LONDON, July 15, 2004- After years of delays in a deal that would have enabled the British firm to launch its own version of the blockbuster acid-relieving drug Nexium last year, the world’s top pharmaceutical company has finally got on board for its latest venture. The UK-based group has launched an exclusive new drug for the heartburn drug Nexium, which it says will bring cost savings of up to 85 per cent over its current cost of around £4 billion.
The British company, which has been on the verge of a blockbuster launch since 1999, said its strategy for the new Nexium drug is to “remain on track” and “remain focused on getting the product in the hands of patients”. The drug, which was first launched in the UK in 2001, was developed by the drug giant AstraZeneca, which said it was the “first ever non-steroidal anti-inflammatory drug to hit the market”. The company’s initial market launch in the UK in 2003, however, was delayed by a year and a half because of a patent expiry.
The drug, known generically as omeprazole, has been nicknamed “Nexium” and “the most expensive drug ever” in the world. It was originally developed by AstraZeneca and sold by a private company in 2001, but AstraZeneca had yet to launch its new drug. AstraZeneca had earlier been selling Nexium for about £3 billion a year. Since the patent expiration in 2004, the company has started selling its own version.
In its latest decision, AstraZeneca said its Nexium drug has a high success rate and an “obvious” way to save money and to reduce the cost to patients, who are often more sensitive to the acid-reducing effect of Nexium than the branded drug.
“Nexium, which is known as omeprazole, is an effective treatment for gastroesophageal reflux disease (GERD), a condition that can cause heartburn, acid regurgitation, and a loss of appetite. It is available in tablet form and the usual dosage is one 50mg capsule in 24 hours, or one 250mg tablet in five days,” AstraZeneca said.
The Nexium drug, which is currently the world’s third-most expensive drug in the UK, is priced at around £4 billion, with a possible 10 per cent per year difference, according to a report in the BMJ-based journalThe Lancet.
This isn’t the first delay in the launch of a new drug for acid-reflux, the company said in a statement.
Last year, AstraZeneca agreed to pay £3.2 billion to resolve lawsuits brought by people who had claimed that their heartburn was caused by the medication.
AstraZeneca’s Nexium was first launched in 2001 and had a “large share of the global market”. It is still on the global market, but it is now the second-best-selling drug, with global sales of £4 billion in the US.
Last year, the US and European governments had approved the new drug as a treatment for chronic acid reflux, with the US having the largest market share, according to the Lancet.
The British firm said it was “further into the stage of its second Phase III trial” of Nexium. The US market size was estimated at £5 billion in 2004, and the UK was the largest in the US.
The global Nexium drug market has been growing over the past several years. In 2002, the global Nexium sales reached £8.3 billion. In 2005, the sales of Nexium totaled £6.7 billion. By 2008, the number of US patients taking Nexium totaled more than 9 billion.
However, it has not been clear whether the increase in the number of patients taking Nexium is the result of a wider market for the drug and whether there are other factors at play.
Nexium is one of the most popular drugs in the US, and the US market is projected to grow at a compound annual growth rate (CAGR) of 4.5 per cent from 2007 to 2012. The global market for the drug, however, is projected to grow at a CAGR of 6 per cent from 2012 to 2013.
In the United Kingdom, Nexium sales reached nearly £1 billion in 2004, while sales in the US reached more than £10.5 billion in 2006.
Salt Composition
Nexium 24HR Heartburn Relief Capsules 10mg
The recommended dose of esomeprazole magnesium 20mg is esomeprazole 20mg per capsule. Take this dose at least 1 hour before or 2 hours after a meal. Drink the2nd to third of a normal amount of alcohol for better effect.
If you have been advised by your doctor to take a proton pump inhibitor or to take other antiparkyric and antacid medications, speak to your doctor or your pharmacist about alternative proton pump inhibitors or alternative medications.
The recommended dose of proton pump inhibitors (e.g., omeprazole, esomeprazole) is esomeprazole 20mg per capsule. Take this dose no sooner than 4 hours after eating, unless your doctor has told you to. It is not recommended to take a proton pump inhibitor for more than 4 hours before or after eating food. Avoid eating high-fat foods or consuming excessive amounts of alcohol while taking proton pump inhibitors.
If you are taking proton pump inhibitors for heartburn or indigestion, your doctor may change the dose to proton pump inhibitors that are taken prior to or after eating or without food. Do not take a dose higher than the dose prescribed by your doctor.
The recommended dose of proton pump inhibitors (e.g., esomeprazole magnesium) is esomeprazole 20mg per capsule. Take this dose no later than 4 hours after eating, unless your doctor has told you to. It is not recommended to take a dose higher than the dose prescribed by your doctor.
If you have been prescribed an antacid medication for acid reflux, the antacids contained within this medication may increase the risk of heartburn. Stop using this product and call your doctor for medical advice about timing of antacids within this medication.
The dosage of Nexium 24HR Heartburn Relief Capsules 10mg Tablets is as follows:
Take this medication by mouth, with or without food, for 14 days. After this, the capsules are empty. If you forget a dose, take it as soon as you remember - unless it is almost time for your next dose. In the event that the next dose is due in 2 hours, take the dose that was promised in the previous 7 days.
Take this medication in the dose and time interval listed above each day for the rest of your life. However, if you have any doubts, please consult your doctor or pharmacist.
