ProEthic and APR to take on COX-2 giants
anti-inflammatory drugs could soon include an upstart competitor
whose new product holds the promise of allaying joint pain but
without the gastrointestinal side effects often caused by current
medications. This is the view of ProEthic Laboratories, a US firm
which has just forged an alliance with Swiss drug delivery
specialist Applied Pharma Research to develop a once-daily
transdermal version of the widely-used NSAID ketoprofen.
The $7.3 billion (€6.8bn) global market for non-steroidal anti-inflammatory drugs could soon include an upstart competitor whose new product holds the promise of allaying joint pain but without the gastrointestinal side effects often caused by current medications. This is the view of ProEthic Laboratories, a US firm which has just forged an alliance with Swiss drug delivery specialist Applied Pharma Research to develop a once-daily transdermal version of the widely-used NSAID ketoprofen.
The anti-inflammatory and analgesic market has been transformed by the introduction of the selective COX-2 inhibitors, such as Celebrex (celecoxib) from Pharmacia and Merck & Co's Vioxx (rofecoxib), which have been promoted as being kinder on the gastrointestinal tract than older NSAIDs. Sales of both drugs are in the blockbuster range, at $3.1 billion in 2002 for Celebrex and around $2.6 billion for Vioxx, despite an ongoing debate over whether their claimed safety advantages justify their higher prices.
The deal with APR and ProEthic is following a different tack. Rather than relying on selective inhibition of the COX-2 enzyme to minimise GI effects, the two companies plan to develop a transdermal patch formulation of ketoprofen that will reduce systemic exposure to the NSAID.
In 2001, Applied PR licensed worldwide rights (excluding the USA, Canada and Japan) to Zambon SpA, a privately-held company based in Milan, Italy. In one of two Phase III clinical trials recently completed in France and Belgium, the effectiveness of this transdermal ketoprofen in patients with periarticular soft tissue pain, such as tendonitis and bursitis, was confirmed. Results of the second trial, aimed at assessing the drug's efficacy on ankle sprains, are expected next month. Upon completion of these trials, Zambon will submit the drug for European Union approval.
In the latest deal, ProEthic gains exclusive US marketing rights to the product and will oversee clinical development in the USA, with a New Drug Application filing scheduled for late next year.
The European market for anti-inflammatory drugs accounts for 160 million units annually with a market value of more than 500 million euros ($532.9 million) for topical, locally-acting anti-inflammatory drugs, according to IMS data quoted by ProEthic. New innovations and formulations of existing products have quickly gained acceptance in Europe, and the US market is expected to do the same, says the company. While no topical or transdermal NSAID has received Food and Drug Administration approval, industry estimates put the potential US market for such a product at $200-$300 million.
Meanwhile, in a recent clinical trial, 10 patients undergoing arthroscopic knee surgery had the 100mg ketoprofen patch applied once-daily for six days prior to surgery. Upon analysis of tissue samples conducted post-operatively, ketoprofen was found in the tendon sheath area at levels 300 times higher than the level found in plasma. The drug levels in the synovial fluid were six times higher than those found in plasma.
