Cosmo pharmaceuticals



  • Advancements in AI-driven Care: Cosmo Pharmaceuticals and Medtronic expanded partnership to advance AI-driven care, potentially revolutionizing healthcare delivery. This AI-driven partnership will further capitalize on the achievements already realized with the GI Genius™ intelligent endoscopy module, offering continued innovation and scalable healthcare advancements for patients and caregivers globally.
  • Debt Free: Cosmo confirmed the full redemption in cash of €175m Convertible Bonds, demonstrating financial stability and strategic planning.
  • Regulatory Milestone: Submission of Winlevi® to the European Medicines Agency (EMA) marked progress in gaining regulatory approval for this pharmaceutical product.
  • Global Licensing Agreements: Cosmo expanded Winlevi®’s reach through license agreements with Hikma in Middle Eastern and North African countries, with Glenmark in Europe and South Africa and with Hyundai Pharm in Korea,strengthening its global presence.
    Adalvo received the exclusive right to develop, register and commercialize Rifamycin SV MMX® 200MG in Europe, APAC, MENA and LATAM Regions
  • New Partnerships and Agreements: The company signed a license and supply agreement with Adalvo for Rifamycin SV MMX® 200MG in multiple regions, while terminating an agreement for the same product with Dr. Falk Pharma, showcasing strategic shifts and expansions.
  • Commercial expansion and Clinical Advancements: Cosmo announced the initiation of Phase III trials for treating Androgenetic Alopecia in males. Cortiment® approval in Japan, Winlevi® approval in Canada and territory expansion agreement for Lumeblue™ (METHYLENE BLUE MMX™) with China Medical System Holdings, demonstrating a robust clinical pipeline and global regulatory progress.


  • Winlevi® continues to be the #1 most prescribed branded topical acne product in the U.S. Commercial partnerships expanded to make Winlevi® available to more patients around the world. Announced four transactions with parties in various regions (China, Japan, Brazil, Russia, Mexico, South East Asia and selected EU countries).
  • Reported first U.S. trial results using GI Genius™ intelligent endoscopy module which showed a 50% reduction in missed colorectal polyps with artificial intelligence technology versus standard colonoscopy.  GI Genius™ was named in the prestigious Fortune 2022 ‘Change the World’ list in October 2022. Medtronic was awarded a contract to install 115 GI Genius™ modules at numerous Veteran Affairs medical facilities across the U.S.
  • Lialda® continues to grow and provide a strong foundation with a 6.5% revenue growth due to an increase in volumes in the U.S.  14% increase in product volumes supplied and 383.9 million tablets.
  • For Cortiment®, a New Drug Application (‘NDA’) for Japan (2nd largest IBD market) was submitted by Ferring and application accepted by PMDA (Pharmaceuticals and Medical Devices Agency). Commercial milestones of €9 million was received and a 14% increase in tablets supplied.
  • Eleview® distribution agreement with Medtronic expanded to include all countries except Canada, following the mutual termination of the license agreement with EA Pharma in Japan.
  • Reported successful phase III trial in China for Lumeblue™, sponsored by China Medical Systems Holdings Limited, met the primary endpoint with very high statistical significance, the proportion of patients with at least one histologically confirmed non-polypoid colorectal lesion was significantly higher in the Lumeblue™ group at 51.0% as compared with placebo at 41.2%.


  • Announced successful outcome of phase II proof of concept (POC) clinical trial of Rifamycin SV MMX® 600mg in irritable bowel syndrome with diarrhoea (IBS-D).
  • Licensed EU rights (plus Switzerland, U.K., EEA countries, Russia and Mexico) for Lumeblue® to Alfasigma S.p.A.
  • FDA approved GI Genius™, the first-to-market device that uses artificial intelligence (AI) to assist clinicians in the detection of lesions in the colon in real time during a colonoscopy.
  • DETECT study showed AI assistance using GI Genius™ reduces missed polyp rate by over 50% on initial colonoscopy.
  • Signed licence and supply agreement between Cassiopea S.p.A. and Sun Pharmaceutical Industries for Winlevi® in the U.S. and Canada.
  • Winlevi® launched by Sun Pharmaceutical Industries in the U.S. in November 2021.
  • Cosmo launched and successfully closed public exchange offer to acquire Cassiopea S.p.A.


