Orange pill ignites flames of passion in men

Media Release

10 September 2004

Orange pill ignites flames of passion in men

Competition in the men’s sexual health business is about to heat up with the start on Sunday (Sept 12) of a spring television advertising campaign promoting Levitra®, from the latest generation1,2 of treatment for men who find it difficult getting or keeping an erection.

Made by Bayer HealthCare, and jointly promoted with GlaxoSmithKline, clinical trials have shown that Levitra works quickly3, giving most men a reliable erection first time,3,4 time after time.4,5

Bayer New Zealand Medical Director Dr Jeff Hassall said Levitra, which is a bright orange tablet, was launched to the medical profession early last year.

“We wanted to spend time educating GPs, cardiologists, urologists and diabetologists about the benefits of Levitra before we started promoting the treatment to the estimated 300,000 New Zealand men who suffer erection problems.6

“With spring in the air, it’s now time to start telling New Zealand men and their partners about the benefits of Levitra, particularly the 50% of men over 40 who suffer some form of erectile dysfunction.”7

According to Bayer, clinical trials have shown that Levitra:

works to restore the natural strength of the man’s erection3 works as quickly as 15 minutes for some men and lasts for up to five hours with most men able to get an erection in 25 minutes3 also has a high success rate in traditionally difficult to treat patients, including men with diabetes3,8 and those who have had nerve sparing prostate surgery.3,9

Dr Hassall said to make it easier for men to evaluate the treatment themselves, Bayer is offering free Levitra Starter Packs through GPs. As a result doctors and medical professionals throughout New Zealand could expect more patient requests for Levitra once the television advertising starts.

Auckland GP Dr Warrick White said he was delighted Levitra was being promoted on television screens.

“Only a small proportion of New Zealand men over 40 have spoken to their GP about erectile problems. The promotion of the free Levitra Starter Packs should make it easier for men to raise the subject with their doctor and then try for themselves.

“All existing oral treatments in this class of medicine for erection problems are paid for by patients. For some the cost may stop them from being successfully treated as there is no way of knowing in advance which treatment will work for them. The free Levitra Starter Pack may encourage men to obtain it and deal with their erection problems with a very effective medicine.”

Bayer has such faith in Levitra that it is prepared to refund the cost of the first pack the man buys from the pharmacy if treatment with Levitra is unsuccessful. The refund is subject to some conditions.

The Levitra television advertisements use a romantic candle-lit scene to get the message across that Levitra can re-ignite your love-life. They advise men to visit their doctor and ask for a free Levitra Starter Pack.

Further information about Levitra is available at www.levitra.co.nz.

Ends

Notes: Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. It is estimated that some degree of ED affects more than one half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED. The number of men with ED is expected to more than double to 322 million by 2025. ,

Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated. Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human penile erectile tissue and is associated with erections. PDE-5 inhibitors typically work by blocking this enzyme to enhance or prolong the erectile response. Levitra was specifically selected for development as an ED therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme. Levitra (vardenafil) is an unfunded, Prescription Medicine, available in 5,10 and 20mg tablets.

For the treatment of Erectile Dysfunction. Consumers will need to pay for this medicine. A charge applies. Normal doctor's office visit fees apply. Recommended starting dose is 10 mg. Maximum of 20 mg in 24 hours. Levitra should be used strictly as directed. No more than one dose should be taken per day. Men can not take Levitra if they are taking medicines called nitrates or HIV protease inhibitors (HIV treatment).

They must tell their doctor if they have: a heart or blood condition, kidney or liver disease, a disease or deformity of the penis, blood or bone cancer, a peptic ulcer; they are taking any other medicines or herbal remedies, including those for erectile dysfunction. Side effects (common): Headache, flushing, heartburn, nausea, dizziness, stuffy/runny nose. Until they know how Levitra will affect them they need to be careful driving/operating machinery.

Men should speak to your doctor, pharmacist or health professional if they have any concerns, feel unwell or have any of these side effects. Prices may vary depending on the pharmacy. Further information on Levitra can be obtained from www.medsafe.govt.nz. Men should always ask their doctor if Levitra is right for them.

Levitra, researched and discovered by Bayer AG, is marketed by Bayer and GlaxoSmithKline plc (GSK) through a worldwide co-promotion and co-development agreement. Levitra was approved on 6 March 2003 by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The US Food and Drug Administration (FDA) approved Levitra for the treatment of ED on 19 August 2003. Levitra Refund

GSK/Bayer are offering a money back refund of the purchase price of one pack of Levitra to those patients for whom Levitra is not effective, on the terms and conditions set out below.

1. This refund is only available where your doctor is satisfied that: (a) Levitra is an appropriate medication for you; (b) you have complied with the guidelines for administration and treatment as outlined in the pack of Levitra; and (c) you have completed the course of four tablets contained in the pack of Levitra (unless you are unable or unwilling to do so due to an adverse event experienced as a result of taking Levitra). 2. This refund is only available if, having taken Levitra as prescribed and in accordance with the pack instructions, you: (a) were not able to attain and maintain an erection adequate to permit satisfactory sexual intercourse; or (b) experienced an adverse event as a result of taking Levitra, sufficiently severe to prevent the patient from having satisfactory sexual intercourse. 3. Except as provided in paragraph 2 above, this refund is not offered to you if Levitra works for you but you experience side effects as a result of Levitra. 4. This offer is open to New Zealand residents only and is limited to one refund per patient. 5. The refund is limited to the purchase price paid by you for one pack of Levitra and does not include consultation fees.

Each refund request must be accompanied by proof of purchase showing the purchase price paid by you. 6. To request your refund, ask your doctor to complete and return a Levitra Refund Faxback Form to the address specified on the form. 7. This offer is valid until December 2004. To be eligible requests for refunds must be received by GSK/Bayer together with proof of purchase before 5:00pm on 31 December 2004. 8. This refund is in addition to and not a substitute to any other rights you may have. 9. GSK/Bayer will not be liable for lost refund requests and proofs of purchase will not be returned.

GSK/Bayer will only retain and use personal information contained in Levitra Refund Faxback Forms for the purpose of administering the Levitra refund in accordance with these terms and conditions. Men can access or request correction of their personal information by phoning 0800 Levitra during working hours.

Bayer Healthcare in New Zealand Bayer HealthCare is an integral arm of Bayer AG, the international research-based group. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals divisions. Providing innovative diagnostics systems, modern prescription pharmaceuticals, world renowned over-the-counter drugs and animal health products, Bayer HealthCare is enhancing wellbeing and quality of life for all New Zealanders.

In New Zealand, Bayer aims to make a positive contribution to the community, not only by providing innovative health care solutions, but also through our educational partnerships.

For example, Bayer HealthCare supports ongoing clinical research and educational initiatives in the treatment of Haemophilia. On a broader scale, we believe social commitment also extends to the environment. We support initiatives to preserve and protect New Zealand’s native flora and fauna, such as the Whangarei Native Bird Recovery Centre, and have established a native plant sanctuary at our East Tamaki warehouse. For more information: www.bayer.co.nz.

About GSK GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

ENDS

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