- Amendment to existing exclusive license agreement with Orion Corporation expands Tenax’s territory rights from
North America , to the entire world - Expanded rights position Tenax to engage potential global strategic pharmaceutical partners
- Improved net sales royalty rate structure, now ranging from high single-digit to low-teen percentages. Lowered maximum cost of goods
- Modified milestone provisions, including additional payment for regulatory approval in
Japan , reflect multi-billion dollar global PH-HFpEF opportunity - Neurological indications excluded from Tenax’s right of first negotiation to commercialize new applications of levosimendan developed by Orion
“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
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:
- Tenax gains global development, commercial, and IP rights for oral and subcutaneous formulations in PH-HFpEF
- Tiered net sales royalty rates, ranging from high single-digit to low-teen percentages, are payable to Orion
- 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 - 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.
“Our efforts to secure global commercial rights and leverage the additional potential IP protection around the world enable us to build significant shareholder value as we advance levosimendan into Phase 3 testing,” said
About the Phase 3 LEVEL Study (NCT05983250)
The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF. Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12. The primary outcome measure for the study is six-minute walk distance from Baseline to Week 12. All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
About Levosimendan (TNX-101, TNX-102, TNX-103)
Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in
About
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Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our need to raise additional funds to pursue our business; risks related to our business strategy, including the prioritization and development of product candidates; intellectual property risks; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks related to our continued listing on Nasdaq; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of the COVID-19 pandemic or similar health epidemics and geopolitical uncertainties such as in
Contacts
Investor Contact:
Managing Director
C: 917-355-2395, or
C: 203-461-1175
Source:
2024 GlobeNewswire, Inc., source