Press Release Details
Radius Health Provides Business Update on Bone Health
- Exclusive extension of research discovery collaboration with Mass General Hospital (MGH)
- Focus of the program: development of novel oral SIK inhibitors for musculoskeletal diseases
- Extension of activity is based on data from existing collaboration which generated nonclinical molecule data demonstrating oral activity of the skeletal anabolic
- TYMLOS® IP: additional patent issued that extends patent protection to January 10, 2040
BOSTON, March 08, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) provided an update on business development and intellectual property progress in its Bone Health franchise.
Massachusetts General Hospital Research Collaboration
On December 15, 2020, Radius announced a discovery research collaboration with Massachusetts General Hospital (MGH) to evaluate novel oral salt-inducible kinase (SIK) inhibitors in an array of musculoskeletal diseases.
Over the past year, the teams achieved their collective goal of demonstrating skeletal anabolic activity of a candidate oral SIK inhibitor. This tangible progress has provided the foundation for both extending the research collaboration and agreeing to an exclusive license agreement with the objective of progressing a molecule for the treatment of musculoskeletal disorders including, but not limited to, osteoporosis.
Dr. Marc Wein M.D., Ph.D., investigator in the Department of Endocrinology at Massachusetts General Hospital with clinical focus on osteoporosis and metabolic bone diseases is the main collaborator with Radius. Dr. Wein’s research first described the role of SIKs in mediating the actions of parathyroid hormone (PTH) in bone.
The agreement also incorporates any application beyond musculoskeletal disorders as literature points to significant therapeutic opportunity due to the central role of the SIK pathway in a broad array of diseases.
Marc Wein M.D. Ph.D. of MGH commented, “Oral bone building medications for osteoporosis remain a major unmet medical need. This collaboration combines our knowledge about the parathyroid hormone signaling pathway with clinical development of new bone anabolic medications. This is a perfect opportunity to move discoveries from the laboratory toward patients.”
Beate Lanske, Ph.D., VP of Discovery Science at Radius who leads the program, added, “We are impressed and encouraged by the data generated during the past year. Our focus from here is progressing a lead optimization program by utilizing a network of external collaborators, including Dr. Wein.”
Bruce Mitlak M.D., the Chief Medical Officer of Radius, commented, “This is a fantastic opportunity for Radius to work with a talented global thought leader and investigator to develop an oral, bone building therapeutic to address the needs of patients with osteoporosis and other musculoskeletal disorders.”
Continuing to Strengthen TYMLOS Intellectual Property
The United States Patent and Trademark Office (USPTO) has granted patent 11,255,842, which extends TYMLOS patent exclusivity to January 10, 2040.
James Harrington, Global Chief Intellectual Property Counsel at Radius, commented, “The issuance of US Patent 11,255,842 extends protection for TYMLOS to January 10, 2040. Our core five issued patents – all covering TYMLOS – provide us with significant depth and breadth in protecting the commercial runway of our asset. By extending the duration of the molecule and deepening the IP protection on multiple levels, we provide a foundation for maximizing the life cycle activity including the launch of the male indication, pre-clinical assessment of a weekly or bi-weekly depot delivery, and the scientific advancement of a possible oral anabolic therapy with the MGH collaboration on SIK inhibitors.”
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan diseases, and oncology. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas, initially targeting Prader-Willi syndrome, Angelman syndrome, and infantile spasms.
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
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.
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: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2021 and subsequent filings 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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