Dublin, Ireland - 13 August 2020: Cosmo Pharmaceuticals NV (SIX: COPN) today announced that that it has entered into a binding term sheet with RedHill Biopharma (Nasdaq: RDHL), a specialty biopharmaceutical company ("RedHill"), with respect to an exclusive licensing and manufacturing agreement for multiple products. The transaction is expected to close in the coming weeks.
Pursuant to the agreement, the companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug. Cosmo will pay RedHill $7 million upon signing of the license agreement, an additional $2 million upon approval in Europe and 30% royalties. The companies plan to jointly execute clinical trials pursuing simultaneous regulatory approvals in the US and Europe with a cost split of 70% RedHill and 30% Cosmo.
Cosmo will become the exclusive worldwide manufacturer with respect to: a) the novel next-generation therapy for the eradication of H. pylori infection; b) Movantik® (naloxegol)[i], which RedHill recently acquired from AstraZeneca, and c) RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections. Cosmo will be paid €5.5 million for tech transfer, formulation and development work in respect of these products.
Additionally, Cosmo will finance the planned pivotal Phase 3 clinical study with RHB-204, which recently received FDA clearance to proceed, with a payment of $5 million upon signing of the agreement and an additional $7 million in two milestone payments. Cosmo will be entitled to 15% royalty payments.
Alessandro Della Chà, Cosmo's CEO, said: "We are happy we have found new ways to expand our relationship with our partner RedHill and now we are eager to start working on these multiple opportunities for the benefit of both companies. With these deals we will simultaneously develop a new next-generation product for H. pylori eradication, expand our manufacturing franchise and help RedHill accelerate the clinical development of RHB-204".
Dror Ben-Asher, RedHill's CEO, said: "We are very pleased to expand our strategic partnership with Cosmo Pharmaceuticals and accelerate the planned pivotal Phase 3 study with RHB-204 in pulmonary NTM infections and the development of a next-generation H. pylori treatment. Importantly, Cosmo has a proven track record of formulating, developing and manufacturing novel therapies for multiple countries thus ensuring high quality supply."
[i] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of BYFAVO™ (Remimazolam) for the US for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com
Investora, Zurich September 23, 2020
Niall Donnelly, CFO & Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70