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Nestlé Health Sciences gains development, commercialization rights for novel UC therapy
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Lipid Therapeutics today announced it has licensed Nestlé Health Sciences with exclusive global rights — excluding Europe and Australia — for LT-02, a novel barrier function treatment for mild-to-moderate ulcerative colitis.
LT-02 (phosphatidylcholine) targets barrier function of the colon in patients with mild-to-moderate UC, and has been shown to improve disease activity in mesalazine-refractory patients in a recent phase 2b trial, according to a press release.
Under the terms of the agreement, Nestlé will pay an upfront fee, milestone payments and royalties on net sales, and will be responsible for ongoing development and commercialization of LT-02 in its territories, according to the press release.
As part of a global phase 3 development program aiming to support regulatory approval of the treatment, phase 3 clinical trials evaluating LT-02 as an adjunct treatment in UC patients who do not have adequate response to 5-aminosalicylic acid are expected to commence in the U.S. in 2016. Furthermore, Lipid’s European co-development partner, Dr. Falk Pharma GmbH, announced a similar phase 3 trial began in October 2014.
“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,” Gerhard Keilhauer, PhD, CEO of Lipid Therapeutics, said in the press release. “Together with Dr. Falk, our development partner in Europe, Nestlé Health Science will provide the resource and expertise to progress LT-02 through phase 3 development and approval in the key U.S. and European markets. With these agreements in place, I am confident that the huge potential of our novel therapy is being successfully translated into significant value for our company.”
“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,” Jan Adams, MD, partner at EMBL Ventures, said in the press release. “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.”
“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,” Greg Behar, CEO of Nestlé Health Science, said in the press release. “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.”
Disclosures: Keilhauer reports he is an employee of Lipid Therapeutics. Adams reports he is an employee of EMBL Ventures. Behar reports he is an employee of Nestlé Health Sciences.