Pulmonary Arterial Hypertension Treatment Biology Essay


Pulmonary arterial hypertension, or PAH, is a disease of the vessels that carry blood from the heart to the lungs. In PAH, there is a constant state of high blood pressure in the vessels of the lungs. PAH is not common, but it affects people of all ages and ethnic backgrounds. PAH can occur on its own, or it can be related to other causes.

Market potential:

Pulmonary Arterial Hypertension (PAH) market was worth $2,653m in 2009. According to the Venice 2003 revised classification system, PAH is categorized as World Health Organization (WHO) Group I - PAH. Prior to 2001, no drug was approved for the treatment of PAH. Only supportive care medication such as anticoagulants, diuretics, oxygen, digoxin and calcium channel blockers was given to the patients. In 2001, the US Food and Drug Administration (FDA) approved Tracleer as the treatment for patients with PAH. This drug is a registered trademark of Actelion Ltd. The sales of Tracleer grew rapidly due to a high patient switch over from off-label drugs to Tracleer. The drug has a better efficacy profile compared to the previously used off-label drugs. The FDA also approved three more drugs, Remodulin, Ventavis, and Revatio in 2002, 2004 and 2005 respectively for the treatment of PAH. However, these three drugs accounted for only a 24% market share to PAH market in 2005. Between 2005 and 2009, the PAH market grew at a Compound Annual Growth Rate (CAGR) of 39.2% and recorded revenues of $2,653m in 2009. According to analysis, the PAH market is forecast to grow at a CAGR of 5% annually over the next six years to reach $3,569m by 2015. Tracleer, the major revenue generating drug of the PAH market is expected to go off patent by 2015. The patent expiry of this drug will be a major barrier for the market growth. Until this time, the growth of the PAH market is primarily attributed to increased competition among existing products, the release of new and enhanced treatment options, and the development of safer and more efficacious therapies. In 2009, Actelion Ltd, with its key drug Tracleer, was the leading player in the global PAH market.

Drivers for the Pulmonary Arterial Hypertension Market

Population Growth

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PAH is a life threatening disease which leads to frequent pulmonary circulation. This disease often occurs in younger women. PAH is characterized by a progressive rise in pulmonary vascular resistance which results in the failure of the right ventricle and premature death. Although a considerable number of therapies for PAH have been approved in the past ten years, the disease has remained a rapidly progressive disease with a poor prognosis for most patients. Only 25% to 50% of patients with PAH will survive beyond five years, despite treatment.


Over the next three to four years the PAH market will witness the expiry of major patented products. Tracleer, Revatio, and Ventavis are going to lose their patent exclusivities by the end of 2015. After the patent expiry of the blockbuster drug Tracleer in 2015, the PAH market will witness a significant decline. The annual cost of the PAH therapies in the market is very high. However, until 2015, the PAH market will not be affected by a price decline due to the limited entry of generic versions of Ventavis and Revatio and the accelerated entry of the promising molecules that are currently in Phase III clinical studies.

Barriers for the Pulmonary Arterial Hypertension Market

Low Treatment Seeking Behavior

Currently only PAH patients with clearly observable symptoms seek treatment for this disease. Majority of the patients who suffer from PAH is ignorant about symptoms and undergo non-pharmacological measures such as recreational and social activities associated with the symptoms of PAH. People with PAH can stay fairly asymptomatic until the underlying disease process is advanced. Most physicians misdiagnose it as either emphysema or asthma and prescribe drugs accordingly. This is because of patients' misconception about the classic PAH symptoms such as shortness of breath and chest pain which are attributed to more common medical conditions. This leads to a low treatment seeking rate and increased self medications. A predominant perception amongst patients is that PAH is not a disease but a minor disruption in response to physical stress and environmental conditions. Patients who perceive their diseased condition in such a manner invariably ignore their condition. This conclusion is further supported by a lack of advocacy groups, patient education activities and so on. This suggests that many PAH patients will likely not seek medical treatment for their disease.

