-CTA Acceptance in the Netherlands Triggers Milestone Payment to Eisai-
CAMBRIDGE, Mass., Jan. 30 /PRNewswire/ -- Radius Health ("Radius") announced today that the Dutch regulatory authority has accepted its Clinical Trial Application (CTA) for RAD1901, Radius' novel tissue-selective SERM (selective estrogen receptor modulator) designed to relieve vasomotor symptoms (hot flashes). Radius plans to begin a Phase I clinical trial of RAD1901 in healthy postmenopausal women in the Netherlands in March 2008. The study will evaluate the safety, tolerability, and pharmacokinetics of escalating doses of RAD1901.
Radius licensed worldwide rights (excluding Japan) to RAD1901 and its analogs from Eisai in June 2006. The acceptance of the CTA triggered an undisclosed milestone payment by Radius to Eisai Co., Ltd.
"We are pleased that the Netherlands regulatory authorities have accepted the CTA for RAD1901 and look forward to advancing into Phase I studies," said Louis O'Dea, MD, Chief Medical Officer of Radius. "Our preclinical data demonstrated RAD1901's potential to relieve hot flashes while preventing postmenopausal bone loss, without estrogenic effects on breast and uterus. If those findings are borne out in our clinical studies, we will have an important new medical option to offer women entering menopause."
"Acceptance of this CTA to initiate clinical development of RAD1901 is an important milestone for Radius," said C. Richard Lyttle, PhD, President and CEO of Radius. "This is particularly exciting because RAD1901 has the potential to be the first in a new class of SERMs that could simultaneously address critical unmet needs of postmenopausal women-a treatment option that would alleviate hot flashes without the administration of an estrogen, while improving bone integrity and preventing or treating breast cancer."
"We are pleased with the progress of our partner, Radius, in achieving acceptance of the CTA filing," said Hideki Hayashi, Senior Vice President, Corporate Business Development, Eisai Co., Ltd. "There is a large underserved market for effective vasomotor symptom relief with a favorable side-effect profile. RAD1901's rapid progress is testimony to Radius' domain expertise in endocrinology and nuclear hormone receptors, and we are confident that this promising therapeutic agent for postmenopausal women will move forward into full clinical development."
RAD1901 is a novel selective estrogen receptor modulator (SERM) discovered by Eisai Co., Ltd. and licensed by Radius (excluding Japan) in 2006. SERMs are small molecules that bind to and selectively modulate estrogen receptors. These molecules have the ability to stimulate or block estrogen's activity in different types of tissue, functioning as estrogen receptor agonists in some tissues and as estrogen receptor antagonists in others. In preclinical studies, Radius has demonstrated RAD1901's potential to reduce vasomotor symptoms, along with a simultaneous bone-protective effect, without stimulating breast or uterine tissues. RAD1901 is distinctive from other SERMs in its unique biological profile, combined with its significant ability to penetrate the blood-brain barrier, which enables RAD1901 to function as an estrogen agonist within the central nervous system and thereby relieve hot flashes.
About Vasomotor Symptoms (Hot Flashes)
Hot flashes are a common symptom during menopause, with more than 75% of women experiencing them during the menopause transition, for a median duration of four years. These symptoms can disrupt sleep and interfere with quality of life. An estimated two million women undergo menopause every year in the U.S., with a total population of 50 million postmenopausal women. In addition, most women receiving systemic therapy for breast cancer suffer hot flashes, often with more severe or prolonged symptoms. Treatment with estrogen or hormone replacement therapy (ERT or HRT) is the standard of care for many women suffering hot flashes, but due to concerns about potential long-term risks and contraindications, there is a significant need for new therapeutic options.
About Radius (http://www.radiuspharm.com)
Radius is a leading company in the discovery and development of a new generation of drug therapies for osteoporosis and women's health. Radius has raised $91.5 million in private equity financing since its establishment in 2003 and is based in Cambridge, Massachusetts.
About Eisai (www. eisai.co.jp)
Eisai Co., Ltd. is a research-based human health care company that
discovers, develops and markets products throughout the world. Eisai
focuses its efforts in three therapeutic areas: integrative neuroscience,
including neurology and psychiatric medicines; gastrointestinal disorders;
and integrative oncology, including oncotherapy and supportive-care
treatments. Through a global network of research facilities, manufacturing
sites and marketing affiliates, Eisai actively participates in all aspects
of the worldwide healthcare system.
(C) 2008 Radius Health Inc.
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