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COX-II Inhibitors: Looking to drive market growth

Posted on: 20 Mar 03


With over $6 billion in sales in 2002, COX-II inhibitors are dominating the market for NSAIDs at a global level. These drugs have however, struggled to make an impact outside the US. With their long-t
With over $6 billion in sales in 2002, COX-II inhibitors are dominating the market for NSAIDs at a global level. These drugs have however, struggled to make an impact outside the US. With their long-term sales potential resting on the ability of drug companies to drive increased penetration in the key European and Japanese territories, Datamonitor examines the future prospects of the NSAID marketplace. In The Future of COX-II Inhibitors: Market Challenges and Pipeline Initiatives , Datamonitor evaluates the current position and future potential of NSAIDS in the key US, European and Japanese territories, with particular focus on the state of the COX-II market. Despite the commercial success of the COX-II inhibitors in the US, where products like Pfizer's Celebrex (celecoxib), Bextra (valdecoxib) and Merck & Co.'s Vioxx (rofecoxib) generate substantial revenues, it has proven a far harder challenge for these big pharma players to repeat this success in Europe. The relative failure of these drugs in Europe means that the next generation of COX-II inhibitors will face considerable challenges to their success. European scepticism of COX-II The level of state intervention and regulatory control of healthcare has historically been higher in Europe than in America, thereby influencing the potential impact of new drugs. The UK's recently established National Institute for Clinical Excellence (NICE), which monitors cost-effectiveness in the state-run National Health Service, stands as an example of how regulatory initiatives can substantially impact the commercial prospects of drugs. High pricing is another factor that accounts for the relative lack of success of COX-II drugs in the EU. The problem is that companies need to expand the use of these products beyond only the high-risk gastrointestinal (GI) patients to generate substantial returns, but that this expansion can be prohibitively expensive. The final handicap for COX-II inhibitors in the EU has been the increasing concern regarding their side effect profile. For example, intensifying criticism of the methodology used in studies such as CLASS and VIGOR has resulted in institutions such as the European Committee for Proprietary Medicinal Products initiating their own investigations into these drugs. As a result new entrants into the European market will have to provide robust, long-term clinical data if they are to stand a chance of generating strong revenues from this market. Unique local challenges With the recent Pharmacia and Yamanouchi (December 2002) announcement that a New Drug Application (NDA) had been supplied to the Japanese Ministry of Health, Labor and Welfare for celecoxib, Datamonitor predicts that Japanese COX-II sales will begin by 2004. However, the Japanese pharmaceutical market as a whole has been going through a period of intensive change in recent years, which means that manufacturers will face unique challenges to their growth strategies. In Japan, there exists a considerable price differential between generic and innovative products. In April 2002 for example, the gap in price between generic and branded drugs increased by an additional 5%. In such a climate, it is essential that the manufacturers of COX-II inhibitors ensure they are viewed as innovative in order to take advantage of this tiered pricing system. The removal of regulatory barriers following the International Conference on Harmonization will however allow western manufacturers to increase their penetration of the Japanese market. Datamonitor believes that this will lead to a substantial shake up of the Japanese market, as Western manufacturers, led by companies such as Merck, either buy large stakes in, or even acquire their Japanese rivals. The focus of the local firms will shift towards in-house development as the opportunities for in-license or co-marketing agreements decrease. New COX contenders Novel challengers to the NSAID market are on the way, but require further differentiation for market success. Merckle’s dual inhibitor of COX and 5-LOX enzymes, licofelone, inhibits production of the leukotrienes and prostaglandins, substances which are important mediators of joint destruction and that lead to inflammation and pain. The drug, currently in phase III testing, has shown similar efficacy to established NSAIDs, in addition to somewhat improved GI safety. Overall, however, the efficacy and safety data show little to differentiate licofelone from the established COX-II inhibitors. A demonstration of the cardiovascular safety of this product, possibly through the ability for patients to continue cardioprotective dosing of aspirin without losing GI safety, could provide a clear competitive advantage for licofelone. Without this advantage, Merckle and its marketing partners will likely be forced to compete on price in order to penetrate the competitive NSAID market. COX inhibiting nitric oxide donators (CINOD) are another class of drugs that have received a good deal of attention as the next generation of NSAIDs. Nitric oxide can stimulate gastroduodenal protection, and thus the French pharmaceutical company NicOx has been seeking to develop a number of compounds that essentially add nitric oxide donating ability to established drugs like naproxen and paracetamol. In collaboration with AstraZeneca , NicOx developed a nitric acid donating analgesic that showed equivalent efficacy to naproxen in phase II testing, although AstraZeneca subsequently decided to withdraw its support after the drug failed to meet its primary endpoint with respect to gastro-intestinal ulcers. Beyond COX-II? While many experts feel that an ‘efficacy ceiling’ has been reached in the NSAID class, (and the experiences of Merckle, NicOX and AstraZeneca would seem to confirm this) companies continue to emphasize the safety features of new products. However, improved efficacy remains an important unmet need in the treatment of pain and arthritis, and pharmaceutical companies must not overlook the desire for improved efficacy from the patient perspective. Manufacturers may need to look at the commercial success of the selective serotonin re-uptake inhibitor (SSRI) antidepressants. As with the COX-II inhibitors, SSRIs were launched on a platform of improved safety compared to existing drugs. However, as physicians became more experienced with these drugs, following their wide scale use, their perception as ‘wonder drugs’, which was a tag given to them upon their launch, has deteriorated. Nevertheless, manufacturers have successfully kept revenues high by instigating different growth strategies, such as gaining indications in anxiety disorders, to compensate for the criticism they were receiving. Those companies developing the next generation of COX-II inhibitors will need to follow this strategy in order to find success in markets outside the US over the next decade. If you found this week's Expert View useful, you may be interested in Datamonitor's reports, all available from
  • · The Future of COX-II Inhibitors: Market Challenges and Pipeline Initiatives priced $1,500
  • · Market Dynamics: Arthritis - The Ongoing Battle for Supremacy priced $6,100
  • · Market Dynamics: Pain - The Escalating Battle Between Merck and Pfizer priced $6,100
  • For a free Datamonitor healthcare report please click here

    Michael Randle

    Last updated on: 27/08/2010 11:40:18

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