Almirall and Simcere enter into a licensing agreement for IL-2-mu-Fc

Rhea-AI Summary

Almirall has entered an exclusive licensing agreement with Simcere for the development and commercialization of SIM0278, an interleukin 2 mutant fusion protein for autoimmune diseases. The deal includes a $15 million upfront payment and potential milestone payments up to $492 million, along with tiered royalties on future sales. Almirall gains exclusive rights outside of Greater China, with Simcere retaining rights in that region. This collaboration aims to enhance Almirall's biologic pipeline and position in medical dermatology.

Positive

• Almirall receives exclusive rights to develop SIM0278 outside Greater China, broadening its R&D pipeline.
• Potential for up to $492 million in milestone payments improves Almirall's future revenue outlook.
• SIM0278 is positioned to treat a range of autoimmune diseases, enhancing product portfolio.

Negative

• None.

• Simcere will receive a $15 million upfront payment and up to US$492 million in development and commercial milestone payments considering successful achievements in several indications, with an important part as sales milestones, as well as up to low double-digit tiered royalties based upon future global sales
• Under the agreement, Almirall will be granted an exclusive right to develop and commercialise SIM0278 for all indications outside of the Greater China region
• SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates T regulatory cells. As an IND ready subcutaneous injection, it can be developed to potentially treat various autoimmune diseases

NANJING, China & BARCELONA, Spain--(BUSINESS WIRE)-- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, and Simcere Pharmaceutical Group（2096.HK), an innovation and R&D-driven pharmaceutical company; today announced that they have entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278.

Under the agreement, Almirall will be granted an exclusive right to develop and commercialise SIM0278 for all indications outside of the Greater China region (Mainland China, Hong Kong, Macau and Taiwan). Simcere will retain all rights to develop and commercialise SIM0278 within Greater China.

Within the terms of the agreement, Simcere will receive a $15 million upfront payment and up to US$492 million in development and commercial milestone payments considering successful achievements in several indications, with an important part as sales milestones, as well as up to low double-digit tiered royalties based upon future global sales.

"We are very excited to have reached a collaborative agreement with Almirall for the development of SIM0278. This innovative IL-2 mutein is one important molecule of our immune-rebalancing strategy for autoimmune diseases,” said Renhong Tang, Ph.D., Co-CEO of Simcere. “SIM0278 is one of the key molecules developed based on Simcere's in-house protein engineering platform. This partnership also marks a milestone for Simcere’s globalisation effort. We look forward to closely working with Almirall to demonstrate the clinical value of SIM0278.”

"At Almirall, we always look for new opportunities to strengthen our R&D pipeline. That is why we are very pleased to close this new development and commercialisation agreement with Simcere," stated Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer. "SIM0278 has great potential to treat a broad spectrum of immunological diseases, and we expect that its development will allow us to reinforce our biologic pipeline and our leading position in Medical Dermatology.”

About SIM0278

SIM0278 is an interleukin 2 mutant fusion protein (IL-2 mu-Fc) that activates regulatory T cells developed in-house by utilizing Simcere’s protein engineering platform. This IND ready subcutaneous injection will potentially be developed to treat various autoimmune diseases. SIM0278 exhibits improved PK profile and selective activation of Treg cells with no activation of effector T cells or NK cells to restore immune balance which has been demonstrated in multiple preclinical disease models.

About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future，aiming to achieve the mission of “providing today’s patients with medicines of the future.” Leveraging its R&D capability and commercialisation excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world-leading innovative companies and research institutes.  www.simcere.com

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life.” We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.    

For more information, please visit almirall.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20220929005090/en/

PR: simcere.mediarelations@simcere.com

Mar Ramírez

Mar.ramirez@almirall.com

Source: Almirall

FAQ

What is the significance of Almirall's agreement with Simcere for SIM0278?

The agreement establishes Almirall's exclusive rights to develop and commercialize SIM0278, enhancing its R&D pipeline and revenue potential.

How much upfront payment did Almirall agree to pay to Simcere?

Almirall will pay Simcere an upfront payment of $15 million.

What are the total potential payments Almirall could make under the agreement?

Almirall could make milestone payments totaling up to $492 million, in addition to tiered royalties based on future sales.

What is SIM0278 and its potential uses?

SIM0278 is an interleukin 2 mutant fusion protein aimed at treating various autoimmune diseases by activating regulatory T cells.

Which regions are excluded from Almirall's licensing rights for SIM0278?

Almirall's rights exclude the Greater China region, where Simcere retains all development and commercialization rights.