SynAct Pharma Signs First Commercial Partnership for Resomelagon with Leading Brazilian Pharmaceutical Company

The partnership will draw on Hipolabor’s established regulatory, manufacturing, distribution and commercial capabilities in Brazil to support the development and potential commercialization of resomelagon for dengue treatment. Importantly, SynAct retains full control over resomelagon and the flexibility to pursue additional development and commercialization partnerships across other indications and territories.

Resomelagon is being developed as a short-term outpatient treatment aimed at alleviating key symptoms of dengue and reducing the risk of progression to severe disease. More than one million patients in Brazil are estimated to seek medical care for dengue each year, highlighting the significant unmet medical need. Resomelagon may offer a promising treatment option, particularly for patients exhibiting a heightened inflammatory response, such as high fever, who are at increased risk of developing severe disease.

The collaboration builds on SynAct’s ongoing RESOVIR-2 clinical development program, with Results from Part 1 expected in 2026 pending feedback from regulatory authorities, topline results of full study expected during the second quarter of 2027, as well as ongoing activities under its RESOVIR research collaboration.

Key terms of the agreement include:

• Commercialization: A commercial license agreement providing for an equal (50/50) profit-sharing arrangement, alongside additional sales milestone payments linked to cumulative net sales of USD 200 million.
• Co-development: An equal (50/50) sharing of development costs associated with pursuing regulatory approval of resomelagon for the treatment of dengue in Brazil.
• Retained rights: SynAct maintains full control over resomelagon, including the flexibility to pursue development and commercialization opportunities across other indications and territories.

“We are delighted to have entered into this agreement with Hipolabor, marking an important milestone in the development of resomelagon. Hipolabor’s established manufacturing, regulatory and distribution capabilities provide a strong foundation for advancing resomelagon towards commercialization in Brazil,” said Jeppe Øvlesen, Chief Executive Officer of SynAct Pharma. “Importantly, this partnership represents a significant step for the broader potential of resomelagon, fueling our ability to pursue future global and regional partnerships in rheumatoid arthritis, dengue, and other inflammatory diseases.”

“Dengue virus represents a true global health issue and we see Brazil as our foundation for reaching markets in Asia and across the globe. With nearly half the global population at risk of the virus, we look to establish further partnerships to address the high unmet needs,” said Mads Bjerregaard, Chief Business Officer at SynAct Pharma.

The potential of resomelagon as a treatment for dengue has also been recognized by the World Health Organization (WHO), which recently identified resomelagon as one of six therapeutic candidates with evidence supporting further clinical development. Notably, resomelagon is the only host-directed therapy included in the assessment, highlighting its differentiated mechanism of action and potential to reduce the risk of progression to severe disease.

“Dengue is one of Brazil’s most urgent public health challenges, and we are proud to partner with SynAct to confront it head-on. We believe resomelagon has the potential to deliver a safe and effective treatment to the millions of patients across the country who need it,” said Renato Alves, Chief Executive Officer of Hipolabor.

With more than 100 pharmaceutical product registrations, Hipolabor brings extensive regulatory experience and established capabilities to support interactions with Brazil’s national health regulatory agency (ANVISA).

Hipolabor’s nationwide distribution network and established commercial relationships will also support the potential commercialization of resomelagon across hospitals and clinics throughout Brazil.

The parties will actively explore non-dilutive funding opportunities through Brazilian and international organizations focused on dengue and other viral infections.

Subject to the negotiation of a separate supply agreement, Hipolabor may also provide manufacturing and packaging services for resomelagon, supporting potential distribution in Brazil and international markets.

About Hipolabor
Hipolabor is one of Brazil’s leading pharmaceutical companies, with more than 40 years of experience in the development, manufacturing and commercialization of pharmaceutical products. Its portfolio comprises more than 100 registered medicines across various formulations, including injectables, solid and semi-solid dosage forms, and liquids. The company has an established presence in both the hospital and outpatient markets, with a focus on providing safe, effective and accessible pharmaceutical products.

Hipolabor is Brazil’s largest manufacturer of generic injectable medicines and ranks among the country’s ten largest generic pharmaceutical manufacturers, according to the 2024 ANVISA Yearbook. The company employs more than 1,200 people across three facilities, comprising two manufacturing sites and a distribution and storage center, supporting its nationwide operations and supply capabilities.

For more information, please visit: https://www.hipolabor.com.br/

About Dengue
Dengue is a mosquito-borne viral infection caused by the dengue virus (DENV), primarily affecting tropical and subtropical regions. Approximately half of the world’s population is at risk of infection, with an estimated 100-400 million infections occurring annually. While many infections are asymptomatic or result in mild illness, dengue can progress to severe disease and, in some cases, become life-threatening.

There is currently no specific antiviral treatment for dengue, and disease management primarily relies on supportive care, early detection and timely medical intervention. Prevention efforts focus largely on controlling mosquito populations and reducing transmission.

Brazil represents one of the world’s largest dengue markets, with reported cases increasing from approximately 500,000 in 2017 to 3.8 million in 2025, although annual incidence varies considerably. The substantial disease burden highlights the need for effective therapeutic options to alleviate symptoms and reduce the risk of progression to severe disease.

Source: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue accessed on 13 August 2026; PAHO, Integrated Arbovirus Platform (PIA), data registered up to week 31 of 2026

For further information, please contact:
Jeppe Øvlesen
CEO, SynAct Pharma AB
Phone: + 45 2844 7567
E-mail: investor.relations@synactpharma.com

Investors and Media
Mary-Ann Chang, Cohesion Bureau
E-mail: synactpharma@cohesionbureau.com

About SynAct Pharma AB
SynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical-stage biotechnology company pioneering pro-resolution therapies for inflammation through selective activation of the melanocortin system. Its lead asset, resomelagon (AP1189), is a once-daily oral, first-in-class biased agonist of the MC1 and MC3 melanocortin receptors, that has completed Phase 2b development in rheumatoid arthritis, and is in Phase 2 development as host-directed therapy to treat inflammation caused by infections, including respiratory viral infection and dengue. Behind resomelagon, SynAct is building a broad portfolio of oral small molecule and injectable peptide melanocortin agonists designed to induce anti-inflammatory pro-resolution activity, helping patients restore immune balance. For more information, please visit www.synactpharma.com.

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SynAct Pharma signs first commercial partnership for resomelagon with leading Brazilian pharmaceutical company