Diagnosis Rate

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There is no single test to diagnose PAH. Diagnosis is mainly based on the interview, medical history and symptoms of PAH. Patients who have symptoms suggestive of PH undergo a non-invasive test, the echo-doppler that find outs the presence of the PH. This test does not identify conditions of the left-heart and valvular diseases. After this test, if the patient is diagnosed as suffering from PH disease, pulmonary function testing is done to identify pulmonary emboli which are associated with lung diseases. A radioisotope lung scan or computer tomographic angiography is also used to identify pulmonary emboli. If any one of these tests are excluded then it is concluded that the patient is suffering from PAH. To identify PAH associated diseases or triggers, a blood test should be performed. Mostly, a patient's condition gets worse by the time they complete all these tests and come to know they are suffering from this disease. Therefore, when PAH is suspected or diagnosed in the patient, a right-heart catheterization should be performed immediately to confirm the diagnosis and the physician should determine the best therapy option to avoid the worsening of the disease. This testing can be frightening for the patient and will take a number of weeks of physician appointments to complete the process. Therefore, the diagnosis rate is hampered by the lack of prominent and accurate diagnostic tests at the correct time. Sometimes, PAH can be diagnosed based on its associated symptoms. Patients diagnosed with PAH have effective and novel therapies, which increase the survival rate from two years to six or seven years. PAH can also be identified by observing factors connected to the lifestyle of a person. This creates a problem for healthcare practitioners diagnosing the disease as most of the symptoms overlap with other common medical conditions. This suggests that many patients who could have benefited from medication will not be diagnosed.

Opportunity and Unmet Need

The PAH market has relatively high unmet needs due to the limited efficacy and safety profiles of the current products, so there is considerable scope for new entrants to capture market share. There is a huge potential for products based on new technologies with reduced or no side-effects. Drugs entering the market should be developed with a better understanding the vasoconstriction of the blood vessels and should introduce effective therapies for vasodilation of blood vessels in order to maximize their growth potential. No particular treatment measure is used to assess the severity, progression and response for the medications given to PAH patients. Clinically, there is no single or composite measure utilized to measure the disease. However, some of the key measures include: a six-minute walk test/distance (6MWT/D); dyspnoea scores on the Borg or Mahler scales; Pulmonary Artery Pressure (PAP), Right Atrial Pressure (RAP); Pulmonary Capillary Wedge Pressure (PCWP); Pulmonary Vascular Resistance (PVR); and cardiac output/cardiac index. Although there are PAH therapies introduced by major companies such as Actelion Pharmaceuticals, Eli Lilly & Company, Pfizer AG, and GlaxoSmithKline in the PAH market, unmet need is projected to remain high. These current products also have significant side effect concerns such as liver damage, lung diseases, and heart failures. However, many patients are left with no choice than to use current products which provide some degree of disease alleviation. Therefore, developing new molecular targeted agents should produce future blockbusters with the potential to capture major market shares.

Drug information: Project

Tracleer is used to treat WHO Functional Class II, III, and IV pulmonary arterial hypertension (PAH). However, it is not a cure.

Tracleer is the only oral PAH treatment with over 8 years of proven experience worldwide. It has been thoroughly studied and prescribed for more than 75,000 patients.

Bosentan is the first of a new drug class, an endothelin receptor antagonist.

Tracleer (bosentan) belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2']-bipyrimidin-4-yl]- benzenesulfonamide monohydrate.

Bosentan has a molecular weight of 569.64 and a molecular formula of C27 H29 N5 O6 S?H2 O. Bosentan is a white to yellowish powder. It is poorly soluble in water (1.0 mg/100 mL) and in aqueous solutions at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive.

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Tracleer may improve patients exercise ability and may slow the worsening of your PAH. Tracleer also may lower high blood pressure in the lungs and help the heart pump blood more efficiently. It's been shown to work as early as four weeks in some patients. Other patients may need as long as several months to realize the benefits of Tracleer.4 Remember, individual results may vary.

Tracleer is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, pregelatinized starch, sodium starch glycolate, povidone, glyceryl behenate, magnesium stearate, hydroxypropylmethylcellulose, triacetin, talc, titanium dioxide, iron oxide yellow, iron oxide red, and ethylcellulose. Each Tracleer 62.5 mg tablet contains 64.541 mg of bosentan, equivalent to 62.5 mg of anhydrous bosentan. Each Tracleer 125 mg tablet contains 129.082 mg of bosentan, equivalent to 125 mg of anhydrous bosentan.

How Tracleer works

Tracleer is a medicine called an endothelin receptor antagonist (ERA). An ERA is a medication that helps PAH patients by blocking the effects of the extra endothelin their bodies produce. Endothelin is a naturally occurring chemical in your body and is involved in blood flow. However, patients with PAH have levels of endothelin that are higher than normal.4,5 Researchers believe that too much endothelin can cause blood vessels to tighten. These changes can make it more difficult for blood to flow easily through the blood vessels, and this can affect how well the heart works. Tracleer was the first oral endothelin receptor antagonist approved for PAH. Tracleer is currently approved for PAH (WHO Group I) WHO Class II, III, IV. If you have any questions, speak to your healthcare team.

Price Information

Tracleer is available in 65mg as well as in 125mg in stores. One pill cost around $76.60 CAD (Canadian Dollar). Normally, it is available in container which contains 56 tablets. By studying these prices, the generic drug (bosentan) would most probably available in market at 10% of the Tracleer drug price i.e around $7-10 CAD per pill.


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