Daewoong Pharmaceutical announces a Global License Agreement for DWP213388, a new drug candidate for autoimmune disease with Vitalli Bio

- Exclusive rights for the development and commercialization of DWP213388 in the global market to Vitalli Bio, a portfolio company of Aditum Bio, the biotech investment firm
- Targeting the KRW 146 trillion global autoimmune disease market with partner who has top global drug development expertise

SEOUL, South Korea and OAKLAND, Calif., April 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical (CEO Jeon Sengho and Lee Chang-jae) announced today that it had signed a Global License Agreement for its autoimmune disease drug candidate DWP213388 with Vitalli Bio, a US biotechnology company, on April 28.

With this agreement, Daewoong Pharmaceutical will grant exclusive rights for the development and commercialization of DWP213388 in the global market to Vitalli Bio, a portfolio company of Aditum Bio. Daewoong Pharmaceutical will retain rights in some Asian regions including Korea. In return, Daewoong will receive over $10 million in upfront commitments, and the deal is worth up to $477 million. In addition, Vitalli Bio will be granted an option to license earlier stage dual-target inhibitors in development by Daewoong.

DWP213388, which is being developed by Daewoong Pharmaceutical, targets Bruton's Tyrosine Kinase (BTK) and Interleukin-2-inducible T-cell kinase (ITK), which are involved in the activation of immune cells such as B cells and T cells. Unlike existing treatments that inhibit only one of B cells and T cells, DWP213388 is a first-in-class new drug that can inhibit both BTK and ITK simultaneously as targets. In last August, Daewoong Pharmaceutical received US Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of DWP213388. In addition, excellent efficacy has been confirmed in various autoimmune disease animal models such as Rheumatoid Arthritis (RA).

Aditum Bio, the biotech investment firm cofounded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman, who is also currently a professor at Harvard Medical School. During Dr. Fishman's tenure, NIBR discovered and brought through successful clinical trials for 90 new medicines in more than 120 indications. Vitalli Bio is the ninth company formed by Aditum Bio, whose unique investment and operating model enables rapid company formation, planning, and execution to advance novel drug candidates into the clinic and speed their delivery to the patients in need. With Aditum Bio's management, who has extensive experience in the global pharmaceutical industry and clinical development, actively participating in the development of DWP213388, Vitalli Bio offers world-class development capabilities in major overseas countries such as the US and Europe.

Jeon Sengho, CEO of Daewoong Pharmaceutical, said, "We are very pleased that this Agreement proves not only the excellence of DWP213388, but also Daewoong Pharmaceutical's new drug development technology. Daewoong Pharmaceutical will continue to introduce innovative new drugs that are recognized in the global pharmaceutical market."

Aditum Bio CEO Joe Jimenez said, "Aditum Bio has been very impressed with the biotechnology research capability of Daewoong, and are looking forward to working together to bring this new therapy to patients in need."

An autoimmune disease is a disease that occurs when the immune system inside the human body recognizes normal cells inside the human body as antigens, rather than external antigens such as bacteria and viruses, and attacks them. According to IQVIA, a global market research institute, the global autoimmune disease treatment market is growing at an average annual rate of 5% to reach $115 billion in 2022.

About Daewoong Pharmaceutical

Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on their course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide.

In 2022, Daewoong expanded its global market presence by entering into a license agreement worth USD 923 million, which granted permission for the use of 'Fexuclue', a medicine licensed for the treatment of gastroesophageal reflux disease, in the Philippines and Ecuador within the first year of its launch. Additionally, Daewoong successfully launched 'Envlo', the first-ever sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of diabetes to be developed in Korea, and signed an export contract worth USD 84.36 million with Brazil and Mexico. For further information on Daewoong Pharmaceutical, please visit our official website.

About Aditum Bio

Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiologies, and spins out individual companies dedicated to bringing each candidate through Phase II clinical trials. Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies. For more information, please visit www.aditumbio.com.

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SOURCE Daewoong Pharmaceutical Co., Ltd