CNS and GI

Alemtuzumab – Potential in Multiple Sclerosis
The neuron is the most important cell in the CNS and the peripheral nervous system. MS is characterised by the loss of the protective myelin sheath (demyelination).	The main forms of multiple sclerosis (MS) are distinguished by their different patterns of development of disability over time. Relapsing-remitting MS is the most common form of the disease.	Major cells are involved in the disease process in multiple sclerosis. Key: APC: antigen-presenting cell; CD8+ T cells: Cytotoxic T cells; TH1, TH2: regulatory (helper) T cells; VLA4: Very Late Antigen 4 adhesion molecule.
Disease-modifying drugs currently used in the treatment of MS.

Almorexant
The hypothalamus is important for regulating the body's sleep-wake patterns.	Diagram illustrating the different stages of the sleep cycle.	The development of orexin antagonists, such as almorexant, represents an exciting new approach to the treatment of sleep disorders.
There are a number of endpoints that can be used to assess the efficacy of drugs for insomnia some of which are sleep-specific outcome measures while others are designed to assess treatment impact on patient well-being.

APD125 - Therapy for Insomnia,
The hypothalamus is important for regulating the body's sleep-wake patterns.	The normal sleep cycle is characterised by five distinct stages.	Current approaches to the treatment of insomnia include both pharmaceutical and non-pharmaceutical remedies, such as herbal preparations.
While the GABA receptor has long been recognised as an important target for developing treatments for sleep disorders, a number of alternative targets are now being explored.

Bifeprunox - Atypical Antipsychotic Drug
Bifeprunox mesilate is a novel atypical antipsychotic agent under development by Solvay Pharmaceuticals.	Atypical antipsychotic drugs routinely used in the treatment of schizophrenia.	Cross section of the human brain showing dopamine and serotonin pathways. (Source: ABPI)
D2 receptor binding of typical and atypical antipsychotic drugs. (Source: ABPI)	Solvay Research & Technology in Neder-over-Hembeek, Belgium, is the company's largest R&D facility	At Weesp in the Netherlands, Solvay Pharmaceuticals carries out research into medicines for psychiatric and neurological disorders such as schizophrenia.
Core symptoms of schizophrenia.	The automated molecular assembly plant (AMAP) boosts the efficiency of Solvay Pharmaceutical's research centre at Weesp in the Netherlands.

Caprospinol, Therapy for Alzheimer's Disease (AD)
Loss of acetylcholine, an important neurotransmitter, is a key pathological feature of Alzheimer's disease (AD) and contributes to the cognitive decline that characterises this disease.	In most patients, Alzheimer's disease (AD) is a slowly progressive disease in which loss of short-term memory is often one of the earliest symptoms.	Potential sites of action of anti-amyloid agents.
Prevalence of Alzheimer's disease (AD) rises steeply in the very elderly.

Cerovive - Neuroprotectant for the
Simplified cross-section of brain. (Source: ABPI)	Artery cross-section. (Source: ABPI)

Cilansetron - New Treatment for IBS
Solvay SA, with headquarters in Brussels, Belgium, was developing Cilansetron, a 5-HT3 antagonist indicated for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS).	Solvay Pharmaceuticals' R&D activities in the US are located in Marietta.	Solvay Pharmaceutical's activities are focused on gastroenterology, hormone treatments, CNS drugs and cardiology.
Relationship between the environmental, physiological and psychological factors in the development of IBS.	Factors that may predispose people to the development of IBS.	Solvay Research & Technology in Neder-over-Hembeek, Belgium, is the company's largest R&D facility.
Diagram of the human GI tract.	Examples of drugs traditionally used in the treatment of IBS.

Dimebon - Investigational Compound Indicated for the Treatment of Alzheimer's and Huntington's disease
Coronal FSPGR through the brain at the level of the caudate nuclei demonstrating marked reduced volume in keeping with the patient's known diagnosis of Huntington's disease.	Transmission electron microscope image of a thin section cut through an area of mammalian lung tissue. The high magnification image shows a mitochondria.	Neurons in the brain. Source: www.nia.nih.gov.

