- Radius Health Summarizes Recent Presentations regarding its Investigational Drug Abaloparatide at the American Society for Bone and Mineral Research and for its Investigational Drug RAD1901 at the 4th Annual Brain Metastases Research and Emerging Therapy Conference
- Investigational Drug Abaloparatide Currently in Phase 3 Clinical Development, Top Line Results Expected in December 2014
WALTHAM, Mass., Sept. 25, 2014 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, today announced that President and CEO, Robert Ward, will present an update on the Company at the BioCentury NewsMakers in the Biotech Industry Conference on Friday, September 26, 2014 at 2:00 p.m. Eastern Time at the Millennium Broadway Hotel & Conference Center in New York.
A live webcast of the presentation may be accessed by visiting the Radius Health website at www.radiuspharm.com. A replay of the presentation will be archived on the Radius Health website following the presentation www.radiuspharm.com.
American Society for Bone and Mineral Research
Radius Health, Inc. presented on September 12-15, 2014 at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting in Houston certain preclinical and clinical data from studies of abaloparatide, an investigational drug currently being evaluated in the Phase 3 ACTIVE trial as a potential therapeutic for the reduction of osteoporotic fracture risk.
At the ASBMR 2014 Annual Meeting, Radius Health presented a poster entitled: "Responder Analysis of the Effects of Abaloparatide and Teriparatide on Bone Mineral Density in Postmenopausal Osteoporosis," and results from this 24-week randomized controlled trial indicated that significantly more women treated with abaloparatide experienced increases in bone mineral density at the spine, femoral neck and total hip (66%) (abaloparatide as compared to teriparatide, p-value<0.05; abaloparatide as compared to placebo, p-value<0.01) as compared to the controls (teriparatide 40%, and placebo 29%). The potential clinical significance of these data is being evaluated in the ongoing Phase 3 ACTIVE trial and is subject to regulatory review of the entire package of data from our abaloparatide development program.
An oral presentation of the most recent preclinical data for abaloparatide was also given in the Osteoporosis Treatment section of the ASBMR 2014 Annual Meeting. In a study of osteopenic primates administered abaloparatide daily for 16 months, the results indicated a continued, significant, bone mineral density increase at the spine and femoral neck throughout the 16-month period accompanied by a commensurate increase in strength without increases in cortical porosity. The potential clinical significance of these data also is being evaluated in the ongoing Phase 3 ACTIVE trial.
Radius Health is nearing the completion of its pivotal Phase 3 ACTIVE fracture prevention trial in 2,400 postmenopausal osteoporotic women randomized to either placebo or 18 months of daily subcutaneous administration with abaloparatide or Eli Lilly's Forteo. As set forth in the protocol, the primary endpoint for the ACTIVE trial is the comparison of the vertebral fracture rate in the placebo and abaloparatide arms. Radius Health expects the last patient in the 18-month daily administration portion of the trial to complete their last visit under the trial protocol by November 2014 and to announce the top line results from the ACTIVE trial in December 2014.
Annual Brain Metastases Research and Emerging Therapy Conference
Radius Health presented an update on September 19, 2014 at the 4th Annual Brain Metastases Research and Emerging Therapy Conference 2014 in Marseille, France, from the ongoing Phase 1 maximum tolerated dose (MTD) study of its investigational drug RAD1901. The Phase 1 MTD clinical study is being conducted in healthy postmenopausal female volunteers to determine the MTD, safety, tolerability and pharmacokinetics (PK) of RAD1901 in these healthy volunteers. The study also includes subjects in which 18F-estradiol positron emission tomography (FES-PET) is used to assess estrogen receptor engagement. The study data presented at the conference from the first healthy volunteer in the PET imaging cohort of the study suggest that RAD1901 suppresses estrogen receptor signal according to FES-PET after 6-days of daily treatment. Following successful completion of the MTD clinical study, the potential clinical significance of these and other data on RAD 1901 must be evaluated in future clinical trials.
