Dublin, Ireland – October 18, 2019 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has concluded a licensing agreement for Aemcolo™ for the USA and a simultaneous share subscription agreement with RedHill Biopharma (NASDAQ: RDHL, Tel-Aviv Stock Exchange: RDHL).
Aemcolo™ is Cosmo’s recently FDA approved antibiotic for the treatment of Travelers’ Diarrhea and is also in Phase II clinical trials for IBS-D.
RedHill Biopharma is focused on the development and commercialization of clinical late-stage drugs for the treatment of gastrointestinal diseases. RedHill already commercializes gastrointestinal products in the U.S. and currently has a sales force of approximately 40 sales representatives, which it plans to further expand to approximately 140 sales representatives assuming approval of its drug RHB-105 (Talicia) for the treatment of H. pylori infection. RHB-105’s PDUFA date is set for November 2, 2019.
The license agreement provides for high twenty percent royalties and potential regulatory and commercial cash milestones totalling up to USD 100m, plus a USD 12m down-payment in RedHill ADSs (American Depositary Shares listed on NASDAQ). Cosmo will be the exclusive supplier of Aemcolo™.
The share subscription agreement provides for an investment of USD 36.3m in RedHill ADSs at a price equal to the last 30-day average. Together with the ADSs received as down-payment, Cosmo will hold an overall stake in the company of 19.56% and will become the largest shareholder in RedHill. Cosmo will be entitled to appoint one board member of RedHill.
Mauro Ajani, Chairman of Cosmo, said: “This deal is another big step in the transformation of Cosmo and it is closer to our history. After the deals with Medtronic, where we partnered AI and Eleview, we have now found the right US partner for Aemcolo™. We are most pleased to become RedHill’s largest shareholder: this stake is strategic and a demonstration of trust. We look forward to contributing towards making RedHill a rousing success.”
Alessandro Della Chà, CEO of Cosmo, said: “After having received several offers, we believe we have found in RedHill the features for a long and successful collaboration: a strong and expert management team with a history of commercial success, a very interesting pipeline, a company size where our contribution could make a substantial difference and the opportunity of an equity for product deal. We are very happy to start this new partnership”.
“Cosmo is a world leader in optimized therapies for gastrointestinal diseases with a strong track record of success, expertise and commitment to changing the treatment landscape for patients”, said Dror Ben-Asher, RedHill’s CEO. “The strategic partnership with Cosmo is an important validation of RedHill’s commercial capabilities, promising late-stage pipeline and overall strategy to become a leading gastrointestinal-focused company in the US. Cosmo’s investment in RedHill ahead of the potential FDA approval and if approved by the FDA, the launch of RHB-105 (Talicia) and the addition of Aemcolo® to our GI product portfolio positions us well for the future. We are proud to have Cosmo as our partner and look forward to a successful strategic collaboration.”
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and 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 its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo is the licensee for US of the novel agent for procedural sedation, Remimazolam. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S.: Donnatal® – a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; EnteraGam® – a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools and Mytesi® – an anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. RedHill’s key clinical late-stage development programs include: (i) RHB-105 (Talicia®) for the treatment and eradication of Helicobacter pylori infection with a U.S. NDA submitted and accepted for priority review with a target PDUFA action date of November 2, 2019; (ii) RHB-104, with positive top-line results from a first Phase 3 study for Crohn’s disease; (iii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) Yeliva® (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at: www.redhillbio.com
Calendar
Credit Suisse Small & Mid Cap Conference, Zurich November 13, 2019
Jefferies Global Health Care Conference, London November 20, 2019
FY Results March 2020
Annual General Meeting May 2020
Contact:
Niall Donnelly, Chief Financial Officer & Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
ndonnelly@cosmopharma.com
Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.
This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.
This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.
This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.
This press release does not constitute an “offer of securities to the public” within the meaning of Directive 2003/71/EC of the European Union (the “Prospectus Directive”) of the securities referred to in it (the “Securities”) in any member state of the European Economic Area (the “EEA”). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.