Fampridine-SR – Treatment for Multiple Sclerosis
The axons of normal nerve cells are surrounded by a myelin sheath, a protective layer that enables electrical impulses to be conducted along the axon.	MS and SCI are characterised by the loss of myelin (demyelination). Demyelinated axons lose the ability to transmit nerve impulses.	Famipridine-SR is designed to block specialised potassium (K+) channels on axons and restore nerve impulses even in a demyelinated state.
Famipridine-SR is the most advanced product in Acorda Therapeutics' R&D pipeline that also includes remyelinating monoclonal antibodies and neuregulins.

Fingolimod - Novel Therapy for Multiple Sclerosis,
The main forms of multiple sclerosis (MS) are distinguished by their different patterns of development of disability over time. Relapsing-remitting MS is the most common form of MS.	The neuron is the most important cell in the CNS and the peripheral nervous system. MS is characterised by the loss of the protective myelin sheath (demyelination).	MRI scan of the brain of a person with MS. Lesions (light spots, arrowed) are often seen clustered around the ventricles (fluid-filled spaces) in the centre of the brain.
Damage to spinal cord nerves affecting the lower limbs is likely to be accompanied by bladder problems, as the bladder is controlled by nerves from the lowest part of the spinal cord.	Major cells involved in the disease process in multiple sclerosis. Key: APC: antigen-presenting cell; CD8+ T cells: Cytotoxic T cells; TH1, TH2: regulatory (helper) T cells; VLA4: Very Late Antigen 4 adhesion molecule.

Florbetaben
Microscopy image of a neurofibrillary tangle, which can cause AD.	Bayer and AC Immune's florbetaben helps to detect beta-amyloid plaques through positron emission tomography, and is hoped to be an answer to the early diagnosis of AD.	AD's prevalence is increasing and diagnostic tools are required to treat and prevent its early onset.

Flurizan – Anti-Amyloid Drug for Treatment of Alzheimer’s Disease,
Cross-section of the human brain showing the regions affected in Alzheimer's disease (AD). Darker shaded areas, such as the cortex and hippocampus, are those most damaged in AD.	Amyloid Precursor Protein (APP) is cleaved by beta- and gamma-secretases.	Graph to illustrate the impact of ageing on the prevalence of Alzheimer's disease (AD).
AD is characterised by progressive cognitive decline and accompanying behavioural problems. It remains an incurable disease.	Alzheimer's disease is named after the German physician Alois Alzheimer.

Gaboxadol - Investigational Agent
Gaboxadol is a direct-acting GABAA agonist under development by Danish pharmaceutical company Lundbeck for the treatment of sleep disorders.	Prevalence of common sleep disorders, of which insomnia is the most common affecting over 160 million people.	Characteristic symptoms of insomnia, which can become chronic if left untreated.
Current approaches to the treatment of insomnia. Non-pharmaceutical remedies, such as herbal preparations are widely used.	Sleep disorders include insomnia, by far the most common, restless leg syndrome (RLS) and sleep apnoea in which there is a brief cessation in breathing causing the patient to wake abruptly.

HCT 3012 - COX-Inhibiting Nitric Oxide-Donator
HCT 3012 is indicated for the treatment of acute and chronic nociceptive pain, such as post-operative and arthritic pain. (Source: ABPI)	NSAIDs are the cornerstone of analgesia, providing relief from everyday pains such as headache, toothache, muscular aches, mild joint pain and period pain. (Source: ABPI)	HCT 3012 is an entirely new chemical entity which provides balanced inhibition of COX enzymes while also donating nitric oxide at sites of inflammation.

