LEVITRAź (vardenafil HCl) APPROVED BY U.S. FDA:
FIRST NEW CHOICE IN FIVE YEARS TO TREAT ERECTILE DYSFUNCTION
West Haven, Conn., and Philadelphia, Pa., August 19, 2003 - LEVITRAź(vardenafil HCl) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).1 Co-developed and co-promoted by Bayer AG [DAX and NYSE: BAY] and GlaxoSmithKline plc [LSE and NYSE: GSK], Levitra (pronounced Luh-VEE-trah) provides men with their first new ED treatment choice in five years. Levitra is expected to be available in pharmacies nationwide within the next few weeks.
"In clinical trials, Levitra was shown to work quickly. More importantly, Levitra was shown to improve the sexual response for the majority of men the first time they took it, and it worked consistently over time," said Myron Murdock, M.D., Levitra investigator and nationally recognized expert in the field of male sexual dysfunction.
"Given my positive experience in a clinical trial for Levitra, I am pleased it is now available," said Akhtar Qureshi, a happily married man for many years. "Over the past few years, I`ve noticed a change in my erectile function - the quality of the erection wasn`t the same. In the clinical trial, Levitra worked consistently for me. I was able to count on my sexual response so I could perform the way that I knew I could."
In Clinical Studies, Levitra Improved Quality of Erections and Demonstrated Rapid and Reliable Response Bayer and GSK evaluated Levitra in an extensive clinical trial program that included more than 50 trials involving more than 5,700 men. Results from phase III clinical studies showed that Levitra:
Helped men get and keep an erection sufficient for satisfactory sexual performance
Provided first-time success and reliable improvement of erection quality for many men,2,3
Worked in men of various ages and race and in those with co-existing medical conditions, such as diabetes, and in men who have had their prostate removed
Demonstrated a rapid response, allowing a man to initiate or respond to sexual stimulation when the time is right.
Can be taken without regard to meals making it convenient for use
"Today`s approval of Levitra means there is now an important alternative in the treatment of erectile dysfunction," said Colin J. Foster, president, Bayer Pharmaceuticals Corporation. "We aim to reach out to the 30 million men in the U.S. with erectile dysfunction."
"We`re delighted with the approval of this promising new therapy," said Chris Viehbacher, president, U.S. Pharmaceuticals, GlaxoSmithKline. "Together with Bayer, we are committed to educating men and their doctors about Levitra and the important role it can play in improving their sexual health."
Levitra is a medicine that may be used up to once a day to treat erectile dysfunction (ED). Levitra is for use by prescription only. Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take Levitra. Men who use alpha blockers, sometimes prescribed for high blood pressure or prostate symptoms, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. The most commonly reported side effects are headache, flushing, and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention.
For more information about Levitra, please visit www.Levitra.com
ED and Levitra
Erectile dysfunction (ED) - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance5 - is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 406 - 152 million men worldwide7 and 30 million men in the United States alone.8 Despite the high prevalence of sexual problems, nine out of 10 men in the U.S. have not yet sought treatment from a physician.
Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for Levitra in November 2001. To date, Levitra has received regulatory approval for the treatment of ED in more than 50 countries. It was launched in major European markets beginning on March 7, 2003.
As previously disclosed, Pfizer has filed suit in the United States alleging that one of its patents would be infringed by the sale of Levitra. The case is in its early stages.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world`s leading innovators in the healthcare and medical products industry.
Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.
Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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.
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group`s operations are discussed under risk factors in the Company`s Preliminary Announcement of Results for the Year Ended 31st December 2002.
1. Package insert.
2. Valiquette L, Hellstrom W, Gittelman M, et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 24, 2002, Montreal, Quebec, Canada.
3. Saenz de Tejada I, Glina S, Becher E, Ulbrich E, Vardenafil Study Group. Vardenafil exhibits long-term efficacy and safety for up to 52 weeks. Presented at the V Congress of the European Society for Sexual and Impotence Research (ESSIR), December 3, 2002, in Hamburg, Germany.
4. Padma-Nathan H, Kaufman J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. Presented at a satellite symposium at the 2003 Annual Meeting of the American Urological Association, April 25, 2003, Chicago.
5. Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-sponsored by the World Health Organization (WHO), International Consultation on Urological Diseases (ICUD) and Societe Internationale d`Urologie (SIU) and held July 1-3, 1999, Paris. 2000, p. 713.
6. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61.
7. Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999;84:50-56.
8. National Institutes of Health, Consensus Development Conference Statement, December 7-9, 1992. Online data: http://odp.od.nih.gov/consensus/cons/091/091_statement.htm. (accessed 8/26/02).
9. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544.
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