ACS Biomed Signs Exclusive Five-Year LATAM Distribution Agreement with Axentra Pharma

Five-year agreement covering Mexico, Brazil, Venezuela, the Dominican Republic and Central America includes €10.6 million in contracted Minimum Purchase Obligations and marks the company's first major international commercial expansion.

ACS Produzioni Biomed S.r.l. (“ACS Biomed”), an Italian biotechnology company focused on the development of innovative topical solutions for Herpes Simplex Virus (HSV) infections, has signed a five-year Exclusive License and Distribution Agreement with Axentra Pharma, a pharmaceutical distribution company headquartered in Mexico, covering five strategic territories across Latin America.

The agreement represents ACS Biomed's first major international commercial partnership and establishes a long-term framework for the commercialization of ErpeCream® and ErpeLips® throughout Mexico, Brazil, Venezuela, the Dominican Republic and selected Central American markets.

Under the terms of the agreement, Axentra Pharma has committed to contracted Minimum Purchase Obligations (MPOs) valued at approximately €10.6 million over the initial five-year period, corresponding to approximately 2.8 million units of ErpeCream® and ErpeLips®. The agreement also includes an option for renewal for an additional five-year term, subject to the commercial performance and mutual agreement of both parties.

A Structured Commercial Partnership

Unlike non-binding commercial discussions or letters of intent, the agreement signed with Axentra Pharma establishes defined contractual commitments designed to support the long-term commercial development of ACS Biomed's HSV product portfolio across Latin America.

The contracted Minimum Purchase Obligations represent binding purchase commitments included within the distribution agreement and provide an important commercial foundation for the company's international expansion strategy. Commercial sales will commence following completion of the applicable regulatory procedures within each territory.

The partnership combines ACS Biomed's proprietary formulation technology with Axentra Pharma's established commercial infrastructure and regional distribution network, creating a scalable platform for market expansion throughout Latin America.

Regulatory Programme Already Underway

Following execution of the agreement, the parties have initiated the regulatory roadmap required for commercial launch.

Regulatory submissions are scheduled to begin with COFEPRIS in Mexico and ANVISA in Brazil, representing the two largest pharmaceutical markets in the region.

The products will initially be submitted under the dermocosmetic regulatory pathway, enabling commercial market access while supporting the company's broader international strategy. In parallel, ACS Biomed intends to pursue subsequent registration under the Medical Device Class I regulatory pathway, where applicable, as part of its long-term product positioning strategy.

Additional regulatory programmes for the remaining territories covered by the agreement will be implemented according to the commercial launch schedule agreed between the parties.

Addressing a Significant Regional Healthcare Market

Latin America represents one of the largest addressable markets for recurrent herpes simplex infections worldwide.

Millions of adults across the region experience recurrent HSV-1 and HSV-2 infections, creating sustained demand for accessible topical therapeutic solutions. Despite the size of this market, treatment options remain relatively limited, particularly within the premium dermocosmetic segment.

ACS Biomed believes that the combination of its proprietary botanical nanoemulsion technology, growing scientific documentation and international regulatory strategy positions the company to address an important unmet commercial opportunity within the region.

Supporting the Company's International Growth Strategy

The agreement with Axentra Pharma represents an important milestone in ACS Biomed's long-term corporate development.

Alongside its ongoing European commercial activities and Phase IIb clinical development programme, the LATAM partnership reflects the company's strategy of combining current commercial revenues with continued pharmaceutical development.

The international expansion programme is designed to create multiple value drivers through commercial distribution, regulatory progression and future pharmaceutical licensing opportunities.

Parallel business development discussions continue across additional international territories, including selected African markets, North America and Europe, as ACS Biomed seeks to establish a broader global commercial presence for its HSV portfolio.

With the execution of its first major international distribution agreement, ACS Biomed has taken a significant step in transforming its proprietary technology platform into an internationally commercialized healthcare business, supported by long-term distribution partnerships, scientific development and a structured regulatory strategy.