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Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf Cooperation Council countries and South Africa

Saint–Louis, France and Weil am Rhein, Germany and Zurich, Switzerland, June 24, 2024 (GLOBE NEWSWIRE) — Allecra Therapeutics (“Allecra”) and Acino today announced the signing of an exclusive licensing agreement under which Acino gains the rights to commercialise Allecra’s antibiotic drug EXBLIFEP® (cefepime/enmetazobactam) within the Republic of South Africa and the member states of the GCC alliance, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, effective from 12 June 2024. In addition, the companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the above territories.

“Acino has established itself as a leader in South Africa and the GCC region. They are an ideal partner to support us as we build towards commercialisation of EXBLIFEP® following our regulatory approvals in the US and EU,” stated Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics. “This agreement reflects the understanding that there remains a significant global need to address the dangerous increase of resistance to standard–of–care antibiotics, and we look forward to working with Acino to address this.”

“At Acino, we are dedicated to providing novel healthcare solutions to physicians and patients, aiming to alleviate the health burden in emerging markets. We are incredibly excited to partner with Allecra to offer access to this innovative product in two key geographic regions and, potentially, beyond,” said Andrew Bird, CEO (ai) at Acino. “We are committed to expediting the registration process in these designated markets to ensure hospitals’ swift access to EXBLIFEP® as they continue to fight against high–risk infectious diseases in patients.”

About EXBLIFEP® (cefepime/enmetazobactam)

EXBLIFEP® is an intravenous antibiotic fixed–dose combination of enmetazobactam, a novel extended–spectrum β–lactamase inhibitor belonging to the penicillanic acid sulfone class, with the fourth–generation cephalosporin cefepime. Enmetazobactam has been shown to restore the efficacy of cefepime against some multi–drug resistant bacteria, including ESBL–producing pathogens alone or in combination with some resistant β–lactamase mutations as OXA–48 or AmpC, which are increasing in Europe and for which there are few therapeutic alternatives.

EXBLIFEP® demonstrated statistically significant superior overall treatment success in Allecra’s pivotal Phase III ALLIUM trial, which compared 1034 randomized patients receiving either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g every 8 h as 2 h continuous intravenous infusion in a multi–centre, randomized, controlled, double–blind, global study in 112 sites within nineteen countries.

In February 2024, the U.S. Food and Drug Administration (FDA) approved EXBLIFEP® as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in patients 18 years and older. In March 2024 the European Commission (EC) granted marketing authorisation for EXBLIFEP® for the treatment of adult patients with cUTI, including pyelonephritis; hospital–acquired pneumonia (HAP), including ventilator–associated pneumonia (VAP); and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed previously.

About Allecra Therapeutics

Allecra Therapeutics, founded in 2013, is a private, clinical–stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate EXBLIFEP® (cefepime/enmetazobactam), has successfully completed a randomized, controlled, double–blind, global Phase 3 trial compared to standard of care in patients with complicated urinary tract infections (cUTIs). Based on these results, the company has received FDA marketing approval in the U.S. and announced approval in the European Union for EXBLIFEP® earlier this year.

Allecra has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors include Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit www.allecra.com for further information.

About Acino

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high–quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out–licensing. For more information, please visit www.acino.swiss.

Acino is part of Arcera, a global company in the life sciences sector headquartered in Abu Dhabi, United Arab Emirates. Arcera was established by ADQ, an Abu Dhabi–based investment and holding company, to build a global life sciences powerhouse poised to make significant contributions to realising the UAE’s aspiration to emerge as a frontrunner in science and technology. To learn more about Arcera, please visit www.arceralifesciences.com.

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Acino significantly expands presence and capabilities in Latin America through acquisition of M8 Pharmaceuticals

Zurich, Switzerland, Sept. 20, 2023 (GLOBE NEWSWIRE) — Acino, a Swiss pharmaceutical company headquartered in Zurich, today announced that it has entered into an agreement to acquire M8 Pharmaceuticals (M8), a fast–growing specialty biopharmaceutical company, headquartered in Mexico City and focused on licensing, marketing, and distributing innovative and established medicines in Mexico and Brazil.

Through this acquisition, Acino will enter the two largest pharmaceutical markets in Latin America, significantly expanding its geographic footprint and strengthening its position in the region, providing a more powerful and comprehensive offering for healthcare professionals and patients. The acquisition will complement Acino's existing Latin American division, which is based in Panama and operates across eight countries in Central America, the Caribbean, and Ecuador, delivering high–quality medicines to improve people's health in this key region.

M8, a Montreux Growth Partners portfolio company, has a highly successful record of signing exclusive licensing agreements with large pharmaceutical and biotech companies for the rights to market and commercialize products in Latin America. M8 brings a portfolio of well–known proven brands and innovative products, a best–in–class deal–making platform and an outstanding reputation among its partners. Moreover, it has built a large pipeline across a broad range of key therapeutic areas, including CNS, cardiometabolism, respiratory, gastroenterology, oncology and hematology, and rare diseases.

Andrew Bird, Interim CEO at Acino commented: "This is a transformative deal for Acino, significantly expanding our presence in Latin America and delivering against our overall strategy and stated intention to increase patient's access to high–quality pharmaceuticals and diversify our footprint in key high–growth markets. We see M8 and Acino as highly complementary offerings, and we are confident that we can use this acquisition as a catalyst to further increase value and accelerate growth for Acino in this key region."

Joel Barlan, CEO at M8 commented: "This agreement will provide M8 with considerable additional resources, expertise, and access to a much wider geographic footprint, which will further accelerate our growth. We look forward to leveraging the skills and capabilities of both teams to grow the combined business and continue to bring proven and innovative treatments to patients and caregivers throughout Latin America and other emerging markets."

Dan Turner, Managing Director at Montreux Growth Partners commented: "We could not be more pleased with what M8 has achieved during our ownership. We first invested in the early stages of its development. We were able to bring on board a world–class management team, who have focused the company on patient critical therapeutic areas, with a product portfolio that now includes over 30 leading brands from major pharmaceutical companies around the world. The company has delivered tremendous growth and profitability, while also doing much good for the lives of patients. Acino is the perfect acquirer to continue that history of success".

The transaction is subject to customary closing conditions, including antitrust clearance, and is expected to be completed by the end of 2023. Banco J.P. Morgan S.A. is acting as exclusive financial advisor, Goodwin LLP as exclusive legal advisor, and PWC as exclusive accounting and tax advisor to Acino. Stifel, Cooley LLP and Credit Suisse, a UBS Group Company acted as advisors to M8.

–ENDS–

About Acino

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. Acino is part of ADQ, an Abu Dhabi based investment and holding company. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high–quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out–licensing.

About M8 Pharmaceuticals

M8 is a specialty biopharmaceutical company focused on licensing, marketing and distributing innovative and established therapeutics in Latin America: Brazil and Mexico. We aim to become the preferred pharmaceutical partner for the licensing of high–value innovative and proven therapies across our main therapeutic areas CNS, respiratory, cardiometabolic, immunology, gastroenterology, onco–hematology, and rare diseases. Our mission is to provide the people of Latin America with access to the proven and innovative medicines they need to transform their lives.

About Montreux Growth Partners

Founded in 1993, Montreux Growth Partners has a long history of investing growth capital into category–leading companies that are advancing healthcare and financial technology. It focuses on commercial stage companies which have highly differentiated products, technologies, and services. It is an active and collaborative investor, working closely with the management teams at its portfolio companies.

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