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Highlights

• Once daily, best-in-class topical NSAID patch
• Efficacy and safety demonstrated in Phase 2 acute musculoskeletal pain study
• Pivotal Phase 3 studies commenced in Q1 2009
• Short path to market entry, with NDA filing in 1H 2010
• Partnering opportunity for U.S. and European commercialization
• Diclofenac Lotion (BID) also available for partnering

The Opportunity

Cerimon Pharmaceuticals is developing a proprietary Diclofenac Patch for the topical treatment of acute, musculoskeletal pain. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that is approved when taken orally for the treatment of pain and inflammation. While oral NSAIDs are effective, they can cause treatment-limiting side effects, including gastrointestinal ulcerations. Cerimon’s Diclofenac Patch is designed to provide pain relief directly to the affected joint or muscle without accumulating high levels of the drug beyond the target area. Cerimon’s patch is approved and sold in other countries including Japan. It is currently in Phase 3 trials. The company has recently demonstrated the efficacy and safety of the Diclofenac Patch in a Phase 2 study in patients with acute pain due to ankle sprains. Due to its favorable product profile relative to other topical NSAIDs, Cerimon anticipates that the Diclofenac Patch will achieve best-in-class status. Given its development-focused business model, Cerimon is looking for a partner for the Diclofenac Patch in the U.S. A proprietary Diclofenac lotion is also in development and available for partnering.

Best-in-Class Product Positioning

Cerimon’s Diclofenac Patch is designed to offer once-daily, site-specific pain relief without the systemic side effects associated with oral NSAIDs. Cerimon expects this product to offer improved patient satisfaction and become the topical NSAID of choice due to its once-daily dosing, superior skin penetration (based on PK data), optimal adhesiveness, and better feel and flexibility than other topical pain patches currently available or in development. Cerimon’s Diclofenac Patch is thus well positioned to capture a significant portion of the growing topical NSAID market, which is expected to reach $1.5 - $3.5 billion by 2012. The recent launch and strong market uptake of King’s Flector Patch and the Voltaren Gel support this opportunity.

Clinical Overview and Data

An IND for the program was filed in August 2007, and a Phase 1 clinical study investigating the safety and pharmacokinetics of the Diclofenac Patch was completed in November 2007. This study confirmed that the PK profile of Cerimon’s Diclofenac Patch supports once-daily dosing.

Cerimon recently completed a multicenter, double-blind, randomized, placebo-controlled clinical trial in 170 subjects with acute pain due to mild-to-moderate ankle sprains. The study achieved statistical significance in its primary efficacy endpoint, demonstrating that treatment with the Diclofenac Patch resulted in a greater percent improvement in average pain during daily activities compared to placebo at day three (45.2% vs. 33.9%, p=0.009). Several secondary endpoints were also met.

Cerimon is currently conducting a Phase 3 program in three acute musculoskeletal indications. These studies have begun and an NDA filing is expected in 2010, with approval in mid-2011. Additional clinical studies in other pain indications, including osteoarthritis pain are also being considered.