Vantas (Histrelin) castration implant
Posted: Sat Jun 03, 2006 11:24 pm
There is now an implant that achieves castration for over one year in men:
http://pharmalicensing.com/licensing/displicopp/1951
Vantas is approved and marketed in the US, and has preregistration development status in Denmark.
Vantas is an implant utilizing Hydron Technology to deliver histrelin over a 12-month period for the palliative treatment of advanced prostate cancer. The total number of patients with advanced prostate cancer in the U.S. was 666,300 in 2004. We estimate the patient population to be similar in Europe, and we plan to file an application for regulatory approval in the European Union in the first half of 2005.
The current standard of care for the palliative treatment of prostate cancer is LHRH agonist therapy. An agonist is a chemical substance capable of activating a receptor to induce a full or partial pharmacological response. LHRH agonist therapies for advanced prostate cancer are designed to suppress the production of testosterone because testosterone promotes and accelerates the growth of tumors associated with prostate cancer. Histrelin, a powerful inhibitor of testosterone production, is the most potent LHRH agonist available.
Total U.S. sales of LHRH agonist products for the palliative treatment of prostate cancer were approximately $973 million in 2004 based on IMS Health market data. The most common dosage forms for the administration of LHRH agonists involve three- and four-month injection formulations such as Lupron and Eligard, which deliver leuprolide, and Zoladex, a biodegradable rod, which delivers goserelin. Another product is Viadur, a rigid metal implant that releases leuprolide over a 12-month period.
We believe that Vantas is a more comfortable and convenient alternative to competing products because it eliminates the requirement of multiple physician visits and repeated injections and is smaller, softer and more flexible than other implants. Some patients, however, may prefer injections over implants. In addition, in our Phase III clinical trial for Vantas, 100% of the evaluable patients achieved chemical castration at week four and testosterone suppression was maintained throughout the 52-week study period for 99% of the patients. Based on these data, we believe Vantas is a highly effective product for the palliative treatment of advanced prostate cancer. During the Phase III clinical trial, side effects included hot flashes, fatigue and implant site reactions, such as swelling and redness.
Prostate cancer is the most common cancer for men and the second leading cause of cancer death in men. According to the American Cancer Society, every year approximately 200,000 men are diagnosed with prostate cancer and 30,000 die from this disease. The National Cancer Institute's SEER Program and the National Oncology Database each project that this patient group will grow at an annual rate of 2% to 3% per year through 2008 and beyond.
We are currently selling and marketing Vantas through our sales force to the urologists that account for the majority of LHRH agonist product sales in the U.S. Our product specialists utilize various promotional materials when making clinical presentations, including instructional videos on proper implantation technique. In remote areas where our product specialists cannot make personal visits, we conduct direct mail programs and telemarketing campaigns to selected physicians. We may also supply physicians, health plan administrators and specialty pharmacies with a pharmaco- economic model to demonstrate the cost effectiveness of Vantas compared to other LHRH agonist products due to decreased utilization of staff time for repeated injections and a single reimbursement claim per year as opposed to three or four. Additionally, we support our sales efforts by employing a wide range of marketing programs to promote Vantas, including journal advertising, industry publications, medical educational conferences and internet initiatives.
http://pharmalicensing.com/licensing/displicopp/1951
Vantas is approved and marketed in the US, and has preregistration development status in Denmark.
Vantas is an implant utilizing Hydron Technology to deliver histrelin over a 12-month period for the palliative treatment of advanced prostate cancer. The total number of patients with advanced prostate cancer in the U.S. was 666,300 in 2004. We estimate the patient population to be similar in Europe, and we plan to file an application for regulatory approval in the European Union in the first half of 2005.
The current standard of care for the palliative treatment of prostate cancer is LHRH agonist therapy. An agonist is a chemical substance capable of activating a receptor to induce a full or partial pharmacological response. LHRH agonist therapies for advanced prostate cancer are designed to suppress the production of testosterone because testosterone promotes and accelerates the growth of tumors associated with prostate cancer. Histrelin, a powerful inhibitor of testosterone production, is the most potent LHRH agonist available.
Total U.S. sales of LHRH agonist products for the palliative treatment of prostate cancer were approximately $973 million in 2004 based on IMS Health market data. The most common dosage forms for the administration of LHRH agonists involve three- and four-month injection formulations such as Lupron and Eligard, which deliver leuprolide, and Zoladex, a biodegradable rod, which delivers goserelin. Another product is Viadur, a rigid metal implant that releases leuprolide over a 12-month period.
We believe that Vantas is a more comfortable and convenient alternative to competing products because it eliminates the requirement of multiple physician visits and repeated injections and is smaller, softer and more flexible than other implants. Some patients, however, may prefer injections over implants. In addition, in our Phase III clinical trial for Vantas, 100% of the evaluable patients achieved chemical castration at week four and testosterone suppression was maintained throughout the 52-week study period for 99% of the patients. Based on these data, we believe Vantas is a highly effective product for the palliative treatment of advanced prostate cancer. During the Phase III clinical trial, side effects included hot flashes, fatigue and implant site reactions, such as swelling and redness.
Prostate cancer is the most common cancer for men and the second leading cause of cancer death in men. According to the American Cancer Society, every year approximately 200,000 men are diagnosed with prostate cancer and 30,000 die from this disease. The National Cancer Institute's SEER Program and the National Oncology Database each project that this patient group will grow at an annual rate of 2% to 3% per year through 2008 and beyond.
We are currently selling and marketing Vantas through our sales force to the urologists that account for the majority of LHRH agonist product sales in the U.S. Our product specialists utilize various promotional materials when making clinical presentations, including instructional videos on proper implantation technique. In remote areas where our product specialists cannot make personal visits, we conduct direct mail programs and telemarketing campaigns to selected physicians. We may also supply physicians, health plan administrators and specialty pharmacies with a pharmaco- economic model to demonstrate the cost effectiveness of Vantas compared to other LHRH agonist products due to decreased utilization of staff time for repeated injections and a single reimbursement claim per year as opposed to three or four. Additionally, we support our sales efforts by employing a wide range of marketing programs to promote Vantas, including journal advertising, industry publications, medical educational conferences and internet initiatives.