Radius believes that previously-completed preclinical studies have established the potential for RAD1901 to be a small molecule tissue-selective estrogen receptor degrader (SERD) that could selectively bind and degrade the estrogen receptor (ER) with the ability to cross the blood-brain barrier and oral bioavailability. In mouse xenograft studies, treatment with RAD1901 decreased estradiol-induced breast cancer tumor growth. Preclinical studies have also indicated that RAD1901 has the potential to be bone protective in a rat ovariectomy-induced osteoporosis model.
Upcoming Company Presentations
Radius Health will also be presenting at the 13th Annual BIO Investor Forum at The Palace Hotel in San Francisco on Tuesday, October 7, 2014 at 1:30 p.m. PT (4:30 p.m. ET). At 3:30 p.m. PT, President and CEO, Robert Ward will also be participating as a Panelist for the BIO Investor Forum Business Roundtable "JOBS Act, from Enactment to IPO: Surprises from the CEOs in the First Generation".
About the Investigational Drug Abaloparatide
Radius' investigational drug abaloparatide (BA058) is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that we believe has the potential to increase bone mineral density. 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. This potential is currently being studied in our ongoing active Phase 3 trial (ACTIVE) and is subject to regulatory review of the entire package of data from our abaloparatide development program. Topline results from an ongoing Phase 3 pivotal trial comparing abaloparatide SC daily injection to placebo and an active comparator for the prevention of new vertebral fractures are expected in December 2014. Radius is also developing the investigational drug 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 the Investigational Drug RAD1901
In June 2014, Radius initiated a Phase 1 MTD study in healthy volunteers, of its investigational drug RAD1901, a SERD, being developed for potential use in the treatment of metastatic breast cancer, including breast cancer brain metastases. As set forth in the protocol, the study is designed to evaluate the tolerability, safety and pharmacokinetics of RAD1901 in healthy volunteers, and also use 18F-fluroestradiol positron emission tomography to provide a pharmacodynamic assessment of estrogen receptor turnover following RAD1901 treatment. Levels of RAD1901 in cerebrospinal fluid samples taken from the study subjects will be measured to determine that RAD1901 has crossed the blood-brain barrier.
Radius believes that there potentially could be a significant therapeutic opportunity for its investigational drug RAD1901 if it is successfully developed and cleared for marketing following completion of its development program, as RAD1901 may offer the following potential clinical options for patients with metastatic breast cancer:
- Protect the skeleton from loss of bone mineral density;
- Ability to penetrate the blood-brain barrier;
- Oral administration; and
- Treatment of hormone driven, or hormone resistant, metastatic breast cancers.
Radius is also developing RAD1901 as an investigational selective estrogen receptor modulator, or SERM, for potential use in the treatment of vasomotor symptoms. Data from a completed Phase 2 proof of concept study demonstrated that RAD1901 at lower doses has the potential to reduce the frequency and severity of moderate and severe hot flashes.
About Radius Health
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius' lead development candidate is the investigational drug abaloparatide (BA058) 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 osteoporosis and the investigational drug RAD1901 for hormone driven, or hormone resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com
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 statements regarding our expectations regarding the potential benefits of abaloparatide and RAD1901, expectations regarding clinical trials, and upcoming presentations.
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 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; 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 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 related to employees' disclosure of former employers' trade secrets; 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; inability to successfully manage our growth; 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 control over us and could delay or prevent a change in control; future sales of our common stock could depress the price of our common stock; inaccurate or unfavorable information about us could cause the price of our common stock to decline; provisions in our charter documents and Delaware law could discourage takeover attempts; and our ability to use our net operating loss carry forwards and certain other tax attributes may be limited. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on August 12, 2014, 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. CONTACT: Investor Relations Barbara Ryan FTI Consulting Managing Director 212-850-5679 Barbara.Ryan@fticonsulting.com Media Relations Kimberly Ha FTI Consulting Senior Director 212-850-5612 Kimberly.Ha@fticonsulting.com
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