Press release: Ignis Therapeutics and STADA partner for apomorphine subcutaneous injection in China
Ein Dokument
Ignis Therapeutics and STADA partner for apomorphine subcutaneous injection in China
- Ignis and STADA’s Britannia sign exclusive licensing agreement to develop and commercialize subcutaneous apomorphine in mainland China, Hong Kong and Macau
- Dr. Eileen Long, CEO of Ignis: “Ignis is now in-licensing drug-device combination therapeutic products, which will further enrich the company’s pipeline and better serve Chinese patients with central nervous system (CNS) diseases.”
- STADA CEO Peter Goldschmidt: “This partnership with Ignis to develop and commercialize a specialty Parkinson’s disease therapy presents STADA with a further pathway into the extensive and growing Chinese pharmaceutical market.“
Shanghai, China and Bad Vilbel, Germany. 18 March 2022 – Ignis Therapeutics and STADA’s Britannia Pharmaceuticals Ltd. (“Britannia”) affiliate today jointly announced that two companies have signed an exclusive licensing agreement under which Ignis Therapeutics will develop and commercialize subcutaneous apomorphine for Parkinson's disease in mainland China, Hong Kong and Macau. Under terms of the agreement, Britannia will receive an undisclosed upfront payment, milestone payments and sales-based royalties.
Parkinson’s disease (PD) currently affects an estimated 3 million people in China, with around 150,000 new diagnoses of the progressive neurological condition every year[1]. A registry study conducted by Stacy et al. (2008) found that 16% of total PD patients fell within the advanced category for which continuous and intermittent dopaminergic treatment could be appropriate.[2]
Apomorphine medicines are used by more than 10,000 PD patients worldwide[3]. STADA, Britannia and their partners supply apomorphine under various brand names in 29 countries across 5 continents.
Ignis and STADA are committed to collaborating on clinical trials and other requirements necessary to obtain approval to bring this therapy option to patients in China. Subcutaneous apomorphine infusion is listed as a therapeutic option in Chinese guidelines for the treatment of Parkinson′s disease.[1]
“We are delighted to have entered into this important strategic partnership with STADA and Britannia," said Dr. Eileen Long, CEO of Ignis. “Following licensing deals for small-molecule drugs and innovative non-drug therapies, Ignis is now in-licensing drug-device combination therapeutic products, which will further enrich the company’s pipeline and better serve Chinese patients with CNS diseases.”
STADA CEO Peter Goldschmidt commented: “This partnership with Ignis to develop and commercialize a specialty Parkinson’s disease therapy presents STADA with a further pathway into the extensive and growing Chinese pharmaceutical market. Bringing new therapeutic options to patients around the world delivers on STADA’s purpose of Caring for People’s Health as a Trusted Partner.“
Robert Wood, CEO of Britannia, said: "We are excited to have signed this agreement with Ignis. As an innovative company focused on CNS therapies, Ignis has a strong and professional team, so we believe we have found the ideal partner for subcutaneous apomorphine in the territory.”
About Apomorphine Subcutaneous Injection
PD is a common neurodegenerative disease in middle‐aged and elderly people. With the aging of the population, the incidence rate is increasing on an annual basis. As the disease progresses, the motor symptoms and non-motor symptoms of Parkinson's disease become progressively worse, thus impair patients’ daily activities and create a huge social and medical burden.
The results of a phase III of the TOLEDO study published in Lancet Neurology [4] showed that treatment with apomorphine subcutaneous infusion for 12 weeks offer significant reductions in OFF time from baseline compared with placebo: -2.47 h/day versus -0.58 h/day respectively - a difference of almost 2 hours (p=0.0025), doubling the change in OFF time. These reductions were observed in the first week of the fast-acting treatment. This is recognized as meaningful endpoints to PD patients.
Apomorphine subcutaneous injection includes two drug-device combinations: Disposable Injection Pen (PEN) and Continuous Infusion Pump (INFUSION). Apomorphine, a dopamine D2 agonist is normally used for the treatment of "OFF" episodes of "on-off" motor symptoms with advanced Parkinson's disease. Apomorphine subcutaneous injection has been successfully marketed in many countries around the world and is recommended by Parkinson's disease guidelines in a number of countries and organizations including China.
PEN is a small, disposable, ready-to-use, pen-shaped injector allowing subcutaneous injection of apomorphine, which bypasses the dysfunctional gastrointestinal tract[3] and provides patients with a rapid OFF release.
INFUSION provides a continuous subcutaneous infusion of apomorphine with a pump, which can contribute to a significant and clinically meaningful reduction in OFF time without increasing dyskinesias and is an effective and well tolerated treatment strategy for patients with Parkinson’s disease.[1]
[1] Chinese guidelines for the Treatment of Parkinson′s disease(Fourth edition)
[2] Stacy M, et al. Parkinsonism and Related Disorders (2008) 14:85–92
[3] Data on file
[4] Katzenschlager R, et al. Lancet Neurol 2018;17(9):749–59
[5] https://www.medicines.org.uk/emc/product/2232/smpc
[6] Marrinan S, et al. Mov Disord 2014;29(1):23–32
About Ignis Therapeutics
Ignis Therapeutics is an innovative life science company developing novel therapies for CNS conditions that have limited treatment options. Through its partnership with world-leading CNS-specialized companies, Ignis is transforming the approach to treating CNS conditions with a strong commitment to self-discovery as well as a development strategy to advance the treatment paradigm. Ignis has gathered an outstanding team of top talent, including industry-renowned business leaders, neuroscientists, and clinicians, with strong track records in the development and commercialization of novel treatments for CNS diseases. At Ignis, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and non-prescription consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2020, STADA achieved group sales of EUR 3,010.3 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 713.3 million. As of 31 December 2020, STADA employed 12,301 people worldwide.
About Britannia Pharmaceuticals Ltd
Britannia Pharmaceuticals Ltd is a pharmaceutical company based in London, UK, part of the Frankfurt-based STADA Arzneimittel AG group. Britannia is committed to the development of innovative, patient-centric technology that effectively delivers therapies to patients with Parkinson’s disease by working with specialist groups, funding clinical trials and investing in care initiatives that will optimize treatment solutions and improve patients’ quality of life.
Ignis Therapeutics Eliena Qian eliena.qian@ignistherapeutics.com STADA additional information for journalists: STADA Arzneimittel AG - Media Relations Stadastrasse 2-18 61118 Bad Vilbel - Germany Phone: +49 (0) 6101 603-165 E-Mail: press@stada.de
Or visit us on the Internet at www.stada.com/press
STADA additional information for capital market participants: STADA Arzneimittel AG - Investor & Creditor Relations Stadastrasse 2-18 61118 Bad Vilbel – Germany Phone: +49 (0) 6101 603-4689 E-mail: ir@stada.de
Or visit us on the Internet at www.stada.com/investor-relations