Multinational agreement related to development-stage candidates and prescription Zegrid excludes U.S., Europe, Australia, Japan, and Canada.
Santarus signed over exclusive rights related to omeprazole products for $11.5 million to GlaxoSmithKline (GSK) for development and commercialization in a number of markets.
The transaction includes exclusive rights to prescription and over-the-counter immediate-release omeprazole products for countries in Africa, Asia, the Middle-East, and Central and South America. GSK also will be able to distribute and sell Zegerid®, a marketed omeprazole product, in Puerto Rico and the U.S. Virgin Islands.
Under the license agreement, GSK will be responsible for the development, manufacture, and commercialization in up to 114 countries, excluding the U.S., Europe, Australia, Japan, and Canada.
Besides the upfront payment, Santarus is also entitled to tiered double-digit royalties, subject to reduction in certain circumstances, on net sales of any products sold under the license and distribution agreements.
GSK has an option to make a buy-out payment 20 years after the effective date of the agreements. After this, GSK’s royalty obligations generally would end. To support GSK’s initial launch costs, Santarus will waive the first $2.5 million of aggregate royalties payable under the license and distribution agreements.
The term of the license agreement continues so long as GSK is obligated to pay royalties. The distribution deal is subject to GSK selling the products, unless the agreements are terminated earlier by either party.
Zegerid contains a combination of omeprazole, a proton pump inhibitor, and sodium bicarbonate, an antacid. In the U.S., Zegerid is indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, erosive esophagitis, and gastric and duodenal ulcers.