News
Proton Pump Inhibitor omeprazole available soon without prescription:
New therapeutic option for heartburn
- OTC-status in Germany effective as of August 1st, 2009
- Bayer Vital will launch omeprazole under the Antra® brand without prescription
- Bayer will market OTC omeprazole based on an exclusive licensing agreement with AstraZeneca
Leverkusen, July 10, 2009 – Bayer Vital, Bayer HealthCare’s German marketing organization, will launch the OTC Proton Pump Inhibitor (PPI) omeprazole in Germany under the Antra® brand beginning in August. This follows the German Federal Council’s approval of the draft regulation for the Rx to OTC switch of omeprazole, which will become effective on August 1st. Bayer Vital received an OTC license for omeprazole from AstraZeneca for the marketing of OTC omeprazole.
The licensing agreement with AstraZeneca also includes options for Bayer to market OTC omeprazole in other countries following the first launch in Germany. Bayer Vital submitted an application for the release of omeprazole from prescription-only status at a maximum daily dose of 20 milligrams, with a maximum pack size of 14 tablets (280 milligrams).
With Antra®, patients will have a new option for self-medication of heartburn and acid regurgitation with one tablet, which is effective for up to 24 hours and allows for sustained symptom relief.
Bayer Vital owns the exclusive OTC marketing rights for the German market for the Antra® 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 Antra® to a new consumer segment and expands Bayer’s gastrointestinals portfolio that currently includes medicinal products such as Rennie®, Talcid® and Lefax®.
AstraZeneca will continue to sell omeprazole as a prescription medication. All rights within this segment as well as the trademark Antra® 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. Antra® (active ingredient: omeprazole) was first approved as a prescription medicine in Germany in 1989. 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. Find more information at www.bayerhealthcare.com.
About Bayer Vital
Bayer Vital GmbH is the German marketing subsidiary of Bayer HealthCare AG, which comprises the Animal Health, Consumer Care, Diabetes Care and Bayer Schering Pharma Divisions. Bayer Vital’s work focuses on conducting research into innovative products in collaboration with its partners in the health care system in Germany, and providing these products to physicians, pharmacists and patients. The products are used in the diagnosis, prevention and treatment of acute and chronic diseases in both human and veterinary medicine. Bayer Vital thus aims to make a sustained contribution towards improving the health of people and animals. More information about Bayer Vital is available on the Internet: www.bayervital.de (in German only)
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® (marketed as Antra® MUPS® in Germany and as Antra® in Italy and Switzerland) is generally well tolerated and has been used in the management of acid-related gastrointestinal disease in approximately 1 billion patient treatments. 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 Germany only as a prescription product, Antra® has now been approved for OTC use in Germany for the treatment of heartburn and acid regurgitation, which will become effective on August 1st.
Your contact at Bayer Vital:
Jutta Schulze, Tel. 0214/30-57284, Fax: 0214/30-57283
E-Mail: jutta.schulze@bayerhealthcare.com
Your contact at Bayer HealthCare, Consumer Care
Daniela Esser, Tel. +41 58 272-7612, Fax: +41 58 272 7202
E-Mail: daniela.esser.de@bayer.ch
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. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
