientific tool and will not be used to treat human diseases. www.ncl.ac.uk Duncan Smith/Getty Images 6 MAY 2008 PHARMACEUTICAL TECHNOLOGIST http://www.datamonitor.com http://www.ncl.ac.uk

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - May 2008

Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.