Dr. Falk Pharma GmbH and Lipid Therapeutics have announced that they have entered into a licensing agreement for the European rights to Lipid Therapeutics’ lead product, LT-02, for ulcerative colitis (UC). The terms of the license include an upfront fee, milestones and royalties.
Following a co-development and option-agreement in 2009, Dr. Falk GmbH will assume full responsibility for the further development and commercialization of LT-02 in Europe, with a Phase III induction trial in UC planned to start in the second half of 2012.
Lipid Therapeutics is currently in discussions with potential development partners in the US.
LT-02 is a delayed release formulation of phosphatidylcholine designed to improve the barrier function of the mucosal layer of the colon.
Data from a positive European Phase II trial conducted in 156 patients with UC will be presented at the Digestive Disease Week (DDW) conference in San Diego on 22 May 2012.
Ursula Falk, CEO of Dr. Falk Pharma, said: “We are pleased to exercise our option to license European rights to LT-02 based on the positive outcome of the recent Phase II trial. The novel mechanism of action, combined with an excellent safety profile, provides a new approach to treating UC patients who are poorly controlled on existing therapies.”
Dr. Gerhard Keilhauer, CEO of Lipid Therapeutics, added: “Our agreement with Dr. Falk Pharma is an important step towards bringing LT-02 to patients suffering from UC. We highly value Dr. Falk’s expertise in the gastrointestinal market. Lipid Therapeutics is now preparing to meet with the FDA to agree on a coordinated development pathway in the US and EU.”
Prof. Dr. Wolfgang Stremmel, Director Dept. Gastroenterology, University Hospital Heidelberg, commented: “I am extremely excited that our research on the contribution of a deficit in mucosal phosphatidylcholine to the pathogenesis of ulcerative colitis has led to the development of a novel treatment option which is now going into pivotal clinical trials.