IHS Global Insight Perspective | |
Significance | Bayer HealthCare's Bayer Vital unit is to market an OTC version of gastric drug omeprazole in Germany, under licence from AstraZeneca. The company has also showcased strong results from its Alzheimer's diagnostic tracer florbetaben. |
Implications | The OTC switch will mean an end to reimbursement for all forms of omeprazole in Germany, which will boost public savings on a widely consumed medicine. Florbetaben, meanwhile, is now set to move on to Phase III trials by the end of 2009. |
Outlook | Prescription-to-OTC switches will grow in number as Germany looks to maximise its public healthcare savings, particularly on very commonly prescribed, genericised drugs. Meanwhile, if florbetaben's success continues into Phase III, the stage at which Alzheimer's disease can be detected looks set to become much earlier, allowing for different treatments to be prescribed at the onset of the condition. |
Bayer HealthCare to Market OTC Omeprazole
Leading German drug maker Bayer HealthCare has signed an exclusive licensing deal with Anglo-Swedish counterpart AstraZeneca to market gastric drug omeprazole as an over-the-counter (OTC) treatment. The Bayer Vital marketing subsidiary is to begin selling the drug in Germany from 1 August, under the brand name Antra, and may also subsequently extend its licence to other countries.
Germany's Federal Council has only recently approved omeprazole's switch in status from prescription-only to OTC, to be sold at a daily dose of 20 mg. This follows a recommendation by drug regulator BfArM earlier this year (see Germany: 16 April 2009: BfArM Calls for Three Migraine and Gastrointestinal Drugs to be Sold OTC in Germany). The OTC drug is indicated for heartburn and acid reflux, and boasts an efficacy of 24 hours. In addition to the regular form of Antra, Bayer Vital will also be marketing a MUPS soluble tablet form of the drug under licence from AstraZeneca.
Bayer HealthCare's portfolio of consumer health products includes a number of household names within the gastrointestinal segment, including Rennie, Talcid and Lefax. Antra will be a major addition to the company's OTC product range, being the main competitor to both AstraZeneca's original brand-name Losec and generic omeprazole produced by German drug maker Schwarz Pharma. Omeprazole has been approved in Germany since 1989.
Florbetaben Helps Early Diagnosis of Alzheimer's Disease
In separate news, the company's leading unit Bayer Schering has unveiled promising Phase II results on experimental contrast agent florbetaben at the International Conference on Alzheimer's Disease (AD) in the Austrian capital, Vienna. The trial saw healthy volunteers and patients with suspected AD each administered florbetaben—a novel positron emission tomography (PET) tracer also known under the developmental name BAY 94-9172—before a diagnosis attempt. According to Bayer Schering, over 90% of healthy volunteers had no demonstrable uptake of the PET tracer in the relevant brain regions during their scans, while 80% of the suspected Alzheimer's patients scanned positively for florbetaben, which suggests the presence of beta-amyloid plaques that are strongly linked to the disease.
Three separate healthcare professionals examined the scans independently of one another during the trial, and Bayer Schering says that "a high inter-reader agreement rate" between the three was noted, suggesting the results of the scans are easy to interpret and reproduce. The pressure to improve diagnosis methods for Alzheimer's disease is considerable, as cognitive tests often have only limited success. A truly conclusive diagnosis can only be made post-mortem. Bayer Schering now says it intends to begin Phase III trials on florbetaben by the end of this year.
Outlook and Implications
The impending German market launch of OTC Antra will have a profound effect on market dynamics for the drug. OTCs are not reimbursed in Germany, and when a product is switched from prescription-only to OTC status, the prescription versions also lose their eligibility for reimbursement. Therefore, both AstraZeneca and Schwarz Pharma are likely to suffer losses as a result. As the Health Ministry looks for ways to reduce public expenditure on medicines, prescription-to-OTC switches such as that for omeprazole are set to become more common in Germany. Outside the country, other European Union member states will now be more likely to follow suit and approve the OTC sale of omeprazole as well, expanding the effect.
Florbetaben's success in Phase II trials is highly encouraging for Bayer Schering Pharma. If the drug performs as well during late-stage clinical trials, the company could be on the verge of an important breakthrough in AD detection and treatment. This could also indirectly have a positive impact on other producers of Alzheimer's drugs. If florbetaben enables physicians to diagnose AD more accurately and at a much earlier stage of the disease than is currently the norm, it would have a knock-on effect on the use of drugs approved to treat early-stage AD, increasing sales and potentially slowing down disease progression among patients diagnosed early enough. According to Bayer Schering, over 26 million people were living with AD in 2006; a figure that could top 100 million people by 2050.