Exclusive collaboration and co-development agreement for NTCD-M3 with Sebela Pharmaceuticals® worth up to $570m plus royalties
- Partnership with Sebela will finance the future clinical development and commercialization costs of NTCD-M3 in North America
- Destiny Pharma retains majority rights for Europe and ROW
- Key strategic target achieved for NTCD-M3
Brighton, United Kingdom – 24 February 2023 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce that it has signed an exclusive collaboration and co-development agreement for the North American (U.S., Canada and Mexico) rights of NTCD-M3, its lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence, with Sebela Pharmaceuticals®, a U.S. pharmaceutical company with a market-leading position in gastroenterology.
Under the terms of the deal, it is anticipated that Sebela will lead and finance the future clinical development and commercialisation activities of NTCD-M3 in North America. The Company retains the majority of rights for Europe and Rest of the World and Sebela has a minority interest in any income generated in these non-North American territories based on the clinical studies it is funding.
The agreement, which could be worth up to $570m to Destiny Pharma in milestones alone, includes;
· an initial upfront payment of $1m;
· success-based development milestones of $19m;
· sales revenues-based milestone payments up to $550m; and
· tiered, double-digit royalties.
Destiny Pharma has the obligation to continue its current plan to complete the ongoing manufacture of all clinical trial supplies needed to undertake the required clinical studies. It is anticipated that Phase 3 studies will commence in 2024.
Commenting on the announcement, Neil Clark, Chief Executive Officer of Destiny Pharma, said:
“We are very pleased to have reached this agreement with Sebela, a high quality, GI specialist company which has the necessary clinical development and commercialisation expertise to take NTCD-M3 through to launch. Such partnering deals are in line with our stated strategy of finding pharma partners to undertake the required Phase 3 clinical studies of our lead assets thus reducing the funding requirements of the Company.
“This deal is not only great news for the many thousands of patients that suffer from C. difficile infections each year but is also a tremendous endorsement of Destiny Pharma’s approach. In a little over two years since acquisition, we have managed to re-activate NTCD-M3 as a very exciting and valuable clinical candidate and find a commercialisation partner in Sebela with the capabilities to implement and fund all further clinical development costs as well as funding NTCD-M3’s launch and commercialisation in the key U.S. market. Destiny retains control over the rights for Europe and the Rest of the World (excluding China region), which we believe, together with our XF-73 programs, contain significant value potential.”
Commenting on the announcement, Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals said:
“We are delighted to partner with Destiny Pharma to advance NTCD-M3 to Phase 3 and plan for commercialization in the U.S. NTCD-M3 provides a unique and differentiated approach to prevent the recurrence of C. difficile infection and represents a significant addition to our valuable development pipeline.”
Full Press Release available here.