Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis - Seite 2

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.