Pharmaceutical Executive Europe - November/December 2007 - (Page 20) 20 Special Report Nov/Dec 2007 Pharmaceutical Executive Europe therapy for Hunter syndrome, and GSK’s Atriance (nelarabine) for non-responsive forms of lymphoblastic leukaemia and lymphoma. The big development in the vaccine field was the European approval of two separate vaccines against the human papilloma virus to prevent certain forms of cervical cancer: Merck & Co’s Gardasil was first, followed closely by GSK’s Cervarix. Several countries, including the UK, France, Germany and Italy, have already announced they are to set up immunisation programmes in pre-teenage girls. One question that refuses to go away is whether drugs are too expensive. Withdrawals and new labels However, just because a drug reaches the market doesn’t mean it will stay on the market, as side-effects that can only be picked up once it is in widespread use become evident. The big story on the safety front has been GSK’s Type II diabetes drug Avandia (rosiglitazone). A meta-analysis published in the New England Journal of Medicine in May claimed that the drug increases the risk of heart attacks significantly. GSK strongly denied that it is unsafe, providing its own evidence that the risk is extremely low, and comparable to those of other available drugs. Avandia remains available, but the FDA now requires it to carry a ‘black box’ warning. The other glitazone, Takeda’s Actos (pioglitazone), also now carries the same warning. Another company that had a run-in with the regulators this year is Roche, this time over manufacturing problems. Its HIV protease inhibitor Viracept (nelfinavir) had its marketing licence suspended after traces of the potential carcinogen ethyl mesylate were found in products on pharmacy shelves. This turned out to be the result of a manufacturing problem, and EMEA required exhaustive tests and process improvements before the drug was allowed back on the market in September. Currently, companies are free to set their own UK prices (within these constraints), which often means they cut the price of older drugs to leave leeway to charge more for more recent launches. Pharma believes the current system, where the PPRS is renegotiated every five years, provides essential stability, but if the rewards companies receive for innovation do not cover the cost of discovering new drugs — and paying for the expensive research into those that don’t make it — then there will be little incentive to keep carrying out that research in Europe, where there are numerous other regulatory and pricing hurdles, not to mention regular threats from pharma to invest in research elsewhere. There are growing signs that these threats aren’t empty, with closure of European manufacturing sites and the opening of research and manufacturing sites in India, China and Singapore. On this note, AstraZeneca has announced the loss of thousands of jobs, including 700 at its manufacturing plant in Macclesfield (UK), and 400 in Plankstadt (Germany), when it stops operations there in 2009. Pfizer’s manufacturing site in Sandwich (UK) is to go, too, after more than half a century, with 420 jobs being cut. This is on top of the announcement earlier this year that it’s cutting back its operations in Ireland, where it had accumulated five manufacturing sites as legacies, although it is constructing a new biologics plant there. Sanofi-aventis is also downsizing in Ireland, cutting 200 jobs in Waterford. Bayer is making big cutbacks across its business in the wake of its acquisition of Schering, half of them in Europe. On a rare positive note, Ipsen is to invest €50 million in upgrading its development and manufacturing site in Dreux, France. Counterfeits and distribution Counterfeit products continue to pose a problem to the supply chain. Back in May and June, fake batches of Lilly’s Zyprexa (olanzapine), AstraZeneca’s Casodex (bicalutamide) and two batches of Plavix (clopidogrel) from Sanofi-aventis were found in UK pharmacies. The packaging indicated they had originated in France, and had been supplied by parallel traders — a practice pharma companies have long complained leaves their products open to counterfeiting. Counterfeiting was the reason cited by Pfizer when it announced last year that it would supply its products only on a direct-topharmacy basis through a single distributor, Unichem. The decision predictably caused a storm amongst the distributors, and an appeal against its legality in the UK High Court was launched by a group of wholesalers, but that did not stop other pharma companies deciding to go down a similar route. AstraZeneca is to supply only through Unichem and AAH, though the implementation of the system has been put back to next year, and Sanofi-aventis is to limit its distribution to three suppliers — the two chosen by AZ plus Phoenix. Novartis and Eli Lilly are also looking at their distribution options. Further developments in distribution are inevitable, as the trend Pricing and manufacturing One question that refuses to go away is whether drugs are too expensive. The Office of Fair Trading in the UK, for example, caused a storm back in February with its report that claimed the UK National Health Service pays too much for its drugs. It proposed that the Pharmaceutical Price Regulation Scheme (PPRS) — the complex system by which drug prices are set that caps company profits rather than setting the prices directly — should be changed, and in August the government took the industry by surprise when it announced it was to review the entire PPRS process.
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.