Iloperidone - Atypical Antipsychotic for Schizophrenia
Cross-section of the brain showing dopamine and serotonin pathways.	The most common subtypes of schizophrenia affect people between the ages of 15 and 45 years.	D₂ receptor binding of typical and atypical antipsychotic drugs.
All currently available antipsychotic drugs bind to dopamine receptors. Typical antipsychotic drugs bind tightly and dissociate slowly from the dopamine receptor, whereas atypical drugs bind more loosely and dissociate more rapidly.

Lexapro
Lexapro is now only the second antidepressant that is approved for the treatment of MDD in adolescents.	Lexapro is available in 5mg, 10mg and 20mg tablets and also as an oral solution (1mg/ml).	Lexapro has been commercially available in the US since its original launch in 2002, and has been prescribed to more than 18 million US adults for depression, anxiety or both.

Licofelone - Novel Analgesic and Anti-Inflammatory
Licofelone (ML3000) is a dual COX/LOX inhibitor currently under evaluation as a treatment for osteoarthritis (OA).	Image of an inflamed knee joint that occurs in osteoarthritis.	Licofelone inhibits both COX -1 and COX-2 enzymes as well as 5-lipoxygenase (5-LOX), which is associated with the production of pro-inflammatory and gastrotoxic leukotrienes.
Age-related prevalence of osteoarthritis in men and women.	New classes of analgesic and antiinflammatory drugs in development.	Chemicals that initiate and perpetuate pain signals. (Source: ABPI)
The WHO analgesic ladder for pain relief. (Source: ABPI)

LY2140023 – Treatment of Schizophrenia
Frequency of schizophrenia varies from an acute episode with little impairment, to a relapsing disease, and more rarely a chronic illness.	Cross-section of the brain showing dopamine and serotonin pathways.	The most common subtypes of schizophrenia affect people between the ages of 15 and 45 years.
All currently available antipsychotic drugs bind to dopamine receptors. Typical antipsychotic drugs bind tightly and dissociate slowly from the dopamine receptor, whereas atypical drugs bind more loosely and dissociate more rapidly.

Lyrica (Pregabalin) - New Gabapentinoid with Wide
Pregabalin is a 3-substituted analogue of gamma-amino butyric acid (GABA) and a compound related to Pfizer's hugely successful antiepileptic drug gabapentin. (Source: ABPI)	Formulae for the drugs Pregabalin and Gabapentin.	At high doses gabapentin has proven effective against neuropathic pain induced by diabetic neuropathy and postherpetic neuralgia. (Source: ABPI)

M6G, A New Morphine Derivative For Post-Operative Pain Relief
CeNes Pharmaceuticals' development pipeline.	Results from CeNes Pharmaceuticals' M6G015, its initial Phase III study. As the graph shows, M6G provided effective analgesia to patients in the post-operative period following knee replacement surgery under spinal nerve block.	Diagram showing how painful stimuli from receptors travel along special nerves (red) to the spinal cord. Impulses then pass up the spinal cord to the brain, which sends messages down the spinal cord to switch off the pain signals (green).
Diagram showing inhibition of pain signals in the spinal cord.	Sites in the CNS at which known analgesic medications act.	The World Health Organisation’s three-step pain ladder, in which opioids are recommended for moderate to severe pain.

Mylinax - Novel Therapy for the Treatment of
Serono's biotech research is centred on increasing understanding of naturally occurring proteins such as the immunomodulator interferon-beta.	Rebif (interferon-beta 1a) is the number one treatment for multiple sclerosis outside the US.	Rebif is given by subcutaneous (under the skin) injection and comes in pre-filled syringes / autoinjectors.
Bioreactors, such as those used at Serono's Biotech Centre in Corsier Vevey, Switzerland, lie at the centre of the biotechnology manufacturing process.	Geneva is the home of Serono, Europe's number one biotech company.	Aubonne, Switzerland, is one of Serono's leading centres for the manufacture of biotechnology-derived products.
Serono Biotech Centre (SBC) 2 in Corsier Vevey, Switzerland.

