Reportlinker Adds Cardiovascular Drug Discoveries 2008

NEW YORK, May 12 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cardiovascular Drug Discoveries 2008

http://www.reportlinker.com/p0192684/Cardiovascular-Drug-Discoveries-2008.html

This market analysis provides:

Unique sales forecasts for key new and current products to 2012

A comprehensive examination of 6 major cardiovascular therapy areas

Critical analyses and competitive ratings for current and upcoming products

6 key cardiovascular therapy areas covered:

Cholesterol and Triglycerides

Hypertension

Coronary Artery Disease

Pulmonary Arterial Hypertension

Atrial Fibrillation

Thrombosis Cardiovascular disease is a global problem. In the developed world, its prevalence is linked to our increasingly unhealthy lifestyle, with risk factors including lack of exercise, overweight and obesity, and smoking. These are also linked to diabetes which increases the risk of developing heart disease.

The global desire for cheaper generic drugs has been putting increasing pressure on the research-based industry, which finds itself having to defend its patents in the courts to ward off generic competition for as long as possible. Legal battles are won and lost on both sides; either way, patents eventually expire and generic competition is inevitable.

But what of the future? Opportunities for new therapies exist in both main and niche markets - the latter being relatively uncompetitive and where there is high unmet clinical need, such as pulmonary arterial hypertension.

Among the market leaders, several will lose, or have recently lost, patent protection in major markets over the next few years. The resulting loss in revenue for the research-based industry can be dramatic.

For example, following peak sales of US$5,580 million in 2002, Merck & Co's Zocor (simvastatin) lost its basic patent protection in Canada and a number of countries in Europe, including the UK and Germany in 2003. Sales subsequently declined in these countries as a result of generic competition.

The US patent on Zocor finally expired on 23rd June 2006, following six months paediatric extension. The FDA approved two generics with 180-days market exclusivity, resulting in a downturn in sales of Zocor to US$2.8 billion for the full year. The entry of multiple generics onto the market from December 2006, however, resulted in a dramatic fall in sales of Zocor in 2007, to US$876 million. The effect of generic simvastatin was not, however, confined to Zocor but rippled through the market, impacting sales of Pfizer's Lipitor (atorvastatin) in the short term.

This report provides a detailed insight into the current and future market for cardiovascular drugs.

It provides an overview of the marketplace, outlining morbidity and mortality around the world and summarising the leading drugs in terms of sales and US patent expiry.

It examines drug development among major pharmaceutical companies, covering both novel drugs and launched products in development as part of their life cycle management programmes.

For each therapy section the major treatments are discussed in depth, including sales forecasts to 2012 for leading drugs. In addition, a number of new and future treatments have been identified and analysed in order to assess their future market potential.

Extensive tables and charts provide insight into leading cardiovascular markets and products.

Cholesterol and Triglycerides

The global market for drugs used in the management of cholesterol is currently valued at around US$34 billion. Sales of the major branded drugs amounted to around US$27.3 billion in 2007.

The most widely prescribed drugs for cholesterol management are HMG-CoA reductase inhibitors, or statins.

In terms of revenue, Pfizer's Lipitor (atorvastatin) remains the largest selling drug of any kind worldwide. Lipitor accounts for around 40% of the market for cholesterol management drugs by value. Without a viable replacement in the pipeline, Pfizer is keen to hold onto its Lipitor revenue for as long as possible.

For some time, the company has been embroiled in a worldwide patent litigation battle with Ranbaxy, which is equally keen to launch generic atorvastatin in key markets. While Pfizer should be able to fend off generic competition in the US at least until its basic patent expires in March 2010, Lipitor has also been facing competition from multiple entries of generic simvastatin. During 2007, sales of Lipitor have been squeezed, particularly in the US. For the full year, Pfizer reported a decline of 8.3% in US sales and 1.6% worldwide.

New fixed-dose combinations aimed at improved cholesterol management, or more than one heart disease risk factor, are also likely to gain in popularity. The approval of Abbott's Simcor (niacin+simvastatin) is just one of several combination products expected over the next few years.

Among the current and upcoming products evaluated with 5-year sales forecasts

Lipitor (atorvastatin) Pfizer

Zocor (simvastatin) Merck & Co

Zetia (ezetimibe) Merck & Co/ Schering-Plough

Crestor (rosuvastatin) AstraZeneca

Vytorin (ezetimibe+simvastatin) Merck & Co/ Schering-Plough

TriCor (fenofibrate) Abbott

Lescol (fluvastatin) Novartis

Niaspan (niacin) Kos Pharmaceutical

Caduet (amlodipine+atorvastatin) Pfizer

Tredaptive (niacin+laropiprant) Merck & Co

Simcor (niacin+simvastatin) Bayer

ABT-335 (SLV348) Abbott

Coronary Artery Disease

The approval of CV Therapeutics' Ranexa (ranolazine) extended-release tablets by the FDA on 27th January 2006 for the treatment of chronic angina in a restricted patient population, marks the first new pharmaceutical approach to treating angina in the US in more than 25 years. Ranexa has anti-anginal and anti-ischaemic effects that do not depend upon reductions in heart rate or blood pressure.

