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WALTHAM, Mass., June 1, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including metastatic breast cancer, today announced that it has engaged Myrtle Potter & Company, LLC. to support the development of the future global commercial strategy for its lead investigational drug abaloparatide-SC for the potential treatment of post-menopausal osteoporosis.
"We are pleased to have the benefit of Myrtle Potter & Company's track record and experience as we prepare to transition Radius from a development stage company to a fully integrated commercial entity. We believe this collaboration will accelerate our disease-awareness efforts to transform the understanding of osteoporosis, which, over the longer term, could help improve the treatment of patients with incident osteoporotic fractures," said Radius Health CEO, Robert E. Ward. "Myrtle and her team's commercial expertise will be a valuable addition to our already strong leadership as we advance our investigational new drug abaloparatide-SC towards regulatory submissions later this year in the U.S. and the EU and prepare for our first potential commercial launch."
In June 2015, Radius expects to report the topline 6 month results from the Phase 3 ACTIVExtend trial. These results from ACTIVExtend will be combined with the already completed Phase 3 ACTIVE trial to provide the 24 month data set to be submitted this year to the FDA as a portion of the new drug application ("NDA") for abaloparatide-SC. In December 2014, Radius reported that our Phase 3 (ACTIVE) study evaluating abaloparatide-SC met the primary endpoint (86% reduction in new vertebral fractures versus placebo) as well as key secondary endpoints (43% reduction in non-vertebral fractures versus placebo). Radius is on track for NDA submission to the FDA and MAA submission to EMA by year-end.
The National Osteoporosis Foundation (NOF) and the National Bone Health Alliance (NBHA) have highlighted the critical need to improve the screening, diagnosis and treatment for the estimated 2 million Americans who suffer osteoporotic fractures each year. Osteoporosis remains a major unmet medical need as NHBA reports a treatment gap that may impact as many as 80% of these cases.
"We have a long history of working with pharmaceutical and biotech companies to maximize the commercial value of their innovative products," said Myrtle Potter, CEO. "We are eager to work with Radius as they seek to launch the first new therapy in many years into the large and growing osteoporosis market, particularly as it may have the potential to benefit the large number of patients at risk of non-vertebral fractures for whom there remains a significant unmet medical need."
Founded in 2005 by Myrtle Potter, Myrtle Potter & Company specializes in devising novel strategies to maximize the value of prescription drug brands and portfolios. Prior to founding Myrtle Potter & Company, Myrtle was president and chief operating officer of Genentech for five years, where she led the company's launch of seven products, including the blockbuster cancer therapy Avastin™. Prior to that, Myrtle was president of Bristol-Myers Squibb's $4 billion U.S. Cardiovascular and Metabolic business and led the launch of four drugs, including Plavix™, Pravachol™ and Glucophage™.
About the Investigational Drug Abaloparatide
Radius' investigational drug is a novel synthetic peptide analog of parathyroid hormone-related protein (PTHrP), a naturally occurring bone-building hormone that we believe has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide-SC is an investigational drug currently in Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis at high risk of fracture. Radius is also developing abaloparatide-TD, for potential use as a short wear-time transdermal patch designed to administer abaloparatide without the need for subcutaneous injection, based on 3M's patented Microstructured Transdermal System technology.
About Radius Health
Radius Health, Inc. is a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including metastatic breast cancer. The company's lead development candidate is the investigational drug abaloparatide for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven, or hormone-resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com.
About Myrtle Potter & Company
Myrtle Potter & Company, founded in 2005, is a life science and healthcare advisory firm. Expertise includes business strategy, product commercialization, customer engagement, product development, business development, loss of exclusivity strategies and organization development. With more than 30 years in the healthcare industry, Potter has built an advisory firm that brings proven and relevant experience to their clients.
About Myrtle Potter
Myrtle Potter was president and chief operating officer of Genentech from 2000 to 2005. In this capacity she led the company's launch of seven products, including the blockbuster cancer therapy Avastin™. Prior to that time, Potter was president of Bristol-Myers Squibb's $4 billion U.S. Cardiovascular and Metabolic business. In this role she led the launch of four drugs, including Plavix™, making it the fastest growing prescription drug at that time and setting it on course to be the largest selling pharmaceutical product in the world. Potter also led the commercial efforts for Pravachol™ (pravastatin) and the Glucophage™ (metformin) franchise, both multi-billion dollar businesses. Potter began her biopharmaceutical career at Merck and Company where she held positions of increasing responsibility over a period of almost fifteen years. Potter currently serves on the board of directors of several public and private companies.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing of the first six months of results of the ongoing ACTIVExtend trial, the timing for the submission of an NDA to the FDA and an MAA in the EU, the benefits of the collaboration for the Company and the likelihood and potential timing of commercial launch of abaloparatide-SC.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues; our need for additional funding, which may not be available; we are not currently profitable and may never become profitable; restrictions imposed on our business by our credit facility, and risks related to default on our obligations under our credit facility; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; risks related to clinical trials, including having most of our products in early stage clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; product candidates for which we obtain marketing approval, if any, could be subject to restrictions or withdrawal from the market and we may be subject to penalties; failure to achieve market acceptance of our product candidates; risks related to the use of our limited resources on particular product candidates and not others; delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals; the dependence of our drug development program upon third-parties who are outside of our control; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; our reliance on third parties to formulate and manufacture our product candidates; failure to establish additional collaborations; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; developments by competitors may render our products or technologies obsolete or non-competitive; risks related to the fact that our drugs may sell for inadequate prices or patients may be unable to obtain adequate reimbursement; the effects of product liability lawsuits on commercialization of our products; failure to comply with obligations of our intellectual property licenses; failure to protect our intellectual property or failure to secure necessary intellectual property related to abaloparatide-SC, abaloparatide-TD, RAD1901 and/or RAD140; our or our licensors' inability to obtain and maintain patent protection for technology and products; risks related to our compliance with patent application and maintenance requirements; failure to protect the confidentiality of our trade secrets; risks related to our infringement of third parties' rights; risks associated with intellectual property litigation, including expending substantial resources and distracting personnel from their normal responsibilities; risks associated with healthcare reform; our failure to comply with healthcare laws and regulations; our exposure to claims associated with the use of hazardous materials and chemicals; as we become involved in drug commercialization, risk related to our inability to successfully manage our growth and expanded operations; risks relating to business combinations and acquisitions; our reliance on key executive officers and advisors; our inability to hire additional qualified personnel; volatility in the price of our common stock; capital appreciation is the only source of gain for our common stock; risks related to increased costs and compliance initiatives associated with operating as a public company; our directors, executive officers and principal stockholders have substantial influence over us and could delay or prevent a change in control; future sales and issuances of our common stock could depress the price of our common stock; risks related to securities or industry analysts ceasing to publish research about us or publishing inaccurate or unfavorable information about us, which could cause the price of our common stock to decline; provisions in our charter documents and Delaware law that could discourage takeover attempts; and our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 10, 2015, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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