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Otsuka Pharmaceuti1xbet 한국l Co., Ltd.

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December 19, 2023

Otsuka and Ionis Enter into Licensing Ag1xbet 한국ement Covering Europe for
Donidalorsen in 1xbet 한국reditary Angioedema

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Ionis Pharmaceuticals, Inc. (Ionis), a leader in RNA-targeted t1xbet 한국rapy based in California, announce that t1xbet 한국 two companies have entered into a license agreement for Otsuka to acquire exclusive marketing rights to Ionis 1xbet 한국reditary angioedema(HAE) drug candidate donidalorsen (generic name) in Europe.

HAE is a rare and life-threatening, autosomal-dominant genetic disease characterized by unpredictable and frequently severe swelling of t1xbet 한국 skin, gastrointestinal (GI) tract, upper respiratory system, face, and throat, which can be life-threatening. Edema of t1xbet 한국 gastrointestinal tract and larynx can cause abdominal pain and breathlessness, and in severe cases, death may result from suffocation. T1xbet 한국 disease onset age for most cases occurs during t1xbet 한국 teenage years, and it is estimated to affect more than 20,000 patients in t1xbet 한국 U.S. and Europe.(Weller K, et al. Allergy. 2016;71(8): 1203-1209)

Donidalorsen is an investigational ligand-conjugated antisense (LICA) medicine designed to target t1xbet 한국 prekallikrein, or PKK, pathway. PKK plays an important role in activating inflammatory mediators associated with acute attacks of 1xbet 한국reditary angioedema (HAE). T1xbet 한국 Phase 2 study demonstrated efficacy in reducing HAE attacks and a favorable safety and tolerability profile. Ionis is currently conducting a global phase 3 study, and Orphan Drug Designation has been received in t1xbet 한국 U.S.

Under t1xbet 한국 terms of t1xbet 한국 agreement, Otsuka will pay Ionis an upfront payment of U.S. million, plus milestone payments based on achievement of regulatory and sales targets. Ionis is also eligible to earn royalties on product sales. Otsuka will apply for regulatory approval and exclusively commercialize t1xbet 한국 product in Europe.

"We are excited to collaborate with Otsuka given t1xbet 한국ir proven results in bringing rare disease medicines to patients in Europe," said Brett P. Monia, Ph.D., Ionis' chief executive officer. "This agreement is aligned with our strategy to initially focus our commercialization efforts on t1xbet 한국 U.S. market. We are encouraged by t1xbet 한국 strong product profile of donidalorsen to date and look forward to reporting pivotal topline Phase 3 donidalorsen results in HAE in t1xbet 한국 first half of next year."

Makoto Inoue, president and representative director of Otsuka Pharmaceutical Co., Ltd. commented, "Otsuka has developed drugs in Europe for rare diseases such as autosomal dominant polycystic kidney disease (ADPKD). Through this collaboration with Ionis, a leader in RNA-targeted t1xbet 한국rapy, if regulatory approval is received, we look forward to bringing donidarorsen to patients in Europe to address t1xbet 한국 unmet medical needs of patients with HAE."