Datamonitor: Pfizer's novel NGF pain drug is potential game changer on reports-research.com

Phase II clinical trials of tanezumab in osteoarthritis, chronic low back pain and interstitial cystitis have demonstrated the drug's analgesic efficacy across these three chronic pain settings. Despite safety concerns and a high price point, Datamonitor expects tanezumab to enjoy a significant first-in-class advantage in a potentially lucrative novel area of pain therapy.

Pfizer has announced positive results from three Phase II trials in pain at the American Academy of Pain Medicine's 26th Annual Meeting. The randomized, double-blind, placebo-controlled six-week trials in patients with chronic low back pain (CLBP) and interstitial cystitis receiving a single intravenous infusion of tanezumab (200mcg/kg) met their primary endpoints of significantly superior pain relief over placebo. The CLBP study also included a third treatment group receiving naproxen twice daily, and tanezumab showed a greater analgesic effect than this competitor. In the 16-week osteoarthritis trial, patients were randomized to received tanezumab (10mcg/kg, 25mcg/kg, 50mcg/kg, 100mcg/kg or 200mcg/kg) or placebo. All doses of the drug achieved a reduction in pain while at the same time demonstrating a favorable safety profile.

Datamonitor estimates that 140 million people suffer from chronic pain across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK). Chronic pain treatments include narcotic analgesics and non-steroidal anti-inflammatory drugs (NSAIDs); however, these therapies suffer from high abuse potential and limited efficacy. Given that pain will become more prevalent in the future due to the aging population, the chronic pain market continues to represent an attractive commercial opportunity for pharmaceutical developers.

Tanezumab is a humanized monoclonal antibody (mAb) against nerve growth factor (NGF) and is in position to become Pfizer's first pain medication since its neuropathic pain treatment Lyrica (pregabalin) was approved in 2005. With strong efficacy demonstrated in different pain settings, the drug is expected to be the first major novel therapy in the management of pain for a number of years. However, while tanezumab offers good evidence as a 'proof of concept' that interfering with the NGF pathway provides an analgesic effect, strong competition exists in the pipeline: Johnson & Johnson's JNJ-42160443; Sanofi-Aventis' and Regeneron's Phase II drug REGN475; and Abbott's PG110, which entered Phase I clinical trials in mid-2009.

Although the NGF class uses a novel mechanism for the treatment of pain, Datamonitor believes that drug safety profiles may limit the patient population. Adverse events documented thus far include an abnormal peripheral sensation (tingling and numbness) and muscle aches. Moreover, given that NGF is involved in the development of the nervous system, reproductive toxicology issues will prevent its use in women of childbearing age. Another limiting factor could be cost: Datamonitor expects that these therapies will be priced similarly to the biologics available to treat rheumatoid arthritis, and as such will be far more expensive than existing pain treatments. This will lead to insurance companies effectively forcing clinicians to try current therapies first, with NGF drugs held back as last-line alternatives.

With the investment made by major pharmaceutical companies, the success of tanezumab (and that of the whole NGF class) will be dependent on the characterized risk-benefit profile. Phase II data suggest efficacy in a number of pain conditions. However, at present no patient has received at least a year's treatment with tanezumab, so its long-term safety profile remains unknown. Datamonitor recommends that NGF drug developers also pursue indications in acute pain, in case the chronic use of these therapies proves intolerable. With the pain market totaling $25.4 billion in 2008 across the seven major markets and the lack of efficacious pain treatments, NGF drugs could capture a considerable proportion of this market. Following analysis of Phase III trials that are due to finish in 2011, Datamonitor anticipates the launch of tanezumab in 2012 as the first biologic for the management of pain.

Datamonitor: Stakeholder Opinions: Back Pain - Gain competitive edge by targeting subpopulations:
http://www.reports-research.com/market-surveys/stakeholder-opinions-back-pain-gain-competitive-edge-targeting-subpopulations-p-61701.html

Datamonitor: Stakeholder Insight: Osteoarthritis - Drug development lags behind rising osteoarthritis population:
http://www.reports-research.com/market-surveys/stakeholder-insight-osteoarthritis-drug-development-lags-behind-rising-osteoarthritis-population-p-66432.html

Datamonitor: Pfizer Inc.: PharmaVitae Profile:
http://www.reports-research.com/market-surveys/pfizer-pharmavitae-profile-p-64288.html

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