MED3000 - Novel topical treatment for erectile dysfunction
Eroxon® is the agreed brand name in certain regions such as the EU whereas MED3000 continues to be the internal code name used by Futura as well as when referring to countries where regulatory approval or commercial distribution agreements have not yet been achieved.
Click here to go to our product website eroxon.com
Click here to go to our commercial partner website www.eroxon.eu
In July 2023 Futura entered into a ground breaking licensing agreement with Haleon plc, a world leading consumer healthcare Company for the rights to exclusively commercialise the Company's innovative topical, gel-based Erectile Dysfunction treatment MED3000, in the USA.
Under the terms of the agreement Haleon will commercialise MED3000 as the first and only clinically proven gel treatment for ED, available without the need for a doctor's prescription ("OTC") in the USA, the biggest consumer healthcare market globally. Haleon will be responsible for all investment and activities related to the launch and marketing of the product in the USA. Futura will provide ongoing technical support for OTC product development and commercialisation opportunities.
Futura received an initial upfront payment of $4 million, will receive royalty payments on all sales of MED3000 by Haleon and potential commercial and performance-driven sales milestone payments totalling between $5 million and $45 million payable over the course of several years.
m8 Pharmaceuticals, Inc ("m8"), is a specialty biopharmaceutical company focused on commercialisation in Latin America.
Under the terms of the agreement Futura and m8 will work together to gain marketing authorisation and commercialise MED3000 as a clinically proven treatment for ED available OTC. The agreement was initially for Brazil and Mexico and in November 2023 M8 took up its rights to extend its licensing agreement to market MED3000 in a further fourteen countries covering the Central and South American region. The agreement remains for an initial term of 15 years.
m8 will be responsible for all costs related to the regulatory approval and marketing of the product. Futura will provide reasonable ongoing technical support for OTC product development and commercialisation. Futura will receive payments on all sales of MED3000 from m8, and up to four milestone payments totalling US$8.5 million based on cumulative sales volumes within the initial term.
Swiss-based specialty pharma Company, Labatec Pharma (“Labatec”) is focused on commercialisation in Europe and the Middle East and North Africa (“MENA”) regions, for the rights to exclusively commercialise MED3000 in the GCC region as well as Jordan, Lebanon and Iraq.
Futura is eligible to receive initial upfront payments, as well as undisclosed milestone payments based on regulatory approval. Labatec will pay an agreed price to Futura for the manufacture and supply of MED3000 by Futura’s Contract Manufacturing Organisation (“CMO”), plus royalties on all sales. Labatec is responsible for all local MED3000 development and regulatory costs as well as all launch and marketing expenses. The initial licence agreement term is for eight years with the ability to extend for successive two-year terms by mutual consent.
Menarini Korea Limited (“Menarini”) will exclusively commercialise MED3000 for the treatment of ED in South Korea. A.Menarini Korea Ltd is a wholly owned subsidiary of the Italian-based specialty pharma Company Menarini Group. Menarini Korea possesses the capability to successfully register, launch and commercialise brands in the market, with key strengths in men's health and consumer health, with local teams that have a deep understanding and experience of the South Korean market.
Futura is eligible to receive initial undisclosed upfront payments and under agreement terms, will support Menarini to gain marketing authorisation and commercialise MED3000 for ED in South Korea. Menarini will be responsible for all costs related to the regulatory approval and marketing of the product in the region including a clinical bridging study, if required. Futura will provide reasonable technical support for product development and commercialisation and provide manufactured product from Futura’s CMO at an agreed price.
Cooper Consumer Health (“Cooper”), a leading European independent self-care organisation.
Under the terms of the agreement, Cooper will commercialise MED3000 in the EEA, United Kingdom and Switzerland as a clinically proven, safe and fast-acting treatment for ED available without the need for a doctor's prescription.
Futura will receive an initial upfront payment, as well as undisclosed cumulative sales milestone payments and will manufacture and supply the product (through its CMO) for the EEA, United Kingdom and Switzerland to Cooper. The agreement is for an initial term of five years complying with EU competition law. Futura will remain Legal Manufacturer1 and be responsible for supply of MED3000 through its CMO.