May 31, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex”) today announced that a license agreement has been signed with Viatris Pharmaceutical Japan Inc. (“Viatris Japan”) to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. Cobitolimod is a TLR9 agonist which is being evaluated in the global phase III program CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis. The agreement including milestones is worth up to USD$50m, excluding royalties.

Under the terms of the agreement, Viatris Japan will pay InDex an upfront fee of USD 10 million for the exclusive rights to commercialize cobitolimod in Japan. In addition, InDex is eligible to receive development and sales milestone payments of up to USD 40 million. Viatris Japan will also pay up to double-digit percentage royalties based on its net sales for the product in Japan.

InDex will continue to fund all development which incorporates the completion of the global phase III-program CONCLUDE, including a cohort of Japanese patients in Induction Study 2 and a PK study in Japanese patients prior to filing. Viatris Japan will fund all regulatory and commercialization expenses, as well as any additional Japanese-specific studies required in Japan.

Jenny Sundqvist, CEO of InDex, says, “We are excited to start our collaboration with Viatris Japan with the common goal to register and commercialize cobitolimod for the Japanese market. Viatris Japan shares our view of how best to position cobitolimod for the treatment of moderate to severe ulcerative colitis in the Japanese market. Their experience and presence in the local gastrointestinal segment will ensure that we maximize our sales potential and bring the benefits of this innovative therapy to patients.”

For more information:
Jenny Sundqvist, CEO
Phone: +46 8 122 038 50
E-mail: jenny.sundqvist@indexpharma.com

Johan Giléus, Deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: johan.gileus@indexpharma.com

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 18:35 CET on May 31, 2023.

Cobitolimod in brief
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod is being evaluated in the phase III program CONCLUDE as a novel treatment of moderate to severe ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.

InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s lead asset is the drug candidate cobitolimod, which is being evaluated in the phase III program CONCLUDE as a novel treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.

InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.

Source:- InDex