Bayer HealthCare Pharmaceuticals Marketing of Viadur(R) to Phase Out by April 2008
Published: Dec 20, 2007
WAYNE, N.J., Dec. 20 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that after careful consideration, the company will discontinue marketing of Viadur(R) (leuprolide acetate implant) with Duros technology. Based on diminished market demand and growing manufacturing costs, Bayer HealthCare Pharmaceuticals has concluded that Viadur has limited long-term market viability. The decision to discontinue marketing of Viadur is not the result of safety or efficacy issues.
Viadur is indicated to manage the symptoms associated with advanced prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Bayer will fulfill orders until current supplies are depleted, expected by the end of April 2008. Alternative therapies are available for the palliative care of prostate cancer patients. Patients should discuss these options with their healthcare providers.
Bayer is committed to continuing patient and physician support services for current and new Viadur patients. Physicians should continue to use the current customer service hotline (800-288-8370) for orders and shipping questions. Information will also remain available at www.viadur.com.
In addition, Bayer HealthCare Pharmaceuticals has arranged for patients currently enrolled in the Viadur Continuous Care patient support program to receive an invitation to join the Us TOO International Patient Education and Support Network. Us TOO International is a grassroots, non-profit prostate cancer education and support network of 325 chapter support groups worldwide, providing men and their families with free information, materials and peer-to- peer support so they can make informed choices on detection, treatment options and coping with ongoing survivorship. More information on Us TOO can be found at www.ustoo.org.
Viadur (leuprolide acetate) is the first and only titanium implant drug- delivery system using Duros technology to manage the symptoms associated with advanced (stage 4) prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Viadur delivers leuprolide acetate to control the symptoms of prostate cancer with an innovative delivery system. Viadur reduces the amount of testosterone produced and circulated in the body in a continuous and steady therapy for a full 12 months.
Important safety considerations
Viadur is contraindicated in patients with hypersensitivity to Gn-RH, Gn- RH agonist analogs, or any of the components in Viadur. Viadur is contraindicated in women and pediatric patients and was not studied in women or children. Viadur, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience a worsening of symptoms or onset of new symptoms including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction, and spinal cord compression. The most common systemic side effects were hot flashes (67.9%), asthenia (7.6%), gynecomastia (6.9%), depression (5.3%), and sweating (5.3%). The most common local side effects were bruising (34.6%) and burning (5.6%).
About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
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 annual and interim reports filed with the Frankfurt Stock Exchange. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
CONTACT: Kimberly Wix of Bayer HealthCare Pharmaceuticals Inc.,
Web site: http://www.berlex.com/