- Collaboration will evaluate Radius' investigational drug, RAD1901, in combination with Novartis investigational CDK4/6 inhibitor LEE011 for the treatment of breast cancer
-Additional studies are planned to evaluate effects of combining RAD1901 with BYL719, Novartis investigational PI3K inhibitor
WALTHAM, Mass., Jan. 27, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) today announced that it has entered into a worldwide clinical collaboration with Novartis Pharmaceuticals (NYSE:NVS) to evaluate the safety and efficacy of combining investigational agent RAD1901, a novel oral selective estrogen receptor degrader (SERD), with investigational agent LEE011 (ribociclib)*, a cyclin-dependent kinase (CDK) 4/6 inhibitor. Preclinical studies of RAD1901 have shown consistent and robust single agent anti-tumor activity in multiple wild type and ESR1-mutant breast cancer models and tumor regression when combined with targeted agents such as CDK 4/6 inhibitors in pre-clinical models. The parties also intend to conduct pre-clinical studies to evaluate the effects of RAD1901 in combination with BYL719 (alpelisib), an investigational phosphoinositide 3-kinase (PI3K) inhibitor, with the goal of initiating future clinical trials.
"We are pleased to begin work with Novartis to explore the potential clinical benefits of RAD1901 in combination with these promising investigational agents for breast cancer, the second most common cancer in the world and the most prevalent cancer in women," said Robert Ward, President and Chief Executive Officer of Radius Health. "This collaboration will evaluate the potential of combination therapies to generate improved clinical results, as compared to single agents alone, and to address the needs of these underserved patient populations."
Under the agreement, Radius and Novartis will each contribute resources and supply compound material necessary for the studies to be conducted under the collaboration and will share third party out-of-pocket research and development expenses. The agreement is non-exclusive and each party will solely own all rights to any invention or discovery solely related to its respective product and/or compound. The parties will jointly own all data and inventions related to the combination use of investigational drug RAD1901 with investigational drugs LEE011, BYL719 or another compound arising under the collaboration.
*LEE011 was developed by the Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. The Radius clinical pipeline 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 in postmenopausal women. Radius' preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential applications in oncology. For more information, please visit www.radiuspharm.com.
Abaloparatide is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. Abaloparatide is a novel synthetic peptide analog of the PTH receptor binding domain of parathyroid hormone-related protein (PTHrP), a naturally occurring bone-building hormone that has the ability to increase bone mineral density by stimulating new bone formation. Abaloparatide was designed to have a unique mechanism of action with the goal of stimulating bone formation, increasing bone mineral density, restoring bone microarchitecture and augmenting bone strength.
Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). In the fourth quarter of 2015, Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of patients with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius plans to submit a New Drug Application (NDA) for abaloparatide-SC to the US Food and Drug Administration at the end of the first quarter of 2016.
Radius is also developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a short wear-time transdermal patch.
RAD1901 is a selective estrogen receptor down-regulator/degrader, or SERD, which at high doses has potential for use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, metastatic breast cancer. RAD1901 is currently being investigated in postmenopausal women with advanced estrogen receptor positive (ER+), HER2-negative breast cancer, the most common form of the disease. The compound has the potential for use as a single agent or in combination with other therapies to overcome endocrine resistance in metastatic breast cancer.
RAD1901 is also being evaluated in a Phase 2b study at low doses for potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov.
RAD140 is a non-steroidal selective androgen receptor modulator, or SARM, that is currently in preclinical development as a potential treatment for breast cancer. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, which is highly expressed in many breast cancers. Due to its receptor and tissue selectivity, potent oral activity and long half-life, RAD140 could have clinical potential in the treatment of breast cancer or other conditions where androgen modulation may play a role.
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 results of prior studies of RAD1901, the potential uses for RAD1901, the potential clinical benefits of combination therapies compared to single agent therapies generally and to the combination of RAD1901 with Novartis's investigational compounds, the potential studies that may be conducted under the collaboration, and the timing and progress of regulatory submissions for abaloparatide-SC in Europe and the United States.
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.
Radius Health Media Contact: Alice L. Pomponio Email: firstname.lastname@example.org Phone: 617-551-4099 Investor Relations Contact: Barbara Ryan Email: email@example.com Phone: 203-274-2825