NG2-73 - A Novel Agent For The Treatment of Insomnia
Diagram of the different stages of the sleep cycle.	The normal sleep cycle is characterised by five distinct stages.	Estimated to affect between 20% and 30% of the general US population, sleep disorders are extremely common.
Characteristic symptoms of insomnia, which can become chronic if left untreated.	Current approaches to the treatment of insomnia. Non-pharmaceutical remedies, such as herbal preparations are widely used.

Olcegepant - Novel Therapy for Acute Migraine
Drugs commonly used in the treatment of an acute migraine attack.	Patients with migraine can experience acute attacks in which the throbbing headache is preceded by a prodromal phase (migraine with aura) or occurs in the absence of a prodromal phase (migraine without aura). Attacks typically last 4-72 hours.	There is evidence to suggest that CGRP plays a pivotal role in the pathophysiology of migraine.
Treatment algorithm for the management of migraine attacks. (Source: ABPI)	Cross-section of the human brain showing some of the nerve connections that may be involved in migraine. (Source: ABPI)	Illustration showing waves of excitation followed by depression of nerve impulses moving through the visual cortex resulting in scinillations and scotomas. (Source: ABPI)
Possible sites of action of anti-migraine therapies. (Source: ABPI)

Osanetant - Novel Investigational Agent for the
Affecting around 1% of the general population, schizophrenia is a severe and debilitating mental illness. (Source: ABPI)	Atypical antipsychotics in clinical use.	Typical vs. atypical agents. (Source: ABPI)
Dopamine receptor binding. (Source: ABPI)

Paxil – SSRI for the Treatment of Major Depressive Disorders
Headquartered in the UK and with operations based in the US, GSK is among the industry leaders, with an estimated 7% of the world's pharmaceutical market.	Paxil (paroxetine hydrochloride) is an orally administered psychotropic drug for the treatment of major depressive disorders.	Paxil works by preventing the uptake of serotonin into platelets in the blood.

Phenserine - Next Generation AChE Inhibitor
Cross-section of the human brain showing the regions affected in Alzheimer's disease (AD). Darker shaded areas, such as the cortex and hippocampus, are those most damaged in AD. (Source: ABPI)	Potential sites of action of anti-amyloid agents. (Source: ABPI)	Graph to illustrate the impact of ageing on the prevalence of Alzheimer's disease (AD). (Source: ABPI)
Site of action of AChE inhibitors, the major class of agents currently used in the treatment of Alzheimer's disease (AD). (Source: ABPI)	Drugs currently used in the treatment of Alzheimer's disease (AD).	Axonyx's drug development pipeline for anti-dementia therapies.

Plectasin NZ2114 - Novel Microbial Agent
Plectasin NZ2114 is a novel antimicrobial peptide under development by Danish biotech company Novozymes A/S.	Defensins are thought to be an exciting new approach to combating antibiotic resistance.	Novozymes A/S and Sanofi-Aventis have signed a global licensing agreement for further development and marketing of plectasin NZ2114.

Prexige - COX-2 Inhibitor
Chemicals involved in pain signals. (Source: ABPI)	Overview of new classes of pain relieving drugs in development.

Rasagiline - Second-Generation MAO-B Inhibitor
Cross-section of the human brain showing the substantia nigra, the region affected by Parkinson's disease. (Source: ABPI)	Some examples of new approaches to the treatment of PD that are being developed.	Drugs currently used in the treatment of PD.
Side effects of treatment with levodopa following short- and long-term administration.	Common symptoms associated with PD.

Rember
Alzheimer's disease is named after the German physician Alois Alzheimer, who in 1906 described amyloid plaques and neurofibrillary tangles in the brain of a 51-year old female patient, Auguste D, who died from severe dementia.	Cross-section of the human brain showing the regions affected in Alzheimer's disease (AD). Darker shaded areas, such as the cortex and hippocampus, are those most damaged in AD.	AD is characterised by progressive cognitive decline and accompanying behavioural problems. It remains an incurable disease.
	Tau proteins normally help to form and maintain microtubules (above). In Alzheimer's disease, tau becomes overloaded with phosphate and clumps together into paired helical filaments (below), which are the basis of the tangles which choke dying neurons.