This medication is a proton pump inhibitor (PPI). When esomeprazole magnesium 20mg is taken prior to or after eating, the amount of proton pump inhibition produced per day will not be 100% complete. It may need to be thrown away or greatly reduced. Still, it is important that you take this medication for the rest of your life. Make sure you have used the product correctly.
This product contains the generic 20mg esomeprazole magnesium.
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Available as CapsulesThis medication is available in 2 doses: Esomeprazole 40mg and Nexium 24HR 40mg.
Take this medication by mouth with or without food, with or without food, for 14 days. The capsules may be thrown away or thrown in water immediately. If you have forgotten a dose of this medication, take it as soon as you remember. However, if you have doubts, please consult your doctor or pharmacist.
Alternate Name:Pharmapure RX Esomep-EZS
Description:Nexium treats gastroesophageal reflux disease (GERD), esophagitis, and stomach ulcers. The generic version of Nexium is esomeprazole magnesium. For a supply of 30 oral tablets of Nexium Delayed-Release Capsules 40 mg is approximately $287. Take advantage of our LowerMyRx discount to receive a typical Nexium discount of up to 80% off of the retail price at participating pharmacies near you.
Dosage Form:Capsule Delayed Release
Administration Route:By mouth
Drug Class:Gastric Acid Secretion Inhibitor, Gastrointestinal Agent
Generic Available:Yes
Strength:20 MG
Warnings:Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lupus, vitamin B12 deficiency, or osteoporosis. This medicine may cause the following problems: Kidney problems, including acute tubulointerstitial nephritisIncreased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS)LupusFundic gland polyps (abnormal growth in the upper part of your stomach) This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine. Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Keep all medicine out of the reach of children. Never share your medicine with anyone. Stomach pain, nausea, vomiting, weight loss, bloody or black stools
Food Warnings:Do not use esomeprazole if you are also using medicines that contain rilpivirine., Some medicines can affect how esomeprazole works. Tell your doctor if you are using any of the following: Atazanavir, cilostazol, diazepam, digoxin, erlotinib, ketoconazole, methotrexate, mycophenolate mofetil, nelfinavir, rifampin, saquinavir, St John's wort, tacrolimus, voriconazoleBlood thinner (including clopidogrel or warfarin)Diuretic (water pill)Iron supplements, This medicine can cause diarrhea. Diarrhea can occur 2 months or more after you stop taking this medicine., Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results., Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments., Keep all medicine out of the reach of children.
ContactsAlcoholereo.com - Nexium Delayed-Release CapsulesNexium Delayed-Release Capsules (esomeprazole) are used to treat gastroesophageal reflux disease (GERD) and other stomach problems caused by excessive stomach acid. Nexium Delayed-Release Capsules are used in conjunction with a properly administered anti-inflammatory medicine (warfarin or aspirin) to reduce the risk of bleeding.
Nexium Delayed-Release Capsules (esomeprazole) can cause serious side effects, including stomach pain, diarrhea, liver damage, hearing loss, and moderately high cholesterol (hypercholesterolemia). These problems can be life-threatening if not treated quickly. You should use Nexium Delayed-Release Capsules only when clearly needed.
Nexium 24HR Once Daily Dosing Tablets provide lasting relief from frequent heartburn and acid reflux.
Nexium 24HR 20mg esomeprazole tablets are for the lasting symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux
Carefully read the enclosed Consumer Medicine Information before use.
AUST R NUMBER:231439
Lactose
INGREDIENTS:Each tablet contains: Esomeprazole 20mg (as Magnesium Trihydrate).
Do not use:- for children under 18 years of age.- if allergic to esomeprazole.- if allergic to any other proton pump inhibitor (omeprazole, rabeprazole, lansoprazole, pantoprazole).- if you are taking antiretroviral medicines, such as atazanavir.- if you are taking cilostazol a medicine used to treat pain and/or cramping in the lower leg (or arms) due to inadequate blood flow to the muscles.- if you are breastfeeding or intend to breastfeed.- -f you are experiencing weight loss, persistent regurgitation of food or vomiting, difficulty swallowing or symptoms of gastro-intestinal bleeding, except on medical advice- if you are pregnant or intend to become pregnant except on the advice of a doctor or pharmacist- if the expiry date printed on the pack has passed. Ask your pharmacist or doctor before use if you:- have or ever have had serious liver disease.- are taking digoxin (a medicine used to treat heart problems).- are taking ketoconazole (a medicine used to treat fungal infections)- are taking clopidogrel or warfarin (medicines used to stop the blood clotting)- are taking other medicines regularlyThis preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Do not use for any purpose other than what is specified on the pack, except on doctor's advice. Keep to recommended dose. If an overdose is taken or suspected telephone your doctor or the Poisons Information Centre (Australia 13 11 26, or New Zealand 0800 764 766) or go to the Accident and Emergency department at your nearest hospital. Tell your pharmacist or doctor if you do not feel well, if new or additional symptoms occur while you are taking Nexium 24HR Once Daily Dosing.
ONLINE MANDATORY STATEMENT:Always read the label and follow the directions for use.
Puerto Rico, US
HimacharyCompanyHUMCARE>US Product Code:C08-082814131750May be used in individual orders.
USNexium 24HR Once Daily Dosing Tablets provide lasting symptomatic relief for frequent heartburn and acid regurgitation.
Active Tablets: Esomeprazole 20mg (as Magnesium Trihydrate).Packaging Size:7 x 20 tabletsPrescription RequiredTo the personPackaging Type:
Tablets
Size: 7 x 20 Tablets