Espicom has identified 15 drugs in development for atherosclerosis and coronary artery disease. Among these are three launched products in Phase III trials for atherosclerosis indications, including AstraZeneca's Crestor (rosuvastatin), which has shown promise in atherosclerosis progression. Of the novel candidates in development, we have selected just one for analysis: Generx (alferminogene tadenovec, Ad5FGF-4) from Cardium Therapeutics, which is in Phase III for myocardial ischaemia and associated angina.

In the pipeline…

Cardium Therapeutics is developing Generx (alferminogene tadenovec, Ad5FGF-4) as a potential treatment for myocardial ischaemia (MI - insufficient blood flow within the heart muscle) and associated angina due to coronary heart disease, and represents a new therapeutic class of cardiovascular biologics.

GSK is developing a small-molecule drug for atherosclerosis in collaboration with Human Genome Sciences (HGS). Darapladib (GSK480848) inhibits the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2).

Hypertension

Hypertension is a leading risk factor for coronary heart disease, heart failure, heart attack, stroke and renal insufficiency. Hypertension is generally defined as blood pressure greater than 140/90mmHg. Risk levels are doubled in people with diabetes.

The global hypertension drugs market is currently valued at around US$38.5 billion. The range of drug classes available to treat high blood pressure contributes to the competitive nature of a market in which there were 12 blockbuster drugs in 2007, with combined sales of US$23.7 billion. In terms of revenue, Pfizer's Norvasc (amlodipine) was the leading hypertension treatment for several years, up to 2006 when its sales peaked at US$4,866 million. Following expiry of the last US patent, however, sales declined in 2007 to US$3,001 million as multiple generics reached the market following FDA ANDA approvals in September 2007. Novartis' Diovan/Co-Diovan (valsartan) took over as market leader in 2007, with sales of US$5,012 million, an increase of 18.7% over 2006. Merck & Co's Cozaar (losartan) ranked second, with sales amounting to US$3,350 million, an increase of 5.9% over 2006.

New fixed-dose combinations aimed at more than one heart disease risk factor are also likely to gain in popularity over the next few years. Patients who suffer from both hypertension and high cholesterol levels have a much greater risk of suffering myocardial infarction or stroke than people who only have one of the conditions.

Current and upcoming products evaluated with

5-year sales forecasts

Aprovel (irbesartan) sanofi-aventis

Diovan (valsartan) Novartis

Cozaar (losartan) Merck & Co

Micardis (telmisartan) Boehringer Ingelheim

Atacand (candesartan cilexetil) AstraZeneca/Takeda

Adalat (nifedipine) Bayer

Accupril (quinapril) Pfizer

Coreg (carvedilol) GSK/Roche

Seloken (metoprolol succinate) AstraZeneca

Cardura (doxazosin) Pfizer

Rasilez (aliskiren) Novartis

Bystolic (nebivolol) Mylan/Forest Labs

Pulmonary Arterial Hypertension

Pulmonary hypertension (PH) is defined by the WHO as a mean pulmonary artery pressure above 25 mmHg. Pulmonary arterial hypertension (PAH) is a rare form of PH.

The patient population for PAH is relatively small; an estimated 160,000 globally. The condition is often not diagnosed until it is quite advanced as early symptoms are often similar to other conditions, such as asthma.

Until recently, treatment options were limited, particularly for patients with more severe PAH. There are, however, a number of new and potential entrants into this market:

Thelin (sitaxsentan), an endothelin receptor antagonist which has been approved for PAH in the EU. In the US, it has been the subject of three approvable letters but a further Phase III trial is required prior to approval;

Letairis/Volibris (ambrisentan), type-A selective endothelin receptor antagonist, approved by the FDA for PAH in June 2007. GSK received a positive opinion from the EMEA's CHMP for ambrisentan in February 2008 with approval anticipated by the end of April;

United Therapeutics is currently conducting Phase III clinical trials of an inhaled form of treprostinil, known as Viveta.

New and current products evaluated with 5-year sales forecasts

Tracleer (bosentan) from Actelion, the current market leader, an orally-active endothelin receptor antagonist which has been available in the US since 2001.

Ventavis (iloprost) from CoTherix, an inhalation solution for the treatment of PAH in patients with NYHA Class III or IV symptoms, launched in March 2005.

Revatio (sildenafil) from Pfizer, approved by the US FDA in June 2005 following a priority review, and by the EMEA in November 2005 for PAH.

Thelin (sitaxsentan), an endothelin receptor antagonist which has been approved for PAH in the EU. In the US, it has been the subject of three approvable letters but a further Phase III trial is required prior to approval.

Letairis/Volibris (ambrisentan), type-A selective endothelin receptor antagonist, approved by the FDA for PAH in June 2007.

