Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine

• Lenalidomide Sandoz is indicated for use in several critical haematology-oncology conditions, per latest ESMO guidelines^1,4
• Cost savings from Lenalidomide Sandoz canexpand treatment options for patients with haemato-oncology conditions^1,2
• Sandoz is committed to developing and providing generic oncology therapies, to provide patients access to affordable, high-quality medicines

Basel, February18, 2022 — Sandoz today announced the launch of generic oncology medicine lenalidomide, indicated for several haemato-oncology conditions as recommended by the latest European Society for Medical Oncology (ESMO) guidelines. The medicine will become available to patients in 19 countries across Europe.

“We are proud to make life-enhancing cancer treatments more accessible by launching our affordable and effective Sandoz Lenalidomide”, said Rebecca Guntern, Head of Sandoz Europe.

She added: “Sandoz is committed to developing and providing generic oncology therapies, to increase patient access to affordable, high-quality medicines. Today, we offer a broad portfolio of more than 50 oncology products³, ranging from biologics to chemotherapeutics, hormones and supportive care treatments, covering a wide range of cancer indications."

The cost of treating multiple myeloma patients is high and continues to rise⁵. Affordability of and access to new multiple myeloma treatments pose a major challenge around the world⁶. Cost savings from Lenalidomide Sandoz promise to expand access to treatment options for multiple myeloma patients^1,2. Similar to multiple myeloma patients, cost savings from Lenalidomide Sandoz will benefit previously treated follicular lymphoma patients, adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality, and relapsed or refractory mantle cell lymphoma patients¹.

Sandoz is the #1 provider of generic oncology medicines in Europe⁷ with a growing portfolio that covers an industry-leading 75% of molecules on the WHO's global Oncology Essential Medicines List^8,9. Sandoz invests in development to improve the lives of cancer patients and free up healthcare resources through increased access to high-quality, affordable medicines.

About Lenalidomide
Lenalidomide is an oral thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties used for the treatment of various haemato-oncology conditions [1]. Lenalidomide is recommended by the latest ESMO guidelines [4]. It is available only through special distribution program because of its serious side effects, including possible birth defects or death of an unborn baby [1]. Lenalidomide is available as hard capsules and need to be taken exactly as prescribed [1].

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 “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s 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 generic or biosimilar versions of such products; 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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity 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. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References

1. [1] Lenalidomide SmPC
2. [2] Sandoz. Access to Healthcare. Available at: https://www.sandoz.com/making-access-happen/access-healthcare.
3. [3] Sandoz. Data on file.
4. [4] Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(†). Ann Oncol. 2021;32(3):309-22.
5. [5] Rajkumar SV. Value and Cost of Myeloma Therapy. American Society of Clinical Oncology Educational Book. 2018(38):662-6.
6. [6] Rajkumar SV, Harousseau JL. Next-generation multiple myeloma treatment: a pharmacoeconomic perspective. Blood. 2016;128(24):2757-64.
7. [7] IQVIA MIDAS MAT_06_2021_Sales USD.
   IQVIA report included Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK & Ukraine.
8. Robertson J, et al. Bull World Health Organ 2016;94:735-742.
9. TaberneroJ et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open 2017;1(6):e000142.

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