Radius Announces European Medicines Agency Validates Marketing Authorization Application for Abaloparatide-SC for the Treatment of Osteoporosis in Postmenopausal Women

  • Radius Initiates Human Pharmacokinetic Study of Optimized Transdermal Patch of Investigational Drug Abaloparatide

WALTHAM, Mass., Dec. 04, 2015 (GLOBE NEWSWIRE) -- Radius Health (Nasdaq:RDUS), today announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for abaloparatide subcutaneous (SC) for the treatment of osteoporosis in postmenopausal women. With this validation, the Radius application is complete and now under review by the EMA.

“The MAA for abaloparatide-SC is based on the results from the ACTIVE and ACTIVExtend trials, which demonstrated significant clinical benefit for postmenopausal women at risk of osteoporotic fracture,” said Robert Ward, President and CEO of Radius Health. “The acceptance of our application for review by the EMA represents a significant step towards potentially bringing abaloparatide-SC to postmenopausal women with osteoporosis in Europe, and Radius looks forward to working with the EMA in the review procedure.”

The MAA submission is based on the final results of the 18 month ACTIVE and the first 6 months of the ACTIVExtend trials in osteoporosis. The clinical trials demonstrated that once daily abaloparatide-SC reduced the risk of vertebral and nonvertebral fractures as compared to placebo.

The MAA for the investigational abaloparatide-SC was submitted in Europe on November 17, 2015 and the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by the end of the first quarter of 2016.

This week Radius initiated the human pharmacokinetic (PK) clinical evaluation of the optimized abaloparatide transdermal patch (TD) based upon 3M’s Microstructured Transdermal System technology with the goal of achieving comparability to abaloparatide subcutaneous injection (SC). This human “replicative” study is intended to confirm in healthy postmenopausal women the pharmacokinetic profile of the transdermal patch as established in primate studies. Radius will use the results from this replicative study to inform the design of the registration program.

About the Investigational Drug Abaloparatide

Abaloparatide is an investigational agent and has not been approved by the FDA or the EMA.

Abaloparatide is a novel synthetic peptide that interacts with the human parathyroid receptor 1 that we are developing as a bone anabolic treatment for potential use in the reduction of osteoporotic fracture risk in postmenopausal women. Abaloparatide-SC is an investigational drug currently completing Phase 3 development for potential use as a daily self-administered injection for the potential treatment of patients with postmenopausal osteoporosis at risk of fracture. Radius also is developing the investigational drug abaloparatide-TD for potential use as a short wear-time transdermal patch designed to administer abaloparatide based on 3M's patented Microstructured Transdermal System technology.

The Phase 3 ACTIVE study evaluated abaloparatide, teriparatide and placebo in postmenopausal women at risk of osteoporotic fracture. The results were presented as a late-breaker at the Endocrine Society Annual Meeting (ENDO) in March 2015 and in an oral presentation at the American Society of Bone and Mineral Research Meeting (ASBMR 2015) in October 2015. The Phase 3 ACTIVExtend results were presented as a plenary oral presentation at the American Society of Bone and Mineral Research (ASBMR) in October 2015.

Radius previously reported preliminary, nonhuman primate pharmacokinetic studies of abaloparatide-TD which showed that a desirable pharmacokinetic profile was achieved with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC. These results were presented at the 2015 Annual Meeting of the American Society of Bone and Mineral Research.

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 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, and vasomotor symptoms. www.radiuspharm.com

About 3M

At 3M, we apply science in collaborative ways to improve lives daily. With $32 billion in sales, our 90,000 employees connect with customers all around the world. Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M or @3MNewsroom.

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 progress and timing of abaloparatide-SC in the regulatory process in Europe and the United States, the timing and sufficiency of data to meet approval requirements in Europe and the United States, the progress of clinical trials for abaloparatide-TD, and the likelihood that the pharmacokinetic results of earlier studies of abaloparatide-TD will be confirmed in on-going studies or be useful for future studies of abaloparatide-TD.

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; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; failure of the financial institutions in which we hold our cash and cash equivalents; market, interest, and credit risk; 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 or the costs of defending against infringement by third parties; claims of wrongful disclosure or use of trade secrets by employees' former employers; 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 the 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 5, 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.

CONTACT: Investor Relations Barbara Ryan Partner Clermont Partners 203-274-2825 bryan@radiuspharm.com Media Alice Pomponio Radius Health 617-551-4099 apomponio@radiuspharm.com

Source:Radius Health