Cosmo's cancer diagnostic hits FDA roadblock
- The Food and Drug Administration has told Cosmo Pharmaceuticals it can't continue review of the specialty pharma's cancer diagnostic, issuing a letter stating the agency found "deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments."
- The user fee action date for Cosmo's Methylene Blue MMX, designed to help endoscopists spot pre-cancerous lesions and polyps in the colon, is May 21. In a statement, Cosmo said it expects to get further information from the FDA by this date.
- Ireland-based Cosmo said it "intends to work with the FDA to understand the nature of the deficiencies once identified and resolve them as quickly as possible."
Methylene Blue MMX was designed to deliver the dye methylene blue along the whole length of the colon to improve visualization of suspected lesions. The diagnostic uses the company's multi-matrix tablet colon-targeting delivery technology — called MMX — which releases the drug in a controlled manner. Patients take eight tablets during the colon preparation procedure.
Cosmo completed its Phase 3 trial of its formulation of methylene blue in late 2016, showing that endoscopists spotted 17.7% more patients with adenomas than with standard-of-care. Following this, the company submitted a New Drug Application for Methylene Blue MMX (then known as LuMeBlue) in July 2017, and the FDA accepted the submission in October 2017.
Peter Welford, equity analyst at Jefferies, remains positive despite the delay. "Absent specifics we are optimistic the issues could be addressed and remain confident in the result/conduct of the Phase 3 study," he wrote in a note to clients.
Welford predicts U.S. approval and EU filing by the end of 2018, and potential peak worldwide sales of $750 million.
Cosmo Pharmaceuticals plans to market Methylene Blue MMX directly to the U.S. following approval through its wholly-owned subsidiary Aries Pharmaceuticals. Aries holds the license for four of Cosmo Pharmaceuticals' gastrointestinal products, including Methylene Blue MMX. Eleview, an FDA 510(k) cleared Class ll medical device, is on the market for use in surgery for polyps, adenomas, early-stage cancers and other gastrointestinal mucosal lesions.
Aemcolo, still in development, is an MMX formulation of rifamycin for travelers' diarrhea, IBS-D and uncomplicated diverticulitis; while remimazolam is an ultra-short-acting benzodiazepine for sedation of patients undergoing colonoscopy and bronchoscopy.
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