Saniona har ingått ett partnerskap med Acadia Pharmaceuticals för att utveckla och kommersialisera SAN711. Affären har ett totalt potentiellt värde om 610 miljoner USD, inklusive en förskottsbetalning på 28 miljoner USD—nästan lika mycket som Sanionas marknadsvärde innan tillkännagivandet. BioStock kontaktade vd Thomas Feldthus för en kommentar.

SAN711 är en first-in-class positiv allosterisk modulator av GABAA α3-receptorer, som tagits fram med hjälp av Sanionas egenutvecklade proprietära plattform för läkemedelsupptäckt inom jonkanaler. Igår offentliggjorde Saniona ett licensavtal med amerikanska Acadia Pharmaceuticals för SAN711 inom neurologiska sjukdomar.

Acadia ska finansiera och styra den fortsatta kliniska utvecklingen av SAN711, hantera dess regulatoriska processer och ansvara för den global kommersialiseringen av kandidaten. Saniona, å sin sida, kommer att övervaka slutförandet av den pågående fas I-studien och bistå i förberedelserna inför fas II.

Acadia planerar att inleda en fas II-studie inom ”essentiell tremor” som en första indikation under 2026. Essentiell tremor är ett neurologiskt tillstånd som kännetecknas av ofrivilliga skakningar för vilket det idag råder stor brist på effektiva behandlingsalternativ.

Affärens finansiella struktur

Avtalet inkluderar en förskottsbetalning om 28 miljoner USD och en potential för upp till 582 miljoner USD i milstolpsbetalningar. Den första milstolpsbetalningen om 10 miljoner USD utlöses när den första fas II-studien inleds. Dessutom är Saniona berättigat till trappstegsbaserade royaltybetalningar från medelstora ensiffriga till låga tvåsiffriga procenttal på nettoförsäljningen av de kommersiella produkter som kan utvecklas från SAN711.

De potentiella milstolpsbetalningarna

Ytterligare betalningar aktiveras vid efterföljande steg i utvecklingen. Till exempel kommer 147 miljoner USD betalas ut vid milstolpar för klinisk utveckling, vid regulatoriska målsättningar och/eller vid tagna kommersialiseringssteg inom potentiella första och andra indikationer. Att avtalet är strukturerat på detta sätt tyder på att ytterligare indikationer utöver essential tremor kan komma att utforskas i framtiden.

Därtill kommer Saniona att erhålla upp till 435 miljoner USD baserat på uppnådda tröskelnivåer för den årliga globala nettoförsäljningen av SAN711.

Vd kommentar

BioStock kontaktade med vd Thomas Feldthus för en kommentar kring avtalet.

Thomas, what does this partnership mean for Saniona’s future, and what are its broader implications for the company?

— Acadia is an exciting company that shares our vision and is dedicated to developing SAN711 for essential tremor and other indications. This partnership demonstrates the value of our early-stage pipeline and our ability to monetize this value. Finally, it restores our balance sheet and enables us to develop some of our other assets.

How will the USD 28 million upfront payment impact the company’s immediate priorities?

— The deal includes an upfront payment and an early-stage milestone payment, plus certain payments to the ongoing Phase 1 study and other services. This adds up to around 40 million USD prior to the start of Phase 2. This amount enables us to move several assets forward to the next inflection point.

Why was essential tremor chosen as the first indication for SAN711?

— Essential tremor is interesting due to the size of the market and the medical need in this indication. It is a relatively common disease that affects about 5 per cent of adults over the age of 60. Many patients are not well treated with the current drugs, and the pipeline of new drugs is thin. This indication also fits well into Acadia’s current products and pipeline.

And what makes Acadia the right partner for SAN711’s global development and commercialization?

— Acadia has successfully developed and commercialized several first-in-class products for various indications, including a drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and a drug for the treatment of Rett syndrome. SAN711 fits very well into Acadia’s pipeline and product portfolio.

— Acadia is directly represented commercially in the most important market, America, and has established partnerships in other major markets.

How does SAN711 stand out in the landscape of neurological treatments?

— SAN711 represents a precision approach as it only modulates one type (GABAA a3) of the many different GABAA ion channels in the brain. GABAA a3 accounts for only 5% of the GABAA ion channels in the brain. However, these ion channels are almost exclusively expressed on neurons found in a small area called the cortico-thalamic (TRN) system.

— This means that SAN711 can slow down the firing of the neurons in this area without affecting other areas in the brain. Therefore, SAN711 is highly relevant for treating neurological diseases caused by too much activity in this area of the brain. This precision approach means that SAN711 has very few side effects.

The deal suggests that more indications could be explored later on. Can you comment on this?

— There are several diseases and medical conditions where it could be beneficial to slow down the activity of neurons in the cortico-thalamic (TRN) system including neurological disease such as essential tremor and absence seizures as well as other types of diseases such as certain sleep disorders and neuropathic pain.

What role will this deal play in advancing Saniona’s broader pipeline?

— It is very challenging for biotech companies to finance the development of their pipeline under the current financial conditions in the Swedish ecosystem. We have now resolved this problem ourselves for the next several years.

Finally, what opportunities could it create for future partnerships?

— As mentioned, there is a good fit between the companies. We are strong in drug discovery and early clinical development, whereas Acadia is strong in late-stage development and commercialization. I trust that our relationship will be strengthened in the coming period. It is much easier to communicate with people you know and trust. This may serve as a base for new collaborations in future.

— We have had several collaborations with the same companies or the same people in the past. Boehringer Ingelheim is a good example. AstronauTx is another good example, as we have worked with several of the people in AstronauTx in the past through their roles in other companies.

— The deal with Acadia also represents a significant deal, which may indirectly promote our company in the industry.

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