Trial expected to support registration in the U.S. and European Union
Sandoz continues to advance biosimilar pipeline with seven Phase III trials across five molecules
Global program underscores Sandoz's leadership in biosimilars
Holzkirchen, Germany, June 24, 2013 - Sandoz, the global leader in biosimilars, announced it has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen's Enbrel®). The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. The global clinical program was developed in consultation with regulatory authorities in the U.S. and EU, and the results from this clinical trial are expected to support regulatory submissions in both the U.S. and EU.
"Sandoz has a strong track record in developing and commercializing biosimilars around the world," said Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables at Sandoz. "We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world."
Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology, and is approved in the U.S. and EU for the treatment of rheumatoid arthritis, psoriasis, and other conditions. Sandoz has invested significant resources in state-of-the art analytical technologies to develop and validate a process for producing its biosimilar etanercept. The company is also making the necessary manufacturing investments to bring this complex biologic to market. Extensive pre-clinical and clinical data show that the Sandoz product is highly similar to Enbrel and justifies proceeding with late-stage clinical studies.
"The continued increase in spending on biological agents for treatment of immune-mediated diseases such as rheumatoid arthritis and psoriasis is a growing concern among physicians in many developed and developing countries," said Alan Menter, M.D., Professor and Chairman of the Division of Dermatology at Baylor University Medical Center, Dallas, United States and immediate past President of International Psoriasis Council. "A high-quality and clinically-proven biosimilar version of etanercept could play an important role in generating much-needed savings for healthcare systems that can be used to fund novel therapies or treat more patients."
"Sandoz remains steadfast in its commitment to significantly increase worldwide access to essential, high-quality and life-enhancing biopharmaceuticals," said Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical Development at Sandoz. "The initiation of this clinical trial stands as an important testament to our deep commitment."
Sandoz is the pioneer in biosimilars and the global market leader with over 50% share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz products occupy the #1 biosimilar position in their respective categories. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience. Sandoz also has an unrivalled pipeline with several molecules in various stages of development. With the start of the etanercept Phase III study, Sandoz now has seven Phase III clinical trials across five biosimilar molecules - more than any other company in the industry.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launches," "expected," "pipeline," "will," "continues," "could," "commitment," or similar expressions or similar expressions, or by express or implied discussions regarding potential marketing approvals for etanercept or other biosimilar products, or regarding potential future revenues from etanercept or such other products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that etanercept or any other biosimilar products will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that etanercept or such other products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding etanercept could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; uncertainties regarding actual or potential legal proceedings, including, among others, intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling etanercept or other biosimilar products, and the uncertain outcome of any such litigation; the particular prescribing preferences of physicians and patients; competition in general; government, industry and general public pricing pressures; unexpected manufacturing difficulties or delays; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sandoz 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.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz offers a broad range of about 1,100 high-quality, affordable products that are no longer protected by patents. With nearly 26,000 employees in approximately 140 countries, Sandoz holds the #1 position globally in biosimilars, injectables, ophthalmics and dermatology as well as a strong global #5 position in inhalables. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances and anti -infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.
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Enbrel® is a registered trademark of Amgen
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