3.1 Cessatech’s solution
The Company’s first product and lead asset, CT001, is an analgesic non-invasive nasal spray for
children aged 1-17 years that experience acute pain or pain related to medical procedures.
Today’s analgesic solutions often require an intravenous access which is not always feasible or
easy and can be painful. In contrast, CT001 has a fast onset and is easy to use. Its composition
includes a fixed combination of the two well-known analgesics ketamine and sufentanil (an
opioid), which are already approved treatments for injection in adults. The two compounds are
also used separately for analgesia but only intravenously in children. The potential advantages of
the fixed combination of sufentanil and ketamine include improved analgesia with approx. 30
percent lower dose of sufentanil and consequently the avoidance of undesirable side effects such
as prolonged sedation and risk of respiratory depression.
With funding from the Novo Nordisk Foundation and the Capital Region of Denmark - in 2014 and
2016 - CT001 has been developed as a ready-to-use nasal spray. These grants, which were given
to Rigshospitalet for the founders’ research project before it was incorporated in Cessatech, have
further covered the process of obtaining the approved Paediatric Investigation Plan as well as a
clinical registry study (0203), which has just been finalized and communicated. Also, a Phase II
study was earlier conducted at Rigshospitalet in Denmark, where a total of 50 children were
treated for procedural pain. The nasal spray was confirmed effective, with a maximum pain score
during the painful procedure of 5 or less on a 0–10 scale (0 indicating no pain and 10 the worst
imaginable pain) in 78 percent of the children. Furthermore, no serious adverse events were
reported. Almost all (94 percent) of the children or parents (for preverbal children) stated that they
would like to receive this treatment again in a similar situation rather than analgesic suppositories,
tablets, oral solutions, or injections.
Cessatech has entered into an agreement with Rigshospitalet. The agreement regards the
assignment of the analgesic nasal spray CT001 to Cessatech, including data, patent rights and
other relevant documents as well as an exclusive license to, among other things, develop and sell
the product. For this, Cessatech will pay a royalty of 1% on all net sales to Rigshospitalet as well
as a royalty of ten (10) percent on all revenue received from sub-licensees irrespective of the
revenue originates from jurisdictions where there is a valid claim or not. The royalties shall be
reported and paid annually to Rigshospitalet. Cessatech is solely responsible for the
development, manufacture and sale of CT001 as well as the commercialization and the patent
rights and the Company or collaboration partners shall bear all costs related thereto.
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