Cosmo announces FDA grants orphan-drug designation of rifamycin for treatment of pouchitis

Cosmo Pharmaceuticals N.V. / Key word(s): Regulatory Approval
Cosmo announces FDA grants orphan-drug designation of rifamycin for treatment of pouchitis
20.10.2022 / 06:00 GMT/BST

Dublin, Ireland – 20 October 2022. Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) announces that the FDA has granted the orphan-drug designation request of rifamycin for treatment of pouchitis.

Patients with ulcerative colitis (UC) may require removal of their colon and rectum (proctocolectomy), and the surgical creation of an ileal pouch to aid stool retention (ileal pouch-anal anastomosis or IPAA). Pouchitis is a nonspecific inflammatory condition and the most common complication of an IPAA, with a reported incidence rate between 23% and 59% in patients with UC. 

Patients with pouchitis can present with a wide range of clinical presentations, including increased stool frequency, urgency, tenesmus, incontinence, nocturnal seepage, abdominal cramping, and abdominal discomfort. Although bloody bowel movements are uncommon in typical pouchitis, patients can have iron-deficient anaemia. Patients with severe pouchitis occasionally present with fever, dehydration, and malnutrition, which may require hospitalization.

Patients with pouchitis are known to respond to off-label antibiotic therapy, although there is not yet an approved antibiotic product. Cosmo has conceived and developed a novel formulation to deliver Rifamycin SV, an antibiotic belonging to the Ansamycin family, to treat pouchitis. The granting of the Orphan Drug Designation (ODD) by the FDA is an essential step to streamline and accelerate the development of a much-needed treatment.

Alessandro Della Chà, CEO of Cosmo, said: “The grant of the ODD for Rifamycin from the FDA to treat pouchitis is another major advancement of our GI pipeline of innovative products. We will now swiftly pursue the clinical development of this new candidate”.

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 Ltd. for the US and has licensed Relafalk® to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com

Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

Contact:

Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V. 
Tel: +353 1 817 03 70
hwinchester@cosmopharma.com

End of Media Release