TOKYO and CLEVELAND, Ohio, November 22, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Juventas Therapeutics (President & CEO: Rahul Aras, “Juventas”) today announced that they have entered into an exclusive, worldwide (excluding China) option and license agreement for Juventas’ lead product candidate, JVS-100. JVS-100 is a non-viral gene therapy that expresses stromal cell-derived factor-1 (SDF-1), a naturally occurring signaling protein that activates the endogenous tissue repair pathways. The agreement grants to Astellas a license to conduct research and to develop JVS-100 through Phase 2a clinical studies with an option to acquire JVS-100 from Juventas for further development and commercialization. Astellas currently plans to focus development efforts on the treatment of fecal incontinence (FI).

FI is the accidental passing of bowel movements including liquid or solid stools, which can result in quality of life issues (both social and hygienic) for those that suffer with this disorder. FI may result from a variety of factors including aging, damage to muscles or nerves and childbirth. At present, there is no standard of care for FI and there is no effective therapy to cure FI.

JVS-100 is a DNA plasmid designed to be delivered directly to the site of injured tissue and is non-immunogenic. Clinical trials have demonstrated its safety profile and the ability to allow for repeat administrations. It has been shown that intramuscular injection of JVS-100 in FI animal models promotes functional/histological improvement in anal sphincter muscle.

“Astellas is committed to exploring all types of partnership opportunities to turn cutting-edge science and technological advances into VALUE for patients,” said Naoki Okamura, Chief Strategy Officer, Astellas. “We look forward to further investigating the promise of JVS-100 as a potential regenerative treatment for patients around the world.”

”JVS-100 has been well tolerated in multiple clinical studies and has demonstrated the potential to revive intrinsic regenerative processes and restore tissue function,” said Rahul Aras, Ph.D., President & CEO, Juventas. “We are excited to partner with Astellas to advance the program for treatment of patients with FI”. 

Under the agreement, Astellas will pay undisclosed up-front and consideration for the option right. Astellas will fund preclinical and clinical studies and be responsible for conducting development efforts directed toward the use of JVS-100 for the treatment of FI in a collaboration with Juventas. 

Summit Pharmaceuticals International Corporation, a subsidiary of Sumitomo Corporation, served as advisor to Juventas in connection with this transaction.

The impact of this transaction on Astellas’ financial results for the fiscal year ending March 31, 2019, is not material.

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