On 2 September – Cessatech A/S (“Cessatech” or “the Company”) releases a short Question and Answers (Q&A) overview, based on the positive feedback and questions received from investors following the agreement with Proveca on CT001.
- How many potential partners have you had dialogue with for Europe?
A: We have had several discussions with 6-7 companies, and the process has taken longer than expected. It was not until our meetings with Proveca that we felt confident about finding the best match for our objectives and aspirations.
- What are your peak sales expectations – and when to anticipate this?
A: Too early to give any revenue guidance, as the price and reimbursement discussions will be the first ‘hurdle’ to overcome, and this can in some markets take time. Proveca has given their own top-level target; high-double digit million euros’
- When do you expect revenue (royalties) from the agreement?
A: We expect a launch sometime in 2026, pending the final study, regulatory process and pricing discussions etc, but both companies will be working hard to have the first countries launches in 2026.
- When will you give the next Company presentation, and where?
A: Soon, and sorry for not being more clear on the timing but we want to combine this with an update on the upcoming US launch. Thanks for having patience.
- Did you consider ‘going alone’ in Europe, and then without a partner?
A: Yes, we have had discussions with the Board around going alone, but Europe is not easy especially for pricing, reimbursement and commercialization, it will be too costly for us – and we learned that we could not do it better than Proveca.
- Can you say more/level about the upfront payment?
A: We agreed with Proveca not to share any financial details, but for us a higher royalty was more important as we believe the product has a large potential.
- Is US or Europe more important for Cessatech?
A: From the beginning we have been very keen on making the product (CT001) available to as many as possible, as we are still too small for being engaged with own operations in both US and Europe, and currently US is a bigger aspiration (also long-term).
- What are the timelines for CT002 and expectations?
A: We are mostly in planning mode, but we have initiated early work within formulation development and will revert later this year with more details, but overall CT002 has a great potential, which is also acknowledged by Proveca.
- What is the biggest upside with this partnership?
A: Proveca is a smaller player, but very dedicated towards medicine for children – and this is super important, being able to understand the implications but also the opportunities commercially. We could not have found a better partner.
- What are the next steps, and when do you expect regulatory filling?
A: First, we need to finalize the ongoing study, and then we will submit the device for regulatory opinion (MDR), before we can submit the entire regulatory file to EMA, and several commercial activities will also start now.
For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com
About Cessatech
Cessatech A/S is a Danish pharmaceutical company committed to developing and commercializing evidence-based and innovative medicines for children for the treatment of paediatric acute pain. Its lead asset (CT001) is an analgesic nasal spray for the treatment of acute and planned painful procedures in children. The advantages include needle-free administration, easy administration, a fast-acting therapeutic effect, and being medically approved for children. CT001 is at its pivotal stage of clinical development, and CT002 is at the early development phase.
