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Tenax Therapeutics announces global license amendment that significantly expands rights to levosimendan.

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Published:21st Feb 2024

Tenax Therapeutics, Inc., a Phase III, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced it has secured global development, commercial, and IP rights to oral and subcutaneous levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)

“We are delighted to enter into this important amendment to our license from Orion. We have achieved a key corporate objective by expanding our development, IP, and commercial territory rights for levosimendan beyond North America,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “By gaining these worldwide rights, we are now positioned to realize a much larger share of this unique and exciting cardiovascular medicine’s value, including through the possible establishment of a global strategic alliance.”

To further maximize the value of these new global commercial rights, Tenax continues to collaborate with Orion in pursuit of additional IP protection for levosimendan use in PH-HFpEF in numerous key countries where Tenax now holds the commercial rights. Tenax hopes to provide additional updates in the coming months regarding additional international IP protection.

Effects of the amendment: i. Tenax gains global development, commercial, and IP rights for oral and subcutaneous formulations in PH-HFpEF. ii. Tiered net sales royalty rates, ranging from high single-digit to low-teen percentages, are payable to Orion. iii. Milestones are payable to Orion based on achievement of net sales targets and certain regulatory approvals, including an additional milestone payment due upon regulatory approval in Japan iv. Improved terms related to transfer price/cost of goods. Tenax’s right of first negotiation to commercialize new applications of levosimendan developed by Orion no longer applies to neurological indications, while Tenax retains such right for all other indications.

Condition: Pulmonary Hypertension + Heart failure
Type: drug

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