Sandoz announces EU launch of ready-to-dilute generic Pemetrexed to treat most prevalent form of lung cancer

  • Pemetrexed is indicated for patients with non-squamous Non-Small Cell Lung Cancer (NSCLC), who represent over 3 in 4 patients with lung cancer1

  • New ready-to-dilute format and 1,000 mg strength option helps avoid unnecessary handling steps to reduce associated contamination risks and patient waiting times2

  • The Pemetrexed launch will expand the Sandoz hospital portfolio in key European markets, strengthening access to treatment options for patients

Basel, June 25, 2021 - Sandoz today announced the launch of generic oncology treatment Pemetrexed in 11 countries across Europe, including Germany, Switzerland, Netherlands, and Spain.

Pemetrexed, as a monotherapy or in combination with cisplatin, is indicated for first-line, second-line and maintenance treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology, and for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.3

Globally, 1.8 million people died from lung cancer in 2020 including over 26,000 deaths from mesothelioma, and approximately 2.2 million new cases of lung cancer including 31,000 new cases of mesothelioma were diagnosed.4 NSCLC is the most prevalent form of the disease, affecting approximately 85% of those diagnosed with lung cancer.5,6

"At Sandoz, we are committed to using our expertise in product development to enable us to deliver high quality, innovative products that address the needs of patients and healthcare professionals," said Rebecca Guntern, Head of Sandoz Region Europe. "By providing Pemetrexed in a ready-to-dilute format and in an additional, higher-strength dosage, we believe that this treatment option will not only be more cost-effective for payers, but patients and physicians will also be able to benefit from the reduced preparation steps required."

Pemetrexed is a multi-targeted antifolate anti-cancer agent that disrupts crucial folate-dependent metabolic processes essential for cell replication. It inhibits folate-dependent enzymes critical to the de-novo biosynthesis of nucleotides leading to the disruption of DNA replication. Patients receive the treatment via a 10-minute intravenous infusion in a hospital setting.3

Further launches across Europe are expected throughout the second half of 2021.

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 all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz/
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CEO Richard Saynor on LinkedIn:  https://www.linkedin.com/in/richard-saynor/

References

  • Narjust D., Rafael S., Julian R. Mayo Clin Proc. 2019; 94(8):1623-1640. Non-Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Accessible at:  https://pubmed.ncbi.nlm.nih.gov/31378236/
  • Favier B, et al. The time-saving and economic advantages of using oxaliplatin concentrated solution for infusion versus oxaliplatin lyophilized powder for infusion. EJHP Practice. 2007; 13(1): 28-34.
  • Alimta Summary of Product Characteristics. Accessible at: https://www.ema.europa.eu/en/documents/product-information/alimta-epar-product-information_en.pdf  (Accessed May 2021)
  • Hyuna Sung et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancer in 185 Countries. CA Caner J Clin. 2021; 0: 1-41
  • Navada S, et al. Temporal trends in small cell lung cancer: analysis of the national Surveillance Epidemiology and End-Results (SEER) database [abstract 7082]. J Clin Oncol. 2006;24(18S) suppl:384S.
  • Tan WW, et al. Non-Small Cell Lung Cancer (NSCLC). Medscape. Updated March 10 2021. Available at:  https://emedicine.medscape.com/article/279960-overview (Accessed June 2021)

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