Introduction

Pain treatment is a multibillion dollar market that is saturated with a wide variety of branded and generic drugs. The NGF class has potential to be first of an entirely new type of painkiller to enter the sector in decades. Nevertheless, high expectations need to be tempered once the long term side effects, safety and pharmacoeconomics have been established.

Scope

*Overview of the current chronic pain market including epidemiology and key unmet needs.

*In depth analysis of the NGF class in development and proposed positioning in the treatment algorithm.

*Insights from interviews with five leading US and European key opinion leaders about the potential impact of NGF therapies.

*Identification of drivers and resistors to the commercial success of NGF therapies.

Highlights

Clinical studies have shown inhibition of nerve growth factor (NGF) has a strong analgesic effect. Three classifications block or sequester the NGF signal transduction pathway; NGF antagonists, tropomyosin-related kinase A inhibitors and NGF trap molecules. The most advanced pipeline candidate is Pfizer’s tanezumab with expected launch in 2012.

The safety of the NGF targeting therapies remains uncertain. Adverse effects shown in tanezumab trials indicate peripheral neuropathy, dysesthesia and paresthesia were the most frequent, but, no patient has taken tanezumab for longer than 6 months. Further long-term trials are required to establish the risk-benefit profile in chronic usage.

The involvement of Huge Pharma will aid the successful long-term commercialization of NGF therapies. Not only do these companies have the resources necessary to conduct the large long-term clinical trials required for chronic pain therapy, but their activity and experience in licensing pain products will encourage higher uptake upon launch.

Reasons to Buy

*Know the development of the NGF class and quantify pipeline.

*Identify where the NGF class will be positioned in the market as determined by interviewed key opinion leaders.

*Evaluation of the commercial considerations which will drive or inhibit the success and impact of the anti-NGFs.

Table of Contents :

