Dilafor AB and Lee's Pharmaceutical Holdings Ltd have announced that they have entered into a license agreement.
According to the agreement, Dilafor grants to Lee's Pharmaceutical the right to manufacture, develop and commercialize tafoxiparin for obstetrics and gynecological indications in China, Hong Kong, Macau and Taiwan.
Pursuant to the terms of the agreement, Dilafor and Lee’s Pharmaceutical will jointly develop tafoxiparin for obstetrical and gynecological indications. The joint clinical development program of tafoxiparin will initially be focused on reducing labor times for patients who do not start labor spontaneously and are induced into labor, an indication where both Dilafor and Lee's Pharmaceutical see a major medical need for the product in terms of improving outcomes for both mother and baby.
Dilafor will receive an upfront payment as well as future development and sales milestones plus royalties on sales of the product which will be manufactured and sold by Lee’s Pharmaceutical in China, Hong Kong, Macau and Taiwan.
Lee’s Pharmaceutical will conduct and finance Phase II and Phase III trials in China, so that the results can be used as the basis for additional development outside the countries where Lee’s Pharmaceutical has its license. Further details on the terms of the agreement are not being disclosed.
“We are looking forward to working together with Lee’s Pharmaceutical and to take tafoxiparin into further clinical development”, says Lena Degling Wikingsson, CEO at Dilafor AB.
In addition to the labor induction indication, tafoxiparin is intended to be used for the treatment of labor arrest. Tafoxiparin has previously been tested in a randomized, double-blind and placebo-controlled Phase II trial conducted in Sweden which included 263 pregnant women. The study showed promising results forming the basis for the continuous clinical development.
"We are excited to work with Dilafor to expand the clinical development of tafoxiparin into China. With nearly 20 million babies born each year, China has significant unmet medical needs in maternal health. It is our intention to leverage our available resources to accelerate the development of tafoxiparin in China", says Dr. Benjamin Li, founder and CEO of Lee’s Pharmaceutical.
“We are very pleased with this license agreement with Lee’s Pharmaceutical. We believe Lee’s Pharmaceutical will be an excellent partner for Dilafor in the further development and commercialization of tafoxiparin. Through KDev Investments AB, we own 49% of Dilafor and this agreement will add value to potential future deals covering all other markets outside China, Hong Kong, Macau and Taiwan”, says Torbjörn Bjerke, CEO of Karolinska Development.