UCB has entered into an agreement with Verus Pharmaceuticals, Inc. (Verus), a paediatric-oriented specialty pharmaceutical company, for the commercialization of Twinject in Europe.
Twinject, a novel epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis), was launched in the US and Canada in 2005; it is the first and only product approved by the FDA and Health Canada that contains two doses of epinephrine in a single, compact device for self-administration.
The agreement includes an upfront payment to Verus, along with future launch and sales milestone payments, and royalties based on sales of Twinject (0.3 mg and 0.15 mg versions) and Twinject line extensions under development by Verus. In addition, UCB has an option to commercialize the entire Twinject product line in all other territories beyond Europe (excluding the US and Canada) and an option to commercialize certain next generation products under development by Verus for the emergency treatment of anaphylaxis.
"There are significant unmet medical needs for those individuals at risk for anaphylaxis and, unfortunately, a dual-dose treatment option is not available in Europe today," said Robert W. Keith, President and Chief Operating Officer of Verus, "As a result, we are very pleased to be partnering with UCB, a company with a premier allergy franchise and significant commercial capabilities, to bring Twinject to European patients at risk for this life-threatening condition."
"The agreement with Verus allows us the opportunity to build a European leadership position in an attractive, high growth market showing strong synergies with UCB's solid allergy business," stated Bill Robinson, Executive Vice President Global Operations of UCB, "UCB will now move toward initiating the European regulatory process for this novel product for the emergency treatment of anaphylaxis."
Anaphylaxis is a severe, life-threatening systemic reaction triggered by exposure to one or more various antigens, including foods, insect stings, drugs, and latex products. Up to 43 million people in the U.S. alone are at risk for anaphylactic episodes, and underlying incidence rates are expected to continue increasing in future years. Up to eight percent of children have food allergies, with sensitivities to peanuts and tree nuts among children having doubled in the past five years. The timing, location, pattern (including onset, severity and length) and specific treatment requirements for each future episode cannot be predicted in advance. As such, all at-risk patients need to be fully prepared at all times for these unpredictable episodes.
Twinject Auto-Injector (epinephrine injection, USP 1:1000) is the only available product approved by the FDA that contains two doses of epinephrine in a single, compact device. This is an important feature, as published studies demonstrate that more than one dose of epinephrine may be required for approximately one in three patients to properly address the allergic reaction, with the second dose often needed within 5-10 minutes after the first. Furthermore, a recent study demonstrated that only 16% of patients carry two single-dose auto-injectors at all times.