Rezular – Oral Treatment for IBS
Diagram of the human GI tract.	Relationship between environmental, physiological and psychological factors in the development of IBS.	AGI Therapeutics is developing a range of drugs to treat a variety of common GI diseases and disorders, including IBS, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease (GERD).

Sativex - Investigational Cannabis-Based Treatment
To meet demands for Sativex, GW Pharmaceuticals has increased production of cannabis at its fortified greenhouses to 60t/y. (Source: ABPI)	Overview of new classes of pain relieving drugs in development.	Neuropathic pain, which is frequently chronic, arises when neurones in the brain or peripheral nervous system become hyper-sensitised and generate abnormal or prolonged impulses. (Source: ABPI)

Semagacestat – Gamma Secretase Inhibitor for Alzheimer's Disease (AD)
Regions of the brain affected in Alzheimer's disease.	There are a number of stages of Alzheimer's disease; the condition runs a course of steady cognitive decline and behavioural issues.	Alzheimer's is a potentially debilitating disease that has been analysed for over a hundred years.
Diagram showing cleavage of APP by proteolytic beta- and gamma-secretase.

TB-402
ThromboGenics' TB-402 is a long-acting anticoagulant for treatment of VTE and AF.	The long-half life of TB-402 may permit reduced dosing, giving it an advantage over treatments that have to be administered on a daily basis.	If trials are successful, TB-402 may reduce the risk of increased bleeding, a known side-effect of anticoagulants, and the need for regular blood coagulation monitoring.

Treximet - Next-Generation Treatment for Migraine
Treatment algorithm for the management of migraine attacks.	Cross-section of the human brain showing some of the nerve connections that may be involved in migraine.	Illustration showing waves of excitation followed by depression of nerve impulses moving through the visual cortex resulting in scinillations and scotomas.
Possible sites of action of anti-migraine therapies.

Tysabri - Therapeutic Monoclonal Antibody (MAb)
Cross-section of the human brain.	MS is a neurological disease characterised by damage to myelin, the protective sheath surrounding nerve fibres.	Frequency of the major types of multiple sclerosis.
Damage to the myelin sheath disrupts signals between the brain and other parts of the body producing a range of symptoms.	Although there is no cure for MS, disease-modifying drugs can help reduce the frequency and severity of exacerbations.

V1512 - Treatment of Parkinson's Disease
Cross-section of the human brain showing the substantia nigra, the region affected in PD.	Vernalis treatment options for PD include Apokyn, marketed in the USA, and V1521 and V2006, both of which are still in development.	Apokyn is the only therapy available in the USA for the acute intermittent, treatment of immobilising 'off' episodes associated with advanced PD.

Vesicare - Oral Selective Muscarinic Receptor
Typical symptoms of OAB.	Examples of some of the specialised tests used to investigate OAB.	Diagram of the bladder.
Sample for urinalysis.

Zegerid – Proton Pump Inhibitor for Treatment of Heartburn
As a treatment for a multitude of gastroesophageal diseases, Zegerid prevents heartburn, which can cause erosive effects throughout the throat and stomach.	Zegerid inhibits gastric acid secretion for 24 hours, with clinical trials showing the drug's efficacy for conditions such as gastric ulcer.	The new formulation of Zegerid is an immediate-release swallowable tablet consisting of omeprazole and a mix of buffers.

Zyprexa – Antipsychotic for the Treatment of Schizophrenia, Psychotic and Bipolar Disorders
Zyprexa is an atypical antipsychotic used for treating schizophrenia and other related disorders.	Zyprexa's mode of action is unknown but it is thought to include antagonism of serotonin receptors.	Although Zyprexa has shown to be effective against schizophrenia, there are concerns over side effects, particularly weight gain and the increasing incidence of diabetes.

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