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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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GLOBENEWSWIRE (Distribution ID 8925525)

Acino acquires selected Aspen brands in South Africa

Zurich, Oct. 22, 2021 (GLOBE NEWSWIRE) — ZURICH, Switzerland, 22 October 2021 – Acino and Aspen Pharmacare Holdings Limited and its subsidiaries (collectively, "Aspen") have signed an agreement for Acino to acquire six South African prescription medicines for over 105 million (R1.8 billion).

The acquired medicines are used for the treatment of gastroenterology, erectile dysfunction and cardiovascular diseases. The acquisition will further strengthen Acino's footprint in South Africa by expanding their offering in these important therapeutic segments.

The transaction includes the Trustan , Altosec , Zuvamor , Ciavor , Grantryl and Aspen Granisetron brands. To secure uninterrupted patient access to these medicines, the parties have also signed a manufacturing and supply agreement in terms of which Aspen will supply the Aspen manufactured products to Acino for a period of seven years.

This partnership is a compelling affirmation of Acino's long–term strategy and purpose to increase people's access to affordable healthcare in the areas where they need them most. This acquisition comes on the heels of a series of other strategic investments, including the acquisition of a women's health portfolio in Russia earlier this year and Takeda's primary care portfolio in 2020.

"This agreement will fortify Acino's presence in South Africa and enable us to expand our diverse portfolio of high–quality, innovative treatments that help improve people's lives", said Steffen Saltofte, CEO of Acino. "Acino is committed to growing its footprint across our core emerging markets to deliver the best value to our patients, customers, suppliers and shareholders."

John Norman, Regional Director English–Speaking Africa at Acino said, "I am very pleased to sign this agreement with Aspen. We work hard to make a meaningful contribution to the South African economy by providing best–in–class products and service to our patients and healthcare practitioners, as well as creating employment opportunities. This further aligns with our commitment to transformation and retaining our BBBEE Level 1 certification. With this acquisition, Acino will enhance the value of these brands through our in–depth expertise and experience in the market."

Aspen's Group Chief Executive, Stephen Saad, said, "This transaction forms part of Aspen's communicated strategy to refine its product portfolio in South Africa. The acquisition of these trusted brands in South Africa represents excellent scaling and commercial opportunities for Acino as it expands its footprint in South Africa by adding these products to its existing product portfolio."

The transaction is subject to customary closing conditions, including regulatory approvals. It is anticipated that the transaction will complete by 31 December 2021.

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About Acino

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Russia, the CIS Region, and Latin America. The company is backed by Nordic Capital and Avista Capital Partners. 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, visit www.acino.swiss. Acino has attained Level 1 BBBEE status in South Africa in 2020 and 2021. For more information: www.acino.swiss

About Aspen

Headquartered in Durban, South Africa, Aspen is a leading global specialty and branded multinational pharmaceutical company in both emerging and developed markets.

Aspen improves the health of patients in more than 150 countries through its high quality, affordable and effective healthcare solutions. The Group's key business segments are manufacturing and commercial pharmaceuticals comprising regional brands and sterile focus brands that include anaesthetics and thrombosis products.

Aspen employs approximately 9,100 people and has 70 established business operations in over 50 countries. The Group operates 23 manufacturing facilities across 15 sites and holds international manufacturing approvals from some of the most stringent global regulatory agencies. Its manufacturing capabilities are scalable to demand and cover a wide variety of product–types including steriles, oral solid dose, liquids, semi–solids, biologicals and active pharmaceutical ingredients. For more information visit www.aspenpharma.com

For more details, please contact:

Acino

Media Relations
Larisa Bernstein
Head of Corporate Communications

Acino International AG

larisa.bernstein@acino.swiss

Aspen

Media Relations
Shauneen Beukes
Aspen Group Communications Manager

sbeukes@aspenpharma.com

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