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PIPELINE

SantoSolve's lead drug candidate, 2PX, is currently being documented for the treatment of osteoarthritis of the knee and for chronic post-amputation pain. The company believes that 2PX can also be effective in the treatment of several other peripheral pain conditions, including both nociceptive and neuropathic pain, and the company is considering initiating late-stage clinical trials also in other indications.

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Osteoarthritis of the knee

Osteoarthritis, or degenerative joint disease, is a chronic condition in which tissue known as cartilage breaks down. When this tissue deteriorates, it leaves bones to rub against each other, causing pain and stiffness. OA usually affects the fingers and weight-bearing joints, including knees and hips. It affects both men and women and usually occurs after the age of 45, and is the most common type of arthritis, affecting the daily life of more than 21 million Americans.

Symptoms of osteoarthritis include joint aching and soreness, pain after overuse or after long periods of inactivity. Factors causing osteoarthritis and the symptoms can range from mild to severe. Factors contributing to osteoarthritis are many, including obesity, injury, heredity, joint overuse and age.

NSAIDS remain the most common pharmacological treatment option, including both over-the-counter and prescription drugs. The use of these drugs however are linked to significant health risks, including cardiovascular and gastrointestinal adverse events causing a significant number of hospitalizations and deaths every year. Hence, the medical need for safe and efficacious treatment options for patients with chronic pain related to osteoarthritis is substantial. SantoSolve believe 2PX can be such a treatment alternative to osteoarthritis patients once the product reaches the market.

Osteoarthis patients

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2PX has been documented to have significant pain relieving effect in open-label clinical trials as well as in double-blinded, placebo-controlled clinical trials The company is currently conducting its first pivotal phase III trial in osteoarthritis of the knee. This study is designed as a two arm, placebo-controlled trial over 6 months, involving 300 patients in 5 countries in Northern Europe and Russia. The recruitment into the trial was completed November 1, 2009 and we expect the trial to report sometime during 3Q 2010.

The company has started the planning activities for a confirmatory phase III trials, and believes that - conditional on positive results - it will be in a position to file for an NDA sometime during 2012.

Post-amputation pain/Stump pain

Post-amputation pain is a collection of neuropathic pain syndromes that occur following limb amputation. Chronic neuropathic pain after amputation is a significant medical problem, with reported incidence during the first year after amputation of up to 70% and is often a disabling condition for amputees.

Stump pain is defined as pain localized to the remaining part of the amputated limb. The pain may be located within a specific peripheral nerve distribution or may be more widespread. Patients may experience a variety of different pain types, including deep aching pain, burning, pressure, or lancinating pain.

As for other chronic pain syndromes, a ladder of treatment options beginning with the simplest and least invasive, progressing to the more complex and invasive, should be undertaken. The anticonvulsants, antidepressants, and opiates are typical drug options. Nerve blocks can be used when pharmacologic measures fail. Currently there is no approved pain drug with documented effect against post-amputation pain.

The company initiated its first pivotal phase III trial in stump pain/post amputation pain in early 2009. The study is designed as a two arm, placebo-controlled trial over 3 months, involving 100 patients in 5 countries in Northern Europa and Russia. The recruitment into the trial is ongoing and the company is expecting the trial to report during the 2nd half 2010.

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Osteoarthritis of the knee

In the US alone more than 20 million patients are suffering from osteoarthritis. Global sales in in the osteoarthritis market 2007 were approximately USDbn 4, around 15% oof the global pain market, and the market is expected to grow 3% annually to reach USDbn 5.5 in 2017 (Datamonitor).


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