January 9, 2014 – Cancer Prevention Pharmaceuticals, Inc. (CPP) and Tillotts Pharma AG (Tillotts), a wholly-owned subsidiary of Zeria Pharmaceutical Co., Ltd. (Zeria), are pleased to announce today that the companies have entered into an exclusive licensing agreement for European and Japanese rights to develop and commercialize the combination of CPP-1X/sulindac for the treatment of familial adenomatous polyposis (FAP), an orphan disease, and other gastrointestinal conditions.
Under the terms of the agreement, Tillotts will provide CPP with upfront and milestone payments for European and Japanese development programs under a co-development framework. CPP may also receive payments of over $100 million, including upfront and milestone payments for development and for reaching certain sales levels as well as royalties escalating to double digits on product sales. The agreement can potentially be expanded into additional indications for which CPP-1X/sulindac has shown promise. CPP will be responsible for product development and Tillotts for regulatory and marketing for the respective markets. In addition, Zeria will be responsible for development and marketing in Japan. CPP continues to retain all rights to CPP-1X/sulindac outside of Europe and Japan and outside the gastrointestinal field.
Thomas A. Tóth von Kiskér, CEO of Tillotts commented, “This deal is an important step in our forceful efforts to build an attractive and innovative product portfolio. It is a prime example of Tillotts’ commitment to develop products that improve the lives of patients with gastrointestinal diseases and we are delighted to join forces on this important project with an experienced company like CPP.”
“We are excited to add CPP-1X/sulindac to our product pipeline, as we believe it has the potential to be an important new therapy for gastrointestinal conditions with a high medical need. It matches our development and marketing capabilities and we look forward to developing CPP-1X/sulindac together with CPP,” said Dirk Reckert, Chief Business Development Officer of Tillotts.
Jeffrey Jacob, Chairman and CEO of CPP, said “We are very pleased to partner with Tillotts and Zeria, companies that have shown strength and focus in the GI therapeutic area in Europe and Japan. We are delighted to share the benefits of both their scientific and business expertise in the development and future commercialization of CPP-1X/sulindac. Tillotts and Zeria share our belief in the great potential of CPP-1X/sulindac in familial adenomatous polyposis, an orphan indication with limited treatment options.”
Geller Biopharm, Inc. served as CPP’s exclusive agent for this license agreement. DLA Piper LLP and Rusing, Lopez & Lizardi, PLLC acted as CPP’s legal counsel on this transaction.
FAP is an inherited disorder characterized by cancer of the colon and rectum. Patients with the classic presentation of FAP begin to develop multiple benign polyps in the colon in their early teenage years. Eventually, the colon becomes carpeted with hundreds to thousands of polyps and there is a near 100% chance that the polyps will become cancerous if left untreated. Current medical practice dictates the removal of the colon and sometimes the rectum in the formative years for the typical FAP patient. CPP’s lead product CPP-1X/sulindac is being developed to minimize the occurrence and/or recurrence of polyps and tumors associated with FAP and offers the potential of non-surgical pharmacopreventive therapy across the spectrum of FAP patients.
Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing prevention therapies for people with an elevated risk of cancer. CPP’s approach has been used with great success in other disease categories such as cardiovascular, neurovascular and infectious disease. Agents that target pre-disease states have helped reduce death rates from these conditions by 50%-70% over the past 30 years (source: Jemal, A. et al. CA Cancer J Clin 2008; 58:71-96). Just as these other prevention therapies represent the largest-selling drug classes on the market today, CPP believes there is even more potential for therapies that reduce the risk of cancer if we are able to move upstream to identify and treat the risk factors associated with cancer. In addition to this Phase III trial, CPP, in collaboration with the National Cancer Institute (NCI) and the SWOG cancer research cooperative group, is sponsoring a large 1,340 patient Phase III trial in colon cancer survivors. CPP is also working collaboratively with non-profit groups to support trials in neuroblastoma—treating and preventing—with three active clinical trials. Additional information is available at www.canprevent.com.
Tillotts Pharma AG is a fast-growing specialty pharma company with 200 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialization of innovative pharmaceutical products, medical devices and diagnostics, all in the field of gastroenterology. Please visit our website www.tillotts.com. Tillotts successfully market its own products Asacol® and Colpermin® as well as in-licensed products, such as Simtomax® in over 55 countries through its own affiliates within Europe and a carefully chosen network of gastroenterology-focused marketing partners throughout the world.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focusing on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information about Zeria please visit www.zeria.co.jp. All trademarks used or mentioned in this release are protected by law. Tillotts’ trademarks Asacol®, Octasa®, Asacolon®, Colpermin®, are either registered or applied for in up to 70 countries. The trademark Asacol® is a registered trademark by Actavis in the United States of America, Canada and the United Kingdom. Asacol® is a registered trademark in Italy by Giuliani. Colpermin® is a registered trademark by Johnson & Johnson for the United Kingdom and Ireland.
Geller Biopharm is a healthcare investment banking division of Financial West Group, member FINRA/SIPC. Geller Biopharm, Inc. and Financial West Group are unaffiliated entities.
Cancer Prevention Pharmaceuticals, Inc.
Tillotts Pharma AG