RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma and Cosmo Pharmaceuticals to Expand Strategic Partnership with Exclusive Licensing Agreement and Manufacturing Agreement for Multiple Products

TEL-AVIV, Israel and RALEIGH, N.C., Aug. 13, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has entered into a binding term sheet with Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”) for 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 and will pay RedHill $7 million upon signing of the license agreement and 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 U.S. and Europe, with a cost split 70% RedHill and 30% Cosmo.

Cosmo will become the exclusive worldwide manufacturer for the novel next-generation therapy for the eradication of H. pylori infection, Movantik® (naloxegol)i, which RedHill recently acquired from AstraZeneca, and RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections. Cosmo will be paid €5.5 million for tech transfer, formulation and development work with 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.

Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “We are very pleased to expand our strategic partnership with Cosmo Pharmaceuticals. This will 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.”

Alessandro Della Chà, Cosmo’s Chief Executive Officer, 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”.

About RHB-204
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC). RHB-204 was granted QIDP designation and is eligible for an expedited development pathway and priority review, as well as a total of eight years of U.S. market exclusivity, if approved. RedHill has also submitted to the FDA an Orphan Drug Designation application for RHB-204, which, if granted, will extend U.S. market exclusivity to a total of 12 years. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.

About Movantik®
RedHill acquired the global rights, excluding Europe, Canada and Israel, to Movantik® for the treatment of opioid induced constipation from AstraZeneca in April 2020 and immediately initiated promotion in the U.S. with its expanded sales force.

Movantik® is a proprietary once-daily oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation. Movantik® is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guidelinesii and the National Comprehensive Cancer Network (NCCN) guidelines. Movantik® is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar’s oral small-molecule polymer conjugate technology. Movantik® was first approved in 2014 and launched in the U.S. by AstraZeneca and Daiichi Sankyo in 2015. Further information about Movantik® is available at: www.Movantik.com.

https://finance.yahoo.com/news/redhill-biopharma-cosmo-pharmaceuticals-expand-101000822.html

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