  • ByFavo™ U.S. rights sub-licenced to Acacia Pharma Group plc (EURONEXT: ACPH) and stake acquired in Acacia.
  • Very positive results of the first investigator initiated prospective clinical study of GI Genius™ intelligent endoscopy device announced.
  • GI Genius™ approved in Australia, United Arab Emirates and Israel.
  • FDA approval of ByFavo™ for the Induction and Maintenance of Procedural Sedation obtained.
  • Italian Agenzia del Farmaco (AIFA) grants Marketing Authorization to Stadmycin™ (Rifamycin SV MMX) for the treatment of Travelers’ Diarrhea.
  • European Commission (EC) approves Methylene Blue MMX for the visualization of colorectal lesions during colonoscopies.
  • Japan’s Pharmaceuticals and Medical Devices Agency approves Eleview®.
  • License agreement with Dr. Falk Pharma Gmbh expanded to include Rifamycin SV MMX in the new 600mg formulation under development in the IBS-D indication.
  • Chinese rights for Methylene Blue MMX licenced to China Medical System Holdings Ltd.


  • Licensing agreement for Aemcolo® for the USA and share subscription agreement signed with RedHill Biopharma.
  • Revolutionary artificial intelligence product for the detection of lesions during colonoscopy unveiled and subsequent worldwide validation deal entered into with Medtronic.
  • Collaboration agreement entered into with Medtronic in the artificial intelligence field for additional applications.
  • Eleview® distribution agreement entered into with Medtronic for USA, China and South America.
  • Investigational New Drug (IND) for new chemical entity CB-03-10 for new oncologic product accepted by the FDA. 
  • ByFavo™ (remimazolam) NDA accepted by the FDA.
  • U.S. organization restructuring completed following denial of approval of Methylene Blue MMX.
  • Aemcolo® Phase II proof of concept study in IBS-D progressed.
  • Health Canada approved Eleview®.
  • Aemcolo® direct marketing strategy launched end of July 2019.
  • GI Genius™ started EU sales in July 2019 by Medtronic.


  • Aemcolo™ New Drug Application seeking marketing authorisation for the treatment of Traveler’s Diarrhoea approved by the FDA. 
  • Dr. Falk Pharma received approval via the European Decentralized Procedure for Relafalk (Rifamycin SV MMX) for the treatment of Travelers’ Diarrhoea. 
  • Aemcolo™ phase II proof of concept study in IBS-D progressed. 
  • Methylene Blue MMX NDA not approved by the FDA in current form. 
  • Eleview® gross sales in the U.S. $10.9 million vs $2.1 million in 2017. 
  • License and supply agreement entered into with Pharmascience for Eleview®, Methylene Blue MMX, Aemcolo™ and Qolotag® for the territory of Canada. 
  • Eleview® agreement with FUJIFILM Europe B.V. expanded to South East Asia, Middle East, Africa, Australia and New Zealand. 
  • License and supply agreement entered into with EA Pharma for Eleview® for the territories of Japan and South Korea. 
  • Generic of Lialda® launched in March in the U.S. 
  • Generic of Uceris® launched in July in the U.S. 
  • Cortiment® net sales by our licensee Ferring increased by 12.1% to €15.1 million. 
  • Successfully placed €175 million senior convertible bonds due 2023 raising net proceeds of €163.4 million. 


  • Methylene Blue MMX® New Drug Application (NDA) accepted by the U.S. Food and Drug Administration (FDA) with a target completion date for review of 21 May 2018. 
  • Started to build-up a U.S. sales and marketing organization putting in place the resources to commercialize our products in the U.S. 
  • Announced the successful clinical trial of Eleview® against standard of care in endoscopic mucosal resection of large sessile polyps, launched the product in the U.S. and established a U.S. co-promotion agreement for Eleview® with Olympus America Inc. Entered into distribution agreement for the product with Fujifilm for Europe and South Africa. 
  • Aemcolo™ granted both QIPD and Fast Track designations by the FDA. NDA submitted to the FDA in March 2018 seeking marketing authorization for the treatment of traveler’s diarrhea under an expedited review process in the U.S. 
  • Dr. Falk Pharma, our licensee for Europe and selected countries excluding the U.S., filed for marketing authorization of Rifafalk® 200mg (Rifamycin SV MMX® tablets). 
  • Remimazolam, a fast-acting intravenous benzodiazepine agent in-licensed by Cosmo from PAION AG, successfully concluded its U.S. phase III clinical trial in procedural sedation in patients undergoing bronchoscopy meeting the primary endpoint.
  • Rifamycin SV MMX® phase II clinical trial for a second indication for diarrhea-predominant irritable bowel syndrome (IBS-D) commenced, first patient randomized in December.
  • Private placement of 933,947 shares (315,447 treasury shares and 618,500 issued as a result of the exercise of stock options) receiving CHF 102.8 million further strengthening our financial profile. 
  • New Methylene Blue MMX® manufacturing plant completed and subsequently approved by the FDA. 