Atrial Fibrillation

Atrial fibrillation (AF) is a disorder in the rhythm of the atria which reduces the heart's ability to effectively pump blood. AF can result in a rapid, irregular heart beat and pulse. In addition, blood which is not completely pumped out of the atria may pool and clot, increasing the risk of stroke. Around 15% of strokes occur in people with AF. According to the American Heart Association, around 2.2 million Americans have AF. The risk of developing AF increases with age; as the population ages, the number of people with this condition is likely to increase. By 2025, the number of people in the US with AF is projected to increase to around 3.8 million and by 2050 it could be as high as 5.6 million, according to a study presented at the 2005 ESC annual congress.

Current treatments for AF include drugs, electrical cardioversion to restore sinus rhythm with an electric shock, radiofrequency ablation to destroy tissue that triggers abnormal electrical signals or to block abnormal electrical pathways, surgery and pacemakers to regulate the rhythm.

Drug treatments include Cordarone (amiodarone), Corvert (ibutilide), Tambocor (flecainide), Rythmol (propafenone), Cardioquine (quinidine), Betapace (sotalol) and Tikosyn (dofetilide). These are limited by modest efficacy or potentially serious side effects, including torsades de pointes. The majority of existing drugs have been on the market for 20 years of more and are available generically. Cost is therefore likely to be an issue for new treatments that reach the market, as well as the need to demonstrate superior efficacy and safety.

New products and approaches evaluated

Espicom has identified nine drugs in development for the treatment of atrial fibrillation and other arrhythmias. Of these, three are in late-stage clinical development:

sanofi-aventis' Multaq (dronedarone)

Solvay's Puzlium IV (tedisamil)

Astellas Pharma/Cardiome Pharma's Kynapid (vernakalant iv)

In addition to Multaq, sanofi-aventis is developing celivarone (SSR149744), a back-up compound to dronedarone with similar electrophysiological effects, currently in Phase IIb trials for atrial fibrillation.

A novel approach to treating and preventing atrial and ventricular arrhythmias, through the modulation of GAP junctions, is rotigaptide (GAP-486; ZP123) which is being co-developed by Wyeth and Zealand Pharma. Rotigaptide increases GAP junction conductance in cardiac myocytes, increasing the heart's ability to transmit signals between muscle cells to maintain natural rhythm. It is the first stable anti-arrhythmic peptide analogue to be advanced into clinical testing.

Thrombosis

Thrombosis is the general term for the formation of a blood clot in the arteries or the veins that obstructs blood flow.

Venous thrombosis, which is usually treated with anticoagulants, is the third most common cardiovascular disorder in the US, affecting almost two million people each year. The most commonly prescribed low molecular weight heparin in the US and major European markets is sanofi-aventis' Lovenox/Clexane (enoxaparin), which is derived from porcine unfractionated heparin. In 2007, sales of Lovenox increased by 7.3% to euro 2.6 billion (US$3.6 billion). Sanofi also developed Fraxiparine (nadroparin), a LMWH produced by nitrous acid degradation of heparin from porcine intestinal mucosa. Fraxiparine was acquired by GlaxoSmithKline (GSK) in 2004 in order to satisfy conditions for Sanofi-Synthélabo's merger with Aventis. In 2007, sales of Fraxiparine declined by 12.0% to £184 million (US$368 million).

Atherothrombosis is treated with antiplatelet drugs which decrease platelet aggregation. By far the largest selling drug in this category is clopidogrel, marketed by sanofi-aventis and Bristol-Myers Squibb as Plavix and Iscover. Clopidogrel is indicated for the prevention of atherothrombotic events in a broad range of patients and can be used in combination with low dose aspirin. In 2007, global sales of Plvix/Iscover amounted to US$8.1 billion.

Current and future products evaluated

Current therapies assessed

Plavix (clopidogrel) sanofi-aventis/BMS

Lovenox (enoxaparin) sanofi-aventis

ReoPro (abciximab) Eli Lilly

Arixtra (fondaparinux) GSK

New and pipeline products assessed

Pradaxa (dabigatran) Boehringer Ingelheim

Prasugrel (CS747) Daiichi Sankyo/Eli Lilly

Rivaroxaban (BAY 59-7939) Bayer/Johnson & Johnson

Apixaban Pfizer/BMS

M118 Momenta

Unique competitor & product evaluation

A key feature of this report is the unique assessment made of products and companies that evaluates not only their pharmacological profile and clinical benefits, but also assesses their chances of succeeding in the market if they are approved.

For a number of promising new and future drugs, Espicom has provided a competitor ratio analysis, based on our assessment of five criteria:

Novelty/rational for mechanism of action;

Proof of concept/clinical data;

Management/clinical expertise;

Competition within the marketplace;

Risks associated with drug development in therapeutic class.

Each of these criteria attracts up to ten points, resulting in a maximum score of 50 overall. The drugs are tabulated and ranked by total score for comparative purposes and each is discussed in more detail in the relevant section of the report.

Table of Contents available upon request

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Drug Discovery and Development Industry: Cardiovascular Drug Discoveries 2008

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