The terms of the license include an upfront fee, milestones payments and royalties on net sales. Under the agreement Nestlé Health Science is responsible for the continued development and commercialisation of LT-02 in its territories, with Phase III clinical trials in the US planned to start in 2016. These trials will primarily assess LT-02 as an add-on therapy in patients with UC not adequately responding to standard doses of 5-aminosalicylic acid, the current standard treatment for the condition. In October 2014, Lipid Therapeutics’ European co-development partner, Dr. Falk Pharma GmbH, a pharmaceutical company specialized in gastroenterology, announced the start of a pivotal Phase III trial with the same compound in Europe. The European and US Phase III trials form part of a global Phase III development programme that aims to provide clinical evidence to support regulatory approval of LT-02.
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, said: “The licensing agreement with Nestlé Health Science represents a major further step towards bringing LT-02 to patients suffering from UC and another key milestone met for Lipid Therapeutics. Together with Dr. Falk, our development partner in Europe, Nestlé Health Science will provide the resource and expertise to progress LT-02 through Phase III development and approval in the key US and European markets. With these agreements in place I am confident that the huge potential of our novel therapy is being successfully translated into signficant value for our company.”
Dr. Jan Adams, Partner at EMBL Ventures commented: “Lipid Therapeutics is a prime example of our investment approach where we build companies from scratch aiming to forge strategic partnerships after proof of concept has been reached. With two licensees now covering global rights for its lead product LT-02, Lipid Therapeutics is looking to receive a very attractive combined payment stream. Being the majority shareholder in the company this will have a significant impact on our fund performance”.
Greg Behar CEO of Nestlé Health Science, said: “LT-02 has paradigm changing potential in the management of ulcerative colitis in terms of improving patient outcomes and reducing the need for biologics and corticosteroids. Chronic gastrointestinal conditions are on the rise worldwide and we are determined to make an impact, through innovative, integrated therapeutic approaches such as LT-02.”
More than one million people worldwide are estimated to suffer from UC, a chronic and debilitating inflammatory condition of the large intestine. It is estimated that 40% of patients receiving the recommended dose of 5-aminosalicylic acid continue to experience flares of disease activity. There therefore exists a significant need for safe and more efficacious UC treatments. LT-02 is a proprietary delayed release formulation of phosphatidylcholine designed as an add-on therapy to 5-aminosalicylic acid to improve the barrier function of the mucosal layer of the colon.