Ipsen's Diphereline® Six-Month Ultra-Long-Acting Formulation Receives First Prescription in China, Accelerating Access for Prostate Cancer Patients

ShanghaiJanuary 30, 2024PR Newswire -- Ipsen's First Super Long-Acting Formulation in China for Prostate Cancer Treatment -- Decapeptyl^®(Injectable Triptorelin Pamoate) Six-month super-long-acting formulation recently issued the first prescription in China at the First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital of Shandong Province), and completed the first injection. Currently, Decapeptyl^®The June formulation has been prescribed for the first time in Shandong, Zhejiang, and Guangdong. This follows the launch of Decapeptyl last June.^®The formal approval of the June formulation for the treatment of locally advanced or metastatic prostate cancer marks another significant milestone for Ipsen in advancing the availability of innovative drugs in the field of prostate cancer treatment and accelerating patient access in China.

As one of the common malignant tumors in the urinary and reproductive systems of elderly men, the incidence and mortality rates of prostate cancer rank 6th and 7th, respectively, among Chinese men.^[1]In recent years, due to the intensification of China's aging population and other reasons, the incidence and mortality of prostate cancer have shown a significant upward trend, with the disease burden increasing day by day.^[2],[3]Currently, ADT (Androgen Deprivation Therapy) is the standard treatment for locally advanced or metastatic prostate cancer. Trelstar^®It is the main drug for ADT treatment and has been used in the field of prostate cancer treatment for many years. It is a gonadotropin secretion inhibitor.

Decapeptyl^®June Formulation is the first ultra-long-acting formulation in China's prostate cancer treatment field, marking a significant breakthrough in the treatment of prostate cancer, enhancing convenience and compliance for Chinese prostate cancer patients. Decapeptyl^®The six-month ultra-long-acting formulation uses PLGA microparticles as a sustained-release system, ensuring that the drug concentration in the blood can be continuously and stably released during the treatment process, maintaining for half a year. This significantly reduces the frequency of drug administration for patients, ensuring therapeutic effects while improving their quality of life. Due to the long-acting nature of the drug's sustained-release effect, the six-month formulation can significantly reduce the frequency of injections for patients, requiring only two injections per year, enhancing patient convenience.^[4],[5],[6], which is more in line with patients' clinical medication needs, helps further improve patient compliance, and significantly reduce the overall treatment costs for patients.^[7]. At the same time, Decapeptyl^®The clinical application of the June formulation can also save medical staff time, allowing doctors to treat more patients.^[8]。

Globally, Trelstar^®The six-month formulation has been clinically used for over 10 years, with efficacy, tolerability, and safety consistent with the one-month and three-month formulations.^[9]. The study results confirmed that Trelstar^®The June formulation can reduce testosterone levels to 20 ng/dl. ^[10],[11], effectively reducing PSA levels to below 4 ng/ml and maintaining stability.^[12]In standardized disease management, both testosterone and PSA are crucial predictive indicators for the survival of prostate cancer patients. The "Chinese Expert Consensus on Testosterone Management in Prostate Cancer 2021 Edition" points out that during ADT, deeply reducing testosterone to a lower level, i.e., suppressing testosterone levels to <20 ng/dl, can serve as a reference indicator for better clinical treatment prognosis and treatment adjustment.^[10]。

Wang Jin, Chief Physician of the Department of Urology at the First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital of Shandong Province), stated: "The treatment of prostate cancer usually requires long-term medication and follow-up. However, in clinical practice, there is a common issue of poor patient compliance due to various reasons." Decapeptyl^®Six-month ultra-long-acting formulation can reduce injection frequency and related adverse reactions, improving the overall quality of life for prostate cancer patients.^[7],[14]. With the advent of Triptorelin^®The June formulation is gradually entering clinical application, with expectations that it will further improve the convenience and adherence of long-term ADT treatment for prostate cancer patients.

Guillaume DELMOTTE, General Manager of Ipsen China, stated: "As a biopharmaceutical company focused on specialty medicines, adhering to the mission of 'Focus, Win-Win, Serve Patients and Society,' Ipsen has been dedicated to the oncology field for many years, committed to continuously improving the accessibility of innovative drugs to meet unmet patient needs. Relying on innovative drug sustained-release technology, Decapeptyl..."^®The June formulation fills the gap in the ultra-long-acting formulation for prostate cancer treatment, providing patients with a more convenient and cost-effective treatment option, thereby improving their quality of life. With the advent of Decapeptyl...^®The first prescription of the June formulation has been implemented, and in the future, we will actively promote Decapeptyl.^®The commercial launch of the June formulation has expanded drug coverage to more provinces and hospitals across China, accelerating the fulfillment of patients' treatment needs.

