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· Agreement expected to establish presence in key regulated markets for diabetes patients while generating savings for healthcare system overseas
· Over 400 million people worldwide have diabetes; the amount of insulin required to treat type 2 diabetes alone is expected to increase by more than 20% from 2018 to 20301,2
Beijing, China, December 19, 2018 – Gan & Lee Pharmaceuticals (Gan & Lee), an industry leading biopharmaceutical company with 20 years’ experience specializing in research, development, production and commercialization of insulin and its analogues in China, today announced it has entered into an agreement to commercialize biosimilar versions of three key insulins used in patients with Type 1 and Type 2 diabetes to Sandoz, a Novartis division and global leader in biosimilar pharmaceuticals.
The strategic cooperation will be a milestone for Gan & Lee’s global business. The agreement covers EU, US and other key regulated markets where Gan & Lee does not have existing commitments. Terms of the agreement are confidential.
“We are delighted to achieve this comprehensive agreement with Sandoz,” said Kai Du, Corporate VP of International Business Development, Gan & Lee. “Through the collaboration we are expecting to provide patients in regulated markets outside of China with more treatment choices.”
When the pancreas does not produce enough insulin, a hormone that regulates blood sugar, a serious chronic disease called diabetes can occur. It is estimated that more than 400 million adults worldwide are living with diabetes, and that number is expected to rise. People with diabetes may develop blindness, kidney failure, heart attacks, stroke, require lower limb amputation, and may suffer from other comorbidities including other cardiovascular diseases1,3. In 2015, diabetes treatments recorded 3 billion in sales, roughly 12% of the overall global healthcare expenditure4.
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 “positive opinion,” “recommendation,” “proposed,” “potential,” “can,” “will,” “believe,” “committed,” “investigational,” “portfolio,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labelling for the investigational or approved biosimilar 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 labelling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such 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 biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Gan & Lee 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. Gan & Lee 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 Gan & Lee
Gan & Lee is a high-tech biopharmaceutical company specializing in research, development, production and commercialization of insulin and its analogues, and is a leader in the diabetes market in China. Relying on technical and cost advantages, Gan & Lee has expanded rapidly into the global market. Currently with marketing and distribution contracts in about 20 countries, Gan & Lee successfully launched a US Phase III clinical trial for insulin glargine in 2017, and is endeavouring to benefit more patients worldwide with high quality and affordable antidiabetic products and services.
1. World Health Organization. Diabetes: Key Facts. Available at: http://www.who.int/news-room/fact-sheets/detail /diabetes. Accessed 3 December 2018.
2. Basu, S et al. Estimation of global insulin use for type 2 diabetes, 2018-30: a microsimulation. Lancet Diabetes Endocrinol. 2018 Nov; Available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30303-6/fulltext. Accessed 3 December 2018.
3. IDF International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, 2017. http://diabetesatlas.org /resources/2017-atlas.html
4. Ogurtsova, K et al. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040.Available at https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(17)30375-3/fulltext. Accessed 11
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