Date: 2011-06-20
Type of information: Licensing agreement
Compound: PLacental eXpanded (PLX) cells
Company: Pluristem Therapeutics (Israel) United Therapeutics (USA)
Therapeutic area: Rare diseases - Cardiovascular diseases - Lung diseases
Type agreement: licensing
development
commercialisation
Action mechanism:
Disease: pulmonary arterial hypertension
Details: Pluristem Therapeutics announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license agreement with United Therapeutics Corporation for the use of Pluristem’s PLacental eXpanded (PLX) cells to develop and commercialize a cell-based product for the treatment of pulmonary arterial hypertension (PH).
Under the terms of the agreement, United Therapeutics will receive exclusive worldwide licensing rights for the development and commercialization of the future product for treating PH patients. Pluristem will retain all manufacturing rights; participate in the pre-clinical and clinical trial activities, as well as provide the commercial grade product.
Financial terms: Under the terms of the agreement, United Therapeutics will make an upfront payment of $7 million to Pluristem. Pluristem is eligible to receive regulatory milestone payments and other payments accumulating together with the upfront payment to a total of approximately $55 million and reimbursement of costs of its development and clinical activities. United Therapeutics will bear all the costs of conducting the clinical trials for this indication. Following commercialization, United Therapeutics shall purchase commercial supplies from Pluristem at a specified margin over Pluristem’s cost. In addition, United Therapeutics will pay Pluristem specified royalties as a percentage from its gross profits generated from the developed product.
Latest news: On August 3, 2011,Pluristem Therapeutics announced that following the consent of the Office of the Chief Scientist of Israel, Pluristem's exclusive out-license agreement signed on June 19, 2011 with United Therapeutics Corporation for the use of Pluristem’s PLacental eXpanded (PLX) cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension (PH) has become effective as of August 2, 2011.
