Pharma Focus Asia

Innovation Pharmaceuticals Announces License Agreement with Alfasigma S.p.A. for the Development and Commercialization of Brilacidin

Tuesday, July 23, 2019

Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, is pleased to report that the Company has executed a license agreement with Alfasigma S.p.A (“Alfasigma”) to develop and commercialize locally-administered Brilacidin (e.g., foam, enema, gel), on a worldwide basis, for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).

The Company will receive from Alfasigma an initial payment, plus be eligible for additional payments based on certain milestones, totaling over $24 million, and receive a 6 percent royalty (net sales) based on the successful marketing of Brilacidin for UP/UPS. The agreement also includes a Right of First Refusal for Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis and Crohn’s Disease, and a Right of First Negotiation for Brilacidin in other Gastrointestinal indications.

“This licensing agreement with Alfasigma is a major milestone for the Company,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Alfasigma is a first-class global pharmaceutical company with proven IBD expertise, marketing products like Xifaxan for Irritable Bowel Syndrome, which makes them an attractive partner to advance Brilacidin in UP/UPS. We are confident that Brilacidin for UP/UPS is in good hands, as Alfasigma works to potentially commercialize the drug. At the same time, we’re excited to be underway with our own Brilacidin oral formulation efforts to treat more extensive forms of IBD. We currently are utilizing sophisticated, controlled-release tablet technology to enable targeted delivery of oral Brilacidin in the colon, with in-human testing anticipated to start as soon as year-end. Millions of patients continue to suffer from hard-to-treat GI diseases, with recent deal-making in the pharmaceutical industry revealing significant premiums being paid for promising oral IBD drugs. As such, we are committed to advancing Brilacidin across multiple IBD indications, and also in other key franchise therapeutic areas, like our Phase 3-ready oral rinse Brilacidin program in Oral Mucositis.”

“We are thrilled to forge this partnership with Innovation Pharmaceuticals,” said Pier Vincenzo Colli, Chief Executive Officer at Alfasigma. “The Phase 2 Brilacidin clinical study results in UP/UPS look promising and reflective of Brilacidin’s unique drug properties and treatment potential. Alfasigma plans to dedicate considerable internal resources, including formulation and IP expertise, and to make a substantial investment to advance Brilacidin, with the objective to offer patients a safe and effective new treatment option in the management of UP/UPS. We will also closely follow Innovation’s progress in developing oral Brilacidin, as we remain highly interested in novel oral IBD treatments. This agreement is a further step in strengthening our pipeline.”

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