Date: 2017-03-31

Type of information: Licensing agreement

Compound: Envarsus® XR (tacrolimus)

Company: Veloxis Pharmaceuticals (Denmark) Taiba Healthcare (Sultanate of Oman)

Therapeutic area: Transplantation - Renal diseases - Kidney diseases

Type agreement: licensing - commercialisation - distribution

Action mechanism: immunosuppressive agent. Envarsus® XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus.

Disease: prevention of organ rejection in kidney transplant patients

Details: • On March 31, 2017, Veloxis Pharmaceuticals announced that its US subsidiary, Veloxis Pharmaceuticals, Inc., has entered into an exclusive license, supply and distribution agreement with Taiba Healthcare, a leading healthcare marketing, distributor and retail pharmacies group known regionally for a focus on specialty and rare diseases, to register, commercialize and distribute Envarsus XR in certain countries throughout the Middle East and North Africa (MENA) region. Under the terms of the agreement, Veloxis will receive an up-front payment and a one-time sales milestone based on achievement of a certain sales target. Veloxis will supply Envarsus XR to Taiba for sale in the Territory at a pre-agreed transfer price. The initial term of the agreement runs for 10 years from the date the product is approved in each country in the Territory.

Financial terms:

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Is general: Yes