  • Clinical endpoints attained in phase III clinical trials of Methylene Blue MMX® for adenoma detection during colonoscopy.
  • Establishment of Aries Pharmaceuticals Ltd, Dublin and its subsidiary Aries Pharmaceuticals Inc, San Diego to market and distribute Eleview™, Methylene Blue MMX®, Aemcolo™ and Remimazolam in the USA.
  • Licensing in of Remimazolam for the US territory.
  • Investment of EUR 9.6 million for 9% of Paion AG, listed on Frankfurt Stock Exchange.
  • Approval of Eleview™ in EU.
  • Clinical endpoints attained in second pivotal phase III trial for Rifamycin SV MMX.
  • Cosmo Pharmaceuticals NV becomes a Dutch Company.


  • Licensing agreement with Ferring for Cortiment in Japan.
  • Spin-off of Cassiopea SpA on SIX.
  • Cosmo Pharmaceuticals becomes a Luxembourg company.


  • Shareholders approve change of seat to Luxembourg.
  • Cosmo announces excellent results in phase II for CB-03-01 acne.
  • Cosmo announces new product SIC 8000 (sub mucosal injectable composition) addressing unmet need in polyp removal.
  • Cosmo announces sale of last part of Santarus shares.


  • Cosmo announces launch of Uceris® in the US.
  • Cosmo announces approval of Cortiment® in the Netherlands.


  • Cosmo announces acceptance of NDA filing by FDA for Uceris®in February.


  • Cosmo announces filing of NDA for Uceris®(Budesonide MMX) in the USA in December.
  • Cosmo announces the additional approval of LIALDA in the U.S. for the maintenance of remission in patients with ulcerative colitis.
  • Cosmo announces filing of MAA for Cortiment®(Budesonide MMX) in the EU in May.
  • Cosmo announces very positive results of the first parts of the phase II clinical trials following the live transmission of Blu-Colonoscopy at the International Meeting for Advanced Gastroenterology Endoscopy at Humanitas Hospital in Milano.


  • Cosmo announces successful results of phase III trials for Budesonide MMX®in the EU and in the US.
  • Cosmo announces delisting of BioXell.
  • Cosmo announces final results of its tender offer for BioXell.


  • Cosmo’s CB-03-01 phase II pilot study in acne demonstrates superiority over Retin A®on 11 December.
  • Cosmo publishes the public tender offer to acquire BioXell on 8 December.


  • Strategic collaboration with Santarus for U.S rights to Budesonide MMX®and Rifamycin MMX®on 15 December.
  • Licensing agreement with Dr. Falk for Rifamycin SV MMX®.
  • Cosmo awarded US patent for use of its MMX®technology.


  • UK Market launch of Mezavant XL®by Shire plc on 05 November.
  • Licensing agreement with Ferring for Budesonide MMX®.
  • US Market launch of Lialda®by Shire plc on 19 March.
  • IPO on the Swiss Stock Exchange (SWX) on 12 March.


  • FDA approval for the manufacturing of tablets to the USA.
  • Completion of 2.000 sq m plant in Lainate, Milan.


  • Completion of first financing round of €20.4 million by Cosmo Holding S.p.A.
  • Lialda®/Mezavant®Supply Agreement with Shire plc.


  • Opening of an R&D laboratory in Catania, Italy.


  • Lialda®/Mezavant®globally out-licensed to Giuliani S.p.A./ Shire plc.


  • Filing of the first MMX®Multi Matrix technology patent for the controlled release of tablets in the gastro-intestinal tract.


  • Strategic decision to develop novel oral formulations of off-patent pharmaceutical products to generate new patentable applications.


  • Foundation of Cosmo S.p.A. by purchasing contract manufacturing unit in Lainate (Milan) from Parke Davis (now Pfizer Group).