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[QUOTE]Originally posted by BooDog: [QB] Innovation Pharmaceuticals Announces License Agreement with Alfasigma S.p.A. for the Development and Commercialization of Brilacidin in Ulcerative Proctitis/Ulcerative Proctosigmoiditis Brilacidin, Corporate · Over $24M in initial and milestone-based payments BEVERLY, MA – July 22, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), 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.” About Brilacidin for IBD Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and enema, foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/ About Alfasigma Alfasigma is a privately-owned, Italy-based integrated multinational pharmaceutical company with 2018 revenues in excess of €1 billion, 5 manufacturing plants, R&D facilities, and 3,000 employees globally. Outside of its core Italian market, Alfasigma has 16 subsidiaries in Europe, Asia, North and Central America and Africa, and is present in more than 90 countries. More than 44% of Alfasigma turnover comes from internally developed proprietary products, one of which is XIFAXAN. More information is available at the Alfasigma website at: http://www.alfasigma.com/en [URL=https://www.ipharminc.com/press-release/2019/7/22/innovation-pharmaceuticals-announces-license-agreement-with-alfasigma-spa-for-the-development-and-commercialization-of-brilacidin-in-ulcerative-proctitis-ulcerative-proctosigmoiditis]https://www.ipharminc.com/press-release/2019/7/22/innovation-pharmaceuticals-ann ounces-license-agreement-with-alfasigma-spa-for-the-development-and-commercializ ation-of-brilacidin-in-ulcerative-proctitis-ulcerative-proctosigmoiditis[/URL] Alfasigma PR in Italian... [URL=https://www.alfasigma.com/CMSContent/Alfasigma/News/012%20ITA%20Brilacidin%20in%20Ulcerative%20Proctitis%20Ulcerative.pdf]https://www.alfasigma.com/CMSContent/Alfasigma/News/012%20ITA%20Brilacidin%20in% 20Ulcerative%20Proctitis%20Ulcerative.pdf[/URL] Translated... Alfasigma agrees with Innovation Pharmaceuticals for develop and market Brilacidin in the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis • Innovation Pharmaceuticals & Alfasigma announced an agreement for Brilacidin, in the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis • For Alfasigma it is the second agreement in a few weeks that strengthens pipeline and portfolio in the Gastrointestinal field • The agreement starts from a base of 24 million dollars Bologna, July 23, 2019 - Alfasigma Spa and Innovation Pharmaceuticals (OTCQB:IPIX), a biopharmaceutical company based in the United States, have entered into a licensing agreement for which Alfasigma will develop and market worldwide Brilacidin for use local, for the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis (PU / PSU). There Proctitis is an inflammatory disease of the rectum, which when extended also to sigma is called Proctosigmoidite. PU and PSU are therefore attributable to chronic intestinal inflammatory diseases (MICI, also known as IBD - Inflammatory Bowel Disease: together they represent one chronic and autoimmune condition difficult to treat affecting about 10 million people all over the world, including 200,000 people in Italy. Brilacidin will be developed as a new non-corticosteroid, non-biological treatment, administered by different formulations, Alfasigma will initially develop topical formulations such as enema, foams and / or gel for PU / PSU. A few weeks after the announcement for the commercial re-introduction of Zelnorm in the States - used for the treatment of irritable bowel syndrome constipation - this is a further step in strengthening the pipeline in the Gastro-intestinal area. "Alfasigma is developing, at a global level, a specific focus in the Gastrointestinal field", stated Pier Vincenzo Colli, CEO of Alfasigma. "We are excited to add to the our portfolio, this partnership with Innovation Pharmaceuticals. The results of the study clinical on Phase 2 Brilacidin in PU / PSU seem promising and enhance properties unique of the drug. To advance Brilacidin, we plan to allocate an important one investment, both in terms of internal resources and expertise for formulations and protection of intellectual property. " "We are proud to be able to work to offer patients a new and effective option safe treatment in the management of PU / PSU ", continues Colli" We will also closely follow i next developments of Innovation Pharmaceuticals in the development of oral Brilacidin, why we are also interested in new treatments for mici. This agreement, along with that a few weeks ago on Zelnorm, represents a further enhancement of ours global pipeline ". The agreement also includes a right of first refusal for Brilacidin in the treatment of forms more extensive inflammatory bowel disease (IBD), such as ulcerative colitis and the Crohn's disease and a first negotiation right for Brilacidin in other gastrointestinal indications. In addition to an initial outlay, the agreement provides for a series of additional payments based on certain milestones, for a total of over $ 24 million and royalties of 6% on net sales in the marketing of Brilacidin for PU / PSU. Information on Alfasigma. Alfasigma is one of the leading Italian pharmaceutical companies: present in over 90 countries, has a workforce of around 3,000 people, Research and Development laboratories, and 5 factories of production. In Italy Alfasigma is a leader in the market for prescription products where, in addition to the strong focus on Gastro-Intestinal, it is present in many primary care therapeutic areas. Produces and it also markets self-medication products, nutraceuticals and food supplements. For more information, visit [URL=http://www.alfasigma.com]www.alfasigma.com[/URL] or send an e-mail to info@alfasigma.com. Information on Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. (IPIX) is a clinical biopharmaceutical company that develops a portfolio of world-class innovative therapies that address multiple users areas of unmet medical needs, including inflammatory diseases, cancer, infectious diseases and dermatological diseases. More information is available on the company website [URL=http://www.IPharmInc.com.]www.IPharmInc.com.[/URL] Alfasigma Corporate Communications & Media Relations: Biagio Oppi biagio.oppi@alfasigma.com +39 3386352349 Innovation Pharmaceuticals Investor & Media Relations: Leo Ehrlich info@ipharminc.com 8-K.. [URL=https://www.sec.gov/Archives/edgar/data/1355250/000147793219004223/0001477932-19-004223-index.htm]https://www.sec.gov/Archives/edgar/data/1355250/000147793219004223/0001477932-19 -004223-index.htm[/URL] [/QB][/QUOTE]
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