Nippon awarded exclusive rights in Japan to IPF treatment C21

Deal could be worth up to $285M for therapy developer Vicore Pharma

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by Mary Chapman |

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Sweden-based Vicore Pharma has granted exclusive rights to pharmaceutical company Nippon Shinyaku to develop and commercialize its treatment candidate C21 (VP01) in Japan, with an initial focus on idiopathic pulmonary fibrosis (IPF).

Nippon will be operationally and financially responsible for the development of C21 in Japan, where it is based. According to Vicore, some 34,000 residents there are thought to live with IPF and have limited treatment options.

Vicore retains the rights to develop and commercialize C21 in markets outside Japan, according to a company press release announcing the deal.

The agreement terms call for Vicore to receive an upfront $10 million payment, as well as up to $275 million in potential development and commercial milestone payments. In addition, Nippon will be responsible for tiered royalty payments to Vicore based on annual net sales of C21 in Japan.

“This partnership is an important milestone in the development of C21,” said Ahmed Mousa, Vicore’s CEO.

“Nippon Shinyaku is an ideal partner that brings expertise in rare disease together with a strong track record of successfully partnering with leading companies to bring innovative treatments to the Japanese market. We look forward to working with the Nippon Shinyaku team and leveraging their expertise to successfully develop and commercialize this product in Japan,” Mousa added.

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The oral therapy C21 is a first-in-class, small-molecule activator of angiotensin II receptor type 2 (AT2R). Activation of this protein receptor helps blood vessels widen and impede fibrosis, or tissue scarring, through the renin-angiotensin system’s protective function.

AT2R is present on the surface of alveolar type 2 (AT2) cells that, along with other cell types, line the small air sacs responsible for gas exchange in the lungs. These cells also contribute to lung tissue repair and regeneration. Dysfunctional AT2 cells can contribute to lung fibrosis.

Through such activation, C21 is crafted to enhance blood flow and mitigate the development of lung scar tissue, at length hindering or blocking further disease progression.

Interim data from a proof-of-concept open-label Phase 2 clinical trial, called AIR (NCT04533022), showed that C21 safely and effectively improved or stabilized lung function in previously untreated IPF patients. A global Phase 2b trial of C21, called ASPIRE, is expected to begin in the first half of the year, according to Vicore.

Nippon is] delighted to enter into an agreement with Vicore to develop this extremely promising therapy for the Japanese market.

C21 was named by regulators in the U.S. and Europe as an orphan drug, a designation that supports the development of therapies that have the potential to address the unmet needs of patients with rare diseases.

“IPF is a disease with a high unmet medical need,” said Toru Nakai, Nippon’s president and representative director.

“I am delighted to enter into an agreement with Vicore to develop this extremely promising therapy for the Japanese market. C21 will be an important addition to the Nippon Shinyaku portfolio of therapies for rare diseases.”