Founded in 1929, Ipsen has consistently upheld an innovative spirit and strived for progress throughout its over 90-year history. In 1992, Ipsen officially entered the Chinese market, and in 2019, it established an innovation center in Shanghai, which is one of Ipsen's four global research and development centers. In 2021, Ipsen set up its China headquarters in Shanghai and underwent a comprehensive corporate transformation to focus on oncology, rare diseases, and neuroscience. In the field of oncology, Ipsen is among the top 15 global oncology pharmaceutical companies, with drug indications covering solid tumors, hematological cancers, and more. In China, Ipsen concentrates on drug research and innovation in the urology field, particularly delving into patient needs for prostate cancer diagnosis and treatment. With highly effective products, Ipsen optimizes prostate cancer care in terms of safety, compliance, and convenience. Moving forward, Ipsen will continue to prioritize the Chinese market as a strategic hub, introducing innovative drugs and new assets simultaneously with global markets. It will focus on expanding its R&D pipeline in China to benefit more Chinese patients.

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company focused on innovative medicines in oncology, rare diseases, and neuroscience. In the fiscal year 2022, Ipsen's total sales of specialty drugs exceeded 3 billion euros, with a sales network covering more than 100 countries worldwide. In addition to its external innovation strategy, the company’s R&D activities are carried out on innovative and differentiated technology platforms located in leading biotechnology and life sciences hubs—Saclay in Paris, France; Oxford, UK; Cambridge, USA; and Shanghai, China. Ipsen currently has approximately 5,200 employees globally and is listed in Paris (Euronext: IPN) and the United States through a sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more detailed information, please visit ipsen.com.

About Ipsen China

Ipsen Group entered China in 1992 and established an innovation center in Shanghai in 2019, which is one of the four global research and development centers. Ipsen set up its China headquarters in Shanghai in 2021 and, in accordance with the group’s business changes in 2022, simultaneously divested its diversified health business to focus on specialty care. Targeting three major disease areas (oncology, rare diseases, and neuroscience), Ipsen continues to introduce innovative treatment solutions in collaboration with the Shanghai Innovation Center to meet the urgent treatment needs of Chinese patients.

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The forward-looking statements, objectives and targets contained in this document are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ significantly from those anticipated in this document. All of these risks may affect the Group's ability to achieve its financial targets in the future, which are set under reasonable macroeconomic conditions based on information available today. The use of terms such as "believe," "expect," and "anticipate" and similar expressions is intended to identify forward-looking statements, including the Group's expectations regarding future events, such as regulatory filings and decisions. Moreover, the targets outlined in this document were established without considering external growth assumptions or potential future acquisitions, both of which could alter the metrics. The objectives are based on data and assumptions that the Group considers reasonable. Targets depend on conditions or facts that may occur in the future and not solely on historical data. Considering the occurrence of certain risks and uncertainties, actual results may differ significantly from these indicators, notably as products that appear promising in early-stage research or clinical trials may ultimately never reach the market or achieve their commercial objectives, particularly due to registration or competitive reasons. The Group must face, or may face, competition from generic drugs, which could translate into a loss of market share. Additionally, the R&D process involves multiple stages, each entailing significant risks, meaning the Group might fail to achieve its goals and be forced to abandon efforts related to products in which it has already invested substantial resources. Therefore, the Group cannot guarantee that favorable results obtained during preclinical trials will be confirmed in subsequent clinical trials or that clinical trial results will sufficiently demonstrate the safety and efficacy of the relevant products. There is no assurance that products will receive the necessary regulatory approvals or prove commercially successful. If underlying assumptions prove inaccurate or if risks or uncertainties do materialize, actual results may differ significantly from those projected in the forward-looking statements. Other risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange fluctuations; the impact of pharmaceutical industry regulations and healthcare legislation; global trends toward healthcare cost containment; competitors gaining technological advances, new products, and patents; inherent challenges in developing new products, including obtaining regulatory approval; the Group's ability to accurately forecast future market conditions; production difficulties or delays; financial instability and sovereign risks in international economies; reliance on the validity of the Group's patents and other protections for innovative products; and potential litigation, including patent and/or regulatory proceedings. Furthermore, the Group relies on third parties to develop and market certain products that may generate substantial royalties; actions by these partners could adversely affect the Group's activities and financial results. The Group cannot ensure that its partners will fulfill their respective obligations. The Group may derive no benefit from these agreements. Any failure by the Group’s partners to meet their obligations would result in lower-than-expected revenues. Such circumstances could negatively impact the Group's business, financial condition, or performance. The Group explicitly states that, unless required by applicable law, it assumes no obligation to update or revise any forward-looking statements, objectives, or assumptions contained in this press release to reflect any changes in the events, conditions, assumptions, or circumstances on which such statements are based, nor will it make any commitment to do so. The Group’s business is subject to the risk factors outlined in its Registration Document filed with the French financial markets authority (AMF). The risks and uncertainties listed in this document are not exhaustive, and readers are advised to consult the Group’s latest Universal Registration Document available on its website (www.ipsen.com).

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[13] "Chinese Expert Consensus on Testosterone Management in Prostate Cancer 2021 Edition" [J]. Chinese Journal of Urology, 2021, 42(4): 241-245.

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