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2019-07-22 07:15 CEST
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Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis

  • Integrated Phase I/lll study for proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with reference medicine[1] 
     
  • Osteoporosis accounts for 8.9m bone fractures annually, including debilitating hip fractures -- number set to increase substantially over next two decades[2]
     
  • Sandoz has eight marketed biosimilar medicines globally and 10+ molecules in the pipeline including proposed biosimilar denosumab

Holzkirchen, July 22, 2019 - Sandoz, a Novartis division and a global leader in biosimilars, today announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar denosumab.

The study aims to confirm that the biosimilar matches the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis[1].

Denosumab is indicated for treating a variety of conditions, such as osteoporosis in postmenopausal women, increased risk of fractures in men, treatment-induced bone loss, to prevent bone complications in cancer that has spread to the bone, and giant cell tumor of the bone[3],[4],[5],[6]. The study will be conducted in osteoporosis as this is an adequately sensitive indication and representative of many patients who are treated with the medicine. 

Approximately 200 million people worldwide suffer from osteoporosis, which results in 8.9 million fractures annually[2],[7]. By 2050, hip fractures are projected to increase by 240% in women and 310% in men compared to 1990[2].

"People with the bone disease osteoporosis are more likely to fracture or break a bone, causing pain and restriction of mobility, which can be extremely debilitating[8]," said Florian Bieber, Global Head of Development, Sandoz Biopharmaceuticals. "As we progress our development program for proposed biosimilar denosumab, we believe it gives patients hope for early and expanded access to advanced biologic medicines, which may change the course of their disease."

In ROSALIA, approximately 520 postmenopausal patients with osteoporosis will be randomized to receive either biosimilar denosumab or the reference medicine for 52 weeks. Following this period, patients receiving the reference medicine will be re-randomized to either continue with a third dose or transition to biosimilar denosumab, until 78 weeks of treatment. The primary endpoints include percentage change in lumbar spine bone mineral density[1]. The global clinical program for biosimilar denosumab was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions.

Sandoz biosimilars are helping patients, particularly in immunology, oncology and endocrinology, access medicines sustainably and affordably. The division has a leading global portfolio with eight marketed biosimilars and a further 10-plus in various stages of development. The Sandoz biosimilar pipeline is a blend of in-house development and collaborations, both for co-development and commercialization, targeting key biologics in oncology, immunology, endocrinology and underserved complex disease areas.

About denosumab

Denosumab is a monoclonal antibody designed to recognize and attach to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue)[3]. By attaching to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone complications[3].

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "proposed," "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential regulatory submissions, marketing approvals, launches, new indications or labeling for biosimilar denosumab and the other biosimilar products described in this press release, or regarding potential future revenues from biosimilar denosumab and such other biosimilar products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that biosimilar denosumab or other Sandoz biosimilars will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar denosumab or any other Sandoz biosimilar will be approved for all indications in the originator product label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional biosimilar versions of denosumab; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

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References
      [1]   www.clinicaltrials.gov. Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis. NCT03974100. Available from: https://clinicaltrials.gov/ct2/show/NCT03974100?term=GP2411&rank=1 [Last accessed: June 2019].
      [2]   International Osteoporosis Foundation. Facts and Statistics. Available from: https://www.iofbonehealth.org/facts-statistics [Last accessed: June 2019].
      [3]   Amgen Europe B.V. Xgeva® (Denosumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf [Last accessed: June 2019].
      [4]   Amgen Europe B.V. Prolia® (Denosumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/prolia [Last accessed: June 2019].
      [5]   Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf [Last accessed: June 2019].
      [6]   Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf [Last accessed: June 2019].
      [7]   Sözen T, Özisik L, Basaran NÇ. An overview and management of osteoporosis. Eur J Rheumatol. 2017;4(1):46-56.
      [8]   NHS. Osteoporosis. Available from: https://www.nhs.uk/conditions/osteoporosis/ [Last accessed: July 2019].

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