New Therapeutic Option For Heartburn

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 07 Aug 2009 - 1:00 PDT

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Bayer Consumer Care New Zealand will launch the OTC Proton Pump Inhibitor (PPI) omeprazole in New Zealand under the Losec® brand in September. This follows the Medicine Classification Committee's recommended approval for the Rx to OTC switch of omeprazole 10 mg, which became effective by Gazette notice on 19 March 2009. Bayer New Zealand received an OTC license for omeprazole from AstraZeneca for the marketing of OTC omeprazole.

With Losec®, patients will have a new option for self-medication of heartburn and acid regurgitation with one daily dose, which is effective for up to 24 hours and allows for sustained symptom relief.

Bayer Consumer Care New Zealand owns the exclusive OTC marketing rights for the New Zealand market for the Losec® brand, as well as the patent-protected MUPS® tablet a formulation that can also be taken dispersed in water or fruit juice. The agreement with AstraZeneca allows Bayer to market Losec® to a new consumer segment and expands Bayer's gastrointestinals portfolio.

AstraZeneca will continue to sell omeprazole as a prescription medication. All rights within this segment as well as the trademark Losec® MUPS® and the patent for the formulation will remain with AstraZeneca.

Proton pump inhibitors (PPI) are the standard medical treatment and the most frequently prescribed medicines for acid-related gastrointestinal diseases and disorders. Losec® (active ingredient: omeprazole) was first approved as a prescription medicine in New Zealand in 1990. Omeprazole has been released from prescription-only status at a maximum daily dose of 20 milligrams, with a maximum pack size of 14 tablets of 10mg omeprazole (140 milligrams). Extensive clinical data have demonstrated its efficacy and safety.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.

About Losec® (omeprazole)

Losec® (omeprazole) is a Proton Pump Inhibitor (PPI) which has been shown to be beneficial in the treatment of patients with acid related gastrointestinal diseases such as gastroesophageal reflux disease (GERD). Losec® is generally well tolerated and has been used in the management of acid-related gastrointestinal disease in approximately 1 billion patient treatments worldwide. Losec® (omeprazole) was first launched in 1988. Losec® is sold under a variety of names in different countries, such as Losec®, Prilosec®, Antra®, Antra® MUPS® and Mopral®. Previously sold in New Zealand only as a prescription product, Losec® has now been approved for OTC use in New Zealand for the treatment of heartburn and acid regurgitation, which became effective on 19 March 2009.

Losec 10 mg tablets is a Pharmacist Only Medicine, for the symptomatic treatment of heartburn and acid regurgitation. Your pharmacist's advice is required. Each tablet contains omeprazole 10 mg. Medicines have benefits and some may have risks. Not recommended for pregnant and breast feeding women. Always read the label carefully and use strictly as directed. If symptoms persist or you have side effects, see your pharmacist or doctor.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

Source: Bayer HealthCare

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