Several subsidiaries of Bausch & Lomb have been granted rights from CROMA Pharma GmbH to co-promote and sell bromfenac ophthalmic solution in Europe when it becomes available to that market, announced Bausch & Lomb.
-Several subsidiaries of Bausch & Lomb have been granted rights from CROMA Pharma GmbH to co-promote and sell bromfenac ophthalmic solution in Europe when it becomes available to that market, announced Bausch & Lomb.
Bromfenac, a non-steroidal anti-inflammatory drug (NSAID), is designed to treat postoperative ocular inflammation and pain following cataract extraction. It has demonstrated both efficacy and safety in pivotal phase III trials and is expected to be the first ocular NSAID in Europe approved for twice-daily dosing.
CROMA, an Austrian-based health-care company, has submitted bromfenac to the European Medicines Agency (EMEA) for centralized approval throughout the European Union. Bromfenac 0.09% (Xibrom, ISTA Pharmaceticals) is approved in the United States. The drug also is approved for use in Japan with a different name and marketer (Bronuck, Senju Pharmaceutical Co. Ltd.).
“We are enthusiastic about the collaboration with CROMA, as we look forward to making bromfenac available in a large number of markets to support the unmet needs of patients and physicians alike,” said Charl van Zyl, vice president of pharmaceuticals for the Europe, Middle East, and Africa region, Bausch & Lomb.
CROMA licensed European development rights to bromfenac in November 2005 from Senju. Under the terms of this subsequent collaboration agreement and pending EMEA approval, the Bausch & Lomb subsidiaries gain the rights to sell bromfenac in all European Union member states plus Belarus, Croatia, Montenegro, Norway, Russia, Serbia, Switzerland, Turkey, and Ukraine.
CROMA will market bromfenac with Bausch & Lomb in Austria, France, Poland, Romania, and Spain. Financial terms of the agreement were not disclosed.