The company has entered a non-binding term-sheet with STADA Arzneimittel for cooperation regarding sales and marketing of Spherotide for Europe, and furthermore, the company updates on its plans to take the product into a phase III study in endometriosis patients.
Non-binding term-sheet with STADA
The company´s non-binding term-sheet with STADA consists of an agreement to cooperate on Spherotide regarding development, sales and marketing for Europe. The non-binding terms of the agreement means that the parties intend to share continued development costs related to Europe and the profit from the sale of the product in Europe. The non-binding agreement also includes development-based milestones, in total amounting to a low single-digit million-euro value. If the due diligence and negotiations proceed according to plan Xbrane and STADA are expected to enter into a binding agreement during 2019[1].
Further development of Spherotide
Xbrane develops two formulations of Spherotide, one administrated once a month and one administered every third month. Xbrane plans to conduct a pivotal phase III trial with the 1-month formulation in approximately 150 endometriosis patients in China and Europe to support market authorization for endometriosis, myoma and breast cancer indications in both regions. Clinical trial application is expected to be submitted during the second half of 2019 after: 1) final binding agreement with STADA is in place; 2) completion of ongoing upgrade of the quality system at Xbrane’s contract manufacturer ICI (expected to be finalized in summer 2019); and 3) conducted scientific advisory meeting with NMPA (National Medical Products Administration in China). Based on the interim data from the endometriosis trial, clinical trials in prostate cancer patients for both 1-month and 3-month formulations will follow.
[1] The non-binding term-sheet that has been signed does not constitute any guarantee for that a binding agreement will be signed.
Photo of Martin Åmark, CEO, Xbrane
