RedHill Biopharma Announces $36 Million Strategic Investment by Cosmo Pharmaceuticals and U.S. Rights to Approved Travelers’ Diarrhea Drug AEMCOLO
The strategic collaboration includes an exclusive license agreement for the U.S. rights to Aemcolo® (rifamycin) and a simultaneous private investment by Cosmo of
Following this transaction, RedHill will maintain a debt-free balance sheet with approximately
Aemcolo® (rifamycin), containing 194mg of rifamycin as delayed-release tablets, is a minimally absorbed antibiotic that is delivered to the colon, approved by the
Under the terms of the license agreement, Cosmo granted RedHill the exclusive rights to commercialize Aemcolo® in the U.S. for Traveler’s Diarrhea and agreed to act as the exclusive supplier of Aemcolo®. The license agreement also provides for the grant to RedHill of certain rights related to the potential development of additional indications for Aemcolo®, as well arrangements related to other pipeline product candidates of Cosmo.
As part of the Aemcolo® license agreement, RedHill will issue Cosmo 1,714,286 ADSs at an agreed value of
“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
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.”
About Traveler’s Diarrhea
Travelers' Diarrhea (TD) is the most common travel-related illness, affecting an estimated 10% to 40% of travelers each year2, with approximately 70 million Americans traveling aboard of which approximately 46 million visiting developing countries3 where TD prevalence may exceed 60%4.
Aemcolo® (Rifamycin) is an orally administered, minimally absorbed antibiotic approved for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. Aemcolo® is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®) which allows for the colonic release of active ingredient. Aemcolo® is also being studied for IBS-D and uncomplicated diverticulitis.
Indication: Aemcolo® is indicated for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults.
Limitations of Use: Aemcolo® is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than non-invasive strains of Escherichia coli.
Contraindications: Aemcolo® is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo®.
Adverse Reactions: Discontinuation of Aemcolo® due to adverse reactions occurred in 1% of patients. The most frequent adverse reactions were abdominal pain (0.5%) and pyrexia (0.3%). The common adverse reactions that occurred in ~2% of Aemcolo®-treated patients in the clinical trials were constipation 3.5% and headache 3.3%. Full prescribing information for Aemcolo® is available at www.ariespharma.com.
About RedHill Biopharma Ltd.
Cosmo is a specialty pharmaceutical company that aims to become a global leader in optimized therapies for certain gastrointestinal diseases. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn’s disease, and colon infections. Cosmo’s first product is LIALDA® / MEZAVANT® that is licensed globally to
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks related to be commencement or timing of our clinical trials with RHB-104, for Crohn’s disease, RHB-204 for NTM infections RHB-102 (Bekinda®) and Yeliva® (ABC294640), risks related to the occurrence or timing of the RHB-105 (Talicia®) PDUFA action date, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully commercialize and promote Donnatal®, EnteraGam® and Mytesi®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the
1 RHB-105 (Talicia®) is an investigational new drugs, not available for commercial distribution. Talicia® is a proposed tradename and is subject to
3 Source: Cosmo Pharmaceuticals Investor Presentation
4 Steffen, Robert. "Epidemiology of traveler's diarrhea." Clinical Infectious Diseases 41.Supplement_8 (2005): S536-S540.
Adi FrishSenior VP of Business Development & Licensing RedHill Biopharma+972-54-6543-112 firstname.lastname@example.org IR contact (U.S.): Timothy McCarthy, CFA, MBA Managing Director, Relationship Manager LifeSci Advisors, LLC+1-212-915-2564 email@example.com
Source: RedHill Biopharma Ltd.