Dublin, Ireland – 4 September 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and Adalvo Ltd. (“Adalvo”) today announced the signing of a license and supply agreement for Rifamycin SV with MMX® technology in Europe, Asia-Pacific (APAC), Middle East/North Africa (MENA) and Latin America (LATAM) regions.

Under the terms of the agreement, Adalvo will receive from Cosmo the exclusive right to develop, register and commercialize Rifamycin SV MMX® 200mg in these respective regions. Cosmo will be the exclusive supplier of the product. Cosmo will receive an upfront payment in addition to potential regulatory and sales milestones and customary double-digit royalties on net sales.

Rifamycin SV MMX® is an orally administered, delayed-release, non-systemic antibiotic approved for the treatment of Travelers' Diarrhea caused by certain bacteria. It works by stopping the growth of the bacteria that cause diarrhea. It is the first antibiotic engineered with Cosmo’s proprietary Multi Matrix Technology (MMX®). MMX technology is designed to deliver the active pharmaceutical ingredients in a delayed and controlled manner directly to the lower intestine.

Rifamycin SV MMX® is approved in the US and EU for the treatment of Travellers’ Diarrhea. In the US it is currently licensed to Cosmo’s partner RedHill Biopharma under the brand name Aemcolo® (containing 200 mg of rifamycin sodium, equivalent to 194 mg of rifamycin). Adalvo will take the lead in obtaining approvals for Rifamycin SV MMX® in the Asia-Pacific (APAC), Middle East/North Africa (MENA) and Latin America (LATAM) regions, as well as selected European countries, extending the reach of this innovative treatment to a broader global audience.

Alessandro Della Chà, CEO of Cosmo, said: “We are looking forward to working together with our new partner Adalvo to make Rifamycin SV MMX® 200mg available in these other regions besides the US.  Adalvo has accessed over 100 markets to date and is able to address over 95% of the global pharmaceutical market worldwide. Travellers’ Diarrhea is a very large market, and we are convinced Adalvo is the right partner to properly exploit it.”

Anil Okay, CEO of Adalvo, stated: “Adalvo is thrilled to embark on this strategic partnership with Cosmo for the distribution of Rifamycin SV MMX® 200mg in the Europe, APAC, MENA, and LATAM regions. This agreement aligns perfectly with Adalvo's commitment to bringing innovative and impactful pharmaceutical solutions to patients around the world. Our extensive global network and dedication to bringing high-quality products make us the ideal partner to introduce Rifamycin to these regions. We look forward to a successful collaboration with Cosmo in advancing healthcare outcomes for patients in need of effective solutions.”

About Adalvo
Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 100 countries and for over 110 commercial partners globally. The Company’s declared purpose is to make a difference for patients all over the world, driven by its smart collaboration network and commitment to delivering highest quality differentiated products and services to our partners.

With headquarters in Malta, the company has additional offices in more than 16 countries. At Adalvo, we know that our partners like to be bigger, better, and smarter in the dynamic pharmaceutical sector. That’s why our approach is unique, customized to our partners, and is designed to challenge the status quo: together, this helps our partners achieve their business goals. 

We take pride in our ability to help its partners reach their goals – be those increasing revenues or pushing into new markets. While partners are a high priority, Adalvo is also committed to its purpose and mission to accelerate the growth and development of employees and local communities. Adalvo tirelessly strives for excellence in all of its endeavors, driven by a deep-rooted passion to making a difference for partners. For more information, please visit www.adalvo.com.
 

About Cosmo
Cosmo is a pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders, to improve endoscopy quality measures through aiding the detection of colonic lesions and to treat selected dermatological conditions. Cosmo develops and manufactures products which are distributed globally by selected partners including Lialda®/Mezavant®/Mesavancol®, Uceris®/Cortiment®, Aemcolo® and Winlevi®. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius™ which uses artificial intelligence to help detect potential signs of colon cancer. The company also has a rich development pipeline. For additional information on Cosmo and its products, please visit www.cosmopharma.com.

Contacts:

Cosmo

Hazel Winchester

Head of Investor Relations

Tel: +353 1 817 03 70

hwinchester@cosmopharma.com

Adalvo

Gabi Cassar

VP, Human Resources & Corporate Communications

gabrielle.cassard@adalvo.com

Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.