The FDA has cleared the Company's Investigational New Drug Application, or IND, for this product candidate and Cumberland has initiated a Phase II dose escalation study to evaluate Hepatoren for the treatment of HRS. The Company has manufactured clinical supplies and filed patent applications to protect intellectual property related to the new indication. The Company has established study sites at institutions around the country and patient screening is now underway. Cumberland believes Hepatoren is an excellent strategic fit given the Company's established presence in the hospital acute care market.
The application for regulatory approval of Caldolor in Canada has been submitted by Cumberland's partner Alveda Pharma. Review of the application for approval of Caldolor in Australia submitted by our partner Phebra Pty Ltd is under review by the Australian regulatory authorities. We are also currently working to identify appropriate arrangements for the registration and commercialization of our products in other markets.
Cumberland has reached an agreement to acquire the remaining rights associated with the Kristalose brand, including the trademark and the approved FDA registration for the product. Cumberland will provide a royalty on product sales in exchange for these assets.
Cumberland Emerging Technologies, or CET, entered into a new collaboration agreement with Washington University in St. Louis to co-develop promising biopharmaceutical technologies. Washington University is a national leader in medical research and ranks among the top U.S. institutions in funding by the National Institutes of Health. This collaboration represents the fourth major university partnership for
|SOURCE Cumberland Pharmaceuticals Inc.|
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