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Sandoz launches oncology generic gefitinib in 13 EU countries at loss of market exclusivity, expanding access to essential medicine

-Sandoz gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer[1] with activating mutations of EGFR-TK[1]
-More than 300,000 European men and women are diagnosed with lung cancer annually, making it the fourth most common cancer[2]
-With launch Sandoz builds on robust 50+ medicine oncology portfolio globally, including chemotherapy, targeted therapy, hormones and supportive care[3]


Holzkirchen, Germany – WEBWIRE

 Sandoz announced the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK[1], which is recommended by ESMO as first-line treatment[4]. The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries through a phased rollout.

“Generics help expand access to medicine, sometimes as much as doubling the amount of patients treated without any increase in cost[5],” said Francesco Balestrieri, ad interim CEO, Sandoz. “At Sandoz, we recognize that oncology still lags behind seven other therapeutic areas that already benefit from considerable generic competition. The day one launch of generic gefitinib, seen by oncology experts as an essential treatment[8], is part of a wider Sandoz effort to change that equation.”

In Europe lung cancer is the fourth most common cancer in both women and men, only exceeded by breast, prostate and colorectal cancer. Each year approximately 312,000 patients are diagnosed with lung cancer[2]. Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for approximately 80% to 85% of all lung cancers cases[6].

Sandoz is the #1 provider of generic oncology medicines worldwide[7] with a broad portfolio of more than 50 products, ranging from chemotherapy, hormones and supportive care to biologics[3]. Its growing oncology portfolio covers an industry-leading 75% of molecules on the WHO’s global Oncology Essential Medicines List[8],[9]. It invests in research and development to improve the lives of cancer patients and liberate healthcare resources through increased access to high-quality, affordable medicines.

About Gefitinib 
Gefitinib is a once-daily, oral, non-chemotherapy medicine indicated for monotherapy treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK[1]. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of this type of cancer[1]. The ESMO guidelines recommend gefitinib as a first-line treatment option for patients with EGFR-activating mutation metastatic NSCLC[4]. Gefitinib is part of the national essential medicines list for cancer[8]. European regulatory approval was received for the generic molecule in July 2018, but generic products can only be made available at loss of market exclusivity of the reference product, provided that the patent protection has already expired.

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,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “portfolio,” or similar terms, or by express or implied discussions regarding potential marketing approvals, launches, new indications or labeling for the 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 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 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 industry conditions; safety, quality or manufacturing issues, 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.

References

[1]   AstraZeneca. Iressa (gefitinib): Summary of Product Characteristics. Last updated: 2019. Available from: https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf [Last accessed: June 2019]. 
[2]   Lung Cancer Europe. LUCE report on lung cancer-Challenges in lung cancer in Europe. November 2016. Available from: https://www.lungcancereurope.eu/wp-content/uploads/2017/10/LuCE-Report-final.pdf [Last accessed: June 2019].
[3]   Sandoz. Data on file.
[4]   Planchard D, et al. Ann Oncol 2018;29(Suppl 4):iv192-iv237.
[5]   IMS Institute for Healthcare Informatics. The Role of Generic Medicines in Sustaining Healthcare Systems: A European Perspective. June 2015. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS_Health_2015_-_The_Role_of_Generic_Medicines_in_Sustaining_Healthcare_Systems_-_A_European_Perspective.pdf [Last accessed: June 2019].
[6]   American Cancer Society. What Is Non-Small Cell Lung Cancer? Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html [Last accessed: June 2019].
[7]   IQVIA through 2018. Data on file.*
[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.

*#1 position in generic oncology does NOT include Sandoz oncology biosimilars.


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