“Overview 1
Catalyst 1
Summary 1
ABOUT  HEALTHCARE 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
insight into the potential of nerve growth factor (NGF) for pain therapy 3
Related reports 5
Upcoming reports 5
Table of Contents 6
1. Pain – Market Potential 7
Key findings 7
Definition 8
Epidemiology 9
Chronic pain prevalence represents a substantial population 9
Back pain and arthritic conditions are the most prevalent chronic pain indications 12
Current treatment options 14
Management of chronic pain severity 16
Consequences of inadequately treated chronic pain 16
Current market overview 17
Unmet needs in pain management 18
Unmet need 1: improved efficacy in hard-to-treat pain conditions 19
Unmet need 2: abuse deterrent and abuse resistant approaches 20
Unmet need 3: safer pain management treatments 21
Unmet need 4: reduction in adverse effects 22
Target product profile versus current level of attainment 26
2. Class development 27
Key findings 27
Nerve growth factor has a key role in pain 28
Therapies targeting nerve growth factor (NGF) in pain 29
NGF antagonists 30
TrkA inhibitors 31
NGF trap molecules that compete with TrkA receptors 32
Pipeline overview 33
Strong presence of Huge Pharma in NGF pipeline 33
Key Nerve growth factor projects in development 34
Overview of NGF antagonists and Overview of TrkA inhibitors 34
Tanezumab (RN624; Pfizer) 35
Drug profile 35
Development overview 36
First Phase III studies to yield results in 2011 36
Promising Phase II data 38
Peripheral neuropathy and paresthesia documented in Phase II studies 41
Product positioning 41
Pfizer will obtain arthritis approval first 41
Tanezumab will be priced equivalent to existing biologics 42
SWOT analysis 43
REGN475 (SAR-164877, Sanofi-Aventis/Regeneron) 43
Drug profile 43
Development overview 44
JNJ-42160443 (formerly AMG403, Ortho-McNeil-Janssen Pharmaceuticals/Amgen) 45
Drug profile 45
Development overview 46
PG110 (hu-alphaD11, Abbott) 47
Drug profile 47
Development overview 48
Overview of TrkA inhibitors 48
BXL1H5 (huMNAC-13; BioXell/Cosmo Pharmaceutical SpA) 49
Drug profile 49
Development overview 50
3. Commercial considerations 51
Key findings 51
Key drivers to commercial success of the nerve growth factor (NGF) class 52
Driver 1: increased efficacy and long duration for NGF antagonists 52
Anti-NGF therapies exhibit stronger efficacy than NSAIDs 52
Long half-life represents more convenient dosing regimen 53
Driver 2: novel target in pain management 53
First novel class to enter pain management in decades 53
Validation of NGF pathway will increase development of small molecule inhibitors 54
Driver 3: strong investment in anti-NGF technologies 54
Entrance of Huge Pharma into the NGF pipeline will act as strong driver for R&D 54
Driver 4: limited abuse potential 55
Anti-NGF therapies offer no euphoric effects that could lead to misuse 55
Driver 5: innovation in technology 56
Improvement in monoclonal antibody technology will limit immunological response 56
Specificity of anti-NGF will limit adverse drug-drug interactions 56
Key resistors to commercial success of the nerve growth factor (NGF) class 57
Resistor 1: safety issues of chronic use unknown 57
Reproductive toxicology issues 57
Long-term safety profile unknown 58
Resistor 2: high pricing will affect reimbursement and positioning 59
NGF therapies will be priced at a premium 59
Insurance companies are likely to insist on last-line usage 60
Set up costs will limit coverage and increase costs 61
High price will restrict usage to last-line 62
Resistor 3: does not treat all pain indications 62
Efficacy is strong in inflammatory disorders compared to neuropathic indications 62
4. Case Study 64
Key findings 64
Will anti-NGFs mirror the impact of anti-TNFs? 65
Similar to anti-TNFs, anti-NGFs will become the first biological drugs in chronic pain 65
Unlike anti-TNF, anti-NGFs will remain the last-line therapeutic choice if cost remains high 66
Less unmet need in chronic pain will result in lower anti-NGF uptake 69
Anti-NGFs will be priced the same as anti-TNFs 71
Proof of concept will open doors to increased competition 71
Anti-NGF usage will also spread to other indications 72
Bibliography 74
Journals 74
Websites 77
reports 79
Presentations 79
Appendix A 80
Data definitions, limitations and assumptions 80
Standard units 80
Appendix B 81
Contributing experts 81
Report methodology 81
About82
About  Healthcare 82
About the Central Nervous System analysis team 83
Disclaimer 85

For more information please visit :

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The medical studies are alarming: during their lives, most people are affected by lower back pain. This medical condition is responsible for more incapacity and sick leave than any other is. Check out the fact:

• Eight out of ten have suffered or will suffer from this debilitating aliment

• Half of all people who experience lower back pain will have repeat attack within twelve months. Lower back pain – Acute or Chronic?

Acute lower back pain occurs suddenly. Very often, you will know exactly what causes it: an accident that jars your back, for instance, such as fall from a chair or a ladder. Or, you may simply stumble and pitch backwards to the ground.

Whatever the cause, you will probably strain and tear the ligaments, tendons and muscles in your lower back. All of these tissues are essential to your well-being, and any trauma affecting them produces severe pain.

A particularly severe accident will cause even more serious hurt. This could be a break in the lumbar spine, or a break in the coccyx at the base of the spinal column. The pain from such injuries can be excruciating, as some of you may already know.

The cause of chronic pain, pain that continues for a long time or constantly recurs, can be more hard to assess. It may cause by deterioration of the discs between the spine’s vertebrae. In other words, the discs may dry out, thereby allowing pressure to be placed on the nerves that run through the spine. The result is severe lower back pain, usually known as osteoarthritis.

Others suffer when the joints of the lower back become inflamed as rheumatoid arthritis enters their body. This condition is not only chronic, it steadily progresses through the system.

Another common cause of chronic lower back pain is osteoporosis, in which the bones of the spine become brittle and fragile because of hormonal changes or vitamin deficiencies. Other causes of lower back pain

• Spondylosis – this occurs when the disc between the vertebrae of the spine distintegrate, allowing the vertebrae to rub against each other.

• Sciatica – degeneration of the spinal discs can also cause compression of the nerve roots in the lower back, resulting in intense pain.

• Lumber spinal stenosis – pressure on the spinal cord, a consequence of hurt to the fiber that houses the cord, can lead to lumbar spinal stenosis. The most noticeable physical sign of this condition is the way that suffers must stand or sit with a hunched posture to ease the appealing pain.

• Depression – for 80% of those who have lower back pain, doctors cannot determine the cause. This adds to the depression that suffers often feel because they have no understanding or control of their disorder.

The CHI institute as recognized the desperate need for a consistent form of relief for lower back pain. Institute researchers studied the available remedies and learned from the practices of many different cultures and people, including the renowned qigong healers of Beijing, China. From these experiences, the institute started developing positive therapeutic solution to the problems of Lower Back Pain in both its forms, acute and chronic.

The first of these solutions, an infrasound massage device, was a tremendous success. But the CHI institute didn’t stop there. Since pain therapy is a constantly developing field, the institute chose it was vital to continue the product evolution to find maximum pain relief.

As result of this continuing research, Sound Vitality, a division of the CHI institute, introduced the Infratonic 4. 3 in 1997. This device was based on digital Chaos Therapy and proved to be a fantastic help for anyone afflicted with the torture of lower back pain.

Is your life ruined by chronic or acute lower back pain? Visit Back pain therapy center

Chronic back pain is a disease in itself. When your back hurts continuously for over three months it is considered chronic pain. The reasons for this condition could be an injury or an ongoing cause like a nerve hurt or arthritis. Lack of Vitamin D, an vital component for calcium absorption and bone health, could also be a cause. Here a supplement of Vitamin D could help. Sometimes this pain has no apparent cause or could be due to a developing illness or imbalance. The condition can be clarified as a persistent dull or burning pain starting at a particular region in the back going down the legs. There could also be tingling or a ‘pins and needles type of sensation in the legs. In some cases patients could experience numbness in the area. It Is All In The Mind Persistent aches in the spine region affects daily activities. It also reduces work place efficiency. Research shows that the emotion center of the brain is more active when you face such a condition. Hence it is considered more of an emotional experience. But we must not forget that the human mind can make or alleviate pain. A patient with a continuous back problem needs to cooperate with the doctor. It is more like an athlete using the focusing technique to help them improve their performance. Speaking of athletes, core stabilization, a bunch of strengthening exercises could also be used to get relief from chronic back pain. A Ray Of Hope So far none of the standard types of medical management gives 100% relief. But, there is hope for those with chronic back pain as extensive research is being done in this area. Novel treatments include new medication, devices and injections, alternative therapies such as biofeedback, acupuncture and an all-encompassing mind/body approach, which makes an attempt at addressing life as a whole. As this problem sets off multiple psychological problems, multidisciplinary pain clinics have been growing in number since the last few decades. Complete healing does not always happen; hence medical professionals make pain management their objective. There are programs like Comprehensive Pain Programs CPP that are relatively efficient and cost effective. These programs aim to enhance your physical, psychological and social functioning. A excellent CPP for chronic back pain can perform a complete evaluation using the latest clinical and diagnostic procedures. Besides, the patient and the physician should together develop a comprehensive individualized treatment plot. Often times a medical and rehabilitation models are integrated as part of continuous and severe back pain management care. Treatment for back pain cure may include therapies, sessions with a psychologist, interventional procedures, and/or medications. This could also help those with severe upper back pain, failed back surgery or disorders caused by nerve pain in the spine.

Review What causes chronic, debilitating back pain, one thing in common – and expensive to treat – diseases in the world? According to Robin McKenzie, New Zealand physiotherapist for over 40 years and written a well loved self-help manuals Treat Your Own Back and manage their own neck of the plates to distort the spine – whether poor posture or injury – cause pain. If by magic, is McKenzie Method – seven very specific exercises to help…
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