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Schwarz Pharma: Lacosamide One Step Closer to the Lucrative Market

Posted on: Friday, 16 February 2007, 12:00 CST

Positive preliminary phase III results show that Schwarz Pharma's anticonvulsant lacosamide is significantly better than placebo in reducing pain scores in patients with painful diabetic neuropathy. However, unless the data illustrate a superior clinical profile, lacosamide is unlikely to pose a great threat to Pfizer's Lyrica and Eli Lilly's Cymbalta, the current market leading oral therapies.

Daily doses of lacosamide up to 400mg/day and placebo are currently being compared in a much larger, long-term trial. During this 16-week treatment duration sub-trial, lacosamide was withdrawn and re-introduced in a blinded fashion at pre-defined time points. Lacosamide was very well tolerated, with the most common side-effects being diarrhea and nausea (both<5%). These initial results bode well for the upcoming FDA filing and it could launch as early as 2008.

Diabetic neuropathic pain (DNP) is a symptom of diabetic neuropathy, which is a nerve disorder caused by chronic hyperglycemia. Millions of diabetics worldwide suffer from the consequences of DNP, and therefore represent a significant target population. DNP belongs to the broader neuropathic pain indication for which just five drugs are approved in the US.

Coupling the large patient population and large unmet need for more effective treatments it is unsurprising that neuropathic pain is one of the most attractive indications in the industry - currently there are over 90 potential therapies in development for this indication. Datamonitor estimates the neuropathic market to be worth $2.79 billion in 2007 with strong growth predicted in the near term through Lyrica (pregabalin, Pfizer), Cymbalta (duloxetine, Eli Lilly) and Lidoderm (lidocaine patch 5%, Endo).

Both Lyrica and Cymbalta are approved by the FDA for DNP but are used widely off-label for other neuropathic pain states. This can also be expected for lacosamide assuming FDA approval.

Schwarz is expected to launch lacosamide in the second half of 2008 for DNP in the US, with an EU launch late in 2009. Datamonitor forecasts strong initial uptake resulting in US sales of $112 million in 2010.

Although little is known about its mechanism of action, lacosamide appears to be a clinically strong product and will take the majority of its share from the anticonvulsants in the market, particularly Lyrica and gabapentin, but also from other approved drug classes. However, without a larger marketing resource and no comparative clinical data, Schwarz will not pose a huge threat to Pfizer and Lilly's share of the market. The recent takeover of Schwarz by Belgium company UCB will nevertheless provide some additional sales and marketing resources, particularly in UCB's specialty area of neurology.

